In a deal worth as much as $600 million, Lanova Medicines Ltd. licensed exclusive global rights to Astrazeneca plc for LM-305, an antibody-drug conjugate (ADC) targeting GPRC5D, for multiple myeloma (MM). Lanova will receive up-front and near-term payments of up to $55 million and development and commercial milestone payments of up to $545 million, as well as tiered royalties on net sales worldwide.
The U.S. FDA issued a complete response letter regarding the BLA for Immunitybio Inc.’s bladder cancer treatment, N-803 (Anktiva), halting the drug’s development and slicing the stock value in half. The problems stem from the FDA’s pre-license inspection of Immunitybio’s third-party contract manufacturing organizations, the company said. It said the FDA also had recommendations for specific chemistry, manufacturing and controls issues and assays that needed to be resolved before the BLA can be approved.
Barely a month and a half after its radioconjugate approach landed a potential $1.7 billion deal with Novartis AG, Bicycle Therapeutics plc drew another big radiopharma player to the table, signing a collaboration agreement with Bayer AG to use Bicycle’s peptide technology to discover and develop radiotherapies against cancer targets. Terms are similar to the Novartis deal, with Bayer paying $45 million up front and Bicycle eligible for development and commercial milestones totaling up to $1.7 billion, and underline the growing interest in the radiopharma space.
Roche AG acquired global rights to Zion Pharma Ltd.’s lead program, ZN-A-1041, an orally administered selective tyrosine kinase inhibitor that is designed to penetrate the blood-brain barrier and can prevent and treat brain metastases in HER2-positive metastatic breast cancer patients.
In the latest deal from the burgeoning antibody-drug conjugate (ADC) space, Eisai Co. Ltd. and privately held Bliss Biopharmaceutical (Hangzhou) Co. Ltd. reached a development and commercialization agreement that could be worth up to $2 billion. The massive collaboration is the eighth largest so far this year and one of three that involve ADCs in the year’s top 10 deals. The year’s biggest, according to BioWorld statistics, is the partnership extension between Evotec SE and Bristol Myers Squibb Co. to identify neurodegenerative disease therapies for eight years. The other ADC deals involve Synaffix BV, which signed a $2 billion pact in January with Amgen Inc., and a $2.2 billion expanded deal in February with Macrogenics Inc.
The idea for a new company, Ten63 Therapeutics Inc., started in 2015, when Gilda Szacher Frenkel passed away at age 62 from pancreatic cancer. After sequencing her tumor, her son Marcel discovered that her cancer was driven by mutations to key proteins that regulate cellular processes – all the “usual suspects,” he said. At the time, he remembers they were initially encouraged by the discovery and excited to search for developed drugs that could help her. “Here was this blueprint telling us what was wrong,” Marcel Frenkel said, “but, unfortunately, those mutations were unactionable. There were no drugs to modulate the main oncologic drivers.”
Fibrogen Inc. and its co-development partners for roxadustat, Astrazeneca plc and Astellas Pharma Inc., were dealt a major blow May 5 as the oral hypoxia-inducible factor prolyl hydroxylase inhibitor failed to meet its primary efficacy endpoint in a phase III trial in patients with anemia caused by transfusion-dependent lower-risk myelodysplastic syndromes (MDS).
While sorting out a second phase III study design for its cancer therapy and light device with the U.S. FDA, Soligenix Inc. produced positive results from a compatibility study evaluating Hybryte (synthetic hypericin sodium) for treating early stage cutaneous T-cell lymphoma (CTCL). That data, according to Soligenix, bolster findings from the phase III FLASH study, which used the same combination in treating CTCL. According to Christopher Schaber, Soligenix CEO, the important corporate objectives for the compatibility study were to replicate results seen in the FLASH study.
Immunogen Inc. scored a major win in top-line data from the confirmatory phase III trial called Mirasol evaluating the approved antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx, “mirv”) vs. chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer (PROC). The victory led shares of the Waltham, Mass.-based firm to close May 3 at $12.26, a rise of $7.06, or 135%.
Cellular Biomedicine Group Inc. (CBMG) licensed a pair of candidates for the treatment of non-Hodgkin lymphoma to Janssen Biotech Inc. for development outside of greater China. The candidates are anti-CD19 and CD20 bispecific CAR T-cell therapy C-CAR039 and anti-CD20 CAR T-cell therapy C-CAR066.
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