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Navigating Advanced Endometrial Cancer Treatment: Expert Guidance for Community Oncologists

Oncology
  • Personalized treatment plans that consider both clinical evidence and individual patient circumstances are essential for managing advanced endometrial cancer patients undergoing immuno-oncology therapy.
  • Community oncologists face significant challenges with insurance approvals for newer therapies, particularly for immunotherapies that may be considered off-label or have prohibitive costs for patients.
  • Effective patient management requires staying updated on emerging therapies, regular assessment of treatment response, prompt management of adverse effects, and involvement of multidisciplinary teams.

Syndax Pharmaceuticals Appoints Dr. Nicholas Botwood as New R&D Head and Chief Medical Officer

OncologyMonoclonal AntibodyLeadership Change
  • Dr. Nicholas Botwood joins Syndax Pharmaceuticals from Bristol Myers Squibb, bringing 25 years of oncology drug development and commercialization experience to accelerate the company's cancer therapy pipeline.
  • The appointment comes as Syndax continues to expand its portfolio, which includes FDA-approved Revuforj (menin inhibitor) and Niktimvo (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor.
  • Dr. Botwood succeeds Dr. Neil Gallagher, who oversaw multiple positive data readouts, two product approvals, and the recent submission of Revuforj's supplemental New Drug Application for relapsed or refractory mNPM1 acute myeloid leukemia.

First U.S. Patient Successfully Treated with Advanced Proton Arc Therapy for Rare Cancer

Oncology
  • A 46-year-old patient with adenoid cystic carcinoma became the first in the U.S. to receive step-and-shoot proton arc therapy, experiencing minimal side effects despite the cancer's invasion of nerves leading to her brain.
  • The groundbreaking radiation technique delivers treatment more precisely and continuously than conventional methods, significantly reducing damage to surrounding healthy tissue and allowing the patient to maintain normal daily activities throughout treatment.
  • Researchers at Corewell Health are already developing the next generation of this technology, called DynamicARC®, which promises even more precise targeting with no lag time between radiation doses and is expected to receive FDA approval next year.

Regeneron Secures FDA Approval for BCMA-Targeted Bispecific Antibody in Multiple Myeloma

Drug ApprovalOncology
  • Regeneron has received FDA approval for its BCMA-targeted bispecific antibody therapy for multiple myeloma treatment.
  • The approval allows Regeneron to enter the competitive US market for BCMA-targeted bispecific antibodies in multiple myeloma.
  • This regulatory milestone represents a significant achievement for Regeneron after a prolonged approval process.
  • The drug joins an increasingly crowded field of BCMA-targeted therapies for multiple myeloma patients.

CAR-T Cell Therapy Funding Surges to $141.2 Billion as Industry Expands Globally

Drug ApprovalCAR-TOncology
  • The CAR-T cell therapy industry has raised over $141.2 billion through various financing mechanisms, with estimates suggesting total industry funding could reach $281.7 billion when including undisclosed deals.
  • More than 170 companies worldwide are developing CAR-T products with 1,944 therapies in development, while 13 CAR-T cell therapies have received regulatory approval globally since 2017.
  • Despite a slowdown in IPOs and M&A activity in 2024, venture capital funding remains strong with 89 CAR-T companies securing $7.7 billion since 2014, supporting advancement in both blood cancer and solid tumor applications.

Orca Bio Appoints Co-Founder Nate Fernhoff as CEO Ahead of 2025 BLA Submission for Orca-T

OncologyLeadership Change
  • Orca Bio has appointed co-founder and Chief Scientific Officer Nate Fernhoff, Ph.D., as Chief Executive Officer, succeeding Ivan Dimov, Ph.D.
  • Co-founder Jeroen Bekaert, Ph.D., has been promoted from Chief Operating Officer to President to oversee operations across all organizational areas.
  • The leadership changes come as the company prepares for a planned 2025 BLA submission to the FDA for Orca-T following positive Phase 3 results.
  • Orca Bio is accelerating investments in manufacturing infrastructure and commercial operations to support the potential launch of its allogeneic T-cell immunotherapy.

AstraZeneca Acquires EsoBiotec for $1 Billion: Revolutionary In Vivo CAR-T Technology to Transform Cancer Treatment

CAR-TOncology
• Belgian biotech EsoBiotec, founded by Congolese-born scientist Jean-Pierre Latere, has been acquired by AstraZeneca for $1 billion, including $425 million upfront and $575 million in milestone payments.
• EsoBiotec's groundbreaking Engineered NanoBody Lentiviral (ENaBL) platform enables in vivo CAR-T cell therapy, turning patients into their own cell therapy factories and potentially eliminating complex ex vivo manufacturing processes.
• The acquisition represents a remarkable success story for a capital-constrained startup that operated on just €22 million, compared to competitors who raised hundreds of millions for similar technology development.

SiVEC's BactPac Platform: Engineered Bacteria Redefining Targeted Drug Delivery for Cancer and Beyond

OncologyTargeted Therapy
  • SiVEC Biotechnologies has developed BactPac, an innovative platform using engineered non-pathogenic bacteria to both produce and deliver therapeutic biologics with precise cellular targeting capabilities.
  • The company's lead asset, SVC-KRAb, delivers circular mRNA to produce nanobodies targeting mutant RAS proteins, reducing tumor volume by over 80% in preclinical studies with clinical trials expected in Q3 2026.
  • BactPac offers significant advantages over conventional delivery systems, including targeted delivery to difficult-to-reach tissues, immune evasion enabling repeat dosing, and simplified manufacturing through bacterial fermentation processes.

CNS Pharmaceuticals Reports Berubicin Trial Results in Glioblastoma Patients

OncologyOrphan Drug
  • CNS Pharmaceuticals released topline data from a Phase II/III clinical trial evaluating Berubicin versus Lomustine in 252 patients with recurrent Glioblastoma Multiforme.
  • The trial showed Berubicin produced clinically relevant outcomes comparable to Lomustine across multiple endpoints but failed to demonstrate statistically significant improvement in overall survival, the primary endpoint.
  • Despite the mixed results, the company is evaluating potential paths forward for the program in consultation with the FDA, given the limited treatment options for glioblastoma patients.

Taiwan's Formosa Pharmaceuticals Signs Exclusive Licensing Deal with Almac Discovery for ADC Development

Monoclonal AntibodyTargeted TherapyOncology
  • Taiwan-based Formosa Pharmaceuticals has entered into an exclusive licensing agreement with Northern Ireland's Almac Discovery to develop novel antibody-drug conjugates for cancer treatment.
  • The partnership combines Formosa's antibody expertise with Almac's proprietary drug-linker technology, aiming to address unmet needs in oncology with more targeted therapeutic approaches.
  • This collaboration represents a significant expansion of Taiwan's growing presence in the global biopharmaceutical sector, particularly in the rapidly evolving ADC market.

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