First patient dosed with LIXTE’s LB-100 in new clinical trial to treat colorectal cancer
- LIXTE Biotechnology Holdings has dosed the first patient in a new clinical trial for metastatic colorectal cancer.
- The trial is in collaboration with the Netherlands Cancer Institute (NKI) and supported by Roche.
- LIXTE is providing its lead compound, LB-100, while Roche is providing atezolizumab (Tecentriq).
- The trial aims to bring immunotherapy to approximately 85% of colorectal cancer patients who have not responded to traditional treatments.
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European Commission approves Rybrevant in combination with chemotherapy for advanced EGFR-mutated NSCLC
- The European Commission has approved Rybrevant (amivantamab) in combination with chemotherapy for adults with advanced EGFR-mutated non-small cell lung cancer (NSCLC) after failure of prior therapy.
- Approval is based on the Phase 3 MARIPOSA-2 study, which showed a 52% reduction in the risk of disease progression or death compared to chemotherapy alone.
- The combination demonstrated significant improvements in progression-free survival (PFS) and intracranial PFS, with a median PFS of 6.3 months versus 4.2 months for chemotherapy alone.
- Next steps include ongoing monitoring and potential future regulatory actions for additional indications and formulations.
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Clearside Biomedical completes final participant visit in ODYSSEY Phase 2b trial of CLS-AX in wet AMD
- CLS-AX is a highly potent tyrosine kinase inhibitor delivered suprachoroidally using Clearside’s proprietary SCS Microinjector.
- Topline data expected to be reported during the week of October 7, 2024.
- ODYSSEY is a 36-week, randomized, double-masked, parallel-group, active-controlled, multi-center Phase 2b trial in wet AMD.
- Primary outcome measure is the mean change from baseline in best corrected visual acuity.
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RedHill's opaganib granted orphan drug designation by the FDA for childhood cancer, neuroblastoma
- The FDA has granted orphan drug designation to RedHill Biopharma's opaganib for the treatment of neuroblastoma, a rare childhood cancer.
- Orphan drug designation provides seven years of marketing exclusivity, accelerated development and review times, potential grant funding, and possible tax credits.
- Neuroblastoma accounts for 10% of all childhood cancer cases in the U.S. and 15% of pediatric cancer-related deaths.
- This is the second orphan drug designation for opaganib in oncology, following its previous designation for cholangiocarcinoma.
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JW Therapeutics announces NMPA approval of the supplemental biological license application for Carteyva in adult patients with relapsed or refractory mantle cell lymphoma
- The National Medical Products Administration (NMPA) of China approved the supplemental Biological License Application (sBLA) for Carteyva (relmacabtagene autoleucel injection) for treating adult patients with relapsed or refractory Mantle Cell Lymphoma (r/r MCL).
- This approval is based on clinical results from a single-arm, multi-center, pivotal study in China, showing high rates of objective response rate (ORR) and complete response rate (CRR) with manageable safety data.
- Carteyva demonstrated an ORR of 81.36% and a CRR of 67.80%, with severe cytokine release syndrome (CRS) and neurotoxicity (NT) incidences both at 6.8%.
- This marks the third marketing approval for Carteyva in China and the first cell therapy product approved for r/r MCL in the country.
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Ordspono (odronextamab) approved in the European Union for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
- The European Commission (EC) has approved Ordspono (odronextamab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
- Approval is based on Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials showing robust and durable response rates.
- In R/R FL, the ELM-2 trial showed an objective response rate (ORR) of 80%, with 73% achieving a complete response (CR).
- In R/R DLBCL, the ELM-2 trial showed a 52% ORR, with 31% achieving a CR in CAR-T therapy naive patients, and a 48% ORR with 32% achieving a CR in post-CAR-T patients.
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Ocugen receives Health Canada approval for phase 3 trial of OCU400 gene therapy
- Health Canada has approved Ocugen to initiate the Phase 3 liMeliGhT clinical trial for OCU400 in Canada.
- The trial will enroll up to 50 subjects across 5 sites, running parallel to the U.S. FDA trial.
- OCU400 targets retinitis pigmentosa (RP) and aims to provide a gene-agnostic treatment option.
- The primary endpoint is the change in functional vision from baseline to week 52, measured by the Luminance Dependent Navigation Assessment (LDNA).
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Invivyd announces pemgarda demonstrated 84% relative risk reduction in symptomatic COVID-19
- PEMGARDA (pemivibart) showed an 84% relative risk reduction in symptomatic COVID-19 compared to placebo in the CANOPY Phase 3 trial.
- In immunocompetent participants, the rate of symptomatic COVID-19 was 1.9% with pemivibart versus 11.9% with placebo.
- In immunocompromised participants, pemivibart demonstrated a 3% rate of confirmed symptomatic COVID-19.
- The safety profile of pemivibart was consistent with previous data, with common adverse events including viral infections and infusion-related reactions.
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CancerVax files new patent for its novel universal cancer treatment platform
- CancerVax has filed a new patent application for its Smart mRNA Technology.
- The technology aims to make cancer cells look like common diseases such as measles or chickenpox.
- This approach uses the body's natural immunity to target and kill cancer cells while sparing healthy cells.
- The technology employs machine learning and AI to identify genetic signatures unique to cancer cells.
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Aura Biosciences presents phase 2 data on bel-sar for choroidal melanoma
- Aura Biosciences will present Phase 2 end of study data on bel-sar for early-stage choroidal melanoma at The Retina Society Annual Meeting in Lisbon, Portugal.
- The presentation, titled 'Final Results of a Phase 2 Trial of Suprachoroidal Administration of Belzupacap Sarotalocan (bel-sar, AU-011) for Choroidal Melanoma,' will be delivered by Dr. Ivana Kim on September 12, 2024.
- Aura will also host a virtual ocular oncology investor event featuring Dr. Ivana Kim and Dr. Prithvi Mruthyunjaya on the same day at 8:00 am Eastern Time.
- A live webcast of the investor event will be available on Aura’s website, with a replay archived for 90 days.
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