Obsidian Therapeutics - FDA Fast Track, Jul 28, 2024
The FDA granted fast track designation to OBX-115, an engineered T-cell therapy for advanced melanoma resistant to PD-1/PD-L1 inhibitors. In a phase 1 trial, it achieved a 44.4% objective response rate and 100% disease control rate, with no severe adverse events. The therapy includes membrane-bound IL-15, eliminating the need for IL-2.
Full Article: FDA grants fast track designation to OBX-115 for advanced melanoma
Scorpion Therapeutics - Series C Investment, Jul 29, 2024
Scorpion Therapeutics secured $150 million in Series C financing co-led by Frazier Life Sciences and Lightspeed Venture Partners. The funds will advance its pipeline, including the PI3Kα inhibitor STX-478, EGFR inhibitors STX-721 and STX-241, and other precision oncology therapies. Shelley Chu and Albert Cha will join the board.
Full Article: Scorpion Therapeutics raises $150 million for enhancing clinical-stage precision oncology pipeline
Boehringer Ingelheim - Acquisitions, Jul 29, 2024
Boehringer Ingelheim has acquired Nerio Therapeutics Inc. for up to USD 1.3 billion to enhance its immuno-oncology pipeline. Nerio’s small molecules target protein tyrosine phosphatases N1 and N2 (PTPN1/2), acting as immune checkpoints to potentially boost the immune system’s ability to fight cancer. This acquisition is expected to expand Boehringer Ingelheim’s portfolio, offering new combination therapy opportunities and advancing their goal of improving cancer treatment outcomes.
Full Article: Boehringer Ingelheim acquires Nerio Therapeutics
BioNTech and Regeneron - Positive Trial Data, Jul 30, 2024
BioNTech and Regeneron’s investigational mRNA cancer immunotherapy BNT111, combined with Libtayo, achieved its primary efficacy endpoint in a Phase II trial for advanced melanoma, showing significant improvement over historical controls. Both treatments were effective individually and well-tolerated. The results position BioNTech and Regeneron to compete with Merck and Moderna, who are testing their own cancer vaccine mRNA-4157/V940 with Keytruda.
Full Article: BioNTech and Regeneron’s mRNA cancer vaccine combo clears Phase II in melanoma
RS Oncology - Positive Trial Data, Jul 30, 2024
RS Oncology presented positive Phase 1 results for its drug RSO-021 at the 2024 ASCO Annual Meeting. In patients with Malignant Pleural Mesothelioma and Malignant Pleural Effusion, RSO-021 was well tolerated at 90 mg, showing minimal systemic exposure. Efficacy data revealed a partial response in one patient and encouraging survival in seven out of ten evaluable patients, with promising responses in other metastatic cancers. Phase 2 trials are ongoing.
Full Article: RS Oncology announces positive data from a Phase 1 clinical trial of RSO-021
LTZ Therapeutics - Series A Investment, Jul 30, 2024
LTZ Therapeutics, an immunotherapy-focused biotech company, completed a Series A financing round of over $20 million, led by Lapam Capital and GL Ventures, with continued support from K2 Venture Partners and Shunwei Capital, bringing its total funding to around $50 million since 2022. The funds will advance the development of LTZ's Myeloid Engager pipeline, including initiating Phase 1 trials for LTZ-301 and IND-enabling work for LTZ-232. LTZ aims to enhance anti-tumor immunity by engaging macrophages in the tumor microenvironment, leveraging reverse translational research to improve cancer and autoimmune disease treatments.
Full Article: LTZ Therapeutics announces over $20 million Series A financing
Pfizer - Company Updates, Jul 30, 2024
In Q2 2024, Pfizer's oncology revenue rose 26% to $3.96 billion, driven by Seagen products. Despite a 9% drop in Ibrance sales, other drugs like Lorbrena and Braftovi/Mektovi saw gains. Net income dropped due to $1.3 billion in restructuring costs and a $230 million charge for discontinuing its Duchenne muscular dystrophy program. Pfizer expects to save $1.5 billion by 2027 and updated its 2024 revenue forecast to $59.5-$62.5 billion.
Full Article: Pfizer oncology product revenues jump 26 percent Q2
Georgiamune - Clinical Trial Updates, Jul 31, 2024
Georgiamune has initiated a Phase I/II trial for its oncology drug candidate GIM-531, designed to address cold tumors and resistance to PD1 inhibitors. The trial will involve 84 patients with advanced solid tumors, focusing on safety, pharmacokinetics, pharmacodynamics, and early anti-tumor activity in its first phase. The second phase will further explore GIM-531 as a single agent and as a rescue therapy for patients unresponsive to anti PD-1 treatments.
Full Article: Georgiamune advances second oncology trial
FibroGen - Company Downsizing, Jul 31, 2024
FibroGen is restructuring, laying off 75% of its U.S. staff and halting investment in pamrevlumab after two late-phase pancreatic cancer trials failed. Following previous workforce reductions due to pamrevlumab's failures in other indications, CEO Thane Wettig had anticipated this outcome. The company is now focusing on earlier-stage candidates, with FG-3246, a CD46-directed antibody-drug conjugate, as the most advanced. Investor skepticism remains high, reflected in a 45% drop in stock value.
Full Article: FibroGen lays off 75% of U.S. staff, asset flunks 2 more trials
Third Arc Bio - Series A Investment, Jul 31, 2024
Third Arc Bio, a biotech firm specializing in multifunctional antibodies for cancer and autoimmune diseases, secured $165 million in Series A financing. The funds will advance their drug development programs, with clinical trials starting in early 2025. Led by CEO Peter Lebowitz and a seasoned team, Third Arc Bio aims to deliver best-in-class therapies leveraging T cell biology.
Full Article: Biotech company Third Arc Bio receives $165 million in financing
FibroGen - Fail Trial Results & Company Downsizing, Jul 31, 2024
FibroGen is suspending pamrevlumab's development and laying off 75% of its US workforce after two Phase III trials failed to meet primary endpoints for pancreatic cancer. This follows previous failures in Duchenne muscular dystrophy, leading to a 40% drop in FibroGen's shares.
Full Article: FibroGen axes 75% of staff after lead cancer therapy fails in Phase III trials
GeoVax - Clinical Trial Updates, Jul 31, 2024
GeoVax Labs, Inc. plans to advance its Gedeptin® cancer therapy to a Phase 2 clinical trial following a positive review of the Phase 1b/2a trial results. The new trial will evaluate the efficacy of Gedeptin combined with an immune checkpoint inhibitor in treating first-recurrence squamous cell head and neck cancer, with activation expected in the first half of 2025.
Full Article: GeoVax announces Phase 2 plans for Gedeptin cancer therapy following clinical advisory committee review
Daiichi Sankyo and Merck - Clinical Trial Updates, Aug 1, 2024
Daiichi Sankyo and Merck have dosed the first patient in the IDeate-Lung02 Phase 3 trial, assessing ifinatamab deruxtecan (I-DXd) in relapsed small cell lung cancer (SCLC). This B7-H3 directed DXd antibody-drug conjugate aims to improve outcomes for SCLC, a rapidly progressing cancer with a 5-year survival rate of just 3%. The trial follows promising Phase 1/2 results and represents a key milestone in the Daiichi Sankyo-Merck collaboration, which also includes the REJOICE-Ovarian01 study for raludotatug deruxtecan.
Full Article: IDeate-Lung02 Phase 3 trial of ifinatamab deruxtecan initiated in patients with relapsed small cell lung cancer
Kiromic BioPharma - Positive Trial Data, Aug 1, 2024
Kiromic BioPharma, Inc. reported positive eight-month follow-up results from the first patient in its Deltacel-01 Phase 1 trial for stage 4 metastatic non-small cell lung cancer (NSCLC). The patient's tumor size decreased by 20% with no new lesions, showing eight-month progression-free survival. This follows a 13% reduction at six months. Additional results from other patients are expected in August.
Full Article: Kiromic BioPharma reports 20% tumor size reduction at eight months in first patient enrolled in Deltacel-01
PDS Biotechnology - Clinical Trial Updates, Aug 1, 2024
PDS Biotechnology Corporation received FDA feedback on its Phase 3 trial for Versamune® HPV, an immunotherapy for HPV16-positive head and neck cancer. The FDA supported the trial’s revised design, including new drug combinations, and granted Fast Track designation. The company is set to start enrollment in the updated VERSATILE-003 trial.
Full Article: PDS Biotechnology aligns with FDA on Phase 3 trial in HPV16-positive first-line recurrent or metastatic head and neck cancer
Context Therapeutics - C-Suite Changes, Aug 1, 2024
Context Therapeutics appointed Dr. Claudio Dansky Ullmann as Chief Medical Officer and Karen Andreas as Vice President of Clinical Operations to advance its T cell engaging assets, CTIM-76 and CT-95, into Phase 1 trials. The company also acquired cancer therapy candidate CT-95 and secured $100 million in private placement funds, extending its cash runway into 2028.
Full Article: Context Therapeutics bolsters leadership for cancer trials
Adaptimmune - Clinical Trial Updates, Aug 2, 2024
Adaptimmune’s Tecelra (afami-cel) has gained accelerated FDA approval as the first engineered cell therapy for a solid tumor, targeting metastatic or unresectable synovial sarcoma. This approval, based on a trial showing a 43% response rate, marks a major milestone for the company and cell therapy in solid tumors. Tecelra, priced at $727,000, offers a new treatment option for patients with limited alternatives. Adaptimmune plans to expand treatment centers across the US.
Full Article: Adaptimmune scores FDA nod for first engineered cell therapy in solid tumor
