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Major Pharmaceutical Companies Face Surge in Generic Drug Patent Challenges in Early 2025

Oncology
  • Major pharmaceutical companies including AstraZeneca, Novartis, and Astellas are defending patents for blockbuster drugs like Lynparza, Entresto, and Xtandi against generic manufacturers in early 2025.
  • The wave of Abbreviated New Drug Application (ANDA) cases spans critical therapeutic areas including oncology, cardiovascular disease, and neurological disorders.
  • Patent litigation activity has intensified with over 100 new cases filed across multiple federal district courts, indicating significant generic competition pressure on brand-name drugs.

Bristol-Myers Squibb, Exelixis, and Novartis Advance Pan-Tumor Rollover Study for Long-Term Nivolumab Safety Assessment

Oncology
  • Bristol-Myers Squibb, Exelixis, and Novartis are collaborating on the Pan-Tumor Rollover Study to evaluate the long-term safety of nivolumab monotherapy and its combinations across various tumor types.
  • The study follows a non-randomized, parallel assignment design and began on August 9, 2019, with the latest update submitted on July 31, 2025.
  • The trial tests nivolumab either alone or in combination with other drugs like ipilimumab, cabozantinib, and relatlimab to assess safety and efficacy in different cancer types.
  • Positive results from this ongoing study could significantly boost investor confidence and market positioning for all three companies in the competitive $200 billion global oncology market.

Cue Biopharma Initiates Phase 1b Trial of CUE-102 for Recurrent Glioblastoma at Dana-Farber

Oncology
  • Cue Biopharma has dosed the first patient with CUE-102 in a Phase 1b investigator-sponsored trial for recurrent glioblastoma multiforme at Dana-Farber Cancer Institute.
  • The study evaluates CUE-102, an IL-2-based biologic targeting Wilms' Tumor 1 protein, in patients with glioblastoma at first recurrence under the leadership of Dr. David Reardon.
  • CUE-102 demonstrated favorable tolerability with no dose-limiting toxicities in previous Phase 1 trials for other WT1-expressing cancers including colorectal and pancreatic tumors.
  • Glioblastoma affects approximately 13,000 new patients annually in the US with median survival of 12-15 months and less than 5% five-year survival rate.

CUE-102 in Recurrent Glioblastoma

NCT06917885RecruitingPhase 1
David Reardon, MD
Posted 7/30/2025

A Phase 1 in Patients with HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers

NCT05360680CompletedPhase 1
Cue Biopharma
Posted 6/14/2022

KIFFIK Biomedical Strengthens Leadership with Strategic Appointments to Advance Interstitial Fluid Diagnostics

Precision MedicineOncology
  • KIFFIK Biomedical appointed Rene Veloso as Chief Investment Officer to secure capital investments for interstitial fluid real-time monitoring applications in cancer and other diseases.
  • Dr. Reginald Swift, CEO of Rubix Life Sciences, joined as fractional Chief Scientific Officer to shape clinical operations and ensure R&D activities meet highest scientific standards.
  • The company's proprietary KIFFIK EXP platform offers needle-free, real-time diagnostics for oncology and therapeutic monitoring through interstitial fluid-based biomarker detection.
  • KIFFIK previously established a strategic partnership with Rubix Life Sciences to advance next-generation ISF extraction technology using aptamer-based precision medicine approaches.

MacroGenics Names Eric Risser as New CEO, Succeeding 24-Year Leader Scott Koenig

Leadership ChangeMonoclonal AntibodyOncologyFDA Approval
  • MacroGenics appointed Eric Risser as President and CEO effective August 13, 2025, replacing Scott Koenig who led the company for 24 years.
  • Risser brings nearly 30 years of biotech experience and has generated over $1.6 billion in non-dilutive capital through corporate development efforts since joining MacroGenics in 2009.
  • The leadership transition comes as MacroGenics focuses on developing innovative monoclonal antibody-based cancer therapeutics, with three FDA-approved products already in its portfolio.
  • Risser aims to create a more focused and capital-efficient biotechnology company that delivers high-value cancer therapies to patients.

Schrödinger Discontinues Blood Cancer Drug SGR-2921 After Two Patient Deaths in Phase I Trial

Oncology
  • Schrödinger has terminated development of its CDC7 inhibitor SGR-2921 after two patient deaths in a Phase I trial for relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndromes.
  • The drug showed early evidence of monotherapy activity but was considered to have contributed to the patient deaths, making further development difficult to pursue.
  • The company's stock dropped 17.5% following the announcement, though Schrödinger maintains other oncology programs including SGR-1505 and SGR-3515.
  • The decision highlights ongoing safety challenges in blood cancer drug development, with limited therapeutic options remaining for relapsed/refractory AML patients.

Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

NCT05961839TerminatedPhase 1
Schrödinger, Inc.
Posted 9/27/2023

Lantern Pharma Reports Complete Responses in Two Cancer Trials, Advances AI-Driven Pipeline

AIOncologyPrecision Medicine
  • Lantern Pharma achieved complete responses in two separate clinical trials, with LP-300 showing complete tumor response in a 70-year-old never-smoker lung cancer patient and LP-284 demonstrating complete metabolic response in a heavily pretreated lymphoma patient.
  • The company successfully completed enrollment of 65 patients in its LP-184 Phase 1a trial and established maximum tolerated dose and recommended Phase 2 dose, positioning the drug candidate for advancement to Phase 1b/2 studies.
  • Lantern narrowed its Q2 2025 GAAP net loss to $0.40 per share from $0.46 per share in Q2 2024, while maintaining disciplined cost management with $15.9 million in cash providing runway through mid-2026.

Study of LP-184 in Patients with Advanced Solid Tumors

NCT05933265RecruitingPhase 1
Lantern Pharma Inc.
Posted 6/9/2023

Allogene Therapeutics Reports Narrowed Q2 Loss Despite Clinical Trial Delays for CAR-T Programs

CAR-TOncology
  • Allogene Therapeutics narrowed its GAAP net loss to $0.23 per share in Q2 2025, beating estimates of $0.27 per share while maintaining a strong cash position of $302.6 million.
  • The company delayed key clinical trial timelines for its lymphoma and autoimmune disease programs by approximately two quarters due to operational challenges at trial sites.
  • Over 250 patients have been consented for screening across trials, with the ALPHA3 futility analysis for cema-cel now expected in the first half of 2026.
  • The company's cash runway is projected to extend into the second half of 2027, supporting continued development of its off-the-shelf CAR-T therapy pipeline.

CIT Therapeutics Secures $2.5M Partnership with IFLI to Advance Novel SUMOylation-Targeted Cancer Therapy

CAR-TOncology
  • CIT Therapeutics has formed a strategic partnership with the Institute for Follicular Lymphoma Innovation (IFLI), securing up to $2.5 million in funding to advance its lead candidate SB-4826 into Phase I/Ib clinical trials.
  • SB-4826 is a first-in-class, orally bioavailable small molecule that selectively inhibits the SUMO E1 enzyme through an allosteric covalent mechanism, targeting SUMOylation pathways in cancer treatment.
  • The upcoming clinical trial will evaluate SB-4826 in patients with Non-Hodgkin Lymphoma, including those with relapsed or refractory follicular lymphoma.
  • This partnership represents part of IFLI's broader 2025 strategy to support multiple innovative programs, including CAR T-cell therapies and real-world data initiatives for follicular lymphoma treatment advancement.

Atossa Therapeutics Streamlines Phase II Breast Cancer Trial Design While Advancing (Z)-Endoxifen Development

Oncology
  • Atossa Therapeutics has amended its Phase II EVANGELINE study of (Z)-endoxifen for premenopausal women with ER+/HER2- breast cancer, reducing participant numbers from 214 to 40-65 to support NDA activities.
  • The I-SPY 2 trial demonstrated promising efficacy with 95% of subjects completing planned dosing and median Ki-67 levels dropping from 10.5% to 5% by week 3.
  • The company's proprietary enteric oral formulation of (Z)-endoxifen has shown favorable safety profiles across over 700 subjects with no maximum tolerated dose identified up to 360 mg/day.
  • Atossa is targeting an IND submission in Q4 2025 for metastatic breast cancer treatment while advancing multiple Phase 2 trials across different breast cancer indications.

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