Duyuru • Jun 18
Gamida Cell Ltd. Names Joe Wiley as Chief Executive Officer Gamida Cell Ltd. has named industry stalwart Dr. Joe Wiley as Chief Executive Officer. Dr. Joe Wiley founded Amryt Pharma and served as the CEO until it was acquired by Chiesi Farmaceutici in April 2023. Prior to his role at Amryt, Wiley served as the Principal at Sofinnova Ventures and Medical Director at Astellas Pharma, and he held multiple investment management roles following his work as a neurologist. Duyuru • May 25
Gamida Cell Files Form 15 Gamida Cell Ltd. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its ordinary shares under the Securities Exchange Act of 1934, as amended. The par value of the company's ordinary shares was ILS 0.01 per share. Duyuru • May 18
Gamida Cell Ltd. announced delayed 10-Q filing On 05/16/2024, Gamida Cell Ltd. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. New Risk • Mar 28
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$2.9m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (30% average weekly change). Negative equity (-US$2.9m). Earnings have declined by 14% per year over the past 5 years. Shareholders have been substantially diluted in the past year (78% increase in shares outstanding). Market cap is less than US$10m (US$7.85m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$75m net loss next year). Revenue is less than US$5m (US$1.8m revenue). Duyuru • Mar 27
Gamida Cell Ltd. announced that it expects to receive $30 million in funding from Highbridge Capital Management, LLC Gamida Cell Ltd. announced a private placement of common stock for the gross proceeds of $30 million on March 27, 2024. The transaction included participation from Highbridge Capital Management, LLC. Duyuru • Mar 23
Gamida Cell Ltd. to Report Q4, 2023 Results on Mar 27, 2024 Gamida Cell Ltd. announced that they will report Q4, 2023 results at 9:30 AM, US Eastern Standard Time on Mar 27, 2024 Duyuru • Nov 27
Gamida Cell Receives Non-Compliance Notice from Nasdaq Regarding Non-Compliance with Minimum Bid Price Requirement of Nasdaq Listing Rule 5450(a)(1) On November 20, 2023, Gamida Cell Ltd. (the ‘Company’) received a letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that because the closing bid price for the Company’s ordinary shares was below $1.00 per share for the last 30 consecutive business days, the Company did not meet the $1.00 per share minimum bid price requirement of Nasdaq Listing Rule 5450(a)(1). This notice of noncompliance had no immediate impact on the continued listing or trading of the Company’s ordinary shares on The Nasdaq Global Market, which will continue to be listed and traded on The Nasdaq Global Market, subject to the Company’s compliance with the other continued listing requirements. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until May 20, 2024 (the ‘Compliance Period’), to regain compliance with Nasdaq’s minimum bid price requirement. If at any time during the Compliance Period, the closing bid price per share of the Company’s ordinary shares is at least $1.00 for a minimum of 10 consecutive business days, Nasdaq will provide the Company with a written confirmation of compliance and the matter will be closed. If the Company does not regain compliance by the end of the Compliance Period, the Company may be eligible for an additional 180 calendar day period to regain compliance during which it may transfer to The Nasdaq Capital Market, provided that it meets the applicable market value of publicly held shares requirement for continued listing and all other applicable requirements for initial listing thereon (except for the bid price requirement) based on the Company's most recent public filings and market information and notifies Nasdaq of its intent to cure the minimum bid price deficiency. If the Company meets the applicable requirements, Nasdaq will inform the Company that it has been granted an additional 180 calendar days to regain compliance. If, however, it appears to Nasdaq that the Company will not be able to cure the minimum bid price deficiency, or if the Company is otherwise not eligible for listing on The Nasdaq Capital Market, Nasdaq could provide notice that the Company’s ordinary shares will become subject to delisting. In such event, Nasdaq rules would permit the Company to appeal the delisting determination to a Nasdaq Hearings Panel. The Company intends to actively monitor the closing bid price of its ordinary shares and will evaluate available options to regain compliance with the minimum bid price requirement. Duyuru • Nov 17
Gamida Cell Ltd. Announces Resignation of Mr. Jeremy Blank as Board of Director On November 14, 2023, Mr. Jeremy Blank submitted his resignation from the board of directors of Gamida Cell Ltd., which resignation was effective immediately. Mr. Blank's resignation was not the result of any disagreement with the Company. The Cooperation Agreement, dated as of August 11, 2023, by and among the Company, Jeremy Blank and Community Master Fund, LP, terminated pursuant to its terms upon Mr. Blank's resignation. Price Target Changed • Nov 17
Price target decreased by 43% to US$4.00 Down from US$7.00, the current price target is an average from 4 analysts. New target price is 1,150% above last closing price of US$0.32. Stock is down 82% over the past year. The company is forecast to post a net loss per share of US$0.77 next year compared to a net loss per share of US$1.24 last year. Duyuru • Nov 17
Gamida Cell Ltd. has filed a Follow-on Equity Offering in the amount of $50 million. Gamida Cell Ltd. has filed a Follow-on Equity Offering in the amount of $50 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Duyuru • Nov 05
Gamida Cell Presents New Data on Allogeneic Stem Cell Therapy Omidubicel and Natural Killer (NK) Cell Therapy Candidate GDA-201 at Society for Immunotherapy of Cancer Annual Meeting Gamida Cell Ltd. shared new data on the impact of the company’s proprietary nicotinamide (NAM) technology on its allogeneic stem cell therapy omidubicel and investigational natural killer (NK) cell therapy candidate GDA-201 at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting in San Diego, CA. Both omidubicel and GDA-201 are powered by Gamida Cell’s proprietary NAM technology, which enhances and expands cells to create potentially curative cell therapies for patients with cancer. Omidubicel was approved under the brand name Omisirge™ (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant; GDA-201 is in Phase 1 study for the treatment of non-Hodgkin lymphoma (NCT05296525). Data on the first three cohorts of the Phase 1 study of GDA-201 were recently reported. Significant myeloid and dendritic cellular enrichment of omidubicel graft suggests fast homeostatic proliferation of lymphoid populations. Highlights: In this study, immunophenotyping was used to evaluate and characterize the cellular populations in the cultured fraction (CF) and non-cultured fraction (NF) of omidubicel (manufactured with Gamida Cell’s proprietary NAM technology) compared to standard umbilical cord blood (UCB). Manufacturing significantly increased the total nucleated cells (1.2-1.6-fold) and myeloid cells (2.2-3.6-fold) in the omidubicel CF compared to UCB. In addition, high resolution analysis of the CF showed a 25-62-fold increase in myeloid populations and dendritic cells and an absence of mature lymphoid cell populations. The NF was found to contain 50-70% fewer total with a comparable percentage of T cells, B cells, NK cells and NK-T cells to UCB. The results of this phenotypic characterization of omidubicel provide a potential mechanism for the rapid engraftment and immune reconstitution observed in transplanted patients. Title: GDA-201, nicotinamide (NAM) expanded NK cells derived from peripheral apheresis, show unique culture kinetics and increased expansion. Highlights: This study evaluated the impact of Gamida Cell’s NAM technology on NK cell kinetics. During the first days of expansion, NAM increased the survival of the feeder cells (45% on day 2-3 vs 13% on day 2-3) and prolonged their support in NK cell expansion, resulting in higher fold expansion persisting up to 21 days. In addition, NK cells expanded using NAM showed significantly higher cytotoxicity against leukemia cells (from a killing cytotoxicity function of 62.54% without NAM to 81.84% with NAM), and preservation of the NK cells in a partially mature state with low expression of CD57. These data provide further evidence for the unique cell culture kinetics of NAM-NK cells, GDA-201, which is currently being evaluated in a Phase 1 clinical trial in patients with non-Hodgkin lymphoma. Duyuru • Nov 02
Gamida Cell Ltd. to Report Q3, 2023 Results on Nov 14, 2023 Gamida Cell Ltd. announced that they will report Q3, 2023 results on Nov 14, 2023 New Risk • Oct 28
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$99.8m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$81m free cash flow). Negative equity (-US$26m). Shareholders have been substantially diluted in the past year (80% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$81m net loss next year). Market cap is less than US$100m (US$99.8m market cap). Duyuru • Oct 17
Gamida Cell Ltd. Reports Preliminary Data from Phase 1 Study of Natural Killer Cell Therapy Candidate GDA-201 Gamida Cell Ltd. announced new early data in 10 patients with CD20 positive non-Hodgkin lymphoma enrolled in the first three cohorts in an ongoing multicenter Phase 1 study of natural killer (NK) cell therapy candidate GDA-201. The study is designed to evaluate safety and determine the maximum tolerated dose. Enrolled patients were heavily pretreated with a median of six prior lines of therapy, including CAR-T cell therapy (six patients) and hematopoietic stem cell transplant (four patients). Preliminary results showed marked shrinkage of target lesions in five patients; efficacy evaluation showed two patients with complete response, two with partial response, and one with stable disease. No dose-limiting toxicities were reported in the 10 patients treated with doses up to 1x108 cells/kg GDA-201 in combination with rituximab. Activity appears to be dose dependent with two of the three patients in Cohort 3 responding. The fourth and final cohort of the study, at the target dose level of 2x108 cells/kg, is currently enrolling. The 10 enrolled patients were diagnosed with diffuse large /high grade B cell lymphoma (6), marginal zone lymphoma (2), follicular lymphoma (1) and mantle cell lymphoma (1). Successive cohorts of patients received dose levels of 2.5x107 cells/kg, 5x107 cells/kg and 1x108 cells/kg of GDA-201 with rituximab after fludarabine/cyclophosphamide lymphodepletion. Two patients treated had cytokine release syndrome (grade 1 and grade 2, respectively). The most common grade 3-4 adverse event was transient neutropenia. There were no reported cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease. There was one death from progressive disease. The NK cells which comprise GDA-201 are powered by Gamida Cell’s proprietary NAM technology, which enhances and expands cells to enhance functionality and phenotype, increase metabolic fitness and reduce oxidative stress. These functional qualities were studied in detail in a recent study published in July 2023 in Science Translational Medicine, which showed that NK cells cultured with NAM had increased energy levels, enhanced ability to arrive at and invade tumors, and an ability to efficiently eradicate malignant cells in the harsh conditions of the tumor microenvironment. Additionally, the publication includes clinical data from 19 non-Hodgkin lymphoma patients who received the fresh formulation of GDA-201 in a Phase 1 study conducted at the University of Minnesota. GDA-201 exhibited a promising efficacy profile, with an overall response rate of 74% and a complete response rate of 68%. While GDA-201 cells were detected up to 14 days in patients’ blood, the median duration of response was 16 months (range: 5-36 months), suggesting that GDA-201 treatment may prime an endogenous anti-tumor immune response. New Risk • Oct 16
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 9.3% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$81m free cash flow). Negative equity (-US$26m). Shareholders have been substantially diluted in the past year (80% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$81m net loss next year). Share price has been volatile over the past 3 months (9.3% average weekly change). Duyuru • Sep 28
Gamida Cell Ltd. Announces First Patient Receives Omisirge (Omidubicel-Onlv) Gamida Cell Ltd. announced that the first patient has received a stem cell transplant with Omisirge (omidubicel-onlv). Omisirge was approved by the U.S. FDA in April 2023 for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Gamida Cell has already exceeded its 2023 launch goals, with 15 transplant centers onboarded across the United States and confirmed coverage with payers that cover 90% of commercial lives. Gamida Cell is actively engaged with more than 90% of the top 70 transplant centers, which conduct approximately 80% of transplants. An increasing number of patients are being enrolled in Gamida Cell Assist®, which signals a transplanter’s intent to use Omisirge as the donor source. Approximately 8,000 stem cell transplants are performed in the U.S. each year in patients with hematologic malignancies and another 1,700 patients are estimated to be eligible for transplant but unable to find a donor. The ability to find a donor is historically more challenging for racially and ethnically diverse populations than for patients who are white. Gamida Cell market analyses indicate that Omisirge has the ability to capture approximately 20% of allogeneic stem cell transplant market share by ~2028. Omisirge Indication: Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Important Safety Information for Omisirge. Boxed Warning: Infusion Reactions, Graft Versus Host Disease, Engraftment Syndrome, And Graft Failure: Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material. Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD. Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids. Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. Contraindications: OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products. Warnings and Precautions: Hypersensitivity Reactions: Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration. Duyuru • Sep 14
Gamida Cell Ltd., Annual General Meeting, Oct 19, 2023 Gamida Cell Ltd., Annual General Meeting, Oct 19, 2023, at 10:00 US Eastern Standard Time. Location: Cooley LLP, 55 Hudson Yards, 44th Floor, New York, New York 10001 New York United States Agenda: To consider and elect Mr. Kenneth I. Moch and Mr. Jeremy Blank, each to serve as a Class II director of the Company, and to hold office until the close of business of the annual general meeting of shareholders to be held in 2026 and until each such individual’s successor is duly elected and qualified, or until each such individual’s earlier resignation or removal; to consider and approve the re-appointment of Kost, Forer, Gabbay & Kasierer, a member firm of Ernst & Young Global, as the Company’s independent auditors for the fiscal year ending December 31, 2023 and until the next annual general meeting of shareholders to be held in 2024; to consider and approve an amendment to the Company’s compensation policy for its office holders; and to consider other business matters. Major Estimate Revision • Aug 21
Consensus EPS estimates fall by 12% The consensus outlook for earnings per share (EPS) in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$10.9m to US$9.96m. Losses expected to increase from US$0.78 per share to US$0.87. Biotechs industry in the US expected to see average net income decline 6.6% next year. Consensus price target of US$7.00 unchanged from last update. Share price fell 5.5% to US$1.21 over the past week. Duyuru • Aug 03
Gamida Cell Ltd. to Report Q2, 2023 Results on Aug 14, 2023 Gamida Cell Ltd. announced that they will report Q2, 2023 results on Aug 14, 2023 Duyuru • Jul 12
Gamida Cell Ltd. Announces Publication in Prospective Sub- Study of the Phase 3 Clinical Trial for Omisirge® Gamida Cell Ltd. announced the publication in press of a prospective sub-study of the Phase 3 clinical trial for Omisirge®? (omidubicel-onlv), the company's allogeneic stem cell transplant therapy, characterizing immune reconstitution kinetics following hematopoietic stem cell transplantation (HCT) with Omisirge compared to umbilical cord blood (UCB). The article appears online on the Transplantation and Cellular Therapy journal website. Thirty-seven patients (Omisirge: n=17, UCB: n=20) from 14 global sites were included in the sub-study and blood samples were collected from seven to 365 days post-transplantation. Omisirge was found to facilitate faster immune reconstitution, including natural killer (NK) cell and helper T (Th) cell reconstitution than UCB before day 28 post-transplantation. The early reconstitution may account for the reduced rate of viral infections observed after transplantation with Omisirge versus UCB. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration. Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests asmaculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops. Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death. Breakeven Date Change • Jun 24
Forecast to breakeven in 2025 The 5 analysts covering Gamida Cell expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 12% per year to 2024. The company is expected to make a profit of US$2.29m in 2025. Average annual earnings growth of 45% is required to achieve expected profit on schedule. Price Target Changed • May 19
Price target decreased by 11% to US$6.80 Down from US$7.60, the current price target is an average from 5 analysts. New target price is 225% above last closing price of US$2.09. Stock is down 5.0% over the past year. The company is forecast to post a net loss per share of US$0.75 next year compared to a net loss per share of US$1.24 last year. Duyuru • May 12
Gamida Cell Ltd. to Report Q1, 2023 Results on May 15, 2023 Gamida Cell Ltd. announced that they will report Q1, 2023 results on May 15, 2023 Breakeven Date Change • Apr 28
Forecast to breakeven in 2025 The 5 analysts covering Gamida Cell expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 22% per year to 2024. The company is expected to make a profit of US$25.3m in 2025. Average annual earnings growth of 56% is required to achieve expected profit on schedule. Major Estimate Revision • Apr 19
Consensus revenue estimates increase by 70% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$9.81m to US$16.7m. Forecast losses expected to reduce from -US$0.927 to -US$0.775 per share. Biotechs industry in the US expected to see average net income decline 51% next year. Consensus price target up from US$6.40 to US$8.00. Share price rose 113% to US$1.60 over the past week. Breakeven Date Change • Apr 19
Forecast to breakeven in 2025 The 4 analysts covering Gamida Cell expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 21% per year to 2024. The company is expected to make a profit of US$25.3m in 2025. Average annual earnings growth of 56% is required to achieve expected profit on schedule. Price Target Changed • Mar 28
Price target decreased by 48% to US$6.40 Down from US$12.40, the current price target is an average from 5 analysts. New target price is 739% above last closing price of US$0.76. Stock is down 82% over the past year. The company is forecast to post a net loss per share of US$0.93 next year compared to a net loss per share of US$1.06 last year. Duyuru • Feb 19
Data Presented on Gamida Cell’s Omidubicel, GDA-201 at the 2023 Tandem Meetings of ASTCT and CIBMTR Gamida Cell Ltd. announced that two oral presentations and a poster presentation highlighting Gamida Cell’s investigational product candidates, omidubicel and GDA-201, were shared at the 2023 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT), and the Center for International Blood and Marrow Transplant Research (CIBMTR). The meetings took place February 15-19 virtually and in person in Orlando, Florida. Duyuru • Dec 14
Gamida Cell Ltd. announced that it has received $25 million in funding from Highbridge Capital Management, LLC On December 12, 2022, Gamida Cell Ltd. closed the transaction. Duyuru • Nov 22
Gamida Cell Ltd. Provides Regulatory Update on Omidubicel Gamida Cell Ltd. provided an update on recent interactions with the U.S. Food and Drug Administration (FDA) relating to the company’s Biologics License Application (BLA) for omidubicel, the company’s advanced cell therapy candidate for allogeneic hematopoietic stem cell transplant. As part of its ongoing BLA review, FDA issued an information request and viewed the data in the response as a major amendment, resulting in an extension of the omidubicel Prescription Drug User Fee Act (PDUFA) date from January 30, 2023 to May 1, 2023. The agency also rescheduled Gamida Cell’s late-cycle meeting to the first quarter of 2023. The data FDA requested were laboratory results for intermediate time points for patients enrolled in the Phase 3 study. These additional data provided by Gamida Cell to FDA are consistent with prior data submissions. Price Target Changed • Nov 16
Price target decreased to US$12.60 Down from US$14.00, the current price target is an average from 5 analysts. New target price is 581% above last closing price of US$1.85. Stock is down 41% over the past year. The company is forecast to post a net loss per share of US$1.19 next year compared to a net loss per share of US$1.52 last year. Duyuru • Nov 08
Gamida Cell Ltd. Announces Encouraging Preclinical Data on GDA-501 Gamida Cell Ltd. announced encouraging preclinical data on GDA-501, a genetically modified NAM (nicotinamide) Natural Killer (NK) pre-clinical cell therapy candidate from Gamida Cell’s expanding pipeline of cell therapy candidates. The data will be presented at the Society for Immunotherapy of Cancer’s 37th Annual Meeting taking place in Boston, MA from November 10-12, 2022. NK cells have generated significant interest as potential new treatment options for patients with cancers. In pre-clinical and clinical studies, Gamida Cell’s proprietary NAM technology has demonstrated successful expansion of NK cells, enhanced functionality, increased cytotoxic activity as well as creating a protective effect against oxidative stress and improved homing to targeted blood and solid tumor cancers. The success of immune cell therapies has been limited in solid tumors due to multiple barriers, including immunosuppressive tumor microenvironment, inefficient trafficking, and heterogeneity of tumor antigens. In a poster presentation titled, “Engineered NAM-NK cells with HER2-CAR expression demonstrate increased cytotoxicity against HER2-expressing solid tumors”, GDA-501, a genetically modified HER2-CAR NAM-NK cell, displayed significantly enhanced and persistent in vitro cytotoxicity and potency when cultured with HER2+ targeted cancer cells. Cryopreserved GDA-501 significantly inhibited tumor growth of a HER2+ solid tumor model in vivo. These preclinical data demonstrate potent antitumor activity and suggest that GDA-501 represents a unique potential treatment option using an allogeneic NAM-enabled cell therapy candidate for this poor prognostic group of patients with cancers that express HER2. Recent Insider Transactions • Oct 05
Independent Chairman of the Board recently bought US$78k worth of stock On the 30th of September, Robert Blum bought around 50k shares on-market at roughly US$1.55 per share. This transaction increased Robert's direct individual holding by 25x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Robert's only on-market trade for the last 12 months. Duyuru • Aug 11
Gamida Cell Announces Dosing of First Patient in Company-Sponsored Phase 1/2 Study of NK Cell Therapy Candidate GDA-201 Gamida Cell Ltd. announces dosing of the first patient in a company-sponsored Phase 1/2 study evaluating a cryopreserved, readily available formulation of GDA-201 for the treatment of follicular and diffuse large B cell lymphomas. The Phase 1 portion of the study is a dose escalation phase, designed to evaluate the safety of GDA-201, and will include patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-celllymphoma, marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in 63 patients comprised of two cohorts of patients with either FL or DLBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant. GDA-201 leverages Gamida Cell’s proprietary NAM (nicotinamide) technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity(ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. Two-year data on outcomes and cytokine biomarkers associated with survival data demonstrated a median duration of response of 16 months (range5-36 months) and an overall survival at two years of 78% (95% CI, 51%–91%). In this study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. There were no incidents of cytokine release syndrome, neurotoxic events, graft versus host disease or marrow aplasia. Duyuru • Aug 02
Gamida Cell Announces FDA Acceptance of Biologics License Application for Omidubicel with Priority Review Gamida Cell Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Biologics License Application (BLA) for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant. Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate with breakthrough and orphan drug designations. The FDA granted Priority Review for the BLA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. The FDA grants Priority Review to product applications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. At this time, the FDA has indicated that it is not planning an advisory committee meeting as part of the BLA review. Duyuru • Jun 23
Gamida Cell Ltd., Annual General Meeting, Jul 27, 2022 Gamida Cell Ltd., Annual General Meeting, Jul 27, 2022, at 10:00 US Eastern Standard Time. Location: 12 Leshem Street Kiryat Gat Israel Agenda: To elect each of Ms. Shawn Tomasello and Mr. Stephen Wills to serve as a Class I director of the company, and to hold office until the close of business of the annual general meeting of shareholders to be held in 2025 and until their respective successors are duly elected and qualified, or until such individuals earlier resignation or retirement; to approve an amendment of the terms of office and employment of the company’s Chief Executive Officer (and a member of the Board), Dr. Julian Adams; and to consider other matters of the business. Breakeven Date Change • Jun 17
No longer forecast to breakeven The 5 analysts covering Gamida Cell no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$7.05m in 2024. New consensus forecast suggests the company will make a loss of US$10.8m in 2024. Duyuru • Jun 11
Gamida Cell Ltd. Announces Board Changes Gamida Cell Ltd. announced the appointment of Ivan M. Borrello, M.D. to its Board of Directors, effective June 9, 2022. Dr. Borrello is an Associate Professor of Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and a renowned physician and author who has made major contributions to better the understanding of immunotherapies and the treatment of hematologic malignancies as well as bone marrow transplant. He will also be joining Gamida Cell’s Science and Technology Committee. The company also announced the resignation of Ofer Gonen from its Board of Directors, effective June 9, 2022. Mr. Gonen will be joining MediWound Ltd. as chief executive officer effective June 30, 2022. Dr. Borrello’s laboratory research has focused on the development of a novel approach of adoptive T-cell therapy utilizing marrow infiltrating lymphocytes as a more tumor-specific T-cell approach. He has held multiple appointments at Johns Hopkins University, including Instructor, Immunotherapy and Hematopoiesis, Johns Hopkins Oncology Center from 1999 to 2000, and Assistant Professor, Immunotherapy and Hematopoiesis, Hematologic Malignancies, Johns Hopkins Oncology Center, from 2001 to 2008. Dr. Borrello is also the director of the myeloma program and medical director of the Cell Therapy Lab. Dr. Borrello received his medical degree from the Medical College of Virginia and completed his residency at the University of Chicago and fellowship at Johns Hopkins. Duyuru • Jun 03
Gamida Cell Completes Rolling Biologics License Application Submission to the FDA for Omidubicel Gamida Cell Ltd. announced completion of the rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant. The FDA has 60 days to determine whether the BLA for omidubicel is acceptable for filing. The omidubicel BLA is supported by the statistically significant results from Gamida Cell’s pivotal Phase 3 study, the results of which were published in Blood, the official journal of the American Society of Hematology. For the study’s primary endpoint, the median time to neutrophil engraftment in patients with hematologic malignancies undergoing allogeneic bone marrow transplant receiving omidubicel compared to standard umbilical cord blood (UCB), the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p < 0.001). In key secondary endpoints of this Phase 3 study: platelet engraftment was significantly accelerated [55% of patients randomized to omidubicel achieving platelet engraftment by day 42, compared to 35% for the comparator (p = 0.028)]; the rate of infection was significantly reduced [cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for patients randomized to omidubicel of 37%, compared to 57% for the comparator (p = 0.03)]; and hospitalization in the first 100 days after transplant was significantly reduced [median number of days alive and out of hospital for patients randomized to omidubicel of 61 days, compared to 48 days for the comparator (p = 0.005)]. Omidubicel was generally well tolerated in the Phase 3 study. Duyuru • Jun 02
Gamida Cell Announces Opening to Enrollment of Company-Sponsored Phase 1/2 Study of NK Cell Therapy Candidate GDA-201 Gamida Cell Ltd. announced the activation of the initial clinical sites to screen and enroll patients in the company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201, a readily available cell therapy candidate for the treatment of follicular and diffuse large B cell lymphomas (NCT05296525). On April 26, 2022, Gamida had announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201. GDA-201 leverages Gamida Cell’s proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. At the December 2021 Annual Meeting of American Society of Hematology, two-year follow-up data were reported on outcomes and cytokine biomarkers associated with survival. The data demonstrated a median duration of response of 16 months (range 5-36 months) and an overall survival at two years of 78% (95% CI, 51%–91%). In the IS study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma. The study of the cryopreserved formulation of GDA-201 is currently open to enrollment at Henry Ford Health (Detroit, MI) and the Masonic Cancer Center at the University of Minnesota; additional sites will be added in the coming months and updated in Clinicaltrials.gov (NCT05296525). The Phase 1 portion of the study is designed to evaluate the safety of GDA-201 in patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL), marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in two patient cohorts, FL and DLBCL/HGBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant. Duyuru • May 08
Gamida Cell Presents New Data from NAM-Enabled Genetically Modified Natural Killer (NK) Pipeline at International Society for Cell & Gene Therapy 2022 Gamida Cell Ltd. will share preclinical data at the International Society for Cell & Gene Therapy (ISCT) 2022, being held in San Francisco, CA, May 4-7, 2022 on GDA-301 and GDA-601, two product candidates in the Company’s NAM-enabled genetically modified natural killer (NK) pipeline. GDA-301 is an investigational genetically modified NAM-NK cell therapy candidate aimed at targeting hematologic malignancies and solid tumors. The poster (#501), titled “GDA-301: Engineered NAM-NK Cells via CISH Knockout and Membrane-Bound IL-15 Expression Increases Cytotoxicity Against Malignancies,” demonstrated that after six hours of co-culture with a chronic myelogenous leukemia (K562) or multiple myeloma (RPMI) cell line, GDA-301, a combined genetic manipulation of CISH gene editing and the engineered expression of mb IL-15, showed increased cytotoxicity compared with control NAM-NK cells. Additional in vitro assays showed elevation of degranulation marker CD107a, and intracellular proinflammatory cytokines interferon-? and tumor necrosis factor-a, suggesting increased potency of GDA-301 compared with control. The potency and cytotoxicity data suggest that GDA-301 represents a novel potential immunotherapeutic targeting hematologic malignancies as well as solid tumors. GDA-301 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority. GDA-601 is an investigational genetically engineered NAM-NK cell therapy candidate designed to target multiple myeloma (MM) cells. The poster (#517), titled “GDA-601: NAM-NK Cells With CD38 Knockout Expresses Enhanced CD38 Chimeric Antigen Receptor and Targets Multiple Myeloma Cells With Increased Cytotoxicity,” showed that in vitro killing assays performed six hours after co-culture of GDA-601 with a MM (RPMI) cell line showed increased cytotoxicity compared with control NAM-NK cells. Fratricide attributable to CD38 antigen was effectively eliminated with GDA-601. There was a significant enhancement of potency against CD38-positive MM cells demonstrated by elevation of the degranulation marker CD107a and intracellular proinflammatory cytokines interferon-? and tumor necrosis factor-a in vitro. These results suggest that GDA-601 displays superior antitumoral responses against MM cells and represent a promising adoptive cell therapeutic strategy against MM. GDA-601 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority. Duyuru • Apr 28
Gamida Cell Ltd. Presents Updated One-Year Post-Transplant Follow Up Data from Phase 3 Study of Omidubicel At 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings Gamida Cell Ltd. announced updated one-year post-transplant data presented on omidubicel at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022. In an oral presentation titled “Allogeneic Hematopoietic Stem Cell (allo-HSCT) Transplant with Omidubicel Demonstrates Sustained Clinical Improvement Versus Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT): Final Results of a Phase III Randomized, Multicenter Study,” Mitchell Horwitz, M.D., Professor of Medicine, Duke Cancer Institute, shared one-year post-transplant follow up data from the omidubicel Phase 3 trial. The data showed sustained clinical benefits in the first-year post-transplant with omidubicel, as demonstrated by significant reduction in infectious complications. Results also showed reduction in non-relapse mortality and no significant increase in relapse rates with omidubicel, compared to UCBT (23% vs. 18%). It was concluded that HSCT with omidubicel results in rapid hematopoietic recovery, reduced rates of infections and no increase in GvHD rates compared with standard UCB. There was a continued trend toward improved OS in favor of the omidubicel arm over time (73% vs. 60%). The overall and sustained clinical benefit of omidubicel makes it an important addition to the options for allogeneic HSCT. Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022. In total, Gamida Cell is presenting two oral and six poster presentations at TCT 2022, including an oral presentation that was selected as a TCT Best Abstract. Price Target Changed • Apr 27
Price target decreased to US$15.00 Down from US$17.86, the current price target is an average from 6 analysts. New target price is 500% above last closing price of US$2.50. Stock is down 68% over the past year. The company is forecast to post a net loss per share of US$1.23 next year compared to a net loss per share of US$1.52 last year. Duyuru • Apr 27
Gamida Cell Announces FDA Clearance of IND and Removal of Clinical Hold for NK Cell Therapy Candidate GDA-201 Gamida Cell Ltd. announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201. GDA-201 is an off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large B cell lymphomas. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022. GDA-201 leverages Gamida Cell’s proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. At the December 2021 Annual Meeting of American Society of Hematology, two-year follow-up data were reported on outcomes and cytokine biomarkers associated with survival. The data demonstrated a median duration of response of 16 months (range 5-36 months) and an overall survival at two years of 78% (95% CI, 51%–91%). In the IS study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. There was no incidents of cytokine release syndrome (CRS), neurotoxic events, GvHD or marrow aplasia. Duyuru • Apr 26
Gamida Cell Ltd. Presents Updated Omidubicel Data During Best Abstract Award Session at 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings Gamida Cell Ltd. announced that updated infection data on omidubicel in comparison to umbilical cord blood transplantation (UCB), was shared in an oral presentation at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022. The presentation, which received a TCT Best Abstract Award, titled “Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with Lower Rates of Severe Infections Compared to Standard Umbilical Cord Blood Transplantation,” was presented by Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA. The data from a sub-study of the Phase 3 randomized trial of omidubicel showed early and enhanced recovery of variety of immune cells, including circulatory dendritic cell subtypes, NK cells and CD4+ T cells within the first 28 days and sustained B-cell recovery from Day 28 onwards, and such immune recovery was associated with lower rates of severe infection. The data from an additional analyses of CD4+ subsets, T-cell receptor repertoire diversity and recent thymic emigrants support the long-term durability and functionality of the omidubicel graft. Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022. Major Estimate Revision • Mar 22
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$3.09m to US$1.55m. EPS estimate increased from -US$1.32 to -US$1.23 per share. Biotechs industry in the US expected to see average net income decline 46% next year. Consensus price target of US$15.00 unchanged from last update. Share price rose 23% to US$4.10 over the past week. Duyuru • Feb 10
Gamida Cell Initiates Rolling Submission of Biologics License Application for Omidubicel Gamida Cell Ltd. announced that it has initiated the Biologics License Application (BLA) rolling submission process with the U.S. Food and Drug Administration for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. The company remains on track to complete the BLA submission in the second quarter of 2022. Omidubicel has the potential to be the first FDA approved advanced cell therapy product for allogeneic stem cell transplant. For patients with hematologic malignancies that are deemed eligible for an allogeneic stem cell transplant, the procedure is their best chance for a potential cure. In the U.S., there are approximately 8,000 patients above the age of 12 with hematologic malignancies who undergo an allogeneic stem cell transplant each year and the company believe that number of patients may grow over time1. Unfortunately, there are approximately 1,000 patients each year, who are above the age of 12 and are deemed eligible for an allogeneic stem cell transplant but cannot find an appropriate donor. Based on its encouraging clinical data and less stringent matching criteria, omidubicel has the potential to improve outcomes for allogeneic stem cell transplant patients compared to other donor sources and expand access for patients who cannot find a suitable donor. Breakeven Date Change • Feb 03
Forecast to breakeven in 2024 The 6 analysts covering Gamida Cell expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$15.8m in 2024. Average annual earnings growth of 51% is required to achieve expected profit on schedule. Duyuru • Jan 20
Gamida Cell Provides Update on Omidubicel BLA Submission Gamida Cell Ltd. announced that following receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration yesterday, the company plans to initiate a rolling Biologics License Application submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. As previously disclosed, in late 2021 the FDA requested a revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced omidubicel for the Phase 3 study. Gamida Cell and the FDA have now reached alignment that analytical comparability has been established between the commercial manufacturing facility and the product that was manufactured for the Phase 3 study. Based on this demonstration of comparability, along with the positive clinical results of the Phase 3 study, the FDA has agreed that the initiation of a rolling BLA submission is appropriate. Additional clinical data will not be required to initiate the BLA submission. Duyuru • Dec 12
Gamida Cell Presents New Omidubicel Data at 63rd ASH Annual Meeting Gamida Cell Ltd. presented clinical updates on omidubicel in two presentations on the first day of the 63rdAmerican Society of Hematology (ASH) Annual Meeting being held in Atlanta, Georgia and virtually December 11-14, 2021. In an oral presentation titled “Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Robust Immune Reconstitution and Lower Rates of Severe Infection Compared to Standard Umbilical Cord Blood Transplantation,” Gamida Cell shared data from an analysis of a subset of 37 patients from the Phase 3 randomized trial of omidubicel. The analysis was aimed at investigating the reduced infection rates observed in the study and showed that the omidubicel-treated patients had more rapid recovery of a wide variety of immune cells including CD4+ T cells, B cells, NK cells and dendritic cell subtypes. The robust recovery of the immune system provides rationale for fewer severe bacterial, fungal and viral infections in patients treated with omidubicel. Further analyses are ongoing to further characterize the immune recovery following omidubicel transplantation. These results demonstrating rapid and functional reconstitution of the immune cells - particularly the T cell recovery which is known to lag in cord blood transplants - provides mechanistic support for the lower rates of severe infection observed in the omidubicel-treated patients. These data provide encouraging support for patients suffering from blood cancers who are particularly vulnerable to devastating infections following transplant. Executive Departure • Dec 01
Independent Director David Fox has left the company On the 24th of November, David Fox's tenure as Independent Director ended after 1.4 years in the role. We don't have any record of a personal shareholding under David's name. A total of 3 executives have left over the last 12 months. The current median tenure of the management team is 1.83 years, which is considered inexperienced in the Simply Wall St Risk Model. Price Target Changed • Nov 17
Price target decreased to US$14.57 Down from US$17.86, the current price target is an average from 7 analysts. New target price is 340% above last closing price of US$3.31. Stock is down 50% over the past year. The company is forecast to post a net loss per share of US$1.43 next year compared to a net loss per share of US$1.66 last year. Price Target Changed • Nov 03
Price target decreased to US$17.86 Down from US$19.50, the current price target is an average from 7 analysts. New target price is 309% above last closing price of US$4.37. Stock is down 19% over the past year. The company is forecast to post a net loss per share of US$1.69 next year compared to a net loss per share of US$1.66 last year. Executive Departure • Aug 19
Independent Director Nurit Benjamini has left the company On the 18th of August, Nurit Benjamini's tenure as Independent Director ended after 2.6 years in the role. We don't have any record of a personal shareholding under Nurit's name. A total of 2 executives have left over the last 12 months. The current median tenure of the management team is 1.58 years, which is considered inexperienced in the Simply Wall St Risk Model. Duyuru • Jun 24
Gamida Cell Announces Publication in Blood, the Journal of the American Society of Hematology, of the First Pivotal Trial to Evaluate a Cell Therapy (Omidubicel) for Patients with Blood Cancer who Require an Allogeneic Stem Cell Transplant Gamida Cell Ltd. announced that the results of a Phase 3 clinical study of omidubicel have been published in Blood, the official journal of the American Society of Hematology. Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant solution for patients with hematologic malignancies. The results demonstrate that transplantation with omidubicel leads to faster neutrophil and platelet recovery compared to a standard umbilical cord blood graft, and results in fewer early bacterial and viral infections and less time in the hospital. Data from this study were previously presented at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research, and most recently during the Presidential Symposium at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation. The pivotal study was an international, multi-center, randomized Phase 3 trial designed to compare the safety and efficacy of omidubicel to standard umbilical cord blood transplant in patients with high-risk hematologic malignancies undergoing a bone marrow transplant. The intent-to-treat analysis included 125 patients aged 13–65 years with a median age of 41. Forty-four percent of the patients treated on study were non-Caucasian, a population known to be underrepresented in adult bone marrow donor registries. Patient demographics and baseline characteristics were well-balanced across the two study groups. Patients with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma were enrolled at more than 30 clinical centers in the United States, Europe, Asia, and Latin America.