1stOncology™: Cancer Intelligence Service – Page 13135 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Arcus Biosciences to Present at the 2019 Cantor Global Healthcare Conference

On September 19, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer therapies, reported that Terry Rosen, Ph.D., Chief Executive Officer, will present at the 2019 Cantor Global Healthcare Conference on Friday, October 4, 2019 at 9:30 a.m. Eastern Time in New York, NY (Press release, Arcus Biosciences, SEP 19, 2019, View Source [SID1234539649]).

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

Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for at least 30 days following the live event.

Five Prime Therapeutics Announces Management Transition

On September 19, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, reported that its Board of Directors has appointed William "Bill" Ringo as Interim Chief Executive Officer, effective immediately (Press release, Five Prime Therapeutics, SEP 19, 2019, View Source [SID1234539648]). Mr. Ringo will succeed Chief Executive Officer and Board Member Aron Knickerbocker, who has resigned from the company to pursue new challenges and opportunities. Mr. Ringo will continue to serve as Chairman of Five Prime’s Board of Directors.

"I look forward to working with the talented executive team at Five Prime as interim CEO to ensure that all clinical programs remain on track as we enter a period where upcoming data events will provide insights to enable prioritization of clinical investments and pipeline programs," said Mr. Ringo. "The Board is initiating a search process to recruit a permanent Chief Executive Officer."

Mr. Ringo has served as the Chairman of the Five Prime Board of Directors since January 2019 and as a Board Member since October 2014. He is an industry leader who has served in numerous executive and board roles across the pharmaceutical, biotech and venture capital sectors. Mr. Ringo served as President and Chief Executive Officer of Abgenix and as Senior Vice President of Business Development, Strategy and Innovation at Pfizer. He also served for 28 years at Eli Lilly and Company in numerous executive roles, including Product Group President for Oncology and Critical Care, President of Internal Medicine Products, President of the Infectious Diseases Business Unit and Vice President of Sales and Marketing for U.S. Pharmaceuticals.

"On behalf of the Board, I thank Aron for his dedication and numerous contributions during ten years of service as Five Prime evolved from a research-oriented private company to a public one with multiple programs advancing in clinical development," Mr. Ringo continued. "As Chief Executive Officer, Aron provided leadership for the expansion of our clinical portfolio and we wish him well in his future endeavors."

Ayala Pharmaceuticals Announces Presentation at the European Society for Medical Oncology (ESMO)

On September 19, 2019 Ayala Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to developing targeted cancer therapies for people living with genetically defined cancers, reported that a poster will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), being held in Barcelona, Spain from September 27 to October 1, 2019 (Press release, Ayala Pharmaceuticals, SEP 19, 2019, View Source [SID1234539647]).

Presentation information is as follows:

Title: ACCURACY a phase (P) 2 trial of AL101, a pan-Notch inhibitor, in recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) patients (pts) with Notch activating mutations (Notchact mut): preliminary safety and efficacy data
Session Title: Poster Display Session
Session Date and Time: Monday, September 30, 2019 at 12:00pm to 1:00pm CET
Presentation Number: 1148P
Location: Poster Area (Hall 4)
Presenter: Alan L. Ho, M.D., Ph.D., Memorial Sloan Kettering Cancer Center

Context Therapeutics and Jefferson Health to Evaluate Apristor Combination Therapy for Women with Advanced Endometrial Cancer

On September 19, 2019 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported a Phase 2 clinical collaboration with the Sidney Kimmel Cancer Center at Jefferson Health (Press release, Context Therapeutics, SEP 19, 2019, View Source [SID1234539646]). This clinical collaboration will evaluate whether the addition of Apristor to the antiestrogen, anastrazole, can enhanced outcomes for patients with metastatic endometrial cancer who have failed multiple prior therapies.

The Phase 2 trial will assess an oral treatment consisting of the progesterone receptor antagonist, Apristor (onapristone ER) plus the antiestrogen, anastrazole, in up to 25 patients who are ER+,PR+,HER2- and who have received prior chemotherapy treatment. The primary endpoint will be overall response rate (ORR), which is the proportion of patients who have either a complete or partial response. To further characterize the activity of Apristor, secondary endpoints will include duration of response, clinical benefit rate, and progression-free survival (PFS). In addition, this study will evaluate the safety and pharmacological profile of oral combination in these patients, as well as biomarker analyses to explore predictive factors of response to complete hormone blockade. This data will support Context’s ongoing Phase 2 studies and help design a future Phase 3 trial.

"Currently, there are limited therapeutic options to treat endometrial cancer in the advanced setting. Recent preclinical findings, together with Phase 1 study results in patients with advanced PR+ ovarian and endometrial cancers, give us reason to believe that Apristor can help women with PR+ gynecological cancers," said Martin Lehr, CEO of Context Therapeutics. [1],[2]. "We believe Apristor can make a meaningful difference for patients in the trial."

The study, sponsored by Jefferson Health, will be led by the Primary Investigator, Dr. Saveri Bhattacharya, an Assistant Professor of Medical Oncology. Dr. Russell Schilder, Director of the Gynecologic Oncology Program, and Dr. Kimberly Aderhold are the study’s Co-Investigators. Final study design and other details will be announced upon enrollment of the first patient, expected around the end of 2019 or early 2020.

"Context is humbled by the support and enthusiasm of Dr. Bhattacharya and her colleagues at Jefferson," said Mr. Lehr. "The gynecologic oncology program at Jefferson is one of the top in the country and we are fortunate that Jefferson is right in our backyard."

"The majority of endometrial cancer patients have hormone driven cancer. The hormones estrogen and progesterone drive endometrial cancer progression in those patients, but antiestrogens are the only antihormonal therapy available to clinicians. Given the broad use of antiestrogens, antiestrogen resistance is now a major clinical challenge," said Dr. Bhattacharya. "We believe that a progesterone receptor antagonist has the potential to address antiestrogen resistance by working with an antiestrogen to deprive the cancer of hormone driven growth signals, which will lead to better outcomes for patients."

About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy in the United States with an incidence that continues to increase each year. More than 60,000 women were diagnosed with endometrial cancer in 2018 and this disease contributes to more than 10,000 deaths annually [3]. Unopposed estrogen production and obesity are the most common risk factors for the development of endometrial cancer. The majority of patients with recurrent endometrial cancer have limited therapeutic options and the development of second line therapies that result in improved response is an unmet clinical need. Using targeted hormonal treatment may present potential opportunities for improved treatment outcomes for these women.

About Apristor
Apristor (onapristone extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that Apristor has anticancer activity by inhibiting the binding of progesterone receptor to chromatin, downregulating cancer stem cell mobilization, and blocking immune evasion. Apristor is an investigational drug that has not been approved for marketing by any regulatory authority.

VBI Vaccines Announces Pricing of $35 Million Public Offering

On September 19, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI or the Company), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported the pricing of its previously announced underwritten public offering of 70,000,000 common shares, at a public offering price of US$0.50 per share (Press release, VBI Vaccines, SEP 19, 2019, View Source [SID1234539645]). VBI also granted the underwriters a 30-day option to purchase up to an additional 10,500,000 common shares at US$0.50 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately US$35 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about September 23, 2019, subject to satisfaction of customary closing conditions.

Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. are acting as joint book-running managers, and National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (Nasdaq: NHLD), is acting as lead manager for the underwritten public offering.

VBI intends to use the net proceeds from the offering to progress its pipeline programs including the completion of the global CONSTANT Phase 3 lot-to-lot consistency study, regulatory submissions, and pre-commercialization activities for Sci-B-Vac, a trivalent hepatitis B vaccine, and for the continued clinical development of VBI-1901, a vaccine immunotherapeutic candidate for recurrent glioblastoma (GBM); VBI-2601, an immunotherapeutic candidate for chronic hepatitis B infection; and VBI-1501, a cytomegalovirus (CMV) vaccine candidate. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (SEC) and declared effective on July 30, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering was filed with the SEC on September 18, 2019. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement (when available) and accompanying prospectus may be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.