CognitrexCancerDigest

Paris-based Sanofi and Houston-based The University of Texas MD Anderson Cancer Center entered a five-year strategic partnership to develop immune therapies and targeted cancer treatments. It will leverage MD Anderson’s clinical trials infrastructure and Sanofi’s cancer pipeline. This is yet another example of Sanofi’s increased investment in the cancer space. On July 8, Sanofi licensed a previously undisclosed K-NK0004 program from The Netherlands-based Kiadis Pharma in a deal just shy of $1 billion. The deal covered Kiadis’ proprietary CD38 knock out (CD38KO) K-NK therapeutics for combination with anti-CD38 monoclonal antibodies. In early June, Sanofi (China) Investment Co. signed a collaboration deal with Alphamab Oncology, based in Suzhou, China, to advance clinical trials of Alphamab’s KN-26 with Sanofi’s Taxotere (docetaxel) in HER2+ breast cancer. Jiangsu Alphamab Biopharmaceuticals Co., a wholly owned subsidiary of Alphamab Oncology, made the deal to advance clinical tria...

Boehringer Ingelheim and  Numab Therapeutics  (Numab) today announced that they have entered into a research collaboration and worldwide licensing agreement. It will start with two projects aiming at novel therapies for difficult-to-treat lung and gastrointestinal (GI) cancers and patients with geographic atrophy (GA), a progressive, irreversible retinal disease that occurs in patients with age-related macular degeneration (AMD) for which there is no current treatment. The collaboration brings together Boehringer Ingelheim’s leading expertise in the research and development of life changing breakthrough therapies with Numab’s multi-specific antibody platform. Lung and GI cancers and retinal diseases are key focus areas of Boehringer Ingelheim’s research and development program. In oncology the company has built a broad and diverse pipeline, combining cancer immunology and cancer cell directed approaches. The novel T-cell engager to be developed with Numab adds to Boehring...

Daiichi Sankyo Company, Limited announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. Trastuzumab deruxtecan was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Validation confirms that the application is complete and commences the scientific review process by the EMA’s CHMP. Accelerated assessment is granted by the CHMP to products expected to be of major interest for public health and therapeutic innovation and can significantly reduce the review timelines. “The accelerated assessment highlights the significant unmet need for patients with HER2 positive metastatic breast cancer that trastuzumab deruxtecan aims at addressing,” said Gilles Gallant, B Pharm, ...

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BAVENCIO (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates. However, most patients will ultimately experience disease progression within nine months of initiation of treatment,3,4 and only 5% of patients with metastatic disease at diagnosis will live longer than five years. "Many patients newly diagnosed with advanced urothelial carcinoma receive benefit from initial chemotherapy, but we still need treatment options that can help patients live lo...

Roche announced that the US Food and Drug Administration (US FDA) has approved Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection. “The US FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Phesgo offers a treatment administration that supports the needs and preferences of individual patients, and helps to meet the increasing demand across the healthcare system for faster and more flexible treatment options.” Phesgo is available in one single-dose vial. Admini...

After launching three products in the Cancer therapy in India market, the company today launched the generic of variant of Axitinib, an tyrosine kinase inhibitor drug with a brand name AXISHIL, as per company release. AXISHIL is available as 1 mg & 5 mg tablets in pack of 14’s tablets in one bottle and is used to treat patients suffering from Advanced Renal Cell Carcinoma (RCC). For the quarter ended 31 March, Shilpa Medicare reported a rise of 44.8% to  ₹ 34.57 crore in net profit against  ₹ 23.88 crore for the same quarter last year. Net Sales gained 10.3% to  ₹ 219.99 crore for the quarter ended 31 March over  ₹ 199.52 crore for the corresponding quarter last year. Driving the Vision of Shilpa Medicare of “Innovating for affordable healthcare", AXISHIL is being launched to provide global quality Indian Brand with greater affordability to cancer patients," said Sundeip Bhatia, Business Head Formulations India of Shilpa Medicare. Shlipa Medicare Ltd de...