On January 2, 2023 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", SEHK : 02315) a clinical-stage biotechnology company with a focus on the antibody discovery and development based on its proprietary RenMice Platforms and Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma", SEHK: 3692), a leading innovation-driven pharmaceutical company with a focus on the treatment of major diseases including oncology, infectious diseases, CNS disorders, metabolic diseases and autoimmune diseases, reported an antibody collaboration, assignment and exclusive license agreement. Biocytogen will provide a license to Hansoh Pharma for their selected fully human antibody molecules against the designated target for the development, manufacturing and commercialization globally (Press release, Biocytogen, JAN 2, 2023, View Source [SID1234625704]). Under the agreement, Biocytogen will receive an upfront payment and will be eligible to receive development and commercial milestones of up to tens of millions of Chinese yuan, as well as single-digit tiered royalties on net sales.

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"We are very excited to partner with Hansoh Pharma, one of the largest pharmaceutical companies in China. The licensed antibodies were selected from Biocytogen’s Project Integrum programs and generated from our proprietary fully human antibody RenMice target-knockout mice. The antibodies possess highest possible diversity to improve the success rate of antibody discovery," said Dr. Yuelei Shen, President and CEO of Biocytogen. "Thanks to Hansoh Pharma’s recognition of our RenMice platforms and Project Integrum. We believe Hansoh Pharma’s strong R&D, manufacturing and commercialization capabilities will accelerate the development of RenMice-derived antibody molecules and bring the benefits to patients worldwide."

About Project Integrum

Project Integrum is a large-scale antibody drug development project for 1000+ potential drug targets using RenMice (RenMab, RenLite and RenNano) target knockout mice. Different from the traditional mechanism of action (MOA)-based drug development strategy, Project Integrum uses large-scale in vivo drug efficacy screening methods to discover innovative drugs with excellent safety and efficacy. So far, we have completed making RenMice KO for 1000+ targets. In addition, we have developed a large variety of preclinical antibody assets including 10 fully human bispecific antibodies, 20+ bispecific ADCs, 10+ TCR-mimic antibodies, 30+ monoclonal antibodies against novel targets, and 600+ antibody hits. Antibody molecules generated by Project Integrum have high specificity, high affinity and good druggability, which have attracted many top biopharmaceutical companys to obtain a license or reach a drug co-development agreement with us, including Merck KGaA, ADC Therapeutics, Remgen, NJCTTQ, etc.

On January 2, 2023 Datar Cancer Genetics Inc reported that the US Food and Drug Administration (FDA) has granted ‘Breakthrough Device Designation’ for its ‘TriNetra-Glio’, a blood test to help in the diagnosis of brain tumors (Press release, Datar Cancer Genetics, JAN 2, 2023, View Source [SID1234625703]). This is the third test from the Company to have received the Breakthrough Device Designation from the US FDA. The Company’s early-stage breast and prostate cancer detection tests became the first liquid biopsies to receive the Breakthrough Device Designation.

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Worldwide, brain cancer is the 12th most lethal cancer, and each year, more than 250,000 adults die due to the disease. Diagnosis of brain tumors is resource-intensive, risk-prone and brain biopsies are impossible to perform in almost 40% of advanced cases. Presently, no blood test is available for diagnosing brain cancers, and doctors have to rely on complex surgical procedures to obtain tumor tissue for histopathological evaluation. The TriNetra-Glio liquid biopsy is intended to detect the cells released in the blood from the brain tumor; these cells are extremely rare and hard to detect.

A prospective, blinded study by a research team at the Imperial College, London, showed the test to be highly accurate. The test requires 15 ml blood and is indicated for patients where a brain biopsy, although necessary, cannot be performed or has been unsuccessful.

"In my opinion, a non-invasive blood test that detects circulating tumor cells (CTCs) would help to address many of the problems associated with complex brain tumor diagnosis. As a surgeon working on other technologies to define the tumor and functional boundary during surgery to a molecular level of accuracy and to shorten the diagnostic pathway that would inform surgeons, I find this technology of significant interest. In particular, the intended indication to provide a liquid biopsy diagnosis from a simple blood test where tumors are deemed inoperable or inaccessible will truly address an unmet clinical need. I have found this test to be highly sensitive and specific. This breakthrough technology has true diagnostic utility by detecting cells rather than picking up molecular indicators of disease, which until now liquid biopsies have been based upon," said Dr. Kevin O’Neill, Consultant Neurosurgeon, Chairman of the Brain Tumor Research Campaign and Principal Investigator for the Brain Tumor Research Charity’s Centre of Excellence working at the Imperial College, London, who led the blinded study to evaluate the test.

"The breakthrough designation is a recognition of the potential benefits of TriNetra-Glio in the clinical setting. The test can help individuals where a brain biopsy or surgical resection of the tumor is not possible due to the location of the tumor or other constraints. With our proprietary CTC-enrichment and detection technology, a diagnosis of inaccessible tumors will become possible through a risk-free and patient-friendly blood test," said Dr. Vineet Datta, Executive Director of the Company. The test has previously received CE certification and is already available to patients as ‘Trublood-CNS’.

The Breakthrough Designation is granted by the FDA after rigorous evaluation indicating a reasonable expectation of analytical and clinical success for devices that demonstrate a potential for more effective diagnosis of life-threatening diseases such as cancer. The Breakthrough Devices Program intends to provide patients and healthcare providers with timely access to medical tests and devices granted such designation by prioritized review to expedite development and assessment.

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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".