September 13, 2024 - 🧬 [nGram] Today’s Oncology Scoop: FDA Approves Roche’s Tecentriq Hybreza, Marengo & Gilead Collaboration, Bicara IPO

1. 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.
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2. 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.
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3. 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.
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4. 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.
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5. 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.
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6. 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.
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7. 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.
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8. 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.
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