ALX Oncology reports topline data from ASPEN-06 phase 2 trial demonstrating evorpacept improves tumor response in patients with HER2-positive gastric cancer
- Evorpacept achieved a confirmed overall response rate (ORR) of 40.3% compared to 26.6% for the control arm.
- Median duration of response (DOR) was 15.7 months for evorpacept vs. 7.6 months for the control.
- In patients with fresh HER2-positive biopsies, ORR was 54.8% for evorpacept vs. 23.1% for the control.
- Evorpacept was generally well tolerated and consistent with the control arm.
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Immuneering granted FDA fast track designation for IMM-1-104 in first-line pancreatic cancer
- IMM-1-104 receives Fast Track designation for both first and second-line pancreatic ductal adenocarcinoma (PDAC).
- Phase 2a trial includes multiple arms for first-line and second-line pancreatic cancer, RAS-mutant melanoma, and RAS-mutant lung cancer.
- Initial data from the Phase 2a trial expected in the second half of 2024.
- Fast Track Designation facilitates development and may expedite FDA review for serious conditions.
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OS Therapies announces pricing of its initial public offering on NYSE American
- OS Therapies priced its IPO at $4.00 per share, raising $6.4 million in gross proceeds.
- The company has granted underwriters a 45-day option to purchase an additional 240,000 shares.
- Net proceeds of approximately $6.0 million will be used for clinical development of OST-HER2 and OST-tADC, and other corporate purposes.
- OST-HER2 is in a Phase IIb clinical trial for osteosarcoma, with topline data expected in Q4 2024.
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Creatv Bio announces its CAML biomarker included in pivotal phase 3 trial in metastatic breast cancer
- Creatv Bio's CAML liquid biopsy biomarker is included in BriaCell Therapeutics' Phase 3 trial for metastatic breast cancer.
- The trial will enroll 404 patients in two arms: Bria-IMT with an immune checkpoint inhibitor vs. treatment of physicians' choice.
- Blood samples will be analyzed for circulating tumor cells, CAML subtyping, and PD-L1 upregulation.
- CAMLs can predict cancer aggressiveness, treatment response, minimal residual disease, and cancer recurrence.
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Myeloid therapeutics initiates patient dosing with MT-303 in phase 1 study for advanced hepatocellular carcinoma
- Myeloid Therapeutics has dosed the first patient with MT-303 in a Phase 1 study for hepatocellular carcinoma (HCC).
- MT-303 is Myeloid's second in vivo mRNA CAR program, targeting GPC3, a protein highly expressed in HCC.
- The Phase 1 study (NCT06478693) is an open-label dose escalation study to investigate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy.
- MT-303 has shown a favorable safety profile in preclinical models and aims to provide a coordinated immune response against HCC.
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Kexing Biopharm's albumin-bound paclitaxel receives EU market authorization
- Kexing Biopharm's Apexelsin® (generic Nab-paclitaxel) approved by the European Commission.
- Developed by WhiteOak Pharmaceutical B.V., Kexing Biopharm handles marketing outside the US.
- Recommended by ESMO for metastatic pancreatic cancer, non-small cell lung cancer, and as a second-line treatment for breast cancer.
- Approval strengthens Kexing Biopharm's international market presence, with ongoing registrations in multiple emerging markets.
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Healx announces $47 million series C financing and FDA clearance of phase 2 IND for neurofibromatosis type 1 trial
- Healx raised $47 million in a Series C round co-led by R42 Group and Atomico.
- Funds will advance the pipeline, including HLX-1502 for neurofibromatosis Type 1 (NF1).
- FDA cleared the Phase 2 IND for HLX-1502, targeting NF1-associated plexiform neurofibroma.
- HLX-1502 has received Orphan Drug and Rare Pediatric Disease designations from the FDA.
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io9 publishes study on OncoGaze AI platform in the Journal of Clinical Oncology
- io9's OncoGaze AI platform aims to eliminate delays and inequities in first-line precision treatment selection for cancer patients.
- The study, published in the Journal of Clinical Oncology, shows that DeepHRD, part of OncoGaze, outperforms FDA-approved HRD diagnostics in identifying patients for PARP-inhibitor and platinum therapy.
- DeepHRD identified 1.8- to 3.1-fold more HRD-positive patients in ovarian and metastatic breast cancers compared to next-generation sequencing (NGS).
- The platform aims to reduce the therapeutic selection timeline from weeks to seconds, potentially improving patient outcomes.
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Biocytogen announces option and license agreement with IDEAYA Biosciences for potential first-in-class B7H3/PTK7 topo-I-payload bispecific ADC program
- Biocytogen and IDEAYA Biosciences enter an option and license agreement for a B7H3/PTK7 BsADC program.
- The agreement includes an upfront fee, option exercise fee, and milestone payments totaling up to $406.5 million.
- The B7H3/PTK7 BsADC program targets multiple solid tumor types and can be developed as a monotherapy or in combination with IDEAYA’s DDR-based therapies.
- A development candidate nomination for the program is expected in the second half of 2024.
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Instil Bio and ImmuneOnco announce license and collaboration agreement for development of IMM2510 and IMM27M
- Instil Bio to in-license ex-China development and commercial rights for IMM2510 and IMM27M.
- IMM2510 is a PD-L1xVEGF bispecific antibody with enhanced tumor penetration and ADCC activity.
- IMM27M is a next-generation anti-CTLA-4 antibody designed to reduce toxicity and enhance efficacy.
- ImmuneOnco to receive up to $50 million in near-term payments and potential milestones exceeding $2 billion.
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