Carrick Therapeutics - Clinical Trial Updates, Sep 23, 2024
Carrick Therapeutics Inc., a biopharmaceutical company focused on oncology, announced the first patient dosed in its Phase 1 clinical trial of CT7439, a novel CDK12/13 inhibitor and Cyclin-K glue-degrader. CDK12/13 plays a critical role in transcription regulation and DNA damage response, and its inhibition may be effective against various cancers, including ovarian, breast, and Ewing's sarcoma. The trial will evaluate the safety and pharmacokinetics of CT7439, aiming for early proof of principle in patients with advanced solid tumors.
Full Article: Carrick Therapeutics Announces First Patient Dosed in Phase 1 Study of CT7439 for Advanced Cancers
Black Diamond Therapeutics - Clinical Trial Updates, Sep 23, 2024
Black Diamond Therapeutics, Inc., a clinical-stage oncology company, announced promising initial Phase 2 data for BDTX-1535 in patients with relapsed/refractory EGFR-mutant non-small cell lung cancer (NSCLC). The data show a 42% preliminary objective response rate (ORR) in patients with known osimertinib resistance mutations. BDTX-1535 has demonstrated favorable tolerability, with mild to moderate adverse events and encouraging durability, offering potential as an oral therapy for patients with limited options. Black Diamond plans to share first-line setting data in early 2025.
Full Article: Black Diamond Therapeutics Announces Initial Phase 2 Data for BDTX-1535 in EGFRm NSCLC
IDEAYA Biosciences - Clinical Trial Updates, Sep 23, 2024
IDEAYA Biosciences, Inc. shared promising interim Phase 2 data for darovasertib in neoadjuvant uveal melanoma (UM), showing approximately 49% of patients achieved over 30% tumor shrinkage, and 61% of enucleation patients had eye preservation. Following a successful FDA Type C meeting, IDEAYA is targeting to initiate a Phase 3 registrational trial. The trial will focus on eye preservation and time to vision loss as primary endpoints, with discussions underway on utilizing overall response rate (ORR) as a surrogate endpoint for potential early approval. The Phase 3 trial aims to enroll around 400 patients.
Full Article: IDEAYA Biosciences Announces Positive Interim Phase 2 Data for Darovasertib and FDA Agreement on Phase 3 Design in Uveal Melanoma
Astellas - Drug Approval, Sep 23, 2024
The European Commission has approved Astellas Pharma's Vyloy (zolbetuximab) in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma expressing CLDN18.2. The approval is based on positive results from the Phase III SPOTLIGHT and GLOW trials, which demonstrated improved progression-free and overall survival with Vyloy plus chemo compared to chemotherapy alone. Vyloy is now the first approved CLDN18.2-targeted therapy in Europe, with similar approvals already granted in the UK and Japan. A regulatory decision from the US FDA is expected by November 9, 2024.
Full Article: Astellas' Vyloy Approved in Europe for CLDN18.2-Positive Gastric Cancer
LIfT BioSciences - Series A Investment, Sep 24, 2024
LIfT BioSciences has raised £10 million in the first close of a Series A financing to advance its allogeneic innate cell therapy platform, Neutrophil Only Leukocyte Infusion Therapy (N-LIfT), into clinical trials. The company's breakthrough therapy, which produces Immunomodulatory Alpha Neutrophils (IMANs), aims to enhance immune response against solid tumors by recruiting the patient's own immune cells. The funds will support a Phase I trial at Galway University, focusing on safety and immune infiltration. LIfT also seeks pharmaceutical partnerships to expand its platform’s applications in cancer treatment.
Full Article: LIfT BioSciences Raises £10M in First Close of Series A to Advance Allogeneic Innate Cell Therapy
Convergent Therapeutics - Clinical Trial Updates, Sep 24, 2024
Convergent Therapeutics has dosed the first patient in its Phase II CONVERGE-01 trial evaluating CONV01-α (Ac-225 rosopatamab tetraxetan) for PSMA PET-positive metastatic castration-resistant prostate cancer (mCRPC). Previous studies showed promising results, with PSA declines of 50% in 67% of patients. The trial will assess safety and efficacy in a multi-part design, targeting patients based on prior Lu-177-PSMA treatment.
Full Article: Convergent Therapeutics Announces First Patient Treated in Phase II Clinical Trial with Lead Therapeutic Candidate
Merck - Fail Trial Results, Sep 25, 2024
Merck & Co.'s attempt to treat microsatellite stable (MSS) metastatic colorectal cancer with a combination of Keytruda and anti-LAG-3 antibody favezelimab has failed to improve overall survival in the KEYFORM-007 trial. The study compared the combo to standard treatments but showed no advantage, delaying progress in finding an effective checkpoint inhibitor for MSS colorectal cancer. Despite this setback, Merck will continue exploring other Keytruda-based combinations and is advancing favezelimab in a Phase 3 trial for relapsed classical Hodgkin lymphoma.
Full Article: Merck's Keytruda LAG-3 Combo Fails to Tame Tough Colorectal Cancer in Phase 3
Atavistik Bio - Executive Changes, Sep 25, 2024
Atavistik Bio has appointed Mohammad Hirmand, M.D. to its Board of Directors as the company advances its oncology-focused precision allosteric therapeutics into clinical development. Dr. Hirmand, with over 20 years of clinical leadership experience at companies like Turning Point Therapeutics and Medivation, brings valuable insights to help guide Atavistik's mission of delivering transformative treatments for unmet medical needs. CEO Bryan Stuart highlighted the importance of Dr. Hirmand's expertise as the company approaches key clinical milestones. Dr. Hirmand expressed enthusiasm for contributing to Atavistik's efforts to improve cancer treatments.
Full Article: Atavistik Bio Appoints Oncology Clinical Development Leader Mohammad Hirmand, M.D. to Board
858 Therapeutics - Series B Investment, Sep 26, 2024
858 Therapeutics secured $50 million in Series B funding led by Avidity Partners, with contributions from Insight Partners, Mirae Asset Capital, and others. The proceeds will advance its small molecule therapeutics pipeline, including lead candidate ETX-19477, a PARG inhibitor targeting advanced solid tumors. Monal Mehta, Ph.D., of Avidity Partners, joins the Board of Directors. The ongoing Phase 1 trial of ETX-19477 will explore its safety and efficacy, with plans for Phase 2 cohorts to follow. CEO Jeffrey Stafford expressed excitement about the strong investor backing.
Full Article: 858 Therapeutics Announces $50 Million Series B Financing
Pasithea Therapeutics - Positive Trial Data, Sep 26, 2024
Pasithea Therapeutics reported positive interim results from its Phase 1 trial of PAS-004, a next-generation MEK inhibitor for NF1 and cancer. The drug showed a favorable safety profile, with no treatment-related adverse events and a 70-hour half-life enabling once-daily dosing. Early efficacy was observed, including a colorectal cancer patient with prolonged stable disease. Further trial updates are expected as higher doses are tested.
Full Article: Pasithea Therapeutics Announces Positive Initial Safety, Tolerability, Pharmacokinetic (PK) and Preliminary Efficacy Data from its Phase 1 Clinical Trial of PAS-004 in Advanced Cancer
Convergent Therapeutics - Series A Investment, Sep 27, 2024
Convergent Therapeutics announced a $40 million Series A extension from Novo Holdings, bringing the total Series A raise to $130 million. The funds will support Convergent’s radiopharmaceutical pipeline development. Jim Trenkle, Ph.D., of Novo Holdings, joins the Board of Directors, while Richard Messmann, M.D., a seasoned oncology drug developer, has been appointed Chief Medical Officer.
Full Article: Convergent Therapeutics Secures $40 Million Series A Extension from Novo
ImPact Biotech - Clinical Trial Updates, Sep 27, 2024
ImPact Biotech announced that its Phase 3 ENLIGHTED trial evaluating Padeliporfin VTP for low-grade UTUC has reached 50% patient enrollment. Chief Medical Officer, Dr. Eyal Morag, highlighted the milestone and expects full enrollment by Q1 2025. Positive interim results shared at ASCO 2024 showed a 77% complete response rate in response-evaluable patients. The trial uses a photosensitizing drug, Padeliporfin, activated via laser fiber illumination during outpatient endoscopy. Additional interim data from the ongoing study will be shared later this year.
Full Article: ImPact Biotech Announces 50% Enrollment in Phase 3 Trial
Estrella Immunopharma - Positive Trial Data, Sep 27, 2024
Estrella Immunopharma announced that the first patient in its STARLIGHT-1 Phase I/II trial achieved a complete response (CR) one month after receiving EB103 CD19-Redirected ARTEMIS® T Cells. The patient, who had relapsed three times from follicular lymphoma and was considered high-risk, experienced no serious adverse events. Estrella's President, Dr. Cheng Liu, emphasized their aim to surpass the efficacy and safety of CAR-T therapies. The trial, which focuses on relapsed/refractory B-cell NHL, will continue to validate these promising early results.
Full Article: Estrella Immunopharma Achieves Complete Response in First Patient Treated with CD19-Redirected ARTEMIS T Cells
Poseida Therapeutics - Positive Trial Data, Sep 28, 2024
Poseida Therapeutics shared interim results from its Phase 1 trial of P-BCMA-ALLO1, an allogeneic CAR-T cell therapy for relapsed/refractory multiple myeloma. Arm C, the optimized lymphodepletion group, showed a 91% overall response rate (ORR) among 23 heavily pretreated patients, with no dose-limiting toxicities or severe CRS/ICANS. Safety results were consistent across trial arms, and efficacy is still evolving. These findings highlight P-BCMA-ALLO1’s potential as a safe, off-the-shelf CAR-T therapy.
Full Article: Poseida Therapeutics Reports Positive Interim Phase 1 Results for Allogeneic CAR-T Therapy P-BCMA-ALLO1
