Exelixis announces FDA acceptance of sNDA for cabozantinib in advanced neuroendocrine tumors
- The FDA accepted Exelixis' supplemental New Drug Application (sNDA) for cabozantinib for advanced pancreatic and extra-pancreatic neuroendocrine tumors (NET).
- Cabozantinib received orphan drug designation for pancreatic NET.
- The sNDA is based on the phase 3 CABINET trial, which showed significant improvement in progression-free survival (PFS) for cabozantinib versus placebo.
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025.
Read more
Senhwa Biosciences receives US FDA Study May Proceed letter for Phase I/II study of Silmitasertib
- Senhwa Biosciences received a 'Study May Proceed' letter from the FDA for a Phase I/II study of Silmitasertib (CX-4945).
- The study targets children and young adults with relapsed refractory solid tumors.
- The trial is led by Dr. Giselle Saulnier Sholler and funded by the Four Diamonds Foundation.
- Senhwa plans to apply for Orphan Drug Designation and Rare Pediatric Disease Designation for Silmitasertib.
Read more
Daiichi Sankyo and Merck enter into global development and commercialization agreement for MK-6070
- Daiichi Sankyo and Merck expand their co-development and co-commercialization agreement to include MK-6070, a DLL3 targeting T-cell engager.
- MK-6070 is being evaluated in a phase 1/2 clinical trial for small cell lung cancer (SCLC) and neuroendocrine tumors.
- Merck will receive an upfront payment of $170 million and will handle manufacturing and supply for MK-6070.
- The companies will share R&D and commercialization expenses and profits worldwide, except in Japan where Merck retains exclusive rights.
Read more
IDRx announces $120 million series B financing to advance new treatment for gastrointestinal stromal tumor
- IDRx completed a $120 million Series B financing led by RA Capital Management, Commodore Capital, and Blackstone Multi-Asset Investing.
- Funds will support the ongoing Phase 1/1b StrateGIST 1 study of IDRX-42, a selective KIT inhibitor for KIT-mutant GIST.
- Preliminary Phase 1 data showed a 23% objective response rate (ORR) across all patients and a 43% ORR in second-line patients.
- The FDA granted Fast Track designation to IDRX-42 for GIST treatment after progression on or intolerance to imatinib.
Read more
ImmunityBio announces study of ANKTIVA in combination with AdHER2DC cancer vaccine for endometrial cancer
- ImmunityBio has initiated a Phase 1/2 clinical trial to study ANKTIVA with the AdHER2DC vaccine in HER2-expressing endometrial cancer.
- The trial, sponsored by the National Cancer Institute, will also include pembrolizumab and lenvatinib.
- Phase 1 will determine the recommended dose, while Phase 2 will assess efficacy based on disease progression at six months.
- The study aims to enroll 60 subjects and is expected to be completed in 2026.
Read more
Compass Therapeutics completes patient enrollment in COMPANION-002 trial
- Completed enrollment of 150 patients in the Phase 2/3 COMPANION-002 trial.
- Trial compares CTX-009 plus paclitaxel versus paclitaxel alone in advanced biliary tract cancers.
- Primary endpoint: overall response rate (ORR); secondary endpoints include progression-free survival (PFS) and overall survival (OS).
- Approved an Investigator Sponsored Trial (IST) of CTX-009 in the first-line setting at MD Anderson Cancer Center.
Read more
Pharmacosmos Group to acquire G1 Therapeutics
- Pharmacosmos A/S to acquire G1 Therapeutics for $7.15 per share in cash, totaling approximately $405 million.
- The acquisition aims to enhance access to G1’s COSELA (trilaciclib) for patients with extensive-stage small cell lung cancer (ES-SCLC).
- Pharmacosmos will leverage its expertise in hematology and supportive care to maximize COSELA's availability.
- The transaction is expected to close late in the third quarter of 2024, subject to customary conditions.
Read more
2seventy bio reports second quarter financial results and recent operational progress
- 2seventy bio reported Q2 2024 financial results, highlighting a strong financial and operational position.
- The company completed the sale of its oncology R&D business to Regeneron and its Hemophilia A program to Novo Nordisk.
- Abecma U.S. revenues were $54 million, with a significant increase in patients undergoing apheresis.
- Total revenues for Q2 2024 were $9.0 million, compared to $36.0 million in Q2 2023.
- Net income for Q2 2024 was $24.9 million, compared to a net loss of $42.1 million in Q2 2023.
Read more
Summit Therapeutics reports financial results and operational progress for Q2 2024
- Summit Therapeutics provided updates on ivonescimab (SMT112), a bispecific antibody combining PD-1 blockade and VEGF inhibition.
- The collaboration with Akeso Inc. was expanded to include Latin America, the Middle East, and Africa.
- Positive results from Phase III HARMONi-A and HARMONi-2 trials in NSCLC were presented at ASCO 2024.
- A five-year strategic collaboration with MD Anderson Cancer Center was announced to accelerate ivonescimab development.
Read more
Summit Therapeutics announces financial highlights for Q2 2024
- Summit received $200 million from an institutional investor for 22.2 million shares at $9.00 per share.
- Cash and cash equivalents were $325.8 million as of June 30, 2024, up from $186.2 million at the end of 2023.
- GAAP R&D expenses increased to $30.8 million in Q2 2024 from $9.5 million in Q2 2023.
- The company updated its cash guidance, expecting to fund operations into Q4 2025.
Read more
Olema Oncology reports second quarter 2024 financial results and provides corporate update
- Presented promising interim clinical results for palazestrant in combination with ribociclib at the 2024 ESMO Breast Cancer Congress.
- Successfully completed IND-enabling studies for OP-3136, with an IND application expected to be filed with the FDA in late 2024.
- Cash, cash equivalents, and marketable securities totaled $239.1 million as of June 30, 2024.
- Upcoming milestones include initiating a Phase 1b/2 study of palazestrant with everolimus and presenting pre-clinical data for OP-3136 in Q4 2024.
Read more
