Biond Biologics - Clinical Trial Updates, Jun 24, 2024
Biond Biologics has begun a phase 1 clinical trial for BND-35, a humanized ILT3/LILRB4 antagonist antibody, dosing the first patient. The study, conducted in Israel and the US, examines BND-35's safety, tolerability, and anti-tumor activity alone and combined with other cancer drugs. BND-35 targets immunosuppression in the tumor microenvironment, enhancing immune responses against tumors.
Full article: https://www.prnewswire.com/il/news-releases/biond-biologics-announces-first-patient-dosed-with-bnd-35-in-phase-1-clinical-trial-302180049.html
IDEAYA Biosciences - Clinical Trial Updates , Jun 24, 2024
IDEAYA Biosciences announced updates for its Phase 2 program of IDE397, a MAT2A inhibitor for MTAP-deletion solid tumors. With over 35 global trial sites activated, the program expands to lung and bladder cancer. A clinical data update, including efficacy and safety, is expected in late 2024. IDEAYA is also conducting combination trials and advancing preclinical programs to enhance IDE397's potential.
Full article: https://www.biospace.com/article/releases/ideaya-biosciences-announces-clinical-program-updates-for-ide397-a-potential-first-in-class-phase-2-mat2a-inhibitor-targeting-mtap-deletion-solid-tumors/
G1 Therapeutics - Fail Trial Results, Jun 24, 2024
G1 Therapeutics' drug Cosela failed to show a significant effect in a Phase III trial for triple-negative breast cancer, leading the company to wind down the trial and cut staff. G1 will now focus on its small cell lung cancer business and other uses for Cosela, aiming for profitability by late 2025. The company's stock fell over 50% in premarket trading.
Full article: https://www.biospace.com/article/g1-therapeutics-fails-late-stage-breast-cancer-trial-plans-targeted-headcount-reductions/
Biodexa - Positive Trial Data , Jun 24, 2024
Biodexa Pharmaceuticals announced 12-month results from a Phase 2 trial of eRapa™ for Familial Adenomatous Polyposis (FAP), presented at the 2024 InSIGHT meeting. The study showed eRapa was safe and well-tolerated, with a median 17% reduction in polyp burden and 75% non-progression. Cohort 2 had the best results with an 89% non-progression rate and 29% reduction in polyp burden. Supported by a $17 million CPRIT grant, a Phase 3 study is planned, aiming to delay or avoid colon surgery and improve patient quality of life.
Full article: https://www.globenewswire.com/news-release/2024/06/24/2902967/0/en/Biodexa-Announces-Positive-Phase-2-Clinical-Trial-Results-of-eRapa-at-12-months-in-Familial-Adenomatous-Polyposis-FAP.html
Omega Therapeutics - Executive Changes, Jun 24, 2024
Omega Therapeutics announced the election of Richard N. Kender to its Board of Directors. Kender, with extensive experience in corporate finance and business development from his 35-year career at Merck & Co., is expected to provide valuable strategic insights as Omega advances its epigenomic mRNA medicines. Kender's background includes roles in M&A, licensing, and global competitive intelligence, and he currently serves on the boards of several biotech companies.
Full article: https://www.quantisnow.com/insight/omega-therapeutics-announces-election-of-richard-n-kender-to-board-of-directors-5572244
Cypris Therapeutics - Pre-seed, Jun 24, 2024
Funding Cypris Therapeutics, launched by Ichor Life Sciences, uses breakthrough synthetic chemistry to develop treatments for resistant diseases like brain and pancreatic cancers. Led by CEO Kyle Parella, PhD, Cypris enhances natural compounds to improve treatment efficacy with fewer side effects. With initial funding from Ichor, Cypris aims to innovate in oncology and expand into age-related conditions.
Full article: https://www.biospace.com/article/releases/cypris-therapeutics-launches-as-newest-ichor-life-sciences-portfolio-company-secures-over-500k-in-pre-seed-funding/
Oncolytics Biotech - C-Suite Changes, Jun 24, 2024
Oncolytics Biotech Inc. announced that CEO Matt Coffey is on medical leave, with Wayne Pisano, Chair of the Board, stepping in as interim CEO. Pisano, with extensive industry experience, expressed confidence in the team's ability to advance pelareorep, their cancer immunotherapeutic agent.
Full article: https://www.newswire.ca/news-releases/oncolytics-biotech-r-announces-president-and-chief-executive-officer-dr-matt-coffey-to-take-medical-leave-of-absence-806300623.html
Merck - Fail Trial Results, Jun 25, 2024
Shares in Germany's Merck KGaA fell 8.9% after announcing the halt of a promising head and neck cancer drug trial due to lack of efficacy. This setback follows recent failures, including a multiple sclerosis drug trial in December and the bintrafusp alfa cancer treatment in 2021. Barclays analysts noted the need for Merck to rebuild its pipeline credibility. The focus now shifts to Merck's specialty chemicals and biotech lab supplies divisions.
Full article: https://www.reuters.com/business/healthcare-pharmaceuticals/merck-kgaa-shares-plunge-after-cancer-drug-hopeful-fails-2024-06-25/
Zentalis Pharmaceuticals - Clinical Trial Updates, Jun 25, 2024
The FDA has placed partial holds on three Zentalis Pharmaceuticals trials testing azenosertib (ZN-c3) due to two fatalities from presumed sepsis. The trials involve patients with solid tumors, platinum-resistant ovarian cancer, and uterine serous carcinoma. Zentalis CEO Kimberly Blackwell emphasized patient safety and is working with the FDA to resolve the issue. Despite the setback, Zentalis plans to share more results later this year, highlighting azenosertib's potential benefits.
Full article: https://www.cancernetwork.com/view/fda-places-partial-holds-on-3-trials-for-solid-tumor-treatment-azenosertib
Anixa Biosciences - Clinical Trial Updates, Jun 25, 2024
Anixa Biosciences has dosed the sixth and final patient in the second cohort of its phase 1 trial for a novel FSHR-targeting CER T-cell therapy for recurrent ovarian cancer. No dose-limiting toxicities were observed. If safety holds, the third cohort will receive a higher dose. This therapy targets FSHR and shows promise in treating ovarian and potentially other solid tumors. The trial also examines the benefits of intraperitoneal versus intravenous delivery.
Full article: https://www.cgtlive.com/view/anixa-biosciences-wraps-dosing-second-cohort-ovarian-cancer-cer-t-trial
Skyhawk Therapeutics - Company Expansion, Jun 25, 2024
Skyhawk Therapeutics has expanded into new state-of-the-art labs at Superlab Suisse in Basel, Switzerland, to support their growing team and advance small molecule therapies targeting RNA. With their Huntington’s disease program progressing and SKY-1214 nearing clinical entry, the expanded lab space will drive upcoming INDs.
Full article: https://themalaysianreserve.com/2024/06/26/skyhawk-therapeutics-expands-into-state-of-the-art-labs-in-its-basel-switzerland-location/amp/
Exsilio Therapeutics - Series A Investment, Jun 25, 2024
Exsilio Therapeutics has secured $82 million in Series A funding co-led by Novartis Venture Fund and Delos Capital, with participation from OrbiMed, Insight Partners, CRISPR Therapeutics, and others. They are developing genomic medicines using mRNA and lipid nanoparticles to integrate genes into safe sites in the human genome, aiming for redosable treatments across various diseases.
Full article: https://www.biospace.com/article/releases/exsilio-therapeutics-launches-with-82-million-series-a-financing-to-develop-redosable-genomic-medicines-for-a-broad-range-of-diseases/
TwoStep Therapeutics - Seed Funding, Jun 25, 2024
TwoStep Therapeutics, founded by CEO Caitlyn Miller and Stanford professors Jennifer Cochran, Ronald Levy, and Nobel Laureate Carolyn Bertozzi, has launched with $6.5 million in seed funding led by NFX. The company aims to advance a versatile platform for targeting solid tumors using a unique polyspecific integrin-binding peptide (PIP). This technology promises to broaden treatment options for various solid tumors by enhancing targeted drug delivery and immunotherapy.
Full article: https://www.businesswire.com/news/home/20240625454173/en/TwoStep-Therapeutics-Launches-with-Funding-to-Advance-Broadly-Applicable-Targeting-Platform-for-Solid-Tumors
Frontier Medicines - Series C Investment & C-suite Changes, Jun 25, 2024
Frontier Medicines Corporation has appointed Gerardo Ubaghs as its new Chief Financial Officer (CFO) and announced the closure of an oversubscribed Series C funding round totaling $100 million, with an additional $20 million raised. This financing supports the development of FMC-376 and accelerates multiple pipeline programs aimed at advancing precision medicine therapies against challenging disease targets.
Full article: https://www.biospace.com/article/releases/frontier-medicines-appoints-gerardo-ubaghs-as-chief-financial-officer-and-announces-20-million-series-c-extension
Lyell Immunopharma - Clinical Trial Updates, Jun 26, 2024
Lyell Immunopharma is adjusting its CAR-T clinical trial approach due to adverse events, including a death. The phase 1 trial of LYL797 targets ROR1 in solid tumors. For patients without lung metastases, doses have reached 300 million cells, while those with lung involvement remain at 75 million cells due to grade 3 pneumonitis and one death. Lyell plans cautious dose increases, aiming for 450 million cells in non-lung metastasis patients, to determine phase 2 doses for breast and lung cancer patients. Additionally, Lyell is expanding to other cancers and preparing its second-generation CAR-T, LYL119, for clinical trials. The company's stock fell 27% following these updates.
Full article: https://www.fiercebiotech.com/biotech/car-t-death-drives-lyell-take-2-track-approach-dose-escalation
Repare Therapeutics - Positive Trial Data, Jun 26, 2024
Repare Therapeutics reported positive initial data from the Phase 1 MINOTAUR trial, showing that lunresertib (RP-6306) with FOLFIRI is effective and well-tolerated in advanced solid tumors with CCNE1 amplification and FBXW7 mutations. The trial established a recommended Phase 2 dose of 60mg BID lunresertib plus FOLFIRI, with an overall response rate of 18.2% and a clinical benefit rate of 51.5%. The combination therapy showed manageable side effects, mainly neutropenia and leukopenia, supporting further development in a Phase 2 study.
Full article: https://www.businesswire.com/news/home/20240626903583/en/Repare-Therapeutics-Announces-Positive-Initial-Data-at-ESMO-GI-from-Phase-1-MINOTAUR-Trial-Evaluating-Lunresertib-in-Combination-with-FOLFIRI
Calidi Biotherapeutics - Executive Changes, Jun 27, 2024
Calidi Biotherapeutics has appointed Dr. George E. Peoples, a cancer immunotherapy expert, to its Board of Directors effective July 1, 2024. Dr. Peoples, founder of the Cancer Vaccine Development Program and LumaBridge, brings extensive experience in cancer vaccine development and clinical research. He will support Calidi's efforts to advance its cancer immunotherapies. Dr. Peoples expressed excitement about contributing to Calidi's innovative treatments.
Full article: https://finance.yahoo.com/news/calidi-biotherapeutics-announces-appointment-cancer-110000313.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAANvXv9-tvo2GH3YaYheMhsY8eNjrlYUUOSGwRlJUZ7zBit4pC07LUBxIe0i3avbaT4QJXddEg3kpAtHTEVGkmuOSx-S7tGexlmwFTCjcfm0uAKWq9WofeSoJECTmzCykA_U2-X6u3wlCG7msUkA6JnikvtYp1hJIHDEUqsbK3atl
Elevation Oncology -Clinical Trial Updates, Jun 27, 2024
Elevation Oncology will expand its Phase 1 trial to evaluate EO-3021 combined with ramucirumab and dostarlimab for advanced gastric or gastroesophageal junction cancer, following agreements with Eli Lilly and GSK. The trial aims to start dosing by the end of 2024 and will assess safety and efficacy. EO-3021 has shown favorable safety in preclinical studies. Initial data are expected by mid-third quarter 2024, with further results in early 2025.
Full article: https://www.prnewswire.com/news-releases/elevation-oncology-announces-planned-combination-strategy-for-eo-3021-in-patients-with-gastric-or-gastroesophageal-junction-cancer-302184118.html
Summit Therapeutics - Executive Changes, Jun 27, 2024
Jeff Huber joins Summit Therapeutics Inc. as a new board member, bringing extensive leadership from Triatomic Capital and past roles at GRAIL and Alphabet Inc. His appointment strengthens Summit's efforts in advancing ivonescimab for solid tumors, aiming to enhance patient care and outcomes through innovative therapies.
Full article: https://quantisnow.com/insight/summit-therapeutics-appoints-jeff-huber-transformational-google-and-grail-executive-to-its-board-of-5581457
Monte Rosa Therapeutics - Clinical Trial Updates, Jun 27, 2024
Monte Rosa Therapeutics updated progress on its lead programs: MRT-2359 for MYC-driven tumors and MRT-6160 for autoimmune diseases. Positive Phase 1/2 data supports a potential Phase 2 dose of 0.5 mg for MRT-2359 on a 21 days on, 7 days off schedule, with enrollment ongoing for a 0.75 mg cohort. The company also submitted an IND for MRT-6160, targeting VAV1, anticipating a Phase 1 study start this summer and initial clinical results by Q1 2025, aiming to address autoimmune conditions including ulcerative colitis and rheumatoid arthritis.
Full article: https://www.biospace.com/article/releases/monte-rosa-therapeutics-provides-development-progress-updates-on-mrt-2359-and-mrt-6160/
Lyell Immunopharma - Positive Trial Data, Jun 27, 2024
Lyell Immunopharma's LYL797, an autologous CAR T-cell therapy targeting ROR1, demonstrated a 60% clinical benefit rate in TNBC patients at the highest dose level in a phase 1 trial. Safety concerns included 61% of patients experiencing cytokine release syndrome (CRS), managed with tocilizumab and steroids. Pneumonitis and cytopenia were also observed, with one fatal case of respiratory failure post-treatment. Plans include expanding trials to ovarian, endometrial cancers and initiating a trial for multiple myeloma and CLL with LYL119, a next-gen CAR-T.
Full article: https://www.cgtlive.com/view/lyell-ror1-targeted-car-t-lyl797-attains-60-clinical-benefit-rate-high-dose-level-phase-1-solid-tumor-trial
Verve Therapeutics - Executive Changes, Jun 28, 2024
Verve Therapeutics appointed Nia Tatsis, Ph.D., from Vertex Pharmaceuticals, and Jodie Morrison, CEO of Q32 Bio Inc., to its board of directors. Both bring extensive leadership in biopharmaceuticals as Verve advances gene editing therapies for cardiovascular disease, focusing on PCSK9, ANGPTL3, and LPA programs.
Full article: https://quantisnow.com/insight/verve-therapeutics-announces-appointment-of-nia-tatsis-phd-and-jodie-morrison-to-its-board-5582435
Waypoint Bio - Seed Funding , Jun 28, 2024
Waypoint Bio has raised $14.5 million in seed funding led by Hummingbird Ventures, along with Recode Ventures and Fifty Years. They specialize in cell therapies for solid tumors using spatial pooled screening technology, enhancing drug discovery by generating detailed spatial readouts for each perturbation. This approach accelerates the development of new drug candidates with high clinical success potential. Their focus includes advancing CAR T-cell therapies against tumor microenvironments and later developing Treg therapies for autoimmune diseases.
Full article: https://www.businesswire.com/news/home/20240628087950/en/Waypoint-Bio-Launches-with-14.5M-to-Turbocharge-Drug-Discovery-using-in-vivo-Spatial-Pooled-Screening-Technology
