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]).

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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

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.

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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.

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.

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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.

On September 19, 2019 Celsius Therapeutics, a company focused on bringing personalized medicine to patients with cancer, autoimmunity and other complex diseases, reported the signing of collaboration agreements with the Parker Institute for Cancer Immunotherapy (San Francisco, USA), Institut Gustave Roussy (Paris, France) and the University Health Network (Toronto, Canada) (Press release, Celsius Therapeutics, SEP 19, 2019, View Source [SID1234539644]). Under these three agreements, Celsius will apply its proprietary single-cell genomics platform to tissue samples from patients receiving immune checkpoint inhibitor therapies for triple negative breast cancer, bladder cancer and kidney cancer, respectively. The goal of these collaborations is the discovery of novel molecular mechanisms and targets for drug discovery.

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"We are delighted to collaborate with these premier academic groups, given their disease expertise and their commitment to cutting-edge research and improving the lives of cancer patients," said Tariq Kassum, M.D., chief executive officer of Celsius. "The heterogeneity of response in immunotherapy studies suggests that a deeper understanding of disease biology and patient subpopulations is needed to fully realize the potential of this approach. These new partnerships highlight our interest in broadly engaging the academic community to better elucidate the cellular ecosystem of cancer, with the ultimate goal of translating new insights into novel precision medicines for patients."

Under these agreements, Celsius will apply its platform approach to generate single-cell data from patient biopsy samples taken pre- and post-treatment with checkpoint inhibitors. In each case, Celsius retains the ability to integrate the clinical information and single-cell genomics data generated from the studies into its growing database. The company plans to utilize its machine learning algorithms and functional genomics capabilities to rapidly identify and prioritize targets for drug discovery.

"Our integrated platform allows Celsius to obtain samples from anywhere in the world, process them in a highly industrialized manner and rapidly deploy a suite of machine learning algorithms to identify new drug targets in relevant cell types," said Christoph Lengauer, Ph.D., co-founder and chief scientific officer of Celsius. "Across just these three collaborations, we expect to analyze more than 300 longitudinal samples from over 150 patients, a scale that is unprecedented for single-cell genomics. Combined with the associated clinical data that is being gathered from these studies, we are building a massive database that will be leveraged to develop novel precision medicines."

On September 19, 2019 Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported that Stanley C. Erck, President and Chief Executive Officer, will present at the Ladenburg Thalmann 2019 Healthcare Conference (Press release, Novavax, SEP 19, 2019, View Source [SID1234539643]).

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Presentation details are as follows:

Date and Time: Tuesday, September 24, 8:30 – 8:55 a.m. E.T.
Location: St. Germain III, Sofitel Hotel, New York
Live webcast: www.novavax.com, "Investors"/"Events"
A replay of the presentation will also be accessible under the "Investors/Events" section www.novavax.com.