Sonnet BioTherapeutics - Clinical Trial Updates, May 20, 2024
Sonnet BioTherapeutics announced that their Phase 1 trials for SON-1010, a recombinant human interleukin-12 therapy, have safely dosed 61 subjects without dose-limiting toxicity. SON-1010 demonstrated a tenfold increase in half-life and prolonged IFNγ responses without cytokine release syndrome. At four months, 35% of patients showed clinical benefits. Both the SB101 monotherapy and SB221 combination with atezolizumab have advanced safely, leading to increased target doses to enhance efficacy. Further updates are expected early next year.
Full Article: Sonnet BioTherapeutics Announces Updated Clinical Data for SON-1010 as Monotherapy or Combined with an Anti-PD-L1 Along with an Increase in the Dose Escalation Target
Immunome - Acquisitions, May 20, 2024
Immunome announced the acquisition of antibodies and related assets from Atreca, Inc. for $5.5 million upfront, with potential milestone payments of up to $7 million. This acquisition includes 28 antibodies, enhancing Immunome’s antibody-drug conjugate (ADC) portfolio. Chief Scientific Officer Jack Higgins stated that these antibodies will bolster their pursuit of novel cancer targets. President and CEO Clay Siegall emphasized that this purchase accelerates their efforts to develop innovative cancer therapies.
Full Article: Immunome Announces Completion of Purchase of Assets from Atreca
AstraZeneca - Corporate Expansion, May 20, 2024
AstraZeneca plans to invest $1.5 billion in building a manufacturing facility in Singapore for antibody drug conjugates (ADCs), with support from the Singapore Economic Development Board (EDB). This move aims to enhance the global supply of ADCs, marking AstraZeneca's first end-to-end ADC production site. The investment reflects confidence in Singapore's biopharmaceutical manufacturing capabilities and aligns with AstraZeneca's commitment to sustainability by aiming for zero carbon emissions from the facility's first day of operations.
Full Article: AstraZeneca to Manufacture ADCs in Singapore
Faron Pharma - Positive Trial Data, May 20, 2024
Faron Pharmaceuticals announced positive phase 2 results from their ongoing Bexmab trial for myelodysplastic syndrome (MDS), confirming promising clinical activity, particularly in median survival after HMA failure. The trial builds on positive phase 1 findings, showing a high overall response rate among HMA-failed MDS patients treated with bexmarilimab + azacitidine. These results suggest the potential of bexmarilimab to fill a crucial clinical gap in managing MDS patients, pending further validation.
Full Article: Faron Pharma Celebrates Positive Read-Out in Ongoing MDS Trial
Imvax - Clinical Trial Updates, May 21, 2024
Imvax has completed enrollment in its Phase 2b trial of IGV-001 for newly diagnosed glioblastoma (ndGBM), with top-line data expected by mid-2025. The FDA granted Fast Track designation to IGV-001 based on promising Phase 1b results. The company also closed a $35 million financing round, ensuring support for trial completion and beyond. CEO John P. Furey highlighted the potential of IGV-001 to address the critical unmet need in GBM treatment.
Full Article: Imvax Announces Completion of Enrollment in Phase 2b Clinical Trial of IGV-001 and Successful Financing
Dragonfly Therapeutics - Collaboration, May 21, 2024
Dragonfly Therapeutics announced a collaboration with Merck to study its EGFR immune engager, DF9001, alongside Keytruda in advanced solid tumors expressing EGFR. The trial will expand Dragonfly's ongoing Phase I study of DF9001, aiming to enhance immunotherapy benefits by engaging both natural killer cells and CD8+ T cells. Treatment is expected to begin in Q4 2024, focusing on non-small cell lung cancer, renal cell cancer, and head and neck cancer as a second-line treatment for EGFR-expressing tumors. Dragonfly CEO Bill Haney expressed optimism about the potential for potent anti-tumor activity with this combination therapy.
Full Article: Dragonfly Therapeutics Study DF9001 Keytruda EGFR-Expressing Solid Tumors
Ractigen Therapeutics - FDA Fast Track, May 21, 2024
The FDA granted Fast Track Designation to RAG-01, a first-of-its-kind small activating RNA therapy for BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), developed by Ractigen Therapeutics. RAG-01 activates the tumor suppressor gene p21 and is administered via intravesical instillation. Clinical trials, including a phase 1 trial in Australia with GenesisCare, aim to assess safety, tolerability, and efficacy, with completion expected by June 30, 2025.
Full Article: FDA Grants Fast Track Designation to RAG-01 in NMIBC
Pheon Therapeutics - Series B Investments, May 21, 2024
Pheon Therapeutics secured $120 million in Series B financing led by TCGX, with participation from BVF Partners, Lightspeed, Perceptive Advisors, and existing investors. The funding will advance their pipeline of next-generation Antibody-Drug Conjugates (ADCs) targeting an undisclosed tumor target. CEO Cyrus Mozayeni plans to start the first Phase 1 clinical trial in 2024, emphasizing the potential therapeutic benefits for patients. Cariad Chester from TCGX will join Pheon's board of directors as part of the financing.
Full Article: Pheon Therapeutics Announces $120M Series B Financing to Fund Development of Its Differentiated ADC Pipeline
Aktis Oncology & Lilly - Collaboration, May 21, 2024
Aktis Oncology and Eli Lilly have joined forces for targeted anticancer radiopharmaceuticals, with Aktis receiving an upfront payment of $60 million plus potential milestone payments of up to $1.1 billion and royalties. Leveraging Aktis' miniprotein technology, Lilly gains global rights to select radiopharma therapeutics and diagnostics, focusing on precise cancer targeting with reduced side effects, particularly in urothelial and Nectin-4-associated cancers. Lilly's undisclosed equity investment in Aktis aligns with significant Big Pharma investments in the radiopharmaceutical space.
Full Article: Lilly Inks Potential $1.1B Radiopharma Deal with Aktis Oncology
Nurix Therapeutics - Executive Changes, May 21, 2024
David L. Lacey, M.D., steps down as chair of Nurix Therapeutics' board of directors after five years, with Julia P. Gregory unanimously elected as the new chair. Dr. Lacey will continue serving on the board and as chair of the Compensation Committee. Nurix's CEO, Arthur T. Sands, M.D., Ph.D., praises Dr. Lacey's contributions, while Ms. Gregory expresses gratitude for her predecessor's leadership and vows to continue advancing the company's mission of developing breakthrough drugs for patients.Full
Full Article: Nurix Therapeutics Announces Board Chair Transition
Roche - Breakthrough Therapy Designation, May 21, 2024
Roche receives breakthrough therapy designation from the FDA for its breast cancer therapy inavolisib, following positive results from the Phase III INAVO120 trial. The study showed a 57% improvement in progression-free survival when inavolisib was combined with Ibrance and Faslodex compared to Faslodex alone. Inavolisib, an oral PI3K inhibitor, targets the PI3K/Akt/mTOR pathway to suppress cancer progression. Roche is also investigating the drug in other combinations in Phase III trials.
Full Article: Roche's PI3K Inhibitor Secures Breakthrough Status in Breast Cancer
Exscientia, May 21, 2024Company Downsizing
Exscientia is cutting 20-25% of its workforce to save $40 million annually starting in 2025, while maintaining its existing drug pipeline. Severance costs are estimated at $7.4 to $9.6 million. The company has $416.9 million in cash, extending its runway into 2027. This follows the firing of CEO Andrew Hopkins for inappropriate relationships, contributing to reduced administrative expenses.
Full Article: Exscientia Cuts Quarter Staff While Preserving AI-Generated Pipeline
Genmab - Acquisitions, May 21, 2024
Genmab completes a USD 1.8 billion cash acquisition of ProfoundBio, gaining access to its clinical candidates and ADC technology platforms. This strengthens Genmab's oncology portfolio, particularly with Rina-S, a promising FRα-targeted ADC, advancing its goal of innovating antibody medicines.
Full Article: Genmab Completes Acquisition of ProfoundBio
Indaptus Therapeutics - Clinical Trial Updates, May 22, 2024
Indaptus Therapeutics announced the successful advancement of its Phase 1 trial for Decoy20, a novel cancer immunotherapy, with the first patient dosed in the multi-dose portion. This stage aims to determine the safety and initial efficacy of Decoy20 across various cancers. Decoy20, composed of attenuated Gram-negative bacteria, activates both innate and adaptive immune systems without intolerable adverse effects. This advancement marks a significant milestone, promising a first-in-class treatment for advanced solid tumors.
Full Article: Indaptus Therapeutics Announces Completion of First Patient to Receive Multiple Doses of Decoy20
Xenetic Biosciences - Executive Changes, May 22, 2024
Xenetic Biosciences appoints James Parslow, CFO, as interim CEO, emphasizing focus on advancing immune-oncology pipeline for hard-to-treat cancers, aiming for first-in-human clinical study and extending cash runway.
Full Article: Xenetic Biosciences Inc. Announces Executive Leadership
Sensei Biotherapeutics - Positive Trial Data, May 23, 2024
Sensei Biotherapeutics' Phase 1/2 trial of SNS-101 showed promising results, with the drug well-tolerated and no dose-limiting toxicities. Encouraging clinical activity was observed in hard-to-treat cancers, including microsatellite stable colorectal and endometrial cancers. The drug demonstrated favorable pharmacokinetics and dose-dependent T-cell changes. The trial will continue to the dose expansion phase, with more data expected by the end of 2024.
Full Article: Sensei Biotherapeutics Presents Promising Clinical Data from Phase 1 Dose Escalation Study of SNS-101
Aulos Bioscience - Positive Trial Data, May 23, 2024
Aulos Bioscience reported interim Phase 1/2 trial results for AU-007, an AI-designed monoclonal antibody for cancer. The trial showed AU-007 is well-tolerated and effective, with significant tumor shrinkage in several cancers. AU-007 also demonstrated favorable pharmacodynamics and pharmacokinetics. Further data will be presented at the ASCO 2024 Annual Meeting, with more results expected in late 2024.
Full Article: Aulos Bioscience Provides Positive Interim Phase 1/2 Data From AU-007 at 2024 ASCO Annual Meeting
Tango Therapeutics - Fail Trial Results, May 23, 2024
Tango Therapeutics announced the discontinuation of its TNG348 program due to liver toxicity observed in patients during the Phase 1/2 trial. Despite this setback, the company will reallocate resources to its existing portfolio, particularly the PRMT5 program. Tango Therapeutics remains committed to providing a clinical update on TNG908 and TNG462 later this year.
Full Article: Tango Therapeutics Announces Discontinuation of TNG348 Program
Radar Therapeutics - Seed Funding, May 23, 2024
Radar Therapeutics has closed an oversubscribed $13.4 million seed financing round led by NfX Bio, with support from major investors like Eli Lilly and Company and Biovision Ventures. The funding will bolster Radar's development of programmable genetic and mRNA-based therapeutics, aiming to enable precise and targeted drug delivery. Their technology, utilizing RNA sensors to control payload expression, offers potential advancements in mRNA.
Full Article: Radar Therapeutics Raises $13.4M Seed Funding
Affimed - Positive Trial Data, May 23, 2024
Affimed announced positive results from its AFM24-102 study in EGFR wild-type non-small cell lung cancer (NSCLC) patients. In 15 response-evaluable patients treated with AFM24 and atezolizumab, the disease control rate was 73.3%, including one complete and three partial responses. Median progression-free survival was 5.9 months. The combination therapy was well tolerated. Detailed data will be presented at the ASCO Annual Meeting on June 1, 2024, with a conference call/webcast to follow. Affimed is enrolling more patients in both EGFR wild-type and mutant NSCLC cohorts.
Full Article: Affimed Announces Positive Early Efficacy and Progression-Free Survival Results of AFM24-102 Study in EGFR Wild-Type Non-Small Cell Lung Cancer
Shanghai Juncell Therapeutics - Positive Trial Data, May 24, 2024
Shanghai Juncell Therapeutics presented their latest clinical research results on GC203, a novel TIL therapy engineered with membrane-bound IL-7, at the ASCO Annual Meeting. Tested on recurrent ovarian cancer patients without aggressive lymphodepletion, GC203 demonstrated promising safety and efficacy profiles, with most adverse events being mild and manageable. The Objective Response Rate was 33.3%, with a Disease Control Rate of 83.3% and a 12-month Overall Survival rate of 68.8%.
Full Article: Juncell Therapeutics Announces Clinical Data of GC203 TIL Therapy in Ovarian Cancer at ASCO 2024
Eli Lilly - Corporate Expansion, May 24, 2024
Eli Lilly and Company is doubling down on its Lebanon, Indiana manufacturing site with a $5.3 billion investment, aiming to increase capacity for medications like Zepbound® and Mounjaro®. This is part of Lilly's $16 billion commitment to new manufacturing sites since 2020. The expansion will create high-wage jobs and address unmet needs in type 2 diabetes and obesity. Operations are expected to start in Lebanon by late 2026.
Full Article: Lilly Increases Manufacturing Investment to $9 Billion
Obsidian Therapeutics - Positive Trial Data, May 24, 2024
Obsidian Therapeutics announced positive safety and efficacy data from its first-in-human study of OBX-115, an engineered TIL cell therapy with membrane-bound IL15, in patients with ICI-resistant advanced melanoma. Presented at the 2024 ASCO Annual Meeting, the single-center study showed no dose-limiting toxicities and limited severe adverse events. Updated efficacy data will be detailed by Dr. Rodabe Amaria. Additionally, Obsidian is enrolling patients in a Phase 1/2 multicenter study for metastatic melanoma and NSCLC.
Full Article: Obsidian Therapeutics Announces Positive Clinical Data
