On December 13, 2024 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of RYTELO (imetelstat) for the treatment of adult patients with transfusion-dependent (TD) anemia due to very low, low or intermediate risk myelodysplastic syndromes (LR-MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (Press release, Geron, DEC 13, 2024, View Source [SID1234649106]). The European Commission (EC), which has the authority to approve medicines in the European Union (EU), will review the CHMP’s recommendation and is expected to make a final decision on the marketing authorization application (MAA) in the following months.

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"The positive CHMP opinion is an important step towards our goal to optimize value and patient access to RYTELO in the European Union, where we look forward to the opportunity to make this important new treatment option for LR-MDS patients available in select markets. If approved, RYTELO would be the first and only telomerase inhibitor available in Europe," said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. "We are deeply appreciative to the patients, caregivers, advocates and investigators across the EU who contributed to the clinical development of RYTELO."

As part of its review of the marketing authorization application (MAA), the CHMP looked at the results from the IMerge Phase 3 clinical trial and assessed that the benefit of RYTELO in patients with transfusion-dependent anemia due to very low, low or intermediate risk MDS is a reduction in the need for red blood cell transfusions in the first 24 weeks of treatment compared to placebo, as observed in the double-blind controlled study. The most common side effects were thrombocytopenia, leukopenia, neutropenia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased alkaline phosphatase (ALP), asthenia and headache.

If approved by the EC, RYTELO will be available as 47 mg and 188 mg lyophilized powder for reconstitution in a solution that is administered as an intravenous infusion. Treatment with RYTELO should be administered and monitored under the supervision of physicians and healthcare professionals who are experienced in hematologic diseases and their treatment.

About Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Lower-risk myelodysplastic syndromes (LR-MDS) is a blood cancer that often progresses to require increasingly intensified management of key symptoms such as anemia and resulting fatigue1 . These symptomatic LR-MDS patients frequently become red blood cell transfusion dependent, which has been shown to be associated with short- and long-term clinical consequences that reduce quality of life and shorten survival2,3 . There is a high unmet need for many LR-MDS patients, particularly those with characteristics having poorer prognosis. Current treatment options for those failing ESA are limited to select sub-populations and there is an unmet need for treatments that can provide extended and continuous red blood cell transfusion independence.

About RYTELO (imetelstat)

A marketing authorization application for RYTELO (imetelstat) is under review by the European Commission as a monotherapy treatment for adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes (MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

RYTELO is an FDA-approved oligonucleotide telomerase inhibitor for the treatment of adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration.

U.S. IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Thrombocytopenia

RYTELO can cause thrombocytopenia based on laboratory values. In the clinical trial, new or worsening Grade 3 or 4 decreased platelets occurred in 65% of patients with MDS treated with RYTELO.

Monitor patients with thrombocytopenia for bleeding. Monitor complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Administer platelet transfusions as appropriate. Delay the next cycle and resume at the same or reduced dose, or discontinue as recommended.

Neutropenia

RYTELO can cause neutropenia based on laboratory values. In the clinical trial, new or worsening Grade 3 or 4 decreased neutrophils occurred in 72% of patients with MDS treated with RYTELO.

Monitor patients with Grade 3 or 4 neutropenia for infections, including sepsis. Monitor complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Administer growth factors and anti-infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose, or discontinue as recommended.

Infusion-Related Reactions

RYTELO can cause infusion-related reactions. In the clinical trial, infusion-related reactions occurred in 8% of patients with MDS treated with RYTELO; Grade 3 or 4 infusion-related reactions occurred in 1.7%, including hypertensive crisis (0.8%). The most common infusion-related reaction was headache (4.2%). Infusion-related reactions usually occur during or shortly after the end of the infusion.

Premedicate patients at least 30 minutes prior to infusion with diphenhydramine and hydrocortisone as recommended and monitor patients for one hour following the infusion as recommended. Manage symptoms of infusion-related reactions with supportive care and infusion interruptions, decrease infusion rate, or permanently discontinue as recommended.

Embryo-Fetal Toxicity

RYTELO can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RYTELO and for 1 week after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 32% of patients who received RYTELO. Serious adverse reactions in >2% of patients included sepsis (4.2%) and fracture (3.4%), cardiac failure (2.5%), and hemorrhage (2.5%). Fatal adverse reactions occurred in 0.8% of patients who received RYTELO, including sepsis (0.8%).

Most common adverse reactions (≥10% with a difference between arms of >5% compared to placebo), including laboratory abnormalities, were decreased platelets, decreased white blood cells, decreased neutrophils, increased AST, increased alkaline phosphatase, increased ALT, fatigue, prolonged partial thromboplastin time, arthralgia/myalgia, COVID-19 infections, and headache.

Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide, available at View Source

On December 13, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), reported that the U.S. Food and Drug Administration ("FDA") has approved UNLOXCYT (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma ("cSCC") or locally advanced cSCC who are not candidates for curative surgery or curative radiation (Press release, Checkpoint Therapeutics, DEC 13, 2024, View Source [SID1234649105]). UNLOXCYT is the first and only programmed death ligand-1 ("PD-L1") blocking antibody to receive FDA marketing approval for this indication.

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The recommended commercial dosage of UNLOXCYT is 1,200 mg administered as an intravenous infusion over 60 minutes every three weeks.

"Today’s FDA approval of UNLOXCYT – the first marketing approval for our company – is a significant milestone both for Checkpoint and for patients with advanced cSCC," said James Oliviero, President and Chief Executive Officer of Checkpoint. "This approval marks Checkpoint’s transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe UNLOXCYT offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 ("PD-1"), to release the inhibitory effects of PD-L1 on the anti-tumor immune response. Additionally, UNLOXCYT has demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity ("ADCC"), another potential differentiating feature of the drug compared to existing marketed therapies for patients with cSCC."

"cSCC is the second most common form of skin cancer, and those diagnosed with advanced disease that has recurred or metastasized face a poor prognosis. cSCC remains a disease with a significant need for more effective and tolerable treatment options, particularly for patients with concomitant hematological malignancies, solid organ transplant recipients, or a history of autoimmune disorders," stated Emily Ruiz, M.D., M.P.H., Academic Director of the Mohs and Dermatologic Surgery Center at Brigham and Women’s Hospital, Director of the High-Risk Skin Cancer Clinic at Dana Farber Cancer Center, and Associate Professor of Dermatology at Harvard Medical School. "UNLOXCYT is the first FDA-approved PD-L1–blocking antibody to demonstrate clinically meaningful objective response rates with durable responses in advanced cSCC. With its dual mechanisms of action and compelling safety profile, this promising drug will provide U.S. oncologists with an important new immunotherapy option for the treatment of cSCC."

FDA approval for UNLOXCYT was granted based on clinically meaningful objective response rates and duration of response data, as assessed by an independent central review committee, from Study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label study of UNLOXCYT in adults with advanced solid tumor cancers, including cSCC.

"We are excited about the approval of UNLOXCYT and are currently developing a commercial launch plan. We want to thank the patients, physicians, nurses, and clinical coordinators for their support and participation in our clinical program, and the FDA for their collaboration throughout this process," concluded Mr. Oliviero.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma ("cSCC") is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, each year approximately 40,000 cases become advanced and an estimated 15,000 people in the United States die from this disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear. The immune-suppressed population in particular represents a challenging target in the treatment of advanced cSCC, as patients present with a more aggressive disease and with a higher risk of developing immune-related toxicities from checkpoint inhibitor treatment.

About UNLOXCYT (cosibelimab-ipdl)

UNLOXCYT is a human immunoglobulin G1 ("IgG1") monoclonal antibody that binds PD-L1 and blocks the interaction between PD-L1 and its T cell receptors, PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the anti-tumor immune response. UNLOXCYT has also been shown to induce ADCC.

INDICATION and IMPORANT SAFETY INFORMATION

INDICATION

UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma ("cSCC") or locally advanced cSCC who are not candidates for curative surgery or curative radiation.

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, and occur at any time after starting a PD-1/PD-L1–blocking antibody, including UNLOXCYT. While immune-mediated adverse reactions usually manifest during treatment, they can also manifest after discontinuation of PD-1/PD-L1–blocking antibodies. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously.
Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue UNLOXCYT depending on the severity of the adverse reaction (see Dosage and Administration in Prescribing Information). In general, if UNLOXCYT requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids.
Immune-Mediated Pneumonitis

UNLOXCYT can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 1% (3/223, Grade 2) of patients receiving UNLOXCYT.
Immune-Mediated Colitis

UNLOXCYT can cause immune-mediated colitis, which may present with diarrhea, abdominal pain, and lower gastrointestinal bleeding. Cytomegalovirus infection/reactivation has occurred in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 0.4% (1/223, Grade 1) of patients receiving UNLOXCYT.
Immune-Mediated Hepatitis

UNLOXCYT can cause immune-mediated hepatitis.
Immune-Mediated Endocrinopathies

Adrenal Insufficiency

UNLOXCYT can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity. Adrenal insufficiency occurred in 0.9% (2/223) of patients receiving UNLOXCYT, including Grade 2 in 0.4% (1/223) of patients.
Hypophysitis

UNLOXCYT can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity.
Thyroid Disorders

UNLOXCYT can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity. Hypothyroidism occurred in 10% (22/223) of patients receiving UNLOXCYT, including Grade 2 in 5% (10/223) of patients. Hyperthyroidism occurred in 5% (12/223) of patients receiving UNLOXCYT, including Grade 2 in 0.4% (1/223) of patients.
Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis

UNLOXCYT can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity.
Immune-Mediated Nephritis with Renal Dysfunction

UNLOXCYT can cause immune-mediated nephritis.
Immune-Mediated Dermatologic Adverse Reactions

UNLOXCYT can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1–blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Withhold or permanently discontinue UNLOXCYT depending on severity. Immune-mediated dermatologic adverse reactions occurred in 7% (15/223) of patients receiving UNLOXCYT, including Grade 3 in 0.9% (2/223) of patients and Grade 2 in 4% (9/223) of patients.
Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred in <1% of the 223 patients who received UNLOXCYT or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.
Cardiac/Vascular: Myocarditis, pericarditis, vasculitis.
Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy.
Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis.
Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.
Endocrine: Hypoparathyroidism.
Other (Hematologic/Immune): Autoimmune hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.
Infusion-Related Reactions

UNLOXCYT can cause severe or life-threatening infusion-related reactions. Infusion-related infusion reactions were reported in 11% (24/223) of patients, including Grade 2 in 5.8% (13/223) of patients receiving UNLOXCYT.
Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue UNLOXCYT based on severity of reaction. Consider premedication with an antipyretic and/or an antihistamine for patients who have had previous systemic reactions to infusions of therapeutic proteins.
Complications of Allogeneic HSCT

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1–blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity

Based on its mechanism of action, UNLOXCYT can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus, resulting in fetal death. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with UNLOXCYT and for 4 months after the last dose.
Common Adverse Reactions

The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.

On January 7, 2022, Century Therapeutics, Inc. (the "Company") reported to have entered into a Research, Collaboration and License Agreement (the "Collaboration Agreement") with Bristol-Myers Squibb Company ("BMS") to collaborate on the research, development and commercialization of induced pluripotent stem cell derived, engineered natural killer cell and/or gamma delta T cell programs for hematologic malignancies (Press release, Century Therapeutics, DEC 13, 2024, View Source [SID1234649104]).

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Following an internal corporate portfolio prioritization process, BMS notified the Company on December 12, 2024 that it would be terminating the Collaboration Agreement in its entirety without cause. The termination will be effective on March 12, 2025. The Company is encouraged by the scientific progress on the programs and will evaluate opportunities in acute myeloid leukemia and multiple myeloma in the context of the ongoing strategic review of Century’s pre-clinical pipeline. Both parties will work together in accordance with the termination provisions of the Collaboration Agreement.

On December 13, 2024 Oxford Vacmedix (OVM), the UK-based biopharma company developing vaccines to treat cancer, reported the finalisation of a licensing deal for its lead cancer vaccine OVM-200, with its largest shareholder Dx&Vx (Press release, Oxford Vacmedix, DEC 13, 2024, View Source;utm_medium=rss&utm_campaign=oxford-vacmedix-licenses-ovm-200-to-dxvx [SID1234649103]). The sub-license will grant Dx&Vx rights to develop and commercialise OVM-200 in South Korea, China, (including Macau, Hong Kong, and Taiwan) and India. In return OVM will receive substantial milestones and double-digit royalties on sales. Under the agreement Dx&Vx will run clinical trials in South Korea, China, and India. Also, Dx&Vx will manage all regulatory and commercial aspects of OVM-200 development. OVM will co-operate on all aspects of clinical development and have access to the clinical trial data generated.

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In anticipation of the sub-licence, the development team from Dx&Vx has recently visited Oxford for very productive discussions on development and CMC of OVM-200 for clinical trials in S. Korea, China, and India.

OVM-200 targets survivin, a protein overexpressed by cancer cells that allow unregulated growth, which stimulates an immune response. The vaccine is in a Phase 1 trial in the UK which is both the first time OVM-200 has been used in people and also the first time any ROP (Recombinant Overlapping Peptide) based vaccine has been tested in the clinic. The ongoing trial is focused on safety and on establishing an immune response in advanced cancer patients in three cancer indications: non-small-cell lung cancer (NSCLC), prostate cancer, and ovarian cancer. Initial results from Phase 1a, the dose escalation part of the trial, have shown very good safety and a strong immune response. Phase 1b for another 18-20 patients is ongoing with extended dosing approved by the UK MHRA (Medicines and Healthcare products Regulatory Agency).

William Finch, CEO of OVM, said:

We are very pleased that Dx&Vx is licensing OVM-200. This demonstrates real confidence in the technology. Our recent discussions in Oxford showed that Dx&Vx have both expertise and capability. We look forward to working closely with Dx&Vx on this programme. OVM-200 will be used both alone and in combination to help patients with advanced cancers.

Kevin Kwon, CEO of Dx&Vx, added:

We are delighted to be licensing-in OVM-200 and intend to implement Phase 1/ Phase 2a clinical trials in major Asian countries (South Korea, China, and India). We will try to launch OVM-200 through an accelerated approval that will allow patients to benefit from this novel technology as early as possible once clinical trials are completed around 2027.

On December 12, 2024 Bristol Myers Squibb ("BMS") reported to Immatics N.V. (the "Company") that, due to ongoing portfolio prioritization efforts within BMS, it has elected to terminate the collaboration agreement, dated June 1, 2022, between Celgene Switzerland LLC and Immatics US, Inc., relating to the development of allogeneic programs, and the opt-in agreement, dated April 28, 2023, between Celgene Switzerland LLC and Immatics GmbH, relating to a target under the parties’ multi-target TCR-T strategic collaboration (Press release, Immatics, DEC 12, 2024, View Source [SID1234649118]). The terminations are effective as of March 12, 2025. The Company is not obligated to refund BMS any part of the $60 million upfront payment received under the collaboration agreement or the $15 million opt-in payment received under the opt-in agreement. The Company’s collaboration with BMS under the 2019 multi-target TCR-T strategic collaboration agreement remains ongoing.

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