On July 30, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Glycotope GmbH (hereafter, Glycotope) reported that have entered into an exclusive worldwide licensing agreement to develop an antibody drug conjugate (ADC) by combining Daiichi Sankyo’s proprietary ADC technology with Glycotope’s investigational tumor-associated TA-MUC1 antibody gatipotuzumab (formerly PankoMab-GEX), building on a previous 2017 option agreement (Press release, Daiichi Sankyo, JUL 30, 2018, https://www.glycotope.com/daiichi-sankyo-enters-worldwide-licensing-agreement-with-glycotope-for-gatipotuzumab-antibody-drug-conjugate/ [SID1234537463]).

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Under the terms of the licensing agreement, Daiichi Sankyo has worldwide exclusive rights to develop and commercialize gatipotuzumab as an ADC. Glycotope will receive an upfront payment and is eligible for clinical, regulatory and sales milestone payments, as well as royalties on net sales worldwide from Daiichi Sankyo. Specific financial terms have not been disclosed.

"With the licensing of gatipotuzumab with the intention of developing an ADC, we now have seven novel ADCs in development, which demonstrate our commitment to maximizing the potential of our proprietary ADC payload and linker technology to help address the unmet needs of patients with cancer worldwide," said Tom Held, Vice President, Head, Antibody Drug Conjugate Task Force, Oncology Research and Development, Daiichi Sankyo. "We are excited by the rapid progress we have made in our collaboration with Glycotope and look forward to the continued clinical development of this potentially first-in-class TA-MUC1-targeting ADC."

"This agreement with Daiichi Sankyo highlights the potential and wide applicability of gatipotuzumab," said Henner Kollenberg, Managing Director of Glycotope. "Our world-leading glyco-biology expertise has allowed us to create a novel anti-TA-MUC1 monoclonal antibody with carbohydrate mediated tumor-specificity and high affinity binding. We look forward to continuing to work with Daiichi Sankyo on this ADC program and on the further development of gatipotuzumab in other formats."

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Daiichi Sankyo’s proprietary ADC technology is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered. Gatipotuzumab is an investigational monoclonal antibody that enables tumor-specific binding to a novel carbohydrate-induced conformational epitope, TA-MUC1, which is extensively expressed in many tumor types including ovarian, lung and breast.1

On July 30, 2018 Eli Lilly and Company (NYSE: LLY) reported a three-year extension of its cancer research collaboration with Dana-Farber Cancer Institute (Press release, Eli Lilly, JUL 30, 2018, View Source [SID1234529756]). Since 2015, scientists from Lilly and Dana-Farber have been working together on pre-clinical and clinical studies, molecular analyses of patient samples and the design and conduct of clinical trials to help advance cancer care.

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"We are pleased to announce the extension of our collaboration with Dana-Farber Cancer Institute. This collaboration provides an opportunity for scientists and clinicians at a premier cancer center to bring creative new ideas about the underlying science and how this might drive future clinical opportunities for multiple Lilly therapeutic candidates," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "The extension will provide continued funding for initial testing of several such ideas in the lab and in the clinic, which could eventually inform new treatment avenues for cancer patients."

During the first three years of the collaboration, Lilly has been allowed access to expertise within Dana-Farber to further develop multiple pre-clinical and clinical compounds in Lilly’s pipeline, including new indications, novel combinations, and biomarker strategies. This collaboration has fostered fresh ideas, strong communication and important feedback in pre-clinical and clinical study design, process and execution.

"Our collaboration with Lilly has provided the opportunity to bridge academia and industry at the early stages of cancer research," said Barrett Rollins, M.D., Ph.D., chief scientific officer of Dana-Farber. "Our shared approach has helped speed learning across labs and disease groups, and serves to enable and accelerate the testing of new hypotheses. This collaboration is important as we consider the potential impact the research may have on cancer care."

Under the agreement, Dana-Farber researchers were, and will continue to be, granted permission to conduct independent pre-clinical and clinical studies on select Lilly compounds. All compounds evaluated through this collaboration will continue to be fully owned by Lilly. Financial terms of the agreement were not disclosed.

On July 30, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company") reported the approval of its Investigational New Drug ("IND") application by the U.S. Food and Drug Administration ("FDA") for eftilagimod alpha ("efti" or "IMP321"), a LAG-3Ig fusion protein.

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The FDA approval of the IND allows the Company, subject to the completion of other preparatory steps, to initiate the TACTI-002 Phase II clinical study in the U.S. that will evaluate the combination of efti and anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with non-small cell lung carcinoma ("NSCLC") or head and neck carcinoma. Immutep expects to commence the TACTI-002 trial in the second half of 2018 and to report the first data from the trial in 2019.

"We are very excited to be able to initiate the Phase II study soon, now that we have received the approval from the FDA of the IND for efti, especially as it enables us to start clinical development of efti in the U.S." said Marc Voigt, CEO of Immutep. "This is one more important milestone for the Company’s pipeline of LAG-3 immunotherapeutic products that aim to transform the treatment of cancer and autoimmune diseases. Through our clinical programs, and the efforts of our partners, we believe Immutep is securely positioned to play an important role in the development of combination therapies utilizing LAG-3."

The IND application allows Immutep to ship efti across U.S. state borders to U.S. clinical investigators participating in the Company’s planned TACTI-002 Phase II clinical study.

About the TACTI-002 clinical trial

Up to 120 patients will be recruited for the TACTI-002 (Two ACTive Immunotherapies) Phase II study which will take place across approximately 15 study centres in the U.S., Europe and Australia. The trial is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It will evaluate the safety and efficacy of the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in patients with non-small cell lung carcinoma or head and neck carcinoma. It will be a Simon two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Patients participating in the trial will be given the combination treatment from day 1 of cycle 1 of KEYTRUDA treatment.

About Eftilagimod Alpha

Eftilagimod alpha is a MHC II agonist that is a soluble recombinant fusion protein consisting of the Fc portion of a human antibody and the four extracellular domains of LAG-3. Efti has been engineered to be

soluble rather than expressed on the surface of cells, is very stable, and has a high affinity for dendritic cells. It is a first-in-class antigen presenting cell ("APC") activator, which has been proven to induce sustained immune responses in cancer patients when used at low dose, as a cancer vaccine adjuvant or used at higher doses to get a systemic effect (i.e. general APC activation). Efti binds to MHC II on immature dendritic cells, with high affinity, which results in boosting and sustaining CD8+ T cell responses.

Efti has been shown to be safe and well tolerated, thus making it an ideal combination partner for other drugs or drug candidates, which is the most promising way to fight cancer.

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.