Achilles Therapeutics sells technology assets to AstraZeneca
- Achilles Therapeutics has transferred the commercial license of data and samples from the TRACERx NSCLC study to AstraZeneca.
- AstraZeneca will also take over as sponsor of Achilles’ Material Acquisition Platform (MAP), receiving tumor samples and data collected so far.
- The transaction is valued at $12 million, marking the conclusion of Achilles’ strategic review.
- Achilles plans further organizational changes, including reducing employee headcount and board size.
Read more
Datopotamab deruxtecan application in the EU for patients with advanced nonsquamous non-small cell lung cancer voluntarily withdrawn
- Daiichi Sankyo and AstraZeneca have withdrawn the EU marketing application for datopotamab deruxtecan for advanced nonsquamous NSCLC.
- The decision followed feedback from the EMA's Committee for Medicinal Products for Human Use.
- The TROPION-Lung01 phase 3 trial evaluated datopotamab deruxtecan versus docetaxel in patients with advanced NSCLC.
- Daiichi Sankyo and AstraZeneca continue to pursue other regulatory submissions and trials for datopotamab deruxtecan.
Read more
Research may help patients overcome resistance to CAR T cell therapy
- City of Hope researchers developed a dual vector system to enhance CAR T cell therapy.
- The new method allows T cells to target up to four antigens simultaneously.
- This approach also uses switch receptors to reduce T cell exhaustion.
- The technique, tested in mouse models, shows promise for clinical translation.
Read more
Preliminary results of Qilu Pharmaceutical's phase Ia study on GPRC5D/CD3-targeting bispecific antibody QLS32015
- Preliminary results from Qilu Pharmaceutical's phase Ia study on QLS32015 were presented at the 2024 ASH Annual Meeting.
- QLS32015 is a bispecific antibody targeting GPRC5D and CD3, designed to treat relapsed/refractory multiple myeloma (RRMM).
- The study is an open-label, dose-escalation/expansion trial assessing safety and preliminary efficacy in RRMM patients.
- As of August 31, 2024, 13 patients were enrolled, with an objective response rate of 76.9% and a tolerable safety profile.
Read more
Viracta Therapeutics closes NAVAL-1 trial and explores strategic alternatives
- Viracta Therapeutics has closed its Phase 2 NAVAL-1 trial for relapsed/refractory EBV+ lymphomas.
- The closure is part of a strategy to conserve resources while exploring strategic alternatives.
- Potential alternatives include mergers, licensing agreements, or sales.
- No new safety concerns prompted the trial's closure.
Read more
Oncology in focus: how emerging therapies are reshaping cancer treatment
- Immunotherapy advancements include a bioengineered platform boosting immune responses and an mRNA-based therapy targeting cancer cells.
- Oncolytics Biotech highlights promising data from the BRACELET-1 breast cancer study, showing significant survival benefits.
- Erasca's SEACRAFT-1 trial data supports ongoing Phase 3 SEACRAFT-2 trial for NRAS-mutated melanoma.
- Allogene's ALLO-316 shows a 50% overall response rate in renal cell carcinoma, supporting FDA's RMAT designation.
Read more
FDA approves Opdivo Qvantig for subcutaneous use in solid tumors
- The FDA approved Opdivo Qvantig, a subcutaneous injection of nivolumab and hyaluronidase, for use in most previously approved adult solid tumor indications.
- Approval was based on the Phase 3 CheckMate-67T trial, which showed non-inferior pharmacokinetic exposures and similar efficacy to intravenous Opdivo.
- Opdivo Qvantig offers a faster administration time of three to five minutes, compared to the 30-minute intravenous infusion.
- The subcutaneous administration may provide flexibility for patients to receive treatment closer to home.
Read more
Tevimbra approved in U.S. for first-line treatment of gastric and gastroesophageal junction cancers
- The FDA has approved Tevimbra (tislelizumab-jsgr) in combination with chemotherapy for first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults with PD-L1 positive tumors.
- Approval is based on the RATIONALE-305 Phase 3 trial, which showed a significant overall survival benefit with a median OS of 15.0 months compared to 12.9 months for placebo.
- Common Grade 3 or 4 adverse reactions include neutropenia, thrombocytopenia, anemia, and fatigue.
- Tevimbra is also under FDA review for first-line treatment of locally advanced unresectable or metastatic esophageal squamous cell carcinoma.
Read more
Vincerx Pharma announces strategic merger with Oqory, Inc.
- Vincerx Pharma has entered a binding term sheet for a merger with Oqory, Inc., a clinical-stage company developing ADCs.
- Post-merger, Oqory equity holders will own 95% of the combined entity, with Vincerx holders owning 5%.
- The merger includes a $20 million equity offering and interim financing of $1.5 million from Oqory investors.
- The merger is subject to regulatory approvals, due diligence, and stockholder approval from both companies.
Read more
Exicure partners with GPCR Therapeutics to fuel new growth in biotech
- Exicure signed an MOU with GPCR Therapeutics to acquire GPCR USA and collaborate on drug development.
- The acquisition includes technology transfer for GPCR Therapeutics’ CXCR4 inhibitor, currently in Phase 2 trials.
- Exicure plans to invest $14 million for the acquisition and ongoing operations.
- GPCR Therapeutics is conducting Phase 2 trials for multiple myeloma and preparing for AML studies.
Read more
Citius Oncology reports fiscal full year 2024 financial results and business update
- Achieved FDA approval for LYMPHIR, an immunotherapy for relapsed or refractory cutaneous T-cell lymphoma.
- Began trading on Nasdaq under the ticker CTOR following a merger, enhancing capital access.
- Advanced preparations for LYMPHIR's commercial launch, including manufacturing and marketing efforts.
- Supported trials exploring LYMPHIR's potential as a combination therapy, showing promising interim results.
Read more
IDEAYA Biosciences licenses SHR-4849 from Hengrui Pharma for SCLC and NET tumors
- IDEAYA Biosciences has secured an exclusive global license (excluding Greater China) for SHR-4849, a Phase 1 DLL3-targeting ADC.
- SHR-4849 shows promising antitumor activity in SCLC and NETs, with a 73% response rate in a Phase 1 trial.
- IDEAYA plans to file a US IND for SHR-4849 in the first half of 2025.
- Hengrui Pharma will receive up to $1.045 billion in payments, including a $75 million upfront fee.
Read more
Telix files BLA for TLX250-CDx in kidney cancer imaging
- Telix Pharmaceuticals has submitted a Biologics License Application (BLA) to the FDA for TLX250-CDx, a PET agent for diagnosing clear cell renal cell carcinoma (ccRCC).
- TLX250-CDx aims to be the first targeted PET agent for kidney cancer in the U.S., with a potential commercial launch in 2025.
- The pivotal Phase III ZIRCON trial showed 86% sensitivity and 87% specificity in detecting ccRCC.
- The FDA will provide a PDUFA goal date after a 60-day review, and the product may qualify for priority review due to its Breakthrough designation.
Read more
European Commission approves amivantamab and lazertinib for EGFR-mutated NSCLC
- The European Commission approved amivantamab and lazertinib for first-line treatment of EGFR-mutated advanced NSCLC.
- The approval is based on the Phase 3 MARIPOSA study, showing a 30% reduction in disease progression risk compared to osimertinib.
- The combination demonstrated a median progression-free survival of 23.7 months versus 16.6 months for osimertinib.
- A decision on marketing authorization for lazertinib is pending following a positive CHMP opinion.
Read more
