Aktis Oncology - Series B Investment, Sep 30, 2024
Aktis Oncology, a biotech company developing targeted alpha radiopharmaceuticals for solid tumors, has closed an oversubscribed $175 million Series B financing, led by RA Capital Management with participation from RTW Investments, Janus Henderson Investors, and others, including strategic partners Bristol Myers Squibb and Merck's MRL Ventures Fund. With over $300 million in cash, Aktis plans to advance its pipeline, particularly its Nectin-4 targeting drug, AKY-1189. The company also announced its participation in the EORTC-NCI-AACR Symposium, with key presentations on its innovations in cancer therapeutics.
Full Article: Aktis Oncology Announces $175 Million Oversubscribed Series B Financing
Johnson & Johnson - Positive Trial Data, Sep 30, 2024
Johnson & Johnson announced positive data for its multiple myeloma treatments, Carvykti and Darzalex Faspro, at the 2024 International Myeloma Society Annual Meeting. Carvykti, a BCMA-directed CAR-T cell therapy, showed a 45% reduction in risk of death in a Phase III trial, while Darzalex Faspro, in combination with VRd, achieved a 61% improvement in minimal residual disease-negativity. These results strengthen J&J's multiple myeloma franchise, which saw significant sales growth, and further position Carvykti and Darzalex as key drivers in the company's oncology portfolio.
Full Article: J&J Posts Positive Phase III Results for Carvykti and Darzalex Faspro in Multiple Myeloma Trials
Leap Therapeutics - Clinical Trial Updates, Sep 30, 2024
Leap Therapeutics has completed enrollment of 188 patients in Part B of its DeFianCe study, evaluating the anti-DKK1 antibody DKN-01 in combination with bevacizumab and chemotherapy as a second-line treatment for advanced colorectal cancer (CRC). This milestone follows promising results from Part A, which showed durable tumor reductions and a favorable safety profile. The Phase 2 trial aims to assess progression-free survival (PFS) and includes a subpopulation of left-sided CRC patients. Initial data from Part B is expected in mid-2025, further advancing DKN-01's potential in CRC treatment.
Pfizer - Positive Trial Data, Sep 30, 2024
Pfizer announced positive Phase II results for ponsegromab in cancer cachexia, increasing its Phase Transition Success Rate to 42%. Meanwhile, IMPACT Therapeutics' senaparib faced a setback with its Phase II trial termination in solid tumors. Merck’s Keytruda saw improved prospects in thymic carcinoma, and Teva completed a Phase II trial of Austedo in dystonia. Ponsegromab showed significant weight gain in cancer cachexia patients, with Pfizer planning registration-enabling studies in 2025.
Full Article: Pfizer Scores in Phase II Cancer Cachexia Trial
Sapience Therapeutics - Clinical Trial Updates, Oct 1, 2024
Sapience Therapeutics has enrolled the first patient in its Phase 2 study of ST316, a β-catenin antagonist targeting the Wnt/β-catenin pathway in colorectal cancer (CRC). Following successful Phase 1 results, ST316 is now being tested in combination with standard CRC treatments. Sapience aims to offer new options for CRC patients, addressing a major unmet need in cancer care.
Full Article: Sapience Therapeutics Enrolls First Patient in Phase 2 Study of ST316
Halda Therapeutics - C-Suite Changes, Oct 1, 2024
Halda Therapeutics has appointed Christian Schade as its new President, CEO, and Board member. Schade brings over 20 years of leadership experience in the biotechnology and pharmaceutical industries, with expertise in guiding companies through clinical development and strategic deals. His background includes leadership roles at Aprea Therapeutics, Novira, and Omthera Pharmaceuticals. Schade will lead Halda as it advances its novel RIPTAC™ cancer therapies into clinical trials, with the first set to begin in 2025, targeting unmet needs in prostate and breast cancer treatment.
Full Article: Halda Therapeutics Appoints Veteran Biopharma Leader Christian Schade as President and Chief Executive Officer
Triveni Bio - Series B Investment, Oct 2, 2024
Triveni Bio Inc. has raised $115 million in a Series B funding round led by Goldman Sachs Alternatives, with support from new and existing investors like Fidelity, Atlas Venture, and OrbiMed. The funds will be used to expand Triveni's pipeline of antibody treatments for immunological and inflammatory (I&I) disorders, including its bispecific program, TRIV-573, which integrates dual mechanisms of action. The company is preparing to submit an IND application for its lead candidate, TRIV-509, in early 2025 and is advancing additional innovative therapies, including treatments for hereditary pancreatitis.
Processa Pharmaceuticals - Clinical Trial Updates, Oct 2, 2024
Processa Pharmaceuticals has announced the dosing of the first patient in a Phase 2 clinical trial for NGC-Cap, a novel treatment for advanced or metastatic breast cancer. This trial aims to evaluate NGC-Cap’s safety and efficacy compared to the commonly used drugs capecitabine and 5-FU, building on positive Phase 1b results. The adaptive, multicenter trial will involve 60 to 90 patients and is designed to determine optimal dosage regimens in line with the FDA Project Optimus Initiative. With breast cancer being the second most common cancer globally, the trial's progress is crucial for developing more effective and better-tolerated treatment options.
Full Article: Processa Pharmaceuticals Announces First Patient Dosed in Phase 2 Clinical Trial of NGC-Cap in Metastatic Breast Cancer
Summit Therapeutics - Clinical Trial Updates, Oct 3, 2024
Summit Therapeutics has completed enrollment in its HARMONi Phase III trial, evaluating ivonescimab combined with platinum-doublet chemotherapy for EGFR-mutated advanced non-small cell lung cancer (NSCLC) post-3rd generation TKI treatment. The FDA granted Fast Track designation for ivonescimab, aiming to expedite its review for serious medical needs. CEO Dr. Maky Zanganeh highlighted the importance of this milestone and thanked participants and collaborators. The trial's analysis will include data from the earlier HARMONi-A trial, reinforcing ivonescimab's potential efficacy.
Full Article: Summit Therapeutics Announces Completion of Enrollment in Its Phase III HARMONi Trial in 2L EGFRm NSCLC
Relay Therapeutics - Workforce Reduction/Layoffs, Oct 3, 2024
Relay Therapeutics is cutting about 10% of its workforce, impacting 30 employees, as part of ongoing efforts to streamline operations and save around $50 million annually. This follows a smaller round of layoffs in July. Despite these cuts, the company’s clinical programs remain unaffected, and Relay continues to advance five new programs while pausing development on two preclinical candidates. Their focus now shifts to RLY-2608, a mutant selective PI3Kα inhibitor being tested in breast cancer and vascular malformations, with a new trial expected in early 2025.
Full Article: Relay Cuts More Staff in Efforts to Save $50M a Year
Enara Bio - Series B Investment, Oct 3, 2024
Enara Bio has raised $32.5 million in a Series B funding round co-led by Pfizer Ventures and M Ventures, with support from existing investors. The funds will advance its pipeline of TCR-based immunotherapies targeting novel Dark Antigens for solid tumors. The Francis Crick Institute also joined as a new investor. Enara’s EDAPT platform, previously validated by Boehringer Ingelheim, has discovered Dark Antigen targets offering potential breakthroughs in cancer immunotherapy. The financing strengthens the board with new appointees from Pfizer Ventures and M Ventures.
Allarity Therapeutics - C-Suite Changes, Oct 4, 2024
Allarity Therapeutics appointed Jeremy Graff, Ph.D., as President and Chief Development Officer, and Jose Iglesias, M.D., as Consultant Chief Medical Officer to advance its lead cancer therapy, stenoparib. Jesper Høiland, former Novo Nordisk U.S. President, joined as Strategic Advisor to guide commercialization efforts. These leadership moves aim to accelerate the development and approval of personalized cancer treatments.
Full Article: Allarity Therapeutics Strengthens Leadership with Key Appointments to Accelerate Stenoparib PARP Inhibitor Program
TiumBio - Clinical Trial Updates, Oct 4, 2024
TiumBio has initiated a Phase 2a clinical trial of TU2218, a dual inhibitor targeting TGFR1 and VEGFR2, in patients with head and neck squamous cell carcinoma (HNSCC) and biliary tract cancer (BTC), with plans to expand to colorectal cancer (CRC) patients. The first patient with HNSCC has been dosed. TU2218 aims to improve immune checkpoint inhibitor efficacy by blocking TGF-β and VEGF pathways. Previous trials showed an 80% disease control rate in patients with advanced solid tumors treated with TU2218 and Keytruda.
Full Article: TiumBio Announces First Patient Dosed in Phase 2 Clinical Trial of Oral Immuno-Oncology Drug TU2218
UroGen Pharma - Clinical Trial Updates, Oct 4, 2024
UroGen Pharma has dosed the first patient in the Phase 3 clinical trial of UGN-103 (mitomycin) for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UGN-103 is a next-generation mitomycin-based formulation utilizing UroGen’s RTGel® platform, designed to enhance drug delivery. The U.S. FDA accepted the Investigational New Drug Application for UGN-103 in April 2024. UroGen plans to enroll 87 patients in the UTOPIA study, with efficacy assessed by complete response rates at the three-month mark.
