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Genialis, Oncologie Form Partnership on Gastric Cancer Biomarker Prediction

On January 22, 2020 Genialis and Oncologie reported that they have formed a partnership to evaluate and predict biomarkers for gastric cancer (Press release, Oncologie, JAN 22, 2020, View Source [SID1234553407]).

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They initially will concentrate on modeling gene expression signatures that might predict potential treatments for the condition. Houston-based Genialis already has begun applying its Expressions software to the clinical and translational expertise of Oncologie in an effort to improve methodologies for patient stratification, according to the companies.

"One of the most encouraging trends in drug development is innovation around integrating and interrogating diverse datasets," Genialis CEO Rafael Rosengarten said in a statement. "Our work in data science requires a great deal of artistry in addition to technology and benefits from hand-in-hand collaboration with biology domain experts, which makes this opportunity with Oncologie so special.

Boston-based Oncologie said that it eventually wants to take its methodologies to expand into other tumor microenvironment phenotypes.

"To be able to better understand the patient’s tumor microenvironment phenotype and how it is related to patient benefit represents a key objective for the future success of our company," Oncologie CEO Laura Benjamin said in a statement.

BioLineRx Completes Recruitment in Triple Combination Arm of COMBAT/KEYNOTE-202 Study in Patients with Second-Line Metastatic Pancreatic Cancer

On January 22, 2020 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported the completion of patient recruitment in the triple combination arm of its ongoing Phase 2a COMBAT/KEYNOTE-202 study (Press release, BioLineRx, JAN 22, 2020, View Source [SID1234553404]).

"We are pleased to see the triple combination arm of our Phase 2a pancreatic study advance according to plan," stated Philip Serlin, Chief Executive Officer of BioLineRx. "This follows very promising initial results that were presented last month at the ESMO (Free ESMO Whitepaper) IO conference, demonstrating robust and durable responses to the triple combination treatment. As previously stated, we remain on track to announce progression-free and overall survival data from the triple combination arm in mid-2020."

A total of 40 patients diagnosed with unresectable stage IV metastatic pancreatic adenocarcinoma (PDAC), who have progressed following first-line gemcitabine-based therapy, were enrolled as planned in the triple combination arm focusing on second-line pancreatic cancer patients. Patients receive Motixafortide (BL-8040) monotherapy priming treatment for five days, followed by combination cycles of chemotherapy (Onivyde/5-fluorouracil/leucovorin), KEYTRUDA and Motixafortide until progression. The primary endpoint of the study is the objective response rate (ORR). Secondary endpoints include overall survival, progression free survival, and disease control rate.

Last month, the Company shared preliminary data at the ESMO (Free ESMO Whitepaper) IO conference showing that the triple combination demonstrated a 32% overall response rate (ORR) and a 77% disease control rate (DCR) out of 22 evaluable patients at the time. This compares favorably to the current chemotherapy standard-of-care treatment in second-line patients with ORR of 17% and DCR of 52%. In addition, the median duration of clinical benefit for all 17 patients with disease control (7 partial response and 10 stable disease patients) was 7.8 months, compared to approximately three months of response duration with other treatments for second-line pancreatic cancer.

The COMBAT/KEYNOTE-202 Study
The Phase 2a COMBAT/KEYNOTE-202 study was originally designed as an open-label, multicenter, single-arm trial to evaluate the safety and efficacy of the dual combination of Motixafortide and KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in over 30 subjects with metastatic pancreatic adenocarcinoma. The study was primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies, and was carried out in the US, Israel and additional territories. The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary.

In July 2018, the Company announced the expansion of its immuno-oncology collaboration with MSD to include the triple combination arm investigating the safety, tolerability and efficacy of Motixafortide, KEYTRUDA and chemotherapy as part of the Phase 2a COMBAT/KEYNOTE-202 study.

About Motixafortide in Cancer Immunotherapy
Motixafortide is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

Motixafortide is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

In a number of clinical and preclinical studies, Motixafortide has been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).

AstraZeneca Young Health Programme to partner with UNICEF to prevent non-communicable diseases among young people

On January 22, 2020 AstraZeneca reported that it will support UNICEF with a $12.5 million grant to support programming which will reach more than five million young people, train 1,000 youth advocates, and positively shape public policy around the world, over the next six years (Press release, AstraZeneca, JAN 22, 2020, View Source [SID1234553403]).

The announcement follows AstraZeneca’s decision in October 2019 to continue to fund its Young Health Programme to 2025 with an overall commitment of $35m (£28m).

The AstraZeneca Young Health Programme will work with UNICEF and other partners to raise awareness of the risks and effects of non-communicable diseases (NCDs) such as cardiovascular disease, preventable cancers and mental health conditions among young people and key decision-makers.

The World Health Organisation (WHO) identifies NCDs as the number one cause of death worldwide1 and found that 70% of premature deaths from NCDs can be linked back to behaviours that first appear in adolescence2. Similarly, the World Economic Forum (WEF) has predicted that NCDs will cost the worldwide economy more than $47 trillion in lost productivity and wages by 20303.

Pascal Soriot, Chief Executive Officer, said: "We believe in the power of young people to change the trajectory of the staggering burden of disease we face today, all over the world. Improving the health outcomes of future generations is a critical part of developing strong and stable healthcare systems, which in turn support sustainable markets and the economic prosperity of nations."

Since its launch in 2010, the Young Health Programme has reached more than 3.5 million young people across six continents and trained more than 50,000 peer educators.

Gary Stahl, Director, UNICEF Private Fundraising and Partnerships, said: "The health and futures of young people must not be compromised by unhealthy lifestyles and behaviours. I am happy that UNICEF is joining a coalition of committed partners with the support of AstraZeneca to bring attention to NCDs which are now the world’s biggest killers. The burden of these diseases is closely linked to socio-economic factors and more work needs to be done on delivering the right messages through the right channels in countries to encourage healthy behaviours."

The other allies in the Young Health Programme are founding partner, and community-based programming lead, Plan International, youth engagement and development lead One Young World, and more than 30 other non-profit partners around the world, all working to improve health outcomes for young people through thoughtful programming, research and youth engagement activities.

The Young Health Programme

Since 2010 the Young Health Programme has reached over three million young people, through a mix of programmes, advocacy and research activities designed to increase awareness and understanding of NCD prevention. These have ranged over 24 countries and six continents from Australia to Zambia. Programmes range from one-to-one mentoring in Sweden, to long-running community-based behaviour change programmes involving hundreds of thousands of young people in Brazil and India. The methods may vary, but the drive is always the same – to help young people to lead longer, happier and healthier lives. For more information please visit younghealthprogrammeyhp.com.

Sierra Oncology Announces Reverse Stock Split

On January 22, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the development and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported that its board of directors has approved a reverse stock split of its shares of common stock at a ratio of 1-for-40 (Press release, Sierra Oncology, JAN 22, 2020, View Source [SID1234553398]). The reverse stock split will be effective today at 4:30 p.m. Eastern Time. At the market open on January 23, 2020, the Company’s common stock will continue to trade on The Nasdaq Global Market under the symbol "SRRA," but will be assigned a new CUSIP number (82640U404) and will trade on a split-adjusted basis.

At the effective time of the reverse stock split, every 40 shares of the Company’s issued and outstanding common stock will be automatically combined and reclassified into one issued and outstanding share of common stock. The reverse stock split will not affect any stockholder’s ownership percentage of the Company’s common stock, alter the par value of the Company’s common stock, have any direct impact on the market capitalization of the Company, or modify any voting rights or other terms of the common stock.

The reverse stock split was approved by Sierra Oncology stockholders on January 21, 2020. Additional information regarding the reverse stock split, other matters voted upon, and the certified voting results will be filed on Form 8-K with the U.S. Securities and Exchange Commission.

As previously announced, shortly following the reverse stock split:

The Series A convertible voting preferred stock issued in the recently completed $103.0 million financing (gross proceeds) will be converted into shares of common stock, subject to the applicable beneficial ownership limitation.
Gilead Sciences, Inc. (Gilead) will be issued approximately 725,000 shares of common stock (on a post-split basis) and a warrant to purchase an equivalent amount of common stock, in consideration for amending the royalty rates and milestones in an Asset Purchase Agreement with Gilead for momelotinib.
Following the reverse stock split, assuming the conversion of all outstanding Series A convertible preferred voting shares to common stock, and the issuance of common stock to Gilead, there are expected to be approximately 10,394,600 total shares of common stock outstanding and warrants to purchase approximately 11,104,000 total shares of common stock outstanding on a post-split basis. Of these warrants, warrants to purchase approximately 2,574,700 shares of common stock (the Series B warrants) may only be exercised by paying the exercise price in cash, and will expire on the 75th day anniversary following the announcement of top-line data from Sierra Oncology’s ongoing Phase 3 clinical trial of momelotinib. If Series B warrants were fully exercised, the company would receive approximately $34.0 million in proceeds.

Sierra Oncology previously reported its cash and cash equivalents totaled $67.7 million as of September 30, 2019, and that subsequently it had closed an underwritten public offering with gross proceeds to Sierra Oncology of $103.0 million. Prior to the end of 2019, a term loan of $5.0 million was repaid to Silicon Valley Bank.

Oncolytics Biotech® Announces Publication of an Abstract for the 2020 Gastrointestinal Cancers Symposium Highlighting CEACAM6 as a Potential Prognostic Biomarker Candidate for Pancreatic Cancer

On January 22, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that abstract for a poster to be presented at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO (Free ASCO Whitepaper) in San Francisco, has been published (Press release, Oncolytics Biotech, JAN 22, 2020, View Source [SID1234553397]). The abstract highlights 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.

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.

Data in the abstract associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep-treated patients with pancreatic cancer, with PFS improving from 5.72 months to 10.32 months (p=0.05). This effect was not seen in non-pelareorep treated patients. Consequently, CEACAM6 may serve as a prognostic biomarker for sensitivity of pancreatic tumors to pelareorep treatment. Additional data will be announced following the poster presentation.

Abstracts are available on the ASCO (Free ASCO Whitepaper) meeting library website at View Source The poster will be added to the Oncolytics corporate website shortly after the presentation.

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.