On January 16, 2020 BioTheryX, Inc., a clinical stage biotechnology company creating new classes of compounds based on multi-kinase inhibition and targeted protein degradation, reported the initiation of patient dosing in its first clinical program (Press release, BioTheryX, JAN 16, 2020, View Source [SID1234553296]). The Phase 1 study of BTX-A51, a small molecule, oral multi-kinase inhibitor will evaluate the safety, pharmacokinetics and tolerability of BTX-A51 in patients with relapsed/refractory AML, as well as high risk myelodysplastic syndrome patients.

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BTX-A51 appears to block a specific leukemic stem cell target (CK1-alpha) as well as super enhancer targets (CDK7/CDK9) preventing transcription of key oncogenic genes. BTX-A51 has demonstrated remarkable preclinical animal efficacy implying the eradication of AML stem cells and the potential for use in multiple malignancies.

"As I stated when the Investigational New Drug application for BTX-A51 was accepted by the FDA, the novel mechanism of BTX-A51 may become one of the most important new treatments for AML in the last 40 years, and has the potential to significantly improve the lives of AML patients and their families," said David Stirling, Ph.D., CEO of BioTheryX.

In addition to its multi-kinase inhibition program, BioTheryX’s other technology platform is in the field of targeted protein degradation. This technology utilizes the body’s own protein disposal system to selectively degrade and remove disease-causing proteins. It has potential applicability to a very broad range of disease targets, including a wide range of targets that have to date been considered "undruggable."

In this area, BioTheryX’s preclinical assets include a large and growing library of novel, small molecule, orally available, cereblon-binding targeted protein degraders which BioTheryX has termed Protein Homeostatic Modulators ("PHMs"). These IP-protected compounds are biologically active against a number of high value therapeutic targets in oncology, inflammation and other diseases. In addition to the therapeutic potential of these "molecular glue" molecules in their own right, these compounds also have a broad range of molecular orientations when bound to cereblon, providing a new level of structural control in the creation of bifunctional chimeric molecules that degrade high-value targets with great specificity. Recognizing this potential, BioTheryX has created a library of PHM-linked, biologically active chimeric molecules, including several that degrade the oncogenic targets of BTX-A51, thus dovetailing BioTheryX’s two major programs.

On January 16, 2020 Eli Lilly and Company (NYSE: LLY) reported that it will announce its fourth-quarter and full-year 2019 financial results on Thursday, January 30, 2020 (Press release, Eli Lilly, JAN 16, 2020, View Source [SID1234553279]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On January 16, 2020 Frazier Healthcare Partners reported the closing of Frazier Life Sciences X, L.P., exceeding its target and closing on more than $617 million in capital commitments in an oversubscribed fundraise (Press release, Frazier Healthcare, JAN 16, 2020, View Source [SID1234553297]). Investing in life sciences has been a core strategy since the firm’s inception 29 years ago, and Frazier Life Sciences X marks the third dedicated Life Sciences fund, bringing the firm’s total committed capital raised since inception to nearly $4.8 billion.

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Led by General Partners Patrick Heron, James Topper and Dan Estes, the Frazier Life Sciences team invests primarily in therapeutics-focused companies developing and commercializing innovative biopharmaceuticals that address important unmet medical needs. Frazier Life Sciences X will continue its three-pronged strategy of investing in company creation, early-stage venture and late private/public opportunities, with two-thirds of its investments expected to be in Seed and Series A rounds.

"We are extremely grateful to our limited partners for their continued support of our Life Sciences strategy, which includes creating innovative therapeutics through company creation, early-stage venture, and late private and public investing," said Patrick Heron. "We were also happy to welcome a small number of new, high-quality institutional investors to our fund."

Recent Frazier Life Sciences IPOs and exits include Acerta (acquired by AstraZeneca), Mirum Pharmaceuticals (NASDAQ: MIRM), and Ignyta (acquired by Roche), as well as Frazier-founded companies Mavupharma (acquired by AbbVie), Phathom Pharmaceuticals (IPO: PHAT), and Silvergate Pharmaceuticals (acquired by CutisPharma). The Frazier Life Sciences team has created or seeded 23 companies since 2005.

On January 16, 2020 Researchers from St. Jude Children’s Research Hospital and the Chinese Children’s Cancer Group led the first randomized, Phase III clinical trial comparing targeted therapies for acute lymphoblastic leukemia (ALL) driven by the Philadelphia chromosome (Press release, St Jude Children’s Research Hospital, JAN 16, 2020, View Source [SID1234553280]). Results showed that the drug dasatinib provides more benefit than the standard of care, which led to changes in the way this leukemia is treated. The findings were reported today in JAMA Oncology.

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Fusions of the BCR-ABL1 genes, resulting in the formation of the Philadelphia chromosome, underlie 3-4% of cases of childhood ALL. This subtype is high risk and associated with poor outcomes.

"Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia."
JAMA Oncology, Published January, 16, 2020.

"This was a very fruitful collaboration," said corresponding and co-senior author Ching-Hon Pui, M.D., St. Jude Department of Oncology chair. "No single institution could enroll enough patients to do this kind of randomized clinical trial. By working with the Chinese Children’s Cancer Group, we were able to answer which targeted therapy provides the most benefit."

Researchers compared the efficacy of imatinib, the first targeted therapy for Philadelphia chromosome-positive (Ph+) ALL, and a next-generation inhibitor called dasatinib. The study showed that dasatinib resulted in an event-free survival rate of 71% compared to 49% with imatinib over four years.

The study enrolled patients with Ph+ ALL at 20 major hospitals throughout China. Of those, 92 patients received dasatinib, and 97 received imatinib. All patients underwent intensive chemotherapy without prophylactic cranial radiation, and only four patients underwent stem cell transplantation.

"This study demonstrates the importance of global medicine," said Carlos Rodriguez-Galindo, M.D., St. Jude Department of Global Pediatric Medicine chair. "Results from studies run in one country can save the lives of children around the world by informing changes in the standard of care."

Findings from this clinical trial were reported at the European Society for Paediatric Oncology and American Society of Hematology (ASH) (Free ASH Whitepaper) annual meetings in 2019. This data helped inform decisions by other national study groups in the U.S. and Europe to include dasatinib for the treatment of Philadelphia chromosome-positive ALL in clinical protocols going forward.

The study’s other St. Jude authors are Deqing Pei, Sima Jeha, Jun J. Yang and Cheng Cheng. Co-first authors Shuhong Shen and Jiaoyang Cai and co-senior author Jingyan Tang are from Shanghai Children’s Medical Center, Shanghai Jiao Tong University School of Medicine, Key Laboratory of Pediatric Hematology and Oncology of China Ministry of Health and National Children’s Medical Center (Shanghai). Co-first author Xiaojuan Chen and co-senior author Xiaofan Zhu are from the Chinese Academy of Medical Sciences and Peking Union Medical College. The study also included collaborators at 20 hospitals in China.

The research was funded by the U.S. National Cancer Institute (grant CA21765), the National Natural Science Foundation of China (grant 81670136), the fourth round of the Three-Year Public Health Action Plan 2015-2017, the CAMS Innovation Fund for Medical Sciences (2016-12M-1-002), St. Baldrick’s Foundation (581580), VIVA China Children’s Cancer Foundation and ALSAC, the fundraising and awareness organization of St. Jude.

On January 16, 2020 LUNGevity reported that it has issued a Request for Applications (RFA) for translational research for Career Development Awards that will be granted in 2020 (Press release, LUNGevity Foundation, JAN 16, 2020, View Source [SID1234553298]). The RFA is available on the LUNGevity website at www.LUNGevity.org/CDA-RFA and is also posted on the proposalCENTRAL website at proposalcentral.com.

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LUNGevity’s Career Development Awards for Translational Research program was created to support future research leaders who will keep the field of lung cancer research vibrant with new ideas. Since 2002, LUNGevity has funded 130 projects at 59 institutions in 23 states, including 26 Career Development Awards.

Projects that will be funded in 2020 are expected to have a direct impact on the early detection of lung cancer and/or individualized lung cancer treatment, including through targeted therapy and immunotherapy.

Successful applicants may receive $100,000 per year for a possible period of three years and will participate as non-voting members of LUNGevity’s Scientific Advisory Board for the duration of the award. Applicants must be within the first five years of their first faculty appointment. The Career Development Awards are mentored awards, and a mentoring plan is part of the required submission.

"The 2020 awards will be the ninth round of LUNGevity Career Development Awards, and we are looking forward to this year’s applications," noted Dr. Upal Basu Roy, Vice President of Research. "This program has attracted outstanding young researchers who have gone on to become leaders in the lung cancer space. The impactful research we have supported has so far generated more than $27 million in follow-up funding, including independent NIH/NCI funding, indicating that the research and its findings have enough likelihood of benefiting patients to require additional funding."