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."

On December 12, 2024 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL siRNA gene silencing technology designed to make the body’s immune cells more effective in killing cancer cells reported its manuscript, Self-delivering RNAi Immunotherapeutic PH-762 Silences PD-1 to Generate Local and Abscopal Anti-tumor Efficacy, has been published in the December, 2024 issue of Frontiers in Immunology (Press release, Phio Pharmaceuticals, DEC 12, 2024, View Source [SID1234649082]).

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The article presents preclinical proof-of-concept data for PH-762, an INTASYL compound designed to silence PD-1, is currently in clinical development for advanced cutaneous malignancies. Phio recently presented data from its second cohort in its on-going Phase 1b clinical trial showing one patient with cutaneous squamous cell carcinoma in the 2nd cohort achieved a complete response (100% tumor clearance) while a second patient with squamous cell carcinoma achieved a partial response (90% tumor clearance).

Frontiers in Immunology is dedicated to propelling advancements in the field of Immunology. The Editor-in-Chief is Luigi Daniele Notarangelo, Director of the Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIH), and Senior Researcher at Boston Children’s Hospital, Harvard Medical School.

"We are delighted to see this publication which presents a comprehensive summary of INTASYL’s uniqueness addressing its selective gene targeting, potent silencing, and is a promising candidate for treatment of solid tumors," said Robert Bitterman, CEO, Phio Pharmaceuticals.

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 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 Alessa Therapeutics, Inc., a clinical-stage drug development company pioneering an innovative and proprietary localized drug delivery technology for the early interception of cancer and other diseases, reported the closing of a $15M seed financing led by Mission BioCapital joined by Johnson & Johnson (through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc. (JJDC)., and a representative of JJDC will join the Board of Directors at Alessa Therapeutics Inc (Press release, Alessa Therapeutics, DEC 12, 2024, View Source [SID1234649066]).

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"We are appreciative of the support provided by this syndicate of leading life science industry investors," said Pamela Munster, M.D., Founder & Chief Executive Officer of Alessa. "Alessa is well positioned to advance our pipeline and leverage our platform of tissue-targeted drug delivery for the treatment of prostate cancer and other solid organ diseases. This funding enables us to pursue our mission and bring new medicines to patients who desperately need more effective treatments."

Alessa will use the funds to advance development of its lead program, Enolen, a novel enzalutamide-eluting seed implant for the treatment of localized prostate cancer. Alessa recently announced the start of a first-in-human trial with Enolen in collaboration with the NCI, and the company anticipates initial data to read out next year. Alessa’s Enolen program builds on the company’s successful proof of concept for the approach with Biolen, which were presented at the 39th Annual EAU Congress (EAU24, April 2024) in Paris, France and at the AUA Annual Meeting (May 2024) in San Antonio, TX.

Prostate cancer is the most common cancer among men in the United States. According to the American Cancer Society, an estimated 299,010 men will be diagnosed with prostate cancer in 2024 in the United States alone. Patients with low-risk prostate cancer face difficult treatment decisions today between potentially invasive surgical and ablative procedures or active surveillance. While many efficacious therapeutics have been developed for regional and metastatic disease, to date, they have failed to move forward to patients with localized low-risk disease given their adverse-event profiles. Alessa’s proprietary localized drug-delivering implants are designed for sustained release of an anti-androgen selectively to the prostate thus limiting systemic side effects despite providing therapeutic concentrations in the prostate.