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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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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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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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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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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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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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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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"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 30, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported that it will host a conference call and live webcast to report its 2018 first quarter financial results on Wednesday, May 9, 2018 at 4:30 p.m. ET (Press release, Inovio, APR 30, 2018, View Source [SID1234525832]).

Schedule your 30 min Free 1stOncology Demo!
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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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

A replay of the conference call will be accessible two hours after the call at 877-481-4010 (domestic) or 919-882-2331 (international) using replay ID 29009.