Nimbus Therapeutics - Executive Changes, May 7, 2024
Nimbus Therapeutics has named Dr. Anita Scheuber as Senior VP, Therapeutic Area Head, Oncology. With over 15 years of oncology clinical development experience, Dr. Scheuber will lead clinical strategy, including advancing ongoing programs targeting HPK1 and WRN. Her appointment reflects MorphoSys's commitment to expanding its oncology focus and developing transformative medicines. Dr. Scheuber looks forward to driving momentum in the oncology programs, citing promising data from the HPK1 trial and the potential of the WRN program.
Full Article: Nimbus Therapeutics appoints Anita Scheuber MD, PhD as Senior VP
Context Therapeutics - FDA Approval, May 7, 2024
Philadelphia-based Context Therapeutics received FDA clearance to start Phase 1 clinical trials for its Investigational New Drug (IND) CTIM-76, a bispecific antibody targeting Claudin 6 for gynecologic and testicular cancers. CEO Martin Lehr expressed optimism about the therapy's potential, with the Phase 1 trial expected to enroll up to 70 patients to evaluate safety, efficacy, and pharmacokinetics. Context focuses on solid tumor treatments, and CTIM-76 also holds promise for lung and gastric cancers based on preclinical research.
Full Article: Context Therapeutics receives FDA approval for clinical trials of cancer drug
Memo Therapeutics - Series C Investment, May 7, 2024
Memo Therapeutics has raised CHF 20 million, extending its Series C financing to CHF 45 million, to advance the clinical development of its lead asset, AntiBKV, a BKV-neutralizing antibody for kidney transplant recipients. The funding will expand the Phase II trial, making it the largest therapeutic study for BK viremia, a condition that threatens over 20,000 of the 100,000 annual kidney transplant patients worldwide. With initial data expected in 2025 and FDA fast track status, MTx aims to address the unmet need for BK virus treatments. New investors Ysios Capital and Kurma Partners joined the round, endorsing MTx's innovative B-cell screening platform and commitment to breakthrough medicines.
Full Article: Memo Therapeutics increases Series C financing to CHF 45 million
Allarity Therapeutics - Conversion of Securities, May 7, 2024
Allarity Therapeutics, Inc. announced the simplification of its capital structure through the recent conversion of all outstanding Series A Preferred Stock into common stock, alongside the conversion of 93% of its outstanding warrants. Following this, only a limited number of warrants remain unexercised. CEO Thomas Jensen highlighted the milestone's significance in streamlining financial architecture and potentially enhancing stock attractiveness. This development allows the company to focus more on sharing information about its lead asset, stenoparib, rather than explaining complex capital structures to investors.
Full Article: Allarity Therapeutics announces Series A preferred stock conversion
Enveric Biosciences - License Deal, May 8, 2024
Enveric Biosciences has inked a non-binding term sheet with an undisclosed biotech company for an exclusive license to two patented methods targeting breast cancer and other cancers. These methods combine cannabinoids with chemotherapeutic drugs. The licensee will handle future development and pay Enveric a License Execution Fee, milestones up to $61 million, and royalties on future sales. Enveric's CEO expressed optimism about the partnership's potential for promising cancer treatments, highlighting the company's commitment to innovation and discovery.
Full Article: Enveric Biosciences inks $61M license deal for cancer treatments
Janux Therapeutics - Financial Results, May 8, 2024
Janux Therapeutics Inc. released its financial results for Q1 2024, reporting a net loss of $14.8 million, an improvement from the previous year. Despite missing revenue estimates, the company generated $1.25 million in collaboration revenue. Janux's cash reserves significantly increased to $651.8 million, providing a strong foundation for its ongoing research and development efforts. Research and development expenses slightly decreased to $14.1 million, while general and administrative expenses rose to $7.3 million. The company is actively enrolling participants for its clinical studies targeting prostate cancer and solid tumors, with updates expected in the second half of 2024 and 2025, respectively.
Full Article: Janux Therapeutics reports financial results for Q1 2024
Oregon Therapeutics & Lantern Pharma - Collaboration, May 8, 2024
Lantern Pharma and Oregon Therapeutics are teaming up to optimize the development of XCE853, a promising protein disulfide isomerase (PDI) inhibitor drug candidate for cancer. Using Lantern's RADR AI platform, they aim to identify biomarkers and efficacy-associated signatures of XCE853 across solid tumors, guiding precision development and patient selection. This collaboration aims to overcome complexities associated with PDI inhibitors, leveraging computational tools to inform future clinical trials and explore combination therapies.
Full Article: Oregon Therapeutics and Lantern Pharma launch AI collaboration for cancer drug development
Attovia Therapeutics - Series B Investments, May 9, 2024
Attovia Therapeutics has closed a $105 million oversubscribed Series B financing, bringing its total capital raised to $165 million since its launch in June 2023. The funds will advance its lead programs, ATTO-1310 and ATTO-002, through initial clinical data readouts, expand its immunology and inflammation pipeline, and further develop the ATTOBOD platform. The Series B round was led by Goldman Sachs Alternatives, with participation from new and existing investors. Colin Walsh, Ph.D., from Goldman Sachs Alternatives, joins the Board of Directors. CEO Tao Fu highlighted the support's significance for advancing their differentiated pipeline and proprietary platform.
Full Article: Attovia Therapeutics raises $105 million in Series B financing
Merck - Fail Trial Results, May 9, 2024
Merck's Keytruda therapy, combined with chemotherapy, did not meet the main goal of disease-free survival in a late-stage trial involving patients with high-risk endometrial cancer. While the trial did not formally test the overall survival goal, it failed to demonstrate significant disease-free survival. Endometrial cancer, affecting the inner lining of the uterus, is the most common type of uterine cancer. Keytruda, a PD-1 inhibitor, aims to enhance the body's immune system to combat tumor cells and is approved for certain endometrial cancer indications in the US, including in combination with Eisai's drug Lenvima.
Full Article: Merck's Keytruda fails late-stage trial for endometrial cancer
Takeda Pharmaceuticals - Restructuring, May 9, 2024
Takeda plans a significant restructuring to improve profitability, aiming to simplify its workforce, cut expenses, and focus on lucrative late-stage drug assets following a decline in operating profit due to patent expirations. The company intends to incur around $900 million in restructuring costs in the coming fiscal year, with a strategy to enhance core operating profit margins by 1% to 2.5% annually from 2025 onward. This involves trimming early-stage drug programs, investing in data and technology, and reducing external spending. Takeda anticipates a return to revenue and profit growth from the 2025 fiscal year onward, with limited patent risks until the early 2030s.
Full Article: Takeda plans significant restructuring to improve profitability
Pfizer - Restructuring, May 9, 2024
Pfizer is restructuring its newly merged cancer business following its acquisition of Seagen, proposing job cuts at Seagen's European headquarters in Switzerland and canceling the construction of a facility in Washington, affecting 120 employees. The decision stems from an evaluation showing role duplications. Pfizer emphasizes last-resort measures and aims to relocate affected workers while expecting significant revenue growth from the Seagen acquisition in the coming years.
Full Article: Pfizer to restructure newly merged cancer business
Commit Biologics - Seed Funding, May 9, 2024
Commit Biologics has secured €16 million ($17.2 million) in seed funding to develop antibody therapies for cancer and autoimmune diseases using its BiCE platform. Backed by Novo Nordisk's investment arm and Bioqube Ventures, the Danish biotech aims to selectively target cells by engaging the complement system, utilizing established antibodies to expedite development and minimize risks. This novel approach holds significant potential in leveraging the immune system against diseases.
Full Article: Commit Biologics secures €16M in seed funding for antibody therapies
PDS Biotech - Positive Trial Data, May 10, 2024
PDS Biotech's Key Opinion Leader event highlighted positive updates from the VERSATILE-002 trial, showing promising results for Versamune® HPV + KEYTRUDA® in HPV16-positive head and neck cancer. The trial demonstrated a median overall survival of 30 months, surpassing immune checkpoint inhibitors' published results. The company announced a new clinical strategy, featuring a two-part registrational trial for a triple combination therapy involving Versamune® HPV, PDS01ADC, and pembrolizumab.
Full Article: PDS Biotech announces positive trial data for Versamune® HPV + KEYTRUDA
MacroGenics - Company Challenges, May 10, 2024
MacroGenics faced safety challenges in its phase 2 trial, leading to a significant drop in its stock value after reporting five deaths and a high rate of severe adverse events. The trial evaluated two doses of MacroGenics' B7-H3-directed antibody-drug conjugate (ADC) in patients with metastatic castration-resistant prostate cancer. After observing concerning adverse events at higher doses in phase 1, the company reduced the dose for phase 2. Despite earlier positive market response to safety data, the recent announcement caused MacroGenics' stock to plummet by over 70%. CEO Scott Koenig addressed the safety concerns, stating they are manageable, and investigators remain encouraged by the trial's activity data.
Full Article: MacroGenics stock crashes after safety challenges in ADC trial
Fusion Pharmaceutical - Clinical Trial Updates, May 10, 2024
Fusion Pharmaceuticals has initiated the Phase 2 portion of the AlphaBreak trial, dosing the first patient with FPI-2265 for metastatic castration-resistant prostate cancer. This trial aims to evaluate the safety and efficacy of FPI-2265 in patients previously treated with 177Lu-PSMA radiotherapy. The Phase 2 portion is expected to enroll about 60 patients by the end of 2024, with plans for a Phase 3 global registration portion in 2025.
Full Article: Fusion Pharmaceuticals starts Phase 2 of AlphaBreak trial
Fusion Pharmaceutical - Clinical Trial Updates, May 10, 2024
Fusion Pharmaceuticals has initiated the Phase 2 portion of the AlphaBreak trial, dosing the first patient with FPI-2265 for metastatic castration-resistant prostate cancer. This trial aims to evaluate the safety and efficacy of FPI-2265 in patients previously treated with 177Lu-PSMA radiotherapy. The Phase 2 portion is expected to enroll about 60 patients by the end of 2024, with plans for a Phase 3 global registration portion in 2025.
Full Article: Fusion Pharmaceuticals starts Phase 2 trial for FPI-2265 in prostate cancer
SN Bioscience - FDA Fast Track, May 10, 2024
The FDA has granted fast track designation to SNB-101, derived from SN-38 as nanoparticles, for small cell lung cancer (SCLC) treatment, allowing potential accelerated approval following phase 2 trials. In a phase 1 trial, SNB-101 showed promising antitumor activity with a 14.3% objective response rate and manageable adverse effects. Plans for a phase 1b/2a trial combining SNB-101 with immunotherapy are underway. Developers aim to further research SNB-101 in other solid cancer types. SNB-101 previously received orphan drug designation for SCLC and pancreatic cancer.
Full Article: FDA grants fast track designation to SNB-101 in small cell lung cancer
Century Therapeutics - Pipeline Expansion, May 11, 2024
Century Therapeutics announced plans to expand regulatory filings for its NK cell therapy, CNTY-101, beyond systemic lupus erythematosus (SLE) with a $60 million private placement led by Bain Capital Life Sciences. The acquisition of Clade Therapeutics bolsters its pipeline with programs across cancer and autoimmune diseases. With a strong financial position and ongoing Phase 1 trials targeting B-cell lymphoma, Century is poised to advance innovative cell therapies, potentially revolutionizing treatments for autoimmune diseases and cancer.
Full Article: Century Therapeutics expands NK cell therapy filings
