FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy
- Tecentriq Hybreza offers a subcutaneous (SC) injection option, reducing treatment time to approximately seven minutes compared to 30-60 minutes for IV infusion.
- Approved for all IV indications of Tecentriq in the U.S., including certain types of lung, liver, skin, and soft tissue cancers.
- FDA approval based on Phase IB/III IMscin001 study showing comparable blood levels and consistent safety and efficacy with IV Tecentriq.
- Phase II IMscin002 study revealed 71% of patients preferred the SC formulation over IV, citing less time in the clinic and increased comfort.
Read more
Halozyme announces FDA approval of Roche's Tecentriq Hybreza with ENHANZE for multiple types of cancer
- FDA approves Tecentriq Hybreza, the first subcutaneous anti-PD-(L)1 cancer immunotherapy.
- Tecentriq Hybreza can be injected in approximately 7 minutes, compared to 30-60 minutes for IV Tecentriq.
- Approved for all adult indications of IV Tecentriq, including lung, liver, skin, and soft tissue cancers.
- Approval based on Phase IB/III IMscin001 study showing comparable blood levels and consistent safety and efficacy with IV formulation.
Read more
US FDA grants RPD designation to Senhwa Biosciences Silmitasertib for pediatric neuroblastoma
- Senhwa Biosciences' Silmitasertib (CX-4945) received rare pediatric disease designation (RPDD) from the US FDA for neuroblastoma.
- Silmitasertib is a CK2 inhibitor that has shown antitumor activity in pre-clinical studies of neuroblastoma.
- The RPD designation qualifies the drug for the priority review voucher (PRV) program, encouraging the development of novel therapies for rare pediatric diseases.
- Neuroblastoma is the third most common pediatric cancer, with an estimated 700 to 800 new cases annually in the US.
Read more
Marengo Therapeutics announces clinical study collaboration with Gilead Sciences
- Marengo Therapeutics and Gilead Sciences to evaluate STAR0602 (Invikafusp alfa) with Trodelvy in metastatic TNBC and HR+/HER2- breast cancers.
- The collaboration will be a multi-center Phase I/II clinical study (START-002) sponsored by Marengo.
- Gilead will provide Trodelvy, while Marengo will conduct and sponsor the trial.
- The study aims to assess the safety, tolerability, and preliminary efficacy of the combination therapy.
Read more
Bicara Therapeutics announces pricing of upsized initial public offering
- Bicara Therapeutics priced its IPO at $18.00 per share, offering 17.5 million shares.
- Shares will trade on the Nasdaq Global Market under the ticker symbol 'BCAX' starting September 13, 2024.
- The IPO is expected to close on September 16, 2024, subject to customary conditions.
- Gross proceeds are anticipated to be approximately $315 million, excluding any exercise of the underwriters’ option to purchase additional shares.
Read more
Cytovation to present full safety and efficacy data from the CICILIA Phase I/IIa trial evaluating CY-101 in solid tumors at ESMO 2024
- CY-101 well tolerated with early signs of clinical activity, especially in tumors with dysregulated Wnt/β-catenin signaling.
- CY-101 granted Orphan Drug Designation in the US for the treatment of Adrenocortical Carcinoma (ACC).
- Data from the CICILIA trial show no dose-limiting toxicities and a disease control rate of 50% in ACC patients.
- Next steps include advancing towards a planned Phase 2 trial in ACC with registrational intent.
Read more
Nxera’s partner Cancer Research UK to present on phase 1/2a clinical trial with cancer immunotherapy drug HTL0039732 at ESMO
- HTL0039732 is an oral EP4 antagonist designed to treat various cancers in combination with other immunotherapies.
- The Phase 1/2a trial, sponsored by Cancer Research UK, is evaluating the drug's safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity.
- The trial includes HTL0039732 as a monotherapy and in combination with the checkpoint inhibitor atezolizumab for patients with advanced solid tumors.
- The first patient was dosed in August 2023, and the trial is currently recruiting at multiple UK hospitals.
Read more
Nona Biosciences enters into collaboration agreement with Umoja Biopharma to advance in vivo CAR-T cell therapies
- Nona Biosciences and Umoja Biopharma have entered a multi-target antibody discovery collaboration.
- The partnership will leverage Nona's HCAb Harbour Mice® and NonaCarFx™ platforms with Umoja's VivoVec™ platform.
- The goal is to develop novel in vivo CAR-T cell therapies to enhance the reach and effectiveness of CAR-T treatments.
- This collaboration aims to produce off-the-shelf CAR-T cell therapy drug candidates with reduced immunogenicity and versatile CAR design.
Read more