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 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 Toronto Innovation Acceleration Partners ("TIAP") reported the launch of a new project developed under the BRIDGE LAB150, a partnership between Evotec SE and TIAP (Press release, Evotec, DEC 12, 2019, View Source;announcements/press-releases/p/toronto-innovation-acceleration-partners-tiap-adds-novel-kras-oncology-project-to-its-lab150-portfolio-5879 [SID1234552313]). The project will be focusing on breakthroughs in novel cellular drug screening systems in oncology-focused scientific KRAS research by Professor Igor Stagljar at the University of Toronto, a TIAP Member, and aims to develop therapeutics targeting the protein-protein interactions of KRAS and its downstream interacting partners.

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The low survival rates of three of the four most lethal cancers in North America – pancreatic, colorectal and lung – are associated with KRAS mutations, a well-established cancer driver. Although there is an urgent need for KRAS-targeting therapeutics, so far there has been a lack of clinically available drugs as oncogenic KRAS is very difficult to target directly.

LAB150 accelerates academic research towards commercial outcomes by providing funding and access to pharmaceutically validated platforms and expertise. For further information on the new LAB150 projects

On December 12, 2019 Zhejiang Medicine, NovoCodex and Ambrx reported positive interim topline data from the ongoing "111" trial (CTR20171162) evaluating ARX788, a novel anti-HER2 ADC, in heavily pretreated patients with metastatic HER2 positive breast cancer (Press release, Zhejiang Medicine, DEC 12, 2019, View Source [SID1234552312]). All patients enrolled had failed prior therapy with trastuzumab and 47% had failed therapy with trastuzumab and lapatinib.

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ARX788 was well tolerated at all dose levels with just two ≥ Grade 3 drug related reversible adverse events observed amongst 51 enrolled patients. ARX788 showed an excellent safety profile with dose escalation continuing. No DLT or MTD was observed as of the November 20, 2019 cut-off date.

Response rates correlated with increased dose levels. As of the cut-off date, the highest dose tested was 1.5mg/kg every three weeks. This cohort, which continues dosing and remains under observation, had already achieved a 63% overall response rate. Prior cohorts at 0.88, 1.1 and 1.3 mg/kg demonstrated overall response rates of 14%, 36% and 56% respectively. Further, the substantial increases in efficacy observed at higher doses was achieved with only mild increases in toxicity.

These data originate from the Fudan University Shanghai Cancer Center in China and are part of a broader global ARX788 development program (NCT03255070 and CTR20171162) that includes clinical sites in China, USA and Australia.

The 42nd Annual San Antonio Breast Cancer Symposium Poster is available at www.ambrx.com

Zhejiang Medicine licensed the commercial rights to ARX788 in China in 2013. The promising clinical data for ARX788 serves as a solid foundation to the second and more recent collaboration. Earlier this year, Ambrx and Zhejiang Medicine (via its subsidiary NovoCodex) entered into their second collaboration to develop and commercialize ARX305 in China. ARX305 is an anti-CD70 Antibody Drug Conjugate for the potential treatment of Renal Cell Carcinoma, Multiple Myeloma, and other solid tumors.

About HER2-Positive Breast Cancer

Almost 300,000 new cases of HER2 positive breast cancer may be diagnosed in 2020 in the US alone (approximately 15-20% of breast cancers are HER2 positive). HER2 positive breast cancer tends to be aggressive and more likely to recur than HER2 negative. There are currently no approved therapies demonstrating progression-free survival or overall survival benefit for the treatment of patients with HER2 positive metastatic breast cancer after progression on T-DM1 (which is not approved in China).

On December 12, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported the closing of its previously announced underwritten public offering of 12,782,439 common shares, including 1,667,274 common shares pursuant to the full exercise of the underwriters’ option to purchase additional common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, DEC 12, 2019, View Source [SID1234552310]). The shares were sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are approximately US$191.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

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Jefferies LLC and SVB Leerink LLC acted as joint book-running managers for the Offering. H.C. Wainwright & Co. LLC, Oppenheimer & Co. Inc., and Bloom Burton Securities Inc. acted as co-managers for the Offering.

For the purposes of the TSX approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as NASDAQ.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, as well as working capital and general corporate purposes.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on March 29, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated March 26, 2018. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") have been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents are available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement are available upon request by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.