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Genmab A/S (Nasdaq: GMAB) announced today that its CEO, Jan van de Winkel, Ph.D., will present a company update at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco at 9:00 AM PST / 12:00 PM EST / 6:00 PM CET on January 11, 2023. The live and archived webcast of the presentation will be available on Genmab’s website at View Source

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Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces strong interim results from the ongoing OPTIMIZE-1 Phase 2 trial of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer.

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This open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. Within this pre-planned interim analysis for futility, data were assessed by the participating investigators and independent experts for the probability of a positive study at primary completion. The interim results demonstrate an objective response rate (ORR) of 52% in 23 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Disease control rate, the proportion of patients with objective response or stabilization of disease, was more than 90%. These data are noteworthy, especially in the light of an ORR of 31.6%[1] reported with FOLFIRINOX in a similar patient population.

Safety data confirm results from the Phase 1b dose escalation phase of the trial, which showed that mitazalimab in combination with mFOLFIRINOX was safe and well tolerated at the recommended dose of 900 μg/kg.

Based on these positive results, Alligator plans to initiate discussions with regulators in the US and Europe on potential accelerated development and approval pathway for mitazalimab in pancreatic cancer, while continuing patient enrolment in this ongoing trial. Top-line data from this trial are expected in Q1 2024.

"We are thrilled with these interim results, which demonstrate that mitazalimab combined with chemotherapy could offer a significant clinical benefit for pancreatic cancer patients over standard of care," said Søren Bregenholt, CEO of Alligator Bioscience. "We are very keen to progress our lead asset through the next stage of its development as quickly as we can, and we look forward to discussing with regulatory authorities the potential accelerated development and approval pathway for mitazalimab in pancreatic cancer. These strong interim data reconfirm out commitment to mitazalimab and supports broadening the mitazalimab clinical development program in additional tumor types."

"We are pleased with the signs of clinical activity observed in the OPTIMIZE-1 interim analysis and believe that mitazalimab in combination with chemotherapy warrants continued development for the treatment of pancreatic cancer patients, which is an area of high unmet need", said Prof. Jean-Luc van Laethem, coordinating principal investigator, Erasmus University Hospital, Brussels (BE), "we will continue enrolment, treatment and follow-up of patients to further characterize the progression-free and overall survival, as the study continues".

Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces an expansion to its research collaboration and license agreement with Orion Corporation, a global pharmaceutical company based in Finland, to discover and develop together new bispecific antibody cancer therapeutics.

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The collaboration has been expanded to add the development of a second bispecific antibody using Alligator’s proprietary bispecific RUBY platform, where Alligator will provide validated monospecific binders for one target and Orion will do the same for the other target.

"We are excited to start another joint project with Alligator Bioscience and continue our development of new immuno-oncology treatments, which has started very well." said Outi Vaarala, Senior Vice President, R&D, of Orion Corporation.

"Our collaboration with Orion is progressing extremely well, with both companies making meaningful contributions to the first program and complementing each other’s scientific expertise," said Søren Bregenholt, PhD, CEO of Alligator Bioscience. "The initiation of this second project is a testament to the strength of Alligator’s technology platform, including our bispecific RUBY format."

Under the initial agreement signed in 2021, Alligator employs its proprietary phage display libraries and RUBY bispecific platform to develop immuno-oncology product candidates based on design criteria identified by Orion. Alligator remains eligible for development, approval and sales milestone payments of up to €469 million across the three potential programs, in addition to royalties if Orion exercises its options to continue development and commercialization of the resulting product candidates.

The initiation of the second program provides Alligator Bioscience with an upfront payment of €1.25 million, including the fee for its validated binders being made available, with an additional €500,000 payment being due to Alligator Bioscience when the technical feasibility of the bispecific antibody has been demonstrated in relation to the validated binders.