On July 30, 2018 Nohla Therapeutics, a leading developer of universal, offthe-shelf cell therapies for patients with hematologic malignancies and other critical diseases, reported the hiring of Sarah Noonberg, M.D. Ph.D., as its new Chief Medical Officer (Press release, Nohla Therapeutics, JUL 30, 2018, View Source [SID1234528471]). Dr. Noonberg will oversee Nohla’s clinical and medical strategy, including clinical development, biostatistics, pharmacovigilance, regulatory and medical affairs. The company also announced today that Nohla founder, Colleen Delaney, M.D., M.S.c., has been named Chief Scientific Officer. In this role, Dr. Delaney
will oversee Nohla’s scientific and research strategy. Both Dr. Noonberg and Dr. Delaney will report to Katie Fanning, President and Chief Executive Officer and serve on Nohla’s executive leadership team. "Sarah’s broad expertise and proven track record in global clinical development will be invaluable to Nohla as we continue to advance our pipeline of universal, off-the-shelf cell therapy products toward commercialization," said Katie Fanning, President and Chief Executive Officer at Nohla Therapeutics. "Sarah joins Nohla at a significant time with data expected later this year from the Phase 2b study evaluating our lead product candidate, dilanubicel, in patients with AML and other leukemias
undergoing a myeloablative cord blood transplant."

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Dr. Noonberg is a board-certified physician-scientist that brings over 14 years of leadership experience in clinical development, from initial drug discovery to global regulatory approvals and commercialization. Prior to joining Nohla, Dr. Noonberg served as the Chief Medical Officer at Prothena, Global Head of Clinical Development at BioMarin, and Senior Vice President at Medivation where she led programs across all phases of development. She currently serves on the Board of Directors at Protagonist Therapeutics. Dr. Noonberg earned her M.D. from the University of California San Francisco, a Ph.D. in Bioengineering from the University of California, Berkeley, and a B.S. in Engineering Science
from Dartmouth College.

Ms. Fanning continued, "These changes support both the near-term opportunities and long-term growth and development of our novel pipeline. Colleen’s role as our scientific founder makes her uniquely qualified to lead Nohla’s scientific strategy as we look to expand the scope of our cell therapy platform through internal development and strategic collaborations. With the hiring of Sarah and appointment of Colleen, we have a seasoned executive leadership team that can deliver on the promise of Nohla’s innovative cell therapy technology."

Dr. Delaney is the Founder and former Chief Medical Officer at Nohla Therapeutics. She is a Member of the Fred Hutch Clinical Research Division and recipient of the Madeline Dabney Adams Endowed Chair, and a Professor at the UW Department of Pediatrics, Division of Pediatric Hematology/Oncology. Dr. Delaney’s group at Fred Hutch developed cryopreserved, non-HLA matched off-the-shelf ex vivo expanded cord blood progenitor cells – the foundation for Nohla’s technology platform. She received a B.S. in Molecular Biology and Biochemistry from Wesleyan University, an M.D. from Harvard Medical School, and an M.Sc. from Oxford University.

On July 30, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported its schedule of medical conference presentations for the fall of 2018 (Press release, Aeglea BioTherapeutics, JUL 30, 2018, View Source [SID1234528358]). The three-conference schedule includes five abstract acceptances on the Company’s latest data concerning the rare genetic disease Arginase 1 Deficiency (ARG1-D), uveal and cutaneous melanoma, and human-derived enzymatic approaches to treating the metabolic disorder homocystinuria.

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"This has been an active and successful year for Aeglea," said Anthony G. Quinn, M.B Ch.B, Ph.D., Aeglea’s president and chief executive officer. "We have a busy fall conference schedule during which we will provide important data updates from our clinical and preclinical programs. The repeat dose update from our ARG1-D trials builds on the initial data presented in April 2018 that demonstrated for the first time that rapid and sustained lowering of plasma arginine levels with pegzilarginase, our lead investigational therapy, was accompanied by clinically relevant treatment effects after only eight weeks of dosing. We look forward to providing new interim data from our rare genetic disease and cancer clinical trials with pegzilarginase in the third and fourth quarters of 2018."

Conference Schedule

Event: Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM)
Date:September 4-7, 2018
Location:Athens, Greece
Title: Improvements in Arginase 1 Deficiency-related Disease Manifestations Following Plasma Arginine Reduction with Pegzilarginase

Event: American Society of Human Genetics (ASHG) Annual Meeting
Date: October 16-20, 2018
Location:San Diego, CA
Title: 1) Improvements in Arginase 1 Deficiency-related Disease Manifestations Following Plasma Arginine Reduction with Pegzilarginase (Early Phase 2 Results); 2) Clinical Features of Arginase 1 Deficiency: Review of Literature Case Series; 3) Improved Survival and Amelioration of Disease-Related Liver Pathology in a Mouse Model of Homocystinuria with a Novel Homocysteine Degrading Enzyme

Event: European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress
Date: October 19-23, 2018
Location: Munich, Germany
Title: Initial Cohort Expansion Results of Sustained Arginine Depletion with Pegzilarginase in Melanoma Patients in a Phase 1 Advanced Solid Tumor Trial

Details regarding the date and time of each abstract will be announced before each conference.

About Pegzilarginase in Arginase 1 Deficiency
Pegzilarginase is an enhanced human arginase that enzymatically degrades the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency, a debilitating urea cycle disorder caused by deficiency of a key arginine metabolizing enzyme that leads to severe and progressive hyperargininemia-related neurological abnormalities, hyperammonemia and early mortality. Pegzilarginase is intended for use as an enzyme replacement therapy in patients to reduce elevated blood arginine levels. The Company’s interim Phase 1/2 data demonstrated clinically relevant treatment effects and rapid and sustained lowering of plasma arginine in Arginase 1 Deficiency patients.

About Pegzilarginase in Cancer
Pegzilarginase is an enhanced human arginase that enzymatically degrades the amino acid arginine. In some cancers, tumor cells stop producing specific amino acids and must acquire them from the blood, making the tumor cells susceptible to starvation through depletion of those amino acids. Aeglea is developing pegzilarginase to exploit vulnerabilities in some cancers that lead to an increased dependency on extracellular arginine. Pegzilarginase targets these arginine dependent cancers by depleting blood arginine levels to below the normal range. Preclinical data demonstrated that the resulting arginine starvation inhibits proliferation, induces cell death, increases turnover of cell components and promotes anti-tumor immune responses. The Company’s Phase 1 data in advanced solid tumors demonstrated that pegzilarginase was well tolerated at doses that produced marked and sustained reductions in blood arginine levels below the normal range.

Champions Oncology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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Odonate Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Odonate Therapeutics, 2018, JUL 30, 2018, View Source [SID1234527953]).

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Champions Oncology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Champions Oncology, 2018, JUL 30, 2018, View Source [SID1234527952]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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