On December 12, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biotechnology company targeting the epigenetic causes of cancer, reported the acceptance of an abstract at the "Epigenetics Symposium: 15 Years of Lysine Demethylases: From Discovery to the Clinic" taking place Monday, December 16, 2019 at the Franklin Institute in Philadelphia, PA (Press release, Flex Pharma, DEC 12, 2019, View Source [SID1234552314]). The trial-in-progress poster presentation will include an overview of the ongoing Phase 1/2 clinical trial for Salarius’ lead drug candidate, Seclidemstat, a potent reversible LSD1 inhibitor being developed as a treatment for Ewing sarcoma, a rare pediatric bone cancer.

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Details of the symposium and poster presentation are as follows:

Abstract Title: Trials in progress: A phase I/II clinical trial of the reversible LSD1 inhibitor, seclidemstat, in patients with relapsed/refractory Ewing sarcoma
Where: The Franklin Institute, 222 North 20th Street, Philadelphia
When: Monday, December 16, 2019 at 8:30 a.m. EST to 7 p.m. EST
Symposium Website: Epigenetics Symposium: 15 Years of Lysine Demethylases: From Discovery to the Clinic

"The Epigenetics Symposium is an ideal event to showcase our progress bringing our lead drug candidate, Seclidemstat, into the clinic and the impact it could have on Ewing sarcoma, a rare and deadly bone cancer that most often strikes children and young adults and for which there are no targeted therapies approved," stated David Arthur, Chief Executive Officer of Salarius Pharmaceuticals. "Lysine demethylase enzymes are a well-known target for epigenetic-based drug development. We have developed Seclidemstat to be a differentiated LSD1 inhibitor, and we are excited that it has reached the clinical trial setting where its safety and therapeutic activity can be assessed. Research shows that LSD1 expression is elevated in 60% of Ewing sarcoma patients and correlates with poor patient prognosis and decreased overall survival. Given the potential of Seclidemstat to address this great unmet need, we look forward to releasing early cohort data next year from our Ewing sarcoma study and a Phase 1 study in advanced solid tumors."

On December 12, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immuno-oncology company, reported updated clinical results from its Phase 2b trial of MDNA55, in patients with recurrent glioblastoma (rGBM), the most common and uniformly fatal form of brain cancer (Press release, Medicenna Therapeutics, DEC 12, 2019, View Source [SID1234552333]). The results were presented by Dr. Fahar Merchant, PhD, President and CEO of Medicenna Therapeutics, at the Inaugural Glioblastoma Drug Development Annual Summit on December 11 at the Westin Boston Waterfront Hotel in Boston, Massachusetts.

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The presentation reported subgroup analysis from the first 40 patients treated with MDNA55 in a Phase 2b clinical trial for patients with rGBM. MDNA55 targets the interleukin 4 receptor (IL4R) known to be over-expressed in GBM, and a biomarker for more aggressive disease. Furthermore, unlike other trials, the MDNA55 study only enrolled patients with rGBM that have genetic features which make the tumor the most aggressive and resilient type of rGBM.

"We are very encouraged to see that by being the only oncology company to target the IL4R, which is over-expressed in 76% of patients with glioblastoma, we are achieving meaningful survival benefits with MDNA55 in a population where the majority of patients have the worst form of rGBM," said Dr. Fahar Merchant, President and CEO of Medicenna. "Our full data set will be complete early in the new year, allowing us to submit our package to the U.S. Food and Drug Administration in Q1, 2020 prior to an End of Phase 2 Meeting enabling us to reach a major milestone on the path to securing key partnerships."

The presentation highlighted that the patient characteristics in the clinical study excluded patients that are known to have a much better prognosis, such as patients that were, (a) eligible for surgery to remove the tumor, (b) had a lower grade of brain cancer at initial diagnosis (only de novo GBM patients were enrolled), and (c) had a known mutation associated with better prognosis (IDH mutation). Furthermore, the presentation emphasized that despite enrolling only patients known to have a very poor prognosis, patients actually did much better and were surviving significantly longer following only one treatment with MDNA55, particularly in patients with high expression of the IL4R target.

Of particular interest, subjects receiving lower doses of steroids (≤ 4mg of concurrent steroid per day) showed a trend towards improved survival, particularly in the IL4R High group, with a median overall survival (mOS) of 16.5 months with 88% of patients being still alive at 12 months. In patients resistant to approved chemotherapy Temodar (rGBM with unmethylated MGMT promoter), MDNA55 treatment in IL4R High patients had a median overall survival of 15.2 months and a 12 month survival rate of 69% versus 22% for Lomustine and less than 19% for Avastin.

Additional data comparing the various prognostic factors on MDNA55 outcome measures are provided in the slide presentation available on-line at View Source

On December 12, 2019 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported the start of enrollment and screening in the Company’s Phase lb/ll clinical development program for previously treated patients with advanced pancreatic cancer (Press release, Helix BioPharma, DEC 12, 2019, View Source [SID1234552315]).

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The study is entitled "A Phase Ib/II Study of the Microenvironment Modifier L-DOS47 plus Doxorubicin for the Treatment of Patients with Previously Treated Advanced Pancreatic Cancer". The Phase Ib portion of the study involves three dose escalating cohorts enrolling a total of nine (9) patients. The Phase II portion of the study will enroll an additional eleven (11) patients depending on meeting safety and efficacy criteria. The principal investigator of the study is Dr. Erkut Borazanci. The study center is located in Scottsdale, Arizona at the Scottsdale Hospital dba HonorHealth.

Pancreatic cancer is the third leading cause of cancer death in the United States for which there are few treatment options. L-DOS47 with its novel mechanism of action aims to transform the treatment landscape by combatting the acidic tumor microenvironment, which is hostile to the body’s immune system.

"I would like to personally thank Dr. Daniel Von Hoff in helping us develop this clinical study," said Dr. Heman Chao, Helix’s Chief Executive Officer. "We are very excited to expand our clinical drug development program to include this new indication. With excellent safety and tolerability data already obtained from a monotherapy study in late stage non-small cell lung cancer and ongoing combination studies in similar patient groups, this new clinical study will add to the expanding utility of L-DOS47 in multiple cancer indications."

On December 12, 2019 Biocept, Inc. (NASDAQ: BIOC) ("Biocept" or the "Company"), a leading commercial provider of liquid biopsy solutions, reported that on December 11, 2019 it closed its previously announced underwritten public offering of 24,600,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase up to 24,600,000 shares of its common stock (Press release, Biocept, DEC 12, 2019, View Source [SID1234552334]). Each share of common stock or pre-funded warrant was sold together with one warrant to purchase one share of common stock at a combined price to the public of $0.405 per share and warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, were approximately $10.0 million. In addition, Biocept granted to Maxim Group LLC a 45-day option to purchase up to an additional 3,690,000 shares of common stock and/or warrants to purchase up to 3,690,000 shares of common stock, at the public offering price less discounts and commissions, of which Maxim Group LLC has partially exercised its option to purchase warrants to purchase up to 1,927,500 shares of common stock.

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The warrants are immediately exercisable at a price of $0.405 per share of common stock and will expire five years from the date of issuance. Additionally, if the volume-weighted average price of our common stock is below the exercise price per share of the warrants on any trading day beginning the earlier of (i) January 8, 2020, and (ii) the trading day on which the aggregate trading volume of Biocept’s common stock is equal to more than three times the number of shares of common stock sold in the offering, then the warrantholders may elect to cashless exercise their warrants for a number of shares equal to 50% of the shares issuable upon cash exercise. Each pre-funded warrant has an exercise price of $0.01 per share, is exercisable immediately and will expire when exercised in full. The shares of common stock or the pre-funded warrants and the accompanying warrants, were sold together in the offering, but were issued separately and were immediately separable upon issuance.

Maxim Group LLC acted as the book-running manager and Dawson James Securities, Inc. acted as a co-manager in connection with the offering.

The offering was conducted pursuant to the Company’s registration statement on Form S-1 (File No. 333-234459), as amended, previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). A final prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.

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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 12, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the acceptance of an abstract highlighting new biomarker data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer (Press release, Oncolytics Biotech, DEC 12, 2019, View Source [SID1234552316]). The data will be part of a poster presentation at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper), January 23 – 25, 2020, in San Francisco.

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The abstract, CEACAM6 is a candidate biomarker for REOLYSIN (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), was co-authored by Dr. Anne Noonan, Department of Medical Oncology, Ohio State University Wexner Medical Center, Richard Solove Research Institute and James Cancer Hospital, and Dr. Tanios Bekaii-Saab Senior Associate Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona.

Abstracts will be published at 5:00 pm ET on Tuesday, January 21, 2020 on the ASCO (Free ASCO Whitepaper) meeting library website at View Source

Abstract ID: 285103
Abstract Number: 746
Poster Board: M13
Abstract Title: CEACAM6 as a candidate biomarker for pelareorep sensitivity in pancreatic adenocarcinoma (PDAC)
Session Information: Poster Session B: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer
Session Date & Time: January 24, 2020 from 12:00 PM-1:30 PM & 4:30 PM-5:30 PM

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.