On January 30, 2017 Tempus, a technology company focused on helping doctors personalize cancer care, and the University of Michigan are partnering to help researchers and physicians to identify customized treatment opportunities for pancreatic cancer patients (Press release, Tempus, JAN 30, 2017, View Source [SID1234517597]).

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As part of the new collaboration, Tempus will provide genomic and transcriptomic sequencing and analysis for pancreatic cancer patients being treated at the University of Michigan. Utilizing bioinformatics and its machine learning platform, Tempus will help physicians analyze these data sets to identify patterns and potentially actionable treatments.

Pancreatic cancer is the third leading cause of cancer-related death in the United States and anticipated to become the second by around 2020. The disease kills more people than breast cancer and has a five-year survival rate of just nine percent.

"Though pancreatic cancer patients face some of the toughest odds, they do not yet have access to a host of targeted therapies with proven effectiveness in the same way that other diseases have, in part because there isn’t enough patient, treatment and outcome data to identify patterns that might lead to actionable treatments," said Eric Lefkofsky, Co-founder and CEO of Tempus. "At Tempus, we are proud to be leading an effort to make that data available to researchers and physicians on the frontlines of care."

The University of Michigan Comprehensive Cancer Center is one of 47 Comprehensive Cancer Centers in the U.S. designated by the National Cancer Institute, and has been a leader in pancreatic cancer, from both a clinical and research perspective, for the past several decades.

"The University of Michigan Comprehensive Cancer Center is committed to providing researchers and physicians with the tools and resources they need to battle pancreatic cancer," said Diane Simeone, Director of the Gastrointestinal Oncology Program. "We are pleased to partner with Tempus, a company that shares our commitment to innovation and collaboration in the pursuit of better treatment options for patients battling this disease."

Tempus provides molecular sequencing and clinical analytic solutions for top academic centers, hospital systems, associations, and healthcare providers.

On January 30, 2017 Incyte Corporation (NASDAQ:INCY) and Calithera Biosciences, Inc. (NASDAQ:CALA) report that the companies have entered into a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology (Press release, Incyte, JAN 30, 2017, View Source;p=irol-newsArticle&ID=2240498 [SID1234517849]). CB-1158 is currently being studied in a monotherapy dose escalation trial and additional studies are expected to evaluate CB-1158 in combination with immuno-oncology agents, including anti-PD-1 therapy.

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"Arginase-expressing tumor-infiltrating myeloid cells have been shown to play an important role in orchestrating the immune suppressive microenvironment in cancer; but, to date, therapeutic targeting of the arginase enzyme has remained elusive," said Reid Huber, Ph.D., Incyte’s Chief Scientific Officer. "The addition of this first-in-class, small molecule arginase inhibitor, CB-1158, to our portfolio expands our innovative immuno-oncology pipeline and allows us to continue to advance our mission of discovering and developing immune-active combination therapies to treat patients with cancer."

"In this strategic partnership with Incyte, CB-1158 is expected to be evaluated in multiple trials of novel therapeutic combinations, accelerating its development across hematological and oncology indications," said Susan Molineaux, Ph.D., Calithera’s Chief Executive Officer.

Terms of the Collaboration
Under the terms of the collaboration and license agreement, Calithera will receive an up-front payment of $45 million from Incyte. In addition, Incyte will make an equity investment in Calithera of $8 million through the purchase of shares at a price of $4.65 per share.

Incyte will receive worldwide rights to develop and commercialize CB-1158 in hematology and oncology and Calithera will retain certain rights to research, develop and commercialize certain other arginase inhibitors in certain orphan indications.

Incyte and Calithera will jointly conduct and co-fund development of CB-1158, with Incyte leading global development activities. Incyte will fund 70 percent of global development and Calithera will be responsible for the remaining 30 percent. In the event of regulatory approvals and commercialization of CB-1158, Incyte and Calithera will share in any future U.S. profits and losses (receiving 60 percent and 40 percent, respectively) and Calithera will be eligible to receive over $430 million in potential development, regulatory and commercialization milestones from Incyte. Per the terms of the agreement, Calithera will have the right to co-detail CB-1158 in the U.S. and also be eligible to receive from Incyte tiered royalties based on future ex-U.S. sales, with rates ranging from low-to-mid double-digits.

The agreement also provides that Calithera may choose to opt out of its co-funding obligations. In this scenario, Calithera would no longer be eligible to receive future U.S. profits and losses but would be eligible to receive up to $750 million in potential development, regulatory and commercialization milestones from Incyte and, if the product is approved and commercialized, also be eligible to receive reimbursement based on previous development expenditures incurred by Calithera and tiered royalty payments on future global sales of CB-1158, with rates ranging from low-to-mid double-digits.

The transaction is expected to close in the first quarter of 2017, subject to customary closing conditions.

On January 30, 2017 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, officially reported that PharmaCyte has retained Facet Life Sciences, Inc. (Facet) to guide PharmaCyte through its pancreatic cancer therapy development lifecycle with the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, JAN 30, 2017, View Source [SID1234517605]). Facet has been working with PharmaCyte and Translational Drug Development (TD2) since September 2016 and was instrumental in expediting PharmaCyte’s pre-IND meeting with the FDA.

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The Chief Executive Officer of PharmaCyte explained retention of Facet, "After we completed much of the Chemistry, Manufacturing and Control (CMC) work for PharmaCyte’s pre-IND submission to the FDA, we decided that PharmaCyte needed to retain a life sciences consulting firm that could guide it in a broad spectrum of areas that will be required for the successful development of PharmaCyte’s therapy for pancreatic cancer.

"Facet’s initial efforts to date have included assembling all of the preclinical and clinical data available on PharmaCyte’s therapy for pancreatic cancer and submission to the FDA as a ‘pre-IND package.’ Subsequently, Facet made arrangements with the FDA for the pre-IND meeting with the FDA and played a significant role in the meeting. We are extremely pleased with Facet’s performance and are convinced, based upon the results of the FDA meeting, that we made the right selection in retaining Facet."

The Facet Life Sciences team is comprised of drug development, regulatory affairs and regulatory writing experts who have scientific degrees and over 100 years of combined experience in the pharmaceutical, biologics, biopharmaceutical and medical device industry. The services offered by Facet span the full spectrum of services that PharmaCyte will need for regulatory approval of its therapy for pancreatic cancer. Facet is the U.S. Agent for PharmaCyte before the FDA and will assist with regulatory and clinical strategy, preparation and support for regulatory meetings, regulatory submission leadership, gap analyses, product labeling, risk management and medical writing in a number of areas.

The President and CEO of Facet, Ken VanLuvanee, commented on Facet’s retention by PharmaCyte saying, "We are extremely pleased to have been selected to work with PharmaCyte on its novel live-cell encapsulation therapy for pancreatic cancer. This is cutting edge technology that presents one of the most complex regulatory product candidates on which we have ever worked. In spite of its complexity, when compared to a single chemotherapy drug for example, we believe that successful development of PharmaCyte’s therapy may change the way tumors of the pancreas and other solid tumors are treated in the future. It’s truly an exciting time for us and PharmaCyte alike."

Facet development experts work closely with client teams to successfully reach their corporate and product goals. Facet has created and managed critical development aspects for some of the industry’s fastest growing life sciences companies. Its specialists deliver expert services and cutting-edge technologies that are designed to help small life science companies with big goals optimize their product research and development efforts.

On January 30, 2019 Incyte Corporation (NASDAQ:INCY) and Calithera Biosciences, Inc. (NASDAQ:CALA) reported the companies have entered into a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology (Press release, Calithera Biosciences, JAN 30, 2017, View Source [SID1234535251]). CB-1158 is currently being studied in a monotherapy dose escalation trial and additional studies are expected to evaluate CB-1158 in combination with immuno-oncology agents, including anti-PD-1 therapy.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Arginase-expressing tumor-infiltrating myeloid cells have been shown to play an important role in orchestrating the immune suppressive microenvironment in cancer; but, to date, therapeutic targeting of the arginase enzyme has remained elusive," said Reid Huber, Ph.D., Incyte’s Chief Scientific Officer. "The addition of this first-in-class, small molecule arginase inhibitor, CB-1158, to our portfolio expands our innovative immuno-oncology pipeline and allows us to continue to advance our mission of discovering and developing immune-active combination therapies to treat patients with cancer."

"In this strategic partnership with Incyte, CB-1158 is expected to be evaluated in multiple trials of novel therapeutic combinations, accelerating its development across hematological and oncology indications," said Susan Molineaux, Ph.D., Calithera’s Chief Executive Officer. Terms of the Collaboration Under the terms of the collaboration and license agreement, Calithera will receive an up-front payment of $45 million from Incyte.

In addition, Incyte will make an equity investment in Calithera of $8 million through the purchase of shares at a price of $4.65 per share. Incyte will receive worldwide rights to develop and commercialize CB-1158 in hematology and oncology and Calithera will retain certain rights to research, develop and commercialize certain other arginase inhibitors in certain orphan indications.

Incyte and Calithera will jointly conduct and co-fund development of CB-1158, with Incyte leading global development activities. Incyte will fund 70 percent of global development and Calithera will be responsible for the remaining 30 percent. In the event of regulatory approvals and commercialization of CB-1158, Incyte and Calithera will share in any future U.S. profits and losses (receiving 60 percent and 40 percent, respectively) and Calithera will be eligible to receive over $430 million in potential development, regulatory and commercialization milestones from Incyte. Per the terms of the agreement, Calithera will have the right to co-detail CB-1158 in the U.S. and also be eligible to receive from Incyte tiered royalties based on future ex-U.S. sales, with rates ranging from low-to-mid double-digits.

The agreement also provides that Calithera may choose to opt out of its co-funding obligations. In this scenario, Calithera would no longer be eligible to receive future U.S. profits and losses but would be eligible to receive up to $750 million in potential development, regulatory and commercialization milestones from Incyte and, if the product is approved and commercialized, also be eligible to receive reimbursement based on previous development expenditures incurred by Calithera and tiered royalty payments on future global sales of CB-1158, with rates ranging from low-to-mid double-digits. The transaction is expected to close in the first quarter of 2017, subject to customary closing conditions.

Conference Call and Webcast Information

Calithera will host a conference call today to discuss this collaboration at 8:30 a.m. ET, 5:30 a.m. PT. Participants may access the call by dialing (855)783-2599 (domestic) or (631)485-4877 (international) and referencing conference ID 58716954. The conference call will also be available by webcast in the Investor Relations page of Calithera’s website, www.calithera.com. The archived webcast will remain available for replay for 30 days.

About Arginase

Arginase is an enzyme produced by immunosuppressive myeloid cells, including myeloid-derived suppressor cells (MDSCs) and neutrophils, which prevents T-cell and natural killer (NK) cell activation in tumors. Arginase exerts its immunosuppressive effect by depleting the amino acid arginine in the tumor microenvironment which subsequently prevents activation and proliferation of the immune system’s cytotoxic T-cells and NK-cells. Inhibition of arginase activity reverses this immunosuppressive block and restores T-cell function. In preclinical models, arginase inhibition has been shown to enhance anti-tumor immunity and inhibit tumor growth.

On January 30, 2017 Lytix Biopharma, a clinical-stage biopharmaceutical company developing novel cancer immune therapies, reported that it has been awarded a NOK 15.9 million grant from The Norwegian Research Council (User-driven Research-based Innovation) to support the investigation of LTX-315’s ability to make ’’cold tumors hot’’ and Phase II trial in Triple Negative Breast cancer (TNBC) (Press release, Lytix Biopharma, JAN 30, 2017, View Source [SID1234517595]).

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Recent developments in immunotherapy have demonstrated a significant clinical impact in the field of cancer treatment. However, it is well known that immune therapy works better when there are immune effector cells present in the tumour microenvironment compared to if they are absent. When the tumour lacks immune effector cells, they are called "cold" and when immune effector cells are present they are named "hot". Preclinical studies have shown that the Lytix compound LTX-315 has the potential to make cold tumours hot and thus increase the overall patient response of combinations with other cancer treatments, for example immune checkpoint inhibitors.

Forty-two patients have so far been treated with LTX-315 alone, in two Phase I trials, and positive signals from these patients form the basis for this project. The primary objective for this project is to document in both preclinical and clinical studies that LTX-315 increase the infiltration of immune effector cells in the tumour and make the "cold" tumour "hot" in combination with immunotherapy. The clinical study will be performed in patients with Triple Negative Breast Cancer, a subtype of breast cancer. These patients have today limited treatment possibilities and the medical need for better treatments is high.