FDA granted full approval for Elahere for certain ovarian cancer patients

CLINICAL AND REGULATORY

FDA granted full approval for Elahere for certain ovarian cancer patients

Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as Elahere. Elahere was first granted FDA accelerated approval in November 2022 and the conversion to full approval is based on data from the confirmatory Phase 3 MIRASOL trial. This trial compared Elahere to investigator's choice of chemotherapy in patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα and who have been treated with up to three prior therapies.

Enhertu demonstrated survival benefit in ultralow HER2 population

Positive high-level results from the DESTINY-Breast06 Phase 3 showed that Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in PFS compared to standard-of-care chemotherapy in the primary trial population of patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer following one or more lines of endocrine therapy. A statistically significant and clinically meaningful improvement in PFS was also observed in the overall trial population (patients with HER2-low and HER2-ultralow [defined as IHC 0 with membrane staining; IHC >0<1+] metastatic breast cancer). A prespecified subgroup analysis showed the clinically meaningful improvement was consistent between patients with HER2-low and HER2-ultralow expression.

FDA granted Orphan drug designation for ATAC candidate HDP-101 from Heidelberg Pharma

Heidelberg Pharma announced that FDA has granted Orphan Drug Designation for the treatment of multiple myeloma to its lead candidate HDP-101. Heidelberg Pharma is investigating the candidate in a clinical Phase 1/2a study for the treatment of relapsed or refractory multiple myeloma. HDP-101 is an antibody-drug conjugate, that consists of an anti-BCMA antibody, a specific linker and the Amanitin toxin.

DEALS AND FINANCING

Biocytogen entered collaboration with ABL Bio to develop novel bispecific ADCs

Biocytogen Pharma, a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, and ABL Bio, a Korean clinical-stage biotechnology company developing novel therapeutics in oncology and CNS diseases, today announced a collaboration to develop new bispecific ADCs. Biocytogen’s RenLite mice platform can produce fully human antibodies with diverse epitopes and high affinity. This platform is notable for its ability to generate antibodies in a common light chain format, offering a distinctive combination of design flexibility, simplified manufacturing processes, and optimal developability for bispecific ADC development. Based on this platform, both companies will be able to discuss expanding their collaboration for various types of ADC development.

Kintara and TuHURA entered into definitive merger agreement

Kintara Therapeutics, a company investigating REM-001 in cutaneous metastatic breast cancer, and TuHURA Biosciences, a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, have entered into a definitive agreement for an all-stock transaction forming a company with expertise and resources to advance a risk diversified late-stage oncology pipeline. The combined company will focus on advancing TuHURA's personalized cancer vaccines and first-in-class bi-functional ADCs. The combined company is expected to operate under the name TuHURA Biosciences and to trade on Nasdaq under the ticker HURA. Post-merger Kintara equity holders are expected to collectively own up to approximately 2.85%, or approximately 5.45% including the shares underlying the CVR to be received by certain of Kintara's equity holders. TuHURA equity holders are expected to collectively own the rest of the shares.

Sutro Biopharma announced pricing of $75 million underwritten offering

Sutro announced the pricing of an underwritten offering of 14,478,764 shares of its common stock at a price of $5.18 per share. The gross proceeds from this offering were approximately $75 million. BofA Securities is acting as sole book-running manager in the offering.