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Kite Acquires Interius BioTherapeutics for $350M to Advance In Vivo CAR-T Platform

CAR-TOncology
  • Kite, a Gilead Company, has entered into a definitive agreement to acquire Interius BioTherapeutics for $350 million to advance in vivo CAR-T cell therapy development.
  • Interius's innovative platform generates CAR-T cells directly within the patient's body through a single intravenous infusion, eliminating the need for preconditioning chemotherapy and complex cell processing.
  • The acquisition aims to expand access to cell therapies for patients with rapidly progressing diseases who previously could not benefit from traditional CAR-T treatments.
  • The transaction is expected to reduce Gilead's 2025 earnings per share by approximately $0.23-$0.25 and will create a center of excellence in Philadelphia for next-generation in vivo therapies.

Safety of INT2104 in Participants Aged 18 Years and Older Who Have B-cell Cancer That Came Back After Prior Treatment

NCT06539338RecruitingPhase 1
Interius BioTherapeutics Inc.
Posted 10/7/2024

Molecular Partners Appoints Martin Steegmaier as Chief Scientific Officer to Advance DARPin Therapeutics Pipeline

Oncology
  • Molecular Partners has appointed Martin Steegmaier, Ph.D. as Chief Scientific Officer effective October 1, 2025, bringing extensive oncology drug development experience from senior roles at Roche, MorphoSys, Boehringer Ingelberg, and SOTIO Biotech.
  • Steegmaier will lead the research organization and advance the company's pipeline of targeted DARPin therapeutics for cancer patients, including Radio-DARPins and Switch-DARPins for logic-gated immune cell activation.
  • The appointment strengthens Molecular Partners' leadership team as the clinical-stage biotech company continues developing its proprietary DARPin platform for medical challenges that other drug modalities cannot readily address.
  • Steegmaier previously served as CSO at SOTIO Biotech and Head of Research at MorphoSys, with particular expertise in antibody-based therapeutics in immuno-oncology and hematology-oncology.

Xoma Royalty Acquires Mural Oncology for $35.2-38.8M in Latest Biotech Liquidation Deal

Oncology
  • Xoma Royalty Corp. agreed to acquire Mural Oncology for $2.035-2.240 per share, valuing the deal at $35.2-38.8 million depending on closing cash balance.
  • The acquisition follows Mural's discontinuation of lead IL-2 therapy nemvaleukin alfa after failed Artistry-6 and 7 trials, leading to 90% workforce reduction in April.
  • Xoma will wind down Mural's operations as part of a growing trend where investment firms acquire struggling biotechs trading below cash value for liquidation.
  • The deal represents Xoma's fourth oncology acquisition this year, following purchases of Turnstone Biologics, Lava Therapeutics, and HilleVax.

NHS Approves Breakthrough Bladder Cancer Treatment That Doubles Survival Rates

Drug ApprovalOncology
  • The NHS has approved enfortumab vedotin combined with pembrolizumab for bladder cancer patients, marking one of the most significant advances in decades for this difficult-to-treat disease.
  • Clinical trials demonstrated the combination therapy nearly doubles survival time from 1.5 years to over 2.5 years compared to standard chemotherapy for metastatic bladder cancer.
  • Approximately 1,250 patients annually in England will be eligible for this treatment, which also showed superior response rates with 30% achieving undetectable cancer levels versus 12.5% with chemotherapy.
  • The dual-mechanism approach targets cancer cells directly while simultaneously boosting immune system recognition, offering patients better outcomes with fewer side effects.

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

NCT04223856Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 3/30/2020

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

NCT03924895Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 7/24/2019

Tivic Health Advances Entolimod Development with Two FDA Investigational New Drug Applications

Oncology
  • Tivic Health received two investigational new drug applications from Statera Biopharma for its lead candidate Entolimod, covering acute radiation syndrome and advanced cancer treatments.
  • The INDs enable Tivic to formally engage with the FDA regarding Entolimod's regulatory pathway and pursue clinical trials in neutropenia and lymphocyte exhaustion.
  • Entolimod is a novel TLR5 agonist that has demonstrated robust survival benefits in animal models and received Fast Track designation for acute radiation syndrome treatment.
  • The company maintains near-term focus on acute radiation syndrome while exploring Entolimod's anti-tumor activity potential in advanced cancer applications.

Invion's INV043 Receives FDA Orphan Drug Designation for Anal Cancer Treatment

OncologyRare Disease
  • Invion Limited has secured FDA Orphan Drug Designation for INV043, its lead cancer drug candidate targeting anal cancer treatment.
  • The designation provides seven years of exclusive marketing rights in the US, financial incentives including tax credits, and potential for accelerated approval pathways.
  • Preclinical data demonstrated approximately 80% tumor control in mouse models when INV043 was combined with immune checkpoint inhibitors.
  • Invion plans to conduct clinical trials in collaboration with Peter MacCallum Cancer Centre for anogenital cancers including anal, vulvar, and penile cancers.

Friends of Cancer Research Partners with MMS to Develop Framework for Interpreting Interim Overall Survival Data in Oncology Trials

Oncology
  • Friends of Cancer Research has selected MMS, a global clinical research organization, to develop practical decision frameworks for interpreting interim overall survival data in oncology clinical trials.
  • The collaboration addresses challenges in assessing long-term treatment benefit when overall survival data remain immature, particularly complications arising from treatment crossover and delayed effects.
  • MMS will utilize its KerusCloud simulation platform to model various clinical trial scenarios and develop evidence-based approaches to support more informed decision-making in cancer drug development.
  • The initiative aims to support confidence in accelerated approval processes from the FDA while maintaining patient access to innovative cancer therapies.

ORIC Pharmaceuticals Appoints Kevin Brodbeck as Chief Technical Officer Ahead of Phase 3 Trials

Oncology
  • ORIC Pharmaceuticals has appointed Kevin Brodbeck, PhD, as Chief Technical Officer to support the company's transition into late-stage clinical development.
  • The appointment reflects ORIC's preparation for potential Phase 3 trials of ORIC-944 and enozertinib starting in 2026.
  • Brodbeck brings over 25 years of experience in technical operations, CMC, and regulatory activities across pharmaceutical development and commercialization.
  • ORIC's clinical pipeline includes ORIC-944 for prostate cancer and enozertinib for multiple genetically defined cancers targeting resistance mechanisms.

FDA Issues Draft Guidance Prioritizing Overall Survival as Primary Endpoint for Cancer Drug Approvals

Drug ApprovalOncology
  • The FDA has published new draft guidance emphasizing overall survival as the preferred primary endpoint for cancer drug trials, marking a shift toward prioritizing long-term patient outcomes in the approval process.
  • The guidance comes less than two weeks after the return of CBER Head Vinay Prasad, who has previously advocated for prioritizing overall survival over surrogate endpoints in oncology drug evaluations.
  • While the new requirements may make accelerated approval more challenging, the FDA still permits this pathway for drugs with significant uncertainty in OS findings but sufficient evidence of efficacy via intermediate clinical endpoints.
  • The guidance recommends limiting crossover study designs to avoid confounding overall survival analysis, permitting them only in diseases with no or very limited therapeutic options.

Cantargia Appoints Biotech Veteran Dr. Hilde Steineger as CEO to Lead IL1RAP-Targeted Therapy Development

Monoclonal AntibodyOncology
  • Cantargia has appointed Dr. Hilde Steineger as Chief Executive Officer effective September 1, bringing extensive biotech leadership experience including a $480M deal with Novo Nordisk.
  • The appointment comes as Cantargia advances two IL1RAP-targeted product candidates in clinical trials, including nadunolimab for cancer treatment and CAN10 for autoimmune diseases.
  • Dr. Steineger will lead the company's strategic partnership with Otsuka Pharmaceuticals and build on the recent CAN10 program acquisition deal.
  • The leadership transition reflects Cantargia's maturation as a clinical-stage biotechnology company with significant pharmaceutical partnerships.

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