Sanofi - Company Updates, Aug 5, 2024
Sanofi will invest up to €1.5 billion in its Frankfurt site for Lantus production, bolstering Germany's economy. Daiichi Sankyo and Eli Lilly also announced significant investments in German research and manufacturing facilities. These moves underscore Germany's attractiveness as a pharmaceutical hub, promising job creation and improved healthcare. Sanofi reported strong Q1 2024 results, driven by robust sales of Dupixent and other drugs.
Full Article: Sanofi eyes €1.5 billion investment in insulin drug plant in Germany
BioNTech - Company Updates, Aug 5, 2024
BioNTech reported a significant increase in second-quarter losses, reaching €807.8 million, compared to €190.4 million the previous year, primarily due to a sharp decline in COVID-19 vaccine sales. Quarterly revenue dropped 23% to €128.7 million. BioNTech is shifting its focus towards new cancer treatments, with 90% of its R&D budget now dedicated to oncology and mRNA projects, aiming for its first oncology launch in 2026. Despite the losses, the company remains committed to its long-term growth strategy, supported by its strong financial position.
Full Article: BioNTech widens loss to €807.8 million in Q2 2024
iTeos Therapeutics - C-Suite Changes, Aug 5, 2024
iTeos Therapeutics has appointed David Feltquate, M.D., Ph.D., as Chief Medical Officer to lead clinical development and regulatory strategies. With nearly 20 years of experience in immuno-oncology at Palleon Pharmaceuticals, Novartis, and Bristol Myers Squibb, Dr. Feltquate is set to play a key role as iTeos advances its TIGIT franchise and oncology pipeline. He expressed enthusiasm about joining iTeos during this pivotal period.
Full Article: iTeos Therapeutics announces appointment of David Feltquate as Chief Medical Officer
Ultimovacs - Fail Trial Results, Aug 6, 2024
Ultimovacs' cancer vaccine UV1 failed to meet primary or secondary endpoints in the Phase II FOCUS trial, showing no improvement in progression-free or overall survival in PD-L1 positive head and neck squamous cell carcinoma patients when combined with pembrolizumab. Despite this, Ultimovacs remains focused on its broad clinical development program, with results from the Phase II DOVACC trial in ovarian cancer expected next year.
Full Article: Ultimovacs cancer vaccine fails to meet endpoints in Phase II FOCUS trial
Nammi Therapeutics - Series B Investments, Aug 6, 2024
Nammi Therapeutics announced a $1M investment from the Myeloma Investment Fund (MIF) as part of a $30M Series B round, ahead of a Phase 1 study of their lead program, QXL138AM, for advanced solid tumors and multiple myeloma. QXL138AM is a Masked Immunocytokine targeting the CD138 protein on tumor cells, demonstrating significant preclinical efficacy and securing Orphan Drug Designation from the FDA. This investment will help advance QXL138AM's development, with Nammi anticipating a fully subscribed Series B round upon treating the first patient.
Full Article: Nammi Therapeutics completes Series B round with $1M investment
Compass Therapeutics - Clinical Trial Updates, Aug 6, 2024
Compass Therapeutics announced the completion of enrollment for its Phase 2/3 COMPANION-002 trial of CTX-009 in 150 patients with biliary tract cancers (BTC). They also announced a new trial at MD Anderson Cancer Center to evaluate CTX-009 in first-line BTC treatment. COMPANION-002 compares CTX-009 plus paclitaxel to paclitaxel alone, focusing on overall response rate and other key outcomes.
Full Article: Compass Therapeutics completes patient enrollment in COMPANION-002 trial
Elevation Oncology - Positive Trial Data, Aug 7, 2024
Elevation Oncology announced promising initial data from the dose escalation portion of their ongoing Phase 1 trial of EO-3021, a selective cancer therapy targeting Claudin 18.2-expressing tumors, including gastric, gastroesophageal junction (GEJ), pancreatic, and esophageal cancers. The trial showed EO-3021 to be well-tolerated with no severe treatment-related adverse events, and it demonstrated a 42.8% objective response rate in patients with high Claudin 18.2 expression. The company plans to advance to the dose expansion phase and explore combination therapies, aiming to further evaluate EO-3021’s efficacy and safety, with additional data expected in the first half of 2025.
Full Article: Elevation Oncology announces promising initial data from Phase 1 clinical trial evaluating EO-3021
ALX Oncology - Executive Changes, Aug 7, 2024
ALX Oncology Holdings appointed Alan Sandler, M.D., to its Board of Directors, bringing over 30 years of oncology expertise to support the advancement of evorpacept. Jaume Pons, Ph.D., and Sophia Randolph, M.D., Ph.D., resigned from the Board to focus on their roles as President and Chief Scientific Officer, and Chief Medical Officer, respectively, aiding the company's clinical development.
Full Article: ALX Oncology appoints Alan Sandler, M.D., to Board of Directors
Precigen - Company Downsizing, Aug 7, 2024
Precigen is cutting its workforce by 20% and pausing several programs to focus on commercializing its PRGN-2012 gene therapy for recurrent respiratory papillomatosis (RRP). The company plans to raise $30 million through a stock offering to fund this shift, including a BLA submission for PRGN-2012 in late 2024. All other programs, except PRGN-2009 and PRGN-3006 trials, will be suspended, and its ActoBio subsidiary will be closed.
Full Article: Precigen cuts workforce by 20% to focus on gene therapy for benign tumors
IDRx - Series B Investment, Aug 7, 2024
IDRx, a clinical-stage biopharma company focused on precision cancer therapies, completed an oversubscribed $120 million Series B financing led by RA Capital Management, Commodore Capital, and Blackstone Multi-Asset Investing. The funds will support the ongoing Phase 1/1b StrateGIST 1 study of IDRX-42, a selective KIT inhibitor for GIST, and the initiation of a pivotal study in 2025. Recently granted Fast Track designation by the FDA, IDRX-42 showed promising preliminary Phase 1 data, including a 43% objective response rate in second-line GIST patients.
Full Article: IDRx announces $120 million Series B financing to advance potential best-in-class new treatment for GIST
Angiex - Clinical Trial Update, Aug 7, 2024
Angiex has announced the dosing of the first patient in its Phase 1 clinical trial for AGX101, a novel TM4SF1-directed antibody-drug conjugate (ADC) developed for treating solid cancers. AGX101 targets the TM4SF1 protein, which is highly expressed in tumor cells and vasculature but limited in normal tissue, allowing the drug to deliver chemotherapeutic payloads directly to the nucleus of cancer cells. The trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of AGX101 in solid tumor patients, with dose escalation and expansion phases planned.
Full Article: Angiex announces first patient dosed in Phase 1 clinical trial of AGX101
Merck - Fail Trial Result, Aug 8, 2024
Merck halted its Phase 3 trial of a TIGIT-targeting drug due to poor results, while Intellia's CRISPR therapy NTLA-2002 met all goals in a Phase 2 trial for hereditary angioedema. Cabaletta Bio faced a serious side effect in a lupus trial, but the study will continue. Vertex secured NHS England reimbursement for its CRISPR therapy Casgevy for beta thalassemia.
Full Article: Merck halts Phase 3 TIGIT trial due to poor results
Merck - Clinical Trial Updates, Aug 8, 2024
Merck halted its Phase 3 KeyVibe-008 trial for a vibostolimab-pembrolizumab combination in lung cancer due to poor survival outcomes and higher adverse events. The company will offer alternative treatments and continues to explore new lung cancer therapies.
Full Article: Merck provides update on Phase 3 KeyVibe-008 trial
Prana Thoracic - Series A Investment, Aug 9, 2024
Prana Thoracic, a Houston-based medtech startup focused on lung cancer intervention, raised $3M in a Series A extension, bringing total funding to $9M. The funds, led by cultivate(MD), GenHenn Capital, and others, will support product development and advance clinical and regulatory plans. The company, led by CEO Joanna Nathan, aims to revolutionize lung cancer treatment with its image-guided, minimally invasive Prana System.
Full Article: Prana Thoracic raises $3M Series A extension
