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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On December 12, 2024 Takeda (TSE:4502/NYSE:TAK) reported the company will host an investor R&D Day today beginning at 8:30 a.m. JST in Tokyo (Press release, Takeda, DEC 12, 2024, View Source [SID1234649098]). The meeting will focus on programs in the company’s late-stage pipeline, the transformative value they could deliver to patients, and the market opportunities they represent.

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"We are focused on advancing our innovative pipeline and accelerating late-stage programs to deliver sustainable revenue growth to 2030 and beyond, building upon the strong momentum of our Growth and Launch Products," said Christophe Weber, Takeda chief executive officer. "The first three Phase 3 programs will read out in 2025, initiating a cadence of potential filings across multiple indications over the next several years."

Eight Regulatory Filings in FY2025 – FY2029
The late-stage pipeline includes oveporexton (TAK-861), zasocitinib (TAK-279), rusfertide (TAK-121), mezagitamab (TAK-079), fazirsiran (TAK-999) and elritercept (TAK-226). Combined these programs have potential peak revenue1 of $10B – $20B. Data from three Phase 3 programs is expected to read out in 2025:

oveporexton, a potential best-in-class and first-in-class investigational oral orexin receptor 2 agonist will report Phase 3 results in narcolepsy type 1;
zasocitinib, an investigational next-generation, highly selective and potent oral allosteric tyrosine kinase 2 (TYK2) inhibitor will deliver Phase 3 results in psoriasis; and
rusfertide, an investigational injectable hepcidin mimetic in development with partner Protagonist Therapeutics, will have Phase 3 results in polycythemia vera.
Filings for these three indications are expected in fiscal years 2025 and 2026. Five additional indication filings for late-stage programs are on pace for fiscal years 2027 through 2029:

zasocitinib in psoriatic arthritis;
mezagitamab, an investigational anti-CD38 antibody providing rapid, selective and sustained depletion of disease-causing immune cells that could set a new standard for the treatment of immune thrombocytopenia (ITP) and immunoglobulin A neuropathy (IgAN);
fazirsiran, an investigational RNA interference (RNAi) therapy that stops the production of misfolded abnormal protein Z-AAT directly addressing the pathology of alpha-1 antitrypsin deficiency liver disease (AATD-LD) and;
elritercept, an investigational activin inhibitor designed to treat anemia associated with certain hematologic cancers, including myelodysplastic syndromes (MDS). Takeda recently signed an exclusive licensing agreement with Keros Therapeutics to further develop, manufacture and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau. The agreement is subject to customary closing conditions, including completion of antitrust reviews.
"Takeda has established an exciting, late-stage pipeline of transformative therapies that we believe will deliver value to our company and, most importantly, to the patients we serve around the world," said Andy Plump, president of R&D at Takeda. "As we continue scaling our capabilities and maximizing R&D investment to deliver the late-stage pipeline, we are also progressing an exciting early-stage pipeline, supporting a cutting-edge research organization, and focusing on creative business development across our therapeutic areas to sustain Takeda’s future and continue to meet significant unmet patient needs."

2024 R&D Day Agenda
The meeting includes the following presentations and speakers:

A Global, Innovation-Driven Biopharmaceutical Company
Christophe Weber, President & CEO

R&D Strategy and Pipeline Highlights
Andy Plump, President, Research and Development

Neuroscience: Deep-Dive on Orexin Franchise
Sarah Sheikh, Head of Neuroscience Therapeutic Area Unit and Head of Global Development
Ramona Sequeira, President of Global Portfolio Division

Gastrointestinal and Inflammation: Deep-Dive on Zasocitinib, Rusfertide, Mezagitamab, Fazirsiran
Chinwe Ukomadu, Head of Gastrointestinal and Inflammation Therapeutic Area Unit
Ramona Sequeira, President of Global Portfolio Division

Oncology: Deep-Dive on Elritercept – Newly Announced Business Development Deal
Teresa Bitetti, President Global Oncology Business Unit
P.K. Morrow, Head of Oncology Therapeutic Area Unit

Webcast Details
A live webcast of the meeting begins at 8:30 a.m. JST December 13 (6:30 p.m. EST December 12). Presentations are available on the Investor Relations section of Takeda’s website where a video replay will be available following the meeting.

On December 12, 2024 PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter "PeptiDream") (Tokyo:4587) reported its second wholly-owned peptide radiopharmaceutical development candidate arising from the company’s ongoing internal peptide radiopharmaceutical discovery and development efforts (Press release, PeptiDream, DEC 12, 2024, View Source [SID1234649097]). The development candidate ("PD-29875") is a novel first-in-class highly-selective macrocyclic peptide-radioisotope (RI) conjugate against Claudin 18.2 ("CLDN18.2"), a member of the claudin family of proteins that are integral components of tight junctions found in epithelial tissues. CLDN18.2 is expressed in a variety of solid tumors, including gastric cancer, pancreatic cancer, biliary cancer, genitourinary tract cancers, and colorectal cancer, and others.

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PD-29875 was discovered using PeptiDream’s proprietary PDPS technology and further optimized at PeptiDream with in vivo imaging and efficacy studies conducted at PDRadiopharma, our wholly owned subsidiary. PeptiDream has initiated IND-enabling studies of PD-29875 and intends to initially develop the therapeutic (225Ac-PD-29875) and paired diagnostic imaging agent (64Cu-PD-29875) for the diagnosis and treatment of gastric cancer. The paired diagnostic imaging agent, which consists of the same peptide and chelator as the therapeutic, will enable us to screen and identify patients, both in clinical trials and in clinical practice, who have CLDN18.2 expressing tumors that are most likely to have a favorable clinical response from PD-29875 treatment. PeptiDream is additionally planning to initiate human Ph0 imaging studies of 64Cu-PD-29875 in 2025, prior to the start of a Phase 1 study.

Gastric cancer is the 5th most common cancer in and the 4th leading cause of cancer death worldwide in 2020, representing 7% of all global cancer diagnoses, with an approximate 5-year survival rate of 32% (worldwide an estimated 1.1 million people were diagnosed with gastric cancer in 2020, with 770,000 deaths), with the incidence expected to increase to ~1.8 million new cases per year by 2040.

"We are extremely excited to announce our second internal peptide-RI clinical development candidate, PD-29875, targeting CLDN18.2 for the potential diagnosis and treatment of gastric cancer, which has a high unmet medical need." said Patrick C. Reid PhD, President & CEO of PeptiDream. "We are preparing to potentially take PD-29875 into human imaging studies in 2025, before bringing the therapeutic and paired diagnostic into clinical development. Our PDPS platform continues to prove extremely effective in discovering novel macrocyclic peptides for the targeted delivery of conjugated radionuclide payloads to tumors, and PeptiDream is focused on creating a robust pipeline of peptide-RI conjugate therapies for the diagnosis and treatment of cancer, both internally and through our collaboration partners."