Innate Pharma Clinical Trial Updates, Jun 17, 2024
Innate Pharma SA announced updated results from the Phase 1/2 study of SAR443579/IPH6101, a CD123 targeting NK Cell Engager developed with Sanofi, at the European Hematology Association 2024 Congress. The study, which focuses on blood cancers like R/R AML, B-ALL, and HR-MDS, showed promising efficacy and safety, progressing to Phase 2. In 59 patients, the optimal dose of 1 mg/kg weekly led to significant responses, with durable complete remissions in some patients. SAR443579, which has FDA Fast Track Designation for AML, demonstrated tolerability up to 6 mg/kg, guiding dose recommendations for further trials.
Full Article: Innate Pharma Shares Updated Results From the Sanofi-Developed Blood Cancer Phase 1/2 SAR443579/IPH6101 Trial
BioNTech Clinical Trial Updates, Jun 17, 2024
The FDA placed a partial hold on BioNTech and MedLink's Phase I trial of ADC cancer therapy BNT326/YL202 after three patient deaths. The hold stops new U.S. enrollments but allows current patients to continue. The deaths were linked to high-dose cohorts, prompting a focus on safer, lower doses below 4.0 mg/kg. The trial targets advanced EGFR-mutated NSCLC and HR+/HER2-negative breast cancer.
Full Article: FDA Imposes Partial Hold on BioNTech-MedLink ADC Trial After Three Patient Deaths
Evaxion Biotech Positive Trial Data, Jun 17, 2024
Evaxion Biotech reported that its Phase 1 study of the personalized cancer vaccine EVX-01 for metastatic melanoma showed a 67% objective clinical response rate, with six partial and two complete responses among 12 patients. No serious adverse events related to the vaccine were observed in patients also receiving anti-PD1 therapy. CEO Christian Kanstrup announced that results from the ongoing Phase 2 study will be reported in the third quarter.
Full Article: Evaxion Biotech EVX-01 Achieves 67% Objective Response Rate in Phase 1 Dose Escalation Study
Arvinas C-Suite Changes, Jun 17, 2024
Arvinas, Inc. has promoted Ian Taylor, Ph.D., to President of Research and Development, and Angela Cacace, Ph.D., to Chief Scientific Officer. Dr. Taylor, who has been pivotal at Arvinas since 2016, will lead strategic efforts across their pipeline in oncology and neuroscience. Dr. Cacace, with a strong background in neuroscience and oncology drug discovery, will succeed Dr. Taylor after playing a key role in advancing Arvinas' PROTAC® protein degrader programs. Both will report directly to John Houston, Ph.D., the company's Chairperson, President, and CEO.
Full Article: Arvinas Announces Promotions of Ian Taylor, Ph.D., and Angela Cacace, Ph.D.
Day One Biopharma Acquisitions, Jun 18, 2024
Day One Biopharmaceuticals, now a commercial-stage company after its first drug approval, has acquired global rights (excluding Greater China) to a novel antibody-drug conjugate (ADC) from MabCare Therapeutics for $55 million upfront. The drug, renamed DAY301, targets PTK7, a protein overexpressed in various adult and pediatric cancers. Day One plans to begin Phase 1 trials by early next year. This acquisition aligns with Day One's strategy of licensing promising candidates, as demonstrated by their recent approval of Ojemda and other pipeline assets. The deal could total up to $1.152 billion, including milestone payments.
Full Article: Day One Biopharmaceuticals Acquires ADC from MabCare Therapeutics
Ability Biologics Seed Funding, Jun 19, 2024
Ability Biologics closed an $18 million seed funding extension to advance its AI-based Abileap platform for developing cancer and immune disorder therapies. The round, led by Amplitude Ventures with Charles River Laboratories and Theodorus participating, follows an initial $12 million raised in December 2023. Ability has preclinical antibody candidates in immunology and oncology.
Full Article: Ability Biologics Closes $18M Seed Funding Round
GenFleet Clinical Trial Updates, Jun 19, 2024
GenFleet Therapeutics received approval from China's NMPA to conduct a clinical trial of GFH375 (VS-7375), targeting advanced solid tumors with the KRAS G12D mutation, which lacks approved therapies. GFH375, a potent KRAS G12D inhibitor, demonstrated promising preclinical results and will be evaluated in a phase I/II study at about 40 hospitals, including Shanghai Chest Hospital. This trial aims to assess safety, efficacy, and dosing in pancreatic, colorectal, and lung cancers, addressing critical medical needs.
Full Article: GenFleet Receives IND Approval from China's NMPA for GFH375
AstraZeneca Fail Trial Results, Jun 19, 2024
AstraZeneca reported that its breast cancer drug, Truqap, combined with paclitaxel, did not meet its primary endpoints in the CAPItello-290 trial aimed at improving overall survival for patients with inoperable or metastatic triple-negative breast cancer. Despite the disappointment, the study's outcomes will contribute to the understanding of the PI3K/AKT pathway in breast cancer, according to Susan Galbraith, AstraZeneca's executive vice president of oncology R&D.
Full Article: AstraZeneca's Breast Cancer Drug Combination Fails in Late-Stage Trial
Tubulis Clinical Trial Updates, Jun 20, 2024
Tubulis has initiated its first Phase I/IIa trial (NAPISTAR 1-01) with TUB-040, an innovative antibody-drug conjugate targeting NaPi2b in patients with platinum-resistant ovarian cancer and relapsed/refractory NSCLC. This trial, conducted across multiple countries, aims to establish TUB-040's safety, efficacy, and optimal dosing as a monotherapy. Utilizing their proprietary P5 technology and Exatecan linker-payload, Tubulis seeks to overcome current ADC limitations, demonstrating promising preclinical results of sustained anti-tumor activity and minimized toxicity.
Full Article: Tubulis Doses First Patient in Phase IIIa Trial Investigating ADC Candidate TUB-040
iOnctura Series B Investments, Jun 20, 2024
iOnctura has raised EUR80 million in Series B financing led by Syncona Limited and the EIC Fund, along with existing investors. This funding will accelerate the development of roginolisib, an innovative PI3Kδ allosteric modulator targeting uveal melanoma. Promising Phase Ib trial results highlight its efficacy and safety in treating this rare eye cancer. iOnctura plans to expand roginolisib's evaluation to other cancers like non-small cell lung cancer and primary myelofibrosis in 2024. Their second asset, cambritaxestat, an autotaxin inhibitor, is progressing in combination trials for metastatic pancreatic cancer.
Full Article: iOnctura Announces EUR80 Million Series B Financing to Progress Pipeline
Medigene AG Pipeline Expansion, Jun 20, 2024
Medigene AG, a company specializing in T cell immunotherapies for solid tumors, has chosen its lead candidate, MDG2021, a TCR-T therapy targeting KRAS G12D with HLA-A*11, combined with their PD1-41BB costimulatory switch protein technology. Using their End-to-End (E2E) Platform, Medigene developed a highly specific and sensitive TCR that shows potential for improved safety by avoiding recognition of healthy cells. This advancement expands their library of TCRs targeting neoantigens and cancer-testis antigens, aiming to provide effective treatments for challenging cancers like colorectal and pancreatic cancers. Early preclinical data on MDG2021 is expected in the latter half of 2024, demonstrating their innovative approach to enhancing T cell therapies.
Full Article: Medigene AG Announces Lead Selection for MDG2021, Expanding TCR-T KRAS Library Targeting Solid Tumors
ITM Isotope Technologies Munich SE C-Suite Changes, Jun 20, 2024
ITM Isotope Technologies Munich SE has named Dr. Andrew Cavey as its new CEO, effective September 1, 2024. Dr. Cavey, formerly of Bristol Myers Squibb and Novartis, brings extensive experience in biotech and radiopharmaceuticals. He will lead ITM's strategic expansion in radiopharmaceuticals and medical isotopes, succeeding Steffen Schuster, who will join the Supervisory Board after twelve years as CEO.
Full Article: ITM Isotope Technologies Munich SE Appoints Dr. Andrew Cavey as CEO
Bristol Myers Squibb Clinical Trial Updates, Jun 21, 2024
Bristol Myers Squibb has received FDA accelerated approval for KRAZATI (adagrasib) in combination with cetuximab to treat KRASG12C-mutated advanced colorectal cancer that has not responded to previous chemotherapies. This decision follows positive Phase 1/2 study results showing a 34% response rate, with responses lasting approximately 5.8 months. KRAZATI is the first KRASG12C inhibitor approved for colorectal cancer beyond lung cancer, offering a new therapeutic option for patients facing limited treatment choices.
Starton Therapeutics Positive Trial Data, Jun 22, 2024
Starton Therapeutics reported positive interim results from its Phase 1b trial of low-dose lenalidomide (STAR-LLD) in multiple myeloma. Given via continuous subcutaneous infusion with dexamethasone and bortezomib, all six patients achieved at least a partial response within 1-3 cycles, meeting safety and tolerability goals. STAR-LLD demonstrated lower toxicity compared to oral lenalidomide, potentially offering a better tolerated treatment option for patients with intolerances.
Full Article: Starton Therapeutics Reports Positive Interim Results from Phase 1b Trial of STAR-LLD in Multiple Myeloma
