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BiocurePharm, Korea (“BPK”) Announces Private Placement

On March 16, 2020 Biocure Technology Corp. ("CURE" or the "Company") (CSE:CURE; OTCQB: BICTF) BiocurePharm, Korea ("BPK"), a subsidiary of Biocure Technology Inc. ("CURE") reported that it has closed its non-brokered private placement through its Korean Subsidiary BiocurePharm, Korea ("BPK"), BPK has issued 5,990 shares at 12.639 CAD per share for gross proceeds of $75,707 (Press release, Biocure Technology, MAR 16, 2020, View Source [SID1234628752]). All dollar values are based on the published Exchange Rate of CAD0.001149/KRW1 on March 13, 2020, Bank of Canada. After the issuance of new BPK shares, CURE holds now 94.32% interest in BPK.

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The net proceeds from the non-brokered private placement are intended to be used for general working capital and clinical trial of CAR T in Korea.

Carna Biosciences Announces License Agreement with BioNova Pharmaceuticals to Develop and Commercialize AS-1763 in Greater China

On March 16, 2020 Carna Biosciences Inc. (JASDAQ: 4572), a biopharmaceutical company focusing on the discovery and development of innovative small molecule drugs, reported that it has entered into a license agreement with BioNova Pharmaceuticals Limited, a China-based biopharmaceutical company focused on the development and commercialization of innovative medicines for the treatment of diseases with high unmet medical needs, to develop and commercialize AS-1763, a novel next-generation non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the Greater China territory (Press release, Carna Biosciences, MAR 16, 2020, View Source [SID1234614079]).

"BioNova is the ideal partner for Carna to accelerate the development of our next generation BTK inhibitor for blood cancers, considering the competitive environment in the US for patient recruitment," said Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences. "We look forward to working together with BioNova to advance AS-1763 forward as quickly as possible."

"This partnership with BioNova gives us more opportunities to maximize the potential of AS-1763 in cancer treatment. We look forward to collaborating with the BioNova team to deliver our innovative drug to patients with cancer," said Kohichiro Yoshino, Ph.D., President and Chief Executive Officer at Carna Biosciences.

"With the recent success of BTK inhibitors becoming standard of care for certain B-cell malignancies, there are emerging acquired resistances, and most commonly C481S mutation in particular, resulted from the treatment of first-generation covalent BTK inhibitors," said Ye Hua, MD, MPH, Founder and CEO of BioNova. "The collaboration with Carna offers us the opportunity to investigate a potential solution for this high unmet medical need with a target therapy that is tailored to overcome drug resistance."

Under the terms of the license agreement, Carna has granted to BioNova an exclusive license to develop and commercialize AS-1763 in Greater China. Carna retains worldwide rights excluding Greater China to develop and commercialize AS-1763. In connection with this agreement, Carna will receive an upfront payment and potential milestone payments up to $205 million upon achievement of certain development and commercial milestones. Carna will also receive tiered royalties up to double digits on net sales in Greater China.

TURNING POINT THERAPEUTICS REPORTS FOURTH-QUARTER, FULL- YEAR 2019 FINANCIAL AND OPERATIONAL RESULTS

On March 16, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported financial and operational highlights for the fourth quarter and year-ended Dec. 31, 2019 (Press release, Turning Point Therapeutics, MAR 16, 2020, View Source [SID1234564377]).

"I am very pleased with all we accomplished in 2019, and in 2020 we are focused on clinical trial and pipeline advancement," said Athena Countouriotis, M.D., president and chief executive officer. "As we advance our clinical programs with site activations and patient enrollment across our three clinical stage assets, we remain pleased with our progress but are in close contact with our CROs and sites as we navigate and assess the impact of COVID-19 on our studies and current timelines."

Fourth quarter 2019 and recent highlights include:

Ongoing site activations and enrollment in the Phase 2 registrational portion of the TRIDENT-1 study of repotrectinib. The study is planned at approximately 100 global sites with enrollment of approximately 320 ROS1-positive advanced non-small cell lung cancer (NSCLC) and NTRK-positive advanced solid tumor patients. Approximately 40 percent of planned sites are now active.

Fast Track designation granted by the U.S. Food and Drug Administration for the treatment of ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior line of a ROS1 tyrosine kinase inhibitor (TKI). There are currently no approved targeted therapies for TKI-pretreated ROS1-positive NSCLC patients.

Ongoing progress in the Phase 1 study of TPX-0022, Turning Point’s MET/CSF1R/SRC inhibitor; and Phase 1/2 study of TPX-0046, Turning Point’s RET/SRC inhibitor trial. Both studies have now enrolled both TKI-naïve and pretreated patients. For TPX-0046, the company previously announced that enrollment had also included RET-positive patients with solvent-front mutations previously treated with other investigational RET inhibitors.

Nomination of TPX-0131, a next-generation ALK inhibitor candidate. TPX-0131 has been designed with a compact macrocyclic structure and in preclinical studies has been shown to potently inhibit wildtype ALK and numerous ALK mutations, in particular the clinically observed G1202R solvent-front mutation and G1202R/L1196M compound mutation.

Acceptance of three abstracts for presentation at the AACR (Free AACR Whitepaper) Annual Meeting, including preclinical repotrectinib combination data and preclinical data for TPX-0131. In light of the postponement of AACR (Free AACR Whitepaper)’s Annual Meeting, these data are planned for presentation by the company in the second quarter.

Naming Siegfried Reich, Ph.D. as executive vice president and chief scientific officer. Dr. Reich has over 25 years of pharmaceutical and biotech experience developing more than 20 drug candidates, including the approved drugs Viracept for HIV and the tyrosine kinase inhibitor Inlyta for the treatment of kidney cancer.
Fourth Quarter Financial Update
Operating expenses for the fourth quarter were $23.1 million compared to $9.5 million for the fourth quarter of 2018 and $22.1 million for the third quarter of 2019. The $13.6 million year-over-year increase was primarily due to increased development spend for repotrectinib, TPX-0022 and TPX-0046 as well as personnel expenses that included $4.2 million in non-cash stock-based compensation. Fourth-quarter net cash used in operating activities totaled $14.1 million.

For the year, operating expenses totaled $77.7 million compared to $25.6 million during 2018. The $52.1 million increase was driven by development expenses for repotrectinib, TPX-0022 and TPX-0046 and personnel expenses that included $12.7 million in non-cash stock-based compensation. Net cash used in operating activities was $57.8 million.

Cash, cash equivalents and marketable securities at Dec. 31, 2019 totaled $409.2 million, a decrease of $14.4 million from Sept. 30, 2019. The company continues to project its cash position funds current operations beyond 2021.

Upcoming Milestones
Key milestones anticipated through 2020 include:

Presenting preclinical repotrectinib combination data and preclinical data for TPX-0131 in the second quarter.

Early interim data from initial patients in some of the registrational cohorts of the repotrectinib TRIDENT-1 Phase 2 study during the second half of the year.

Early interim data from initial patients treated with TPX-0022 during the second half of the year.

Submitting the IND for TPX-0131 by early 2021.
Webcast and Conference Call
Turning Point Therapeutics will not host a Quarterly Update conference call this quarter. The company has posted an updated investor presentation on the "Investors" section of tptherapeutics.com.

Beijing Tide Pharmaceutical and Insilico Medicine enter into a strategic partnership agreement for cancer therapy

On March 16, 2020 Beijing Tide Pharmaceutical Co., Ltd. (Tide), a subsidiary of Sino Biopharmaceutical Limited, and Insilico Medicine, an artificial intelligence company developing end-to-end drug discovery pipelines, reported that they are entering a collaboration, applying artificial intelligence (AI) technology to drug discovery, to jointly accelerate the process for multiple types of cancer treatment (Press release, Beijing Tide Pharmaceutical, MAR 16, 2020, View Source [SID1234555626]). This agreement includes an upfront payment, milestone payments, and royalties based on the sales of the products from the collaboration.

"Tide is the second pharma company of Sino Biopharmaceutical Limited working with Insilico Medicine. We see a great potential of applying AI technology to drug discovery and healthcare sections, and we will invest more in AI applications," said Sino Biopharmaceutical Limited’s Chairlady Theresa Tse.

Alex Zhavoronkov, CEO of Insilico Medicine, is likewise excited about the joint effort: "This collaboration was established for a single purpose: to support combined efforts to find a cure for and eliminate cancer. By using our resources and working with others dedicated to a common cause, there is a hope that together we can beat this disease."

Tide is a high-tech pharmaceutical enterprise in China with the capability of developing, manufacturing as well as marketing series of targeted drugs. Through years of experience, Tide has been identified as one of the innovation pilot enterprises, committed to innovation in science and technology. With the help of Insilico Medicine’s AI platform, the new era of research and development of the Pharmaceutical industry has arrived. Tide Pharmaceutical and Insilico Medicine look forward to a long term and win-win partnership from the joint alliance of both companies.

Last September Insilico Medicine published a landmark paper in Nature Biotechnology demonstrating the application of its generative tensorial reinforcement learning systems to generate novel molecules for kinases in just 46 days including experimental validation which was widely covered by the press. The emerging AI technologies are expected to improve drug discovery process, and Tide commits to be a part of the AI revolution.

Bridge Medicines Enters Exclusive License Agreement with The Rockefeller University for Novel Epigenetic Leukemia Program

On March 16, 2020 Bridge Medicines and The Rockefeller University reported an exclusive license agreement to develop novel inhibitors of ENL-YEATS for the treatment of acute leukemias such as Acute Myelogenous Leukemia (AML) and potentially solid tumors (Press release, Bridge Medicines, MAR 16, 2020, View Source [SID1234555625]).

ENL-YEATS is an epigenetic "reader" protein that emerged from breakthrough science conducted in the laboratory of Lasker Award winner C. David Allis, Ph.D. The work was led by scientist Liling Wan, Ph.D., who was a postdoctoral fellow in the Allis lab at the time. Dr. Allis is the Joy and Jack Fishman Professor, Laboratory of Chromatin Biology and Epigenetics; Dr. Wan was recently appointed Assistant Professor of Cancer Biology and Assistant Investigator of the Abramson Family Cancer Research Institute, Perelman School of Medicine, University of Pennsylvania.

Epigenetic pathways have been shown to regulate cancer cell proliferation and growth, which have recently proven to be successful drug targets. Drs. Wan and Allis found that ENL-YEATS was essential for leukemogenesis and leukemia maintenance by assuring transcription of several oncogenes, including MYC, a regulator gene.

The researchers also discovered a role for ENL-YEATS in Wilms Tumor, a rare kidney cancer found in children, suggesting that ENL-YEATS may be a driver in tumor types beyond acute leukemias.

The Tri-Institutional Therapeutics Discovery Institute, Inc. (Tri-I TDI) advanced the pioneering discoveries from the Allis Laboratory into early-stage drug molecules. Tri-I TDI’s mission is to work with innovative scientists at its founding institutions, The Rockefeller University, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medicine, in a close collaboration with Takeda Pharmaceutical Company Ltd, to accelerate the discovery of new drug molecules.

For this ENL-YEATS program, the scientists at Tri-I TDI, in collaboration with Drs. Wan and Allis, were able to synthesize promising, patented, new molecules that may represent future new drug products. Bridge Medicines will further develop and advance these molecules through preclinical and clinical trials in an effort to bring a new treatment to patients.

"The ENL-YEATS discovery is a major scientific advancement in the area of cancer treatment, and we are thrilled to bring this important program into our portfolio," said Bill Polvino, CEO of Bridge Medicines. "We are encouraged by the promising data developed by these premier academic scientists and look forward to rapidly accelerating the development of this program, in keeping with our mission of translating brilliant discoveries into innovative medicines."

Dr. Allis added, "The ENL-YEATS program offers great promise and hope for patients with AML and Wilms Tumor. We are gratified to have Bridge Medicines partner with us in advancing this program and look forward to seeing it develop into a successful epigenetic therapy to combat these and potentially other diseases."

About AML
Acute Myeloid Leukemia (AML) is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal cells that build up in the bone marrow and blood, interfering with normal blood cells. AML progresses rapidly and is typically fatal within weeks or months if left untreated. Current standard of care is chemotherapy, followed by radiation therapy or stem cell transplant. In 2015, AML affected about one million people and resulted in 147,000 deaths globally, and accounts for about 1.8% of cancer deaths in the United States.

About Wilms Tumor
Wilms Tumor, also known as nephroblastoma, is a cancer of the kidneys that typically occurs in children. It is named after Max Wilms, a German surgeon (1867-1918) who first described it. Approximately 650 cases are diagnosed in the U.S., annually. The majority of cases occur in children with no associated genetic syndromes; however, a minority of children with Wilms Tumor have a congenital abnormality.