Merck provides update on phase 3 KEYNOTE-867 and KEYNOTE-630 trials
- Merck is discontinuing the Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA in combination with SBRT for stage I or II NSCLC due to lack of improvement in event-free survival (EFS) or overall survival (OS).
- The decision follows a recommendation from an independent Data Monitoring Committee (DMC) after a planned interim analysis showed no significant benefit and higher adverse events.
- Merck is also discontinuing the Phase 3 KEYNOTE-630 trial evaluating KEYTRUDA for high-risk locally advanced cSCC post-surgery and radiation, based on DMC's recommendation for futility.
- Data analyses for both trials are ongoing, and results will be shared with the scientific community and regulatory agencies.
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CancerVax taps Flashpoint Therapeutics’ nanotechnology platform to drive universal cancer treatment
- CancerVax has entered into a research agreement with Flashpoint Therapeutics.
- The collaboration aims to develop CancerVax’s Universal Cancer Treatment platform using Flashpoint’s structural nanomedicine technology.
- CancerVax’s platform is designed to detect, mark, and kill cancer cells by making them appear like common diseases to the immune system.
- Flashpoint’s technology will help deliver Smart mRNA payloads efficiently and accurately.
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Innovent to present clinical data of multiple novel molecules at WCLC and ESMO 2024
- Innovent Biologics will present nearly 20 clinical data sets at WCLC and ESMO 2024.
- Key presentations include updated Phase 1 and Phase 2 results for IBI363, Dupert, and IBI354.
- Presentations will cover various cancers including NSCLC, colorectal cancer, and HER2+ solid tumors.
- Innovent aims to showcase the efficacy and safety of its innovative bispecific antibodies and ADC molecules.
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Vaxart publishes preclinical data on mucosal vaccine for HPV-related cervical dysplasia
- Vaxart's HPV vaccine constructs stimulate specific T cell immune responses, reduce tumor size, and increase survival in an animal model.
- The mucosal vaccine platform shows promise for a non-invasive treatment for HPV-related cervical dysplasia.
- Preclinical data indicate that the vaccine generates a specific T cell response to HPV16 E6 and E7 proteins.
- Concurrent administration of anti-PD-1 with vaccination further increased survival in animal models.
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Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan
- Biocon Biologics has signed a settlement and license agreement with Janssen to commercialize Bmab 1200, a proposed biosimilar to Stelara.
- The agreement resolves patent disputes, allowing market entry in Europe, the UK, Canada, and Japan.
- Regulatory filings in these markets are currently under review.
- Bmab 1200 is also set for a U.S. launch no later than February 22, 2025, pending FDA approval.
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Reimagine Care and Memorial Hermann Health System unveil expanded on-demand cancer care partnership
- Reimagine Care and Memorial Hermann Health System announce a multi-year expansion of their partnership.
- The first phase showed enhanced patient satisfaction, strong clinical outcomes, and improved well-being for physicians and nurses.
- Key achievements include 98% patient engagement at Day 30, a Net Promoter Score of +86, and 87% independent symptom resolution.
- The next phase will expand services to more patients and physicians across the Greater Houston area.
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Repare Therapeutics announces strategic reprioritization to focus on broad clinical portfolio
- Repare Therapeutics is streamlining operations to focus on advancing its clinical-stage oncology programs.
- The company will reduce its workforce by approximately 25%, primarily affecting the preclinical group.
- Repare expects to report data from the MYTHIC dose expansion trial of lunresertib and camonsertib in Q4 2024, with a potential registrational trial in 2025.
- The strategic shift aims to extend the company's cash runway into the second half of 2026.
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Medigene AG secures two additional patents for technologies in its end-to-end platform
- Medigene AG has been issued a patent by the European Patent Office for its JOVI technology, which enriches T cells using a specific anti-Cβ antibody.
- A further patent has been granted by the Hong Kong Patent Office for Medigene's inducible Medigene T cell receptor (iM-TCR) technology, enhancing control and safety of TCR-T therapies.
- These patents complement previously granted patents from the European and Japan Patent Offices, strengthening Medigene's international intellectual property portfolio.
- The iM-TCR technology allows fine-tuned regulation of TCR activity, reducing inflammatory side effects, while the JOVI technology facilitates the selection of optimal TCRs for enhanced safety and efficacy.
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Processa Pharmaceuticals provides product pipeline and financial update
- Initiated Phase 2 trial with NGC-Cap in metastatic breast cancer after FDA clearance.
- NGC-Cap Phase 1b trial showed favorable safety and preliminary anti-tumor activity.
- Preclinical studies indicated NGC-Iri delivers more cancer-killing SN-38 molecules to tumors.
- Research and development expenses for Q2 2024 were $1.7 million, unchanged from Q2 2023.
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