NEW YORK – Ideaya Biosciences this week amended its clinical trial collaboration and supply agreements with Pfizer to include a study of darovasertib and Pfizer's ALK inhibitor Xalkori (crizotinib) combination therapy in a Phase II/III registrational trial in first-line metastatic uveal melanoma patients with an HLA-A*02:01 (HLA-A2) negative serotype. Pfizer will provide an initial supply of Xalkori for the trial at no cost to Ideaya and a second supply at a lump sum cost. Under the amended agreement, the two companies will jointly own any inventions related to the combined use of darovasertib and Xalkori.
Innovent Biologics said this week that China's National Medical Products Administration granted breakthrough therapy designation to IBI351 as a treatment for patients with KRAS G12C-mutated colorectal carcinoma. In a pooled analysis of two ongoing clinical trials of IBI351, the drug had favorable safety and tolerability and antitumor activity. Innovent and GenFleet Therapeutics are developing and commercializing IBI351 in China under a 2021 license agreement.
Immpact Bio said this week that the US Food and Drug Administration granted fast track designation to its autologous CD19- and CD20-directed CAR T-cell therapy, IMPT-314, as third- or later-line treatment for patients with relapsed or refractory aggressive B-cell lymphoma, diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal B-cell lymphoma, and DLBCL arising from follicular lymphoma. The FDA grants orphan designation to drugs for rare diseases, which provides sponsors tax credits for clinical trials, exemption from user fees, and seven years of market exclusivity for the drug after regulatory approval.
Korio, a randomization and trial supply management company, this week said it will support patient enrollment and randomization within the Leukemia & Lymphoma Society's Beat AML master clinical trial. In that study, LLS is using genomics tools to match acute myeloid leukemia patients to targeted therapies based on biomarker information. Doylestown, Pennsylvania-based Korio hopes to streamline enrollment and randomization in the umbrella trial using its platform, which employs interactive response technology.
Beijing Xisike Clinical Oncology Research (CSCO) Foundation, Ping An Health Insurance Company (PAH), and OrigiMed Shanghai this week said they're working together to develop "an innovative ecosystem" to enable precision medicine access to cancer patients in China. Cancer is a leading cause of death in the country, with 4.5 million new cases a year and annual cancer-related medical expenses exceeding RMB 220 million ($31.43 million).
Under the terms of the agreement, the three organizations will collaboratively advance a "full-cycle medical service for insured Chinese patients," in which PAH will provide coverage of OrigiMed's genetic testing, online molecular tumor board, clinical trial recruitment, and follow-on e-hospital services. CSCO Foundation's professional oncologist network will provide patients with online personalized diagnosis and treatment services. In a statement, Jin Li, chairman of CSCO Foundation, said the collaboration promises to not only improve outcomes for cancer patients in China but also help build a real-world database for the China Cancer Genomic Atlas.
Liquid biopsy firm Cellsway and genetics lab Omega Genetik said this week that they have entered into a partnership and commercialization agreement to provide cancer management solutions to patients and healthcare professionals throughout Turkey. Under the agreement, Omega Genetik will use Cellsway's circulating tumor cell isolation technology to analyze tumor-associated gene expression for noninvasive monitoring and treatment personalization. Financial terms were not disclosed.
Kiyatec said this week that it received a new investment from The Brain Tumor Investment Fund, an affiliate of the National Brain Tumor Society and Sontag Innovation Fund, a subsidiary of Sontag Foundation. The funds will support commercialization of Kiyatec's 3D-Predict testing platform. The 3D-Predict Glioma test is commercially available in the US to inform therapy selection for glioblastoma and other high-grade gliomas. The amount of the investment was not disclosed.
Zai Lab this week said that China's National Medical Products Administration granted priority review to its application seeking approval for repotrectinib as a treatment for patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. Zai and Turning Point Therapeutics are evaluating repotrectinib in the TRIDENT-1 Phase I/II study in adults with tumors harboring ROS1-positive or NTRK1-3 gene fusions and the CARE Phase I/II trial in children and young adults with advanced cancers harboring ALK, ROS1, or NRTK1-3 alterations.
Orgenesis this week said it has signed a collaboration agreement with SCTbio to facilitate point-of-care development of its cell and gene therapies through its US subsidiary Morgenesis. Orgenesis' Mobile Processing Units and Labs facilitate processing of cell and gene therapies near local hospitals and treatment facilities, aiming to decrease turnaround time for patient treatment. The company expects its latest agreement with SCTbio, a full-service contract development and manufacturing organization, will help it open new point-of-care sites in the Czech Republic. SCTbio's GMP facility will also enable production of lentivirus vectors for Morgenesis' point-of-care customers globally for CAR T-cell and gene therapies.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Medicine Online.