On January 07, 2019 CytoReason, a leader in machine learning for drug discovery and development, reported that it has entered into a collaboration agreement with Pfizer Inc. that will leverage CytoReason’s cell-centered models of the immune system (Press release, CytoReason, JAN 7, 2019, View Source [SID1234619714]).

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CytoReason will receive from Pfizer payments potentially equaling up to low double digit millions of US$ for technology access fees, research support and certain success-based payments.

CytoReason’s proprietary platform helps rebuild lost cellular information from gene expression data and associates genes to specific cells. This information is then integrated with additional omics and literature data to create a cell-based model of the trial-specific immune response. Integration with the CytoReason disease model empowers the study analytics and allows the model to learn and improve, leading to robust target discovery, drug response biomarkers and indication selection.

"We believe that CytoReason’s platform has the potential to offer valuable insights that may be applied to our research into the human immune system," said Michael Vincent, Chief Scientific Officer, Inflammation & Immunology, Pfizer. "Leveraging technologies such as this can help us understand disease and prioritize targets, and support our mission of bringing innovative new therapies to patients who need them."

"The collaboration with Pfizer will further strengthen our models in our core therapeutic areas. This will be our fifth major partnership, which we believe will help make our model unparalleled in its accuracy for assets across the pipeline," said David Harel, CytoReason’s CEO. "CytoReason’s model brings together thousands of samples on a cell-protein-gene level, allowing for fast and accurate insights."

About CytoReason

Based on more than 10 years of research, CytoReason’s technology uses a proprietary data and machine learning model to reconstruct cellular information from bulk tissue, to train an immune-specific NLP engine, and to integrate multi-omics data. The company’s platform organizes and standardizes collaborators’ data (gene, protein, cell, and microbiome) and integrates it into CytoReason’s proprietary disease model to generate mechanistic understanding of the immune system, leading to novel insights.

CytoReason’s technology has yielded 2 pending patents, 10 commercial and scientific collaborations and 16 peer reviewed publications. Fully applicable to cancer immunotherapy, autoimmune, neurodegenerative and infectious disease research, CytoReason is at the cutting edge of society’s boldest attempts to improve health outcomes through better understanding of the immune system.

On January 7, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported that the ongoing multi-center clinical trial of CK-301 has been expanded to enroll patients in three cohorts intended to support requests for accelerated approval and Biologics License Application (BLA) submissions to the U.S. Food and Drug Administration (FDA) (Press release, Checkpoint Therapeutics, JAN 7, 2019, View Source [SID1234532508]). These cohorts include:

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• Microsatellite instability-high (MSI-H) endometrial cancer that has progressed following one or two prior anti-cancer therapies;

• Microsatellite stable (MSS) endometrial cancer that has progressed following one or two prior anti-cancer therapies; and

• MSI-H or mismatch repair deficient (dMMR) colorectal cancer that has progressed on or after, or been intolerant of, previous treatments, including a fluoropyrimidine-and oxaliplatin-and irinotecan-based chemotherapy.

Each cohort is evaluating a fixed dose of 800 mg CK-301 every two weeks (Q2W). The primary endpoint for each cohort is objective response rate (ORR), and secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS). The ongoing trial is also enrolling cohorts of patients with non-small cell lung cancer (NSCLC) and cutaneous squamous cell carcinoma.

"We are excited to advance our first immuno-oncology drug candidate, CK-301, into these potentially registration-enabling cohorts, representing a significant milestone in the execution of our strategy to obtain multiple accelerated approvals for our anti-PD-L1 antibody," said James F. Oliviero, President and Chief Executive Officer of Checkpoint. "We look forward to presenting interim safety and efficacy data from the ongoing clinical trial in the coming months."

The Phase 1, open-label, multi-center trial is evaluating the safety and tolerability of ascending doses of CK-301 in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers. Following completion of dose escalation in 2018, multiple dose expansion cohorts were initiated. Preliminary data from the ongoing trial suggest that CK-301 is safe and well-tolerated across dose levels ranging from 200 mg to 800 mg administered every two weeks and 1200 mg administered every three weeks, with treatment-related adverse events consistent with marketed anti-PD-1/PD-L1 antibodies.

About CK-301
CK-301 is a fully-human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death Ligand-1 (PD-L1) and blocks the PD-L1 interaction with the Programmed Death Receptor-1 (PD-1) and B7.1 receptors. PD-L1 is an immune-inhibitory checkpoint molecule expressed on epithelial and vascular endothelial cells, as well as by a number of immune cells, and is utilized by tumor cells as an immune escape mechanism. CK-301’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response

On January 7, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), a commercial biosimilar company, reported that it has entered into a $75 million senior secured credit facility agreement with Healthcare Royalty Partners (Press release, Coherus Biosciences, JAN 7, 2019, View Source [SID1234532524]).

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"We are pleased to have the renewed support of HealthCare Royalty Partners," said Denny Lanfear, President and CEO of Coherus. "This financing bolsters our cash position and working capital, enabling us to accelerate and enhance the manufacture and sale of UDENYCA (pegfilgrastim-cbqv), which we launched January 3, 2019. We look forward to providing significant value to cancer patients, oncology clinics and hospitals, as well as providing significant savings to payers."

"This investment reflects our continued confidence in the Coherus leadership team, as well as their ability to execute on their commercial plan," said Clarke Futch, Managing Partner and Chairman of the Investment Committee of Healthcare Royalty Partners. "We are honored to help Coherus in its mission to serve patients and deliver savings to the healthcare system. With this second investment in Coherus, we look forward to their continued growth and success."

The senior secured credit facility matures on January 7, 2025 and pays interest quarterly at a rate of 3–month LIBOR plus 7% per annum. Subject to other customary fees, the senior secured credit facility will also be subject to a 4% final payment premium owed on the entire principal amount funded.

On January 7, 2019 Generex Biotechnology Corporation (OTCQB:GNBT) is reported that Joe Moscato, the company’s CEO is attending the annual J.P. Morgan Healthcare Conference from January 7 to 9, 2019 (Press release, Generex, JAN 7, 2019, View Source [SID1234532540]). Mr. Moscato is meeting with leading healthcare investors to present the corporate vision for Generex Biotechnology as an integrated healthcare holding company with a unique strategy to provide end-to-end, patient centric solutions to enhance the doctor patient relationship.

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With 9,000 attendees and representation from over 450 companies, the annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment symposium in the industry, bringing together industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community.

"We are pleased to unveil the "New" Generex to the biotech and healthcare investment community," stated Joe Moscato, CEO of Generex. "After two-plus years of reorganizing the operations, capital structure, and strategic vision for the company, Generex is poised to deliver on our corporate mission to provide physicians, hospitals, and healthcare providers an end-to-end solution for patient centric care from rapid diagnosis through delivery of personalized therapies, streamlining care processes, minimizing expenses, and delivering transparency for payers. Entering 2019, we are building value in Generex by executing on our strategic plan with our newly acquired MSO and pharmacy network, the advancement of our clinical stage assets in immune-oncology, and through acquisitions in cutting-edge areas like regenerative medicine."

On January 7, 2019 Genocea Biosciences (the "Company") is presented the corporate slide presentation (Presentation, Genocea Biosciences, JAN 7, 2019, View Source [SID1234532556]).

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