On April 30, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi reported that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery (Press release, Regeneron, APR 30, 2018, View Source [SID1234525830]). Advanced CSCC is the deadliest non-melanoma skin cancer. Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed cell death protein-1) and was granted Breakthrough Therapy designation status by the FDA in September 2017. The target action date for the FDA decision is October 28, 2018.

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The BLA submission is based on a Phase 2 pivotal, single-arm, open-label clinical trial of cemiplimab for advanced CSCC (EMPOWER-CSCC 1) in addition to Phase 1 data from two advanced CSCC expansion cohorts. Both clinical trials enrolled patients with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery. Topline results from EMPOWER-CSCC 1 were previously announced in December 2017, and Phase 1 expansion cohort results were presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Updated results from both clinical trials will be presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting.

In the European Union, the European Medicines Agency accepted for review in April 2018 the Marketing Authorization Application for cemiplimab in patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery.

Cemiplimab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement and was invented by Regeneron using the company’s proprietary VelocImmune technology that yields optimized fully-human antibodies.

Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.

About CSCC
Cutaneous squamous cell carcinoma (CSCC) is the second most common type of skin cancer in the U.S., with the number of newly diagnosed cases expected to rise annually. Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses. Advanced CSCC is the deadliest non-melanoma skin cancer, responsible for approximately 7,000 deaths in the U.S. each year. There are currently no FDA-approved treatments for advanced CSCC.

On April 30, 2018 Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, reported that it will hold a conference call on Thursday, May 3, 2018 at 1:30 PM Pacific Time (4:30 PM Eastern Time) to discuss first quarter 2018 financial results and provide a corporate update (Press release, Arbutus Biopharma, APR 30, 2018, View Source [SID1234525848]).

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To access the conference call, a live webcast of the call can be accessed through the Investor section of Arbutus’ website at www.arbutusbio.com. Or, alternatively, to access the conference call, please dial 1-914-495-8556 or 1-866-393-1607.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling 1-404-537-3406 or 1-855-859-2056 and referencing conference ID 4169558.

On April 30, 2018 Synthorx Inc. reported the completion of a $63 million Series C financing, led by OrbiMed and joined by new investors, Medicxi and Osage University Partners, and existing investors, Avalon Ventures, RA Capital Management, and Correlation Ventures (Press release, Synthorx, APR 30, 2018, View Source [SID1234525867]). In addition, Peter Thompson, M.D., private equity partner at OrbiMed, and Vickie Capps, an independent advisor with extensive financial and audit experience, will join the Synthorx board of directors. The proceeds of the financing will be used to advance the company’s pipeline of Synthorin cytokines, including an IL-2 tuned specifically for activity on certain immune cells. Using the company’s expanded genetic alphabet technology based on a breakthrough in synthetic biology, Synthorin cytokines are designed to selectively tune receptor pharmacology and extend half-life. These properties allow for efficacious immune system activation with convenient dosing schedules and without safety limitations to enhance the antitumor activity of leading immuno-oncology approaches, including checkpoint inhibitors, cancer vaccines, CAR-T therapies, and oncolytic viruses.

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"The ability to activate tumor-fighting immune cells has been a tremendous breakthrough in curing cancer in some patients, but the rate of responses leading to long-term remission and overall survival is still limited. Combination therapies are needed that demonstrate improved efficacy but are safe and convenient for patients. IL-2 has proven activity but limited use due to safety issues," said Laura Shawver, Ph.D., president, CEO, and director of Synthorx. "Our investors immediately recognized the remarkable ability of our lead molecule, Synthorin IL-2, to deliver sustained cancer-killing activity without the safety liability through our unique ability to modify protein therapeutics for tuning receptor pharmacology and extending half-life."

"Since its discovery nearly 40 years ago, IL-2 is the most studied cytokine and potentially the most valuable molecule for boosting the efficacy of immuno-oncology therapies," said Marcos Milla, Ph.D., who was recently promoted to chief scientific officer of Synthorx. "To make the best IL-2 we have seen to date, the scientific team at Synthorx applied the company’s expanded genetic alphabet technology to create specific receptor interactions with great precision that bias IL-2’s activity to immune activation versus repression."

"We are impressed with the data for Synthorin IL-2 and how the Synthorx technology platform can specifically identify and select protein modifications that result in the desired therapeutic effect and pharmacokinetics. It is easy to see how this platform could be applied to a variety of protein therapeutics," said Dr. Thompson.

About OrbiMed

OrbiMed is a leading investment firm dedicated exclusively to the healthcare sector, with over $14 billion in assets under management. OrbiMed invests globally across the spectrum of healthcare companies, from venture capital start-ups to large multinational corporations, utilizing a range of private equity funds, public equity funds, royalty/credit funds and other investment vehicles. OrbiMed maintains its headquarters in New York City, with additional offices in San Francisco, Shanghai, Mumbai and Herzliya. OrbiMed seeks to be a capital provider of choice, with the flexibility to provide equity and debt capital solutions that are tailored to the unique needs of our portfolio companies. The firm’s global team of over 80 professionals brings the resources and experience required to be an exceptional long-term partner in building world-class healthcare companies. For more information, please visit www.orbimed.com.

On April 27, 2018 Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, reported that it has completed the sale of BioServe Biotechnologies (India) Private Limited, a wholly-owned subsidiary of Cancer Genetics to biomedical research company, REPROCELL Incorporated, for $1.9 million (Press release, Cancer Genetics, APR 27, 2018, View Source [SID1234525791]).

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Under the terms of the definitive agreement, Cancer Genetics received an upfront payment of $1.6 million in cash from REPROCELL. The remaining balance will be payable approximately 6 months from closing and is subject to BioServe’s revenues for a four month period post-closing being equivalent to the same four month period in 2017.

"The sale of BioServe to REPROCELL is consistent with our 2018 transformation and strategic plan to focus our business and execute against a path to profitability. We expect this transaction will be beneficial to the Company and our shareholders," said Jay Roberts, Interim Chief Executive Officer and COO of Cancer Genetics. "For CGI, this divestiture is one of several deliberate actions to focus our business, simplify our operating structure and generate monetary value to help fund new programs and assist in reducing overall operating expenses. Additionally, as part of our forward looking strategy, we intend to explore licensing opportunities with REPROCELL, among other business partners internationally, to bring our vast test and services menu to other regions with high demand and volume expectations. Overall, we remain focused on developing and bringing to market unique and innovative diagnostic assets from our industry leading pipeline and collaborating with biopharma companies to augment their therapeutics development capabilities."

The Company announced on April 2, 2018 that it has engaged Raymond James & Associates, Inc. as a financial advisor to assist with evaluating options for the Company’s strategic direction. These options may include raising additional capital, the acquisition of another company and / or complementary assets, the sale of the Company, or another type of strategic partnership. The Company’s Board of Directors is committed to evaluating all potential strategic opportunities and to pursuing the path most likely to create both near- and longer-term value for Cancer Genetics’ shareholders.

On April 27, 2018 Compugen Ltd. (Nasdaq: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) requested that the Company provide additional CMC information in support of its IND application for COM701, initially submitted in late March 2018 (Press release, Compugen, APR 27, 2018, View Source [SID1234525792]). COM701 is a first-in-class immuno-oncology therapeutic antibody targeting PVRIG. FDA recommended a lower starting dose of COM701 for the trial, which now requires a more sensitive COM701 assay detection method for this dose. The FDA informed the Company that the IND application review can be completed and the application can be taken off clinical hold once the requested information is provided by Compugen. The IND is intended to support initiation of a planned Phase 1 clinical trial of COM701 in patients with advanced solid tumors. This trial is not yet active at any investigational sites and has not recruited any patients.

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"We are working closely with the FDA to provide the additional information requested as quickly as possible. In anticipation for FDA clearance, site selection activities in multiple centers in the United States are currently ongoing to allow future patient enrollment, and we look forward to evaluating COM701 in a clinical setting," stated Anat Cohen-Dayag, PhD, President and CEO of Compugen. "We continue to be encouraged by the preclinical data for COM701, which suggest that targeting PVRIG may be a primary means of stimulating an anti-tumor immune response in certain cancers that may be unresponsive to available treatments."

The Company will continue to provide updates on this matter as appropriate.