On July 30, 2019 HiFiBiO Therapeutics, a world leader in the discovery of therapeutic antibodies through single-B-cell screening and analysis, reported a multi-target agreement with Takeda Pharmaceutical Company Limited (Takeda) to enable the discovery of breakthrough antibody therapies to potentially treat various gastrointestinal diseases, cancers and other disorders (Press release, HiFiBiO Therapeutics, JUL 30, 2018, View Source [SID1234537507]). HiFiBiO Therapeutics will receive upfront, R&D, milestone, and royalty payments based on antibodies delivered to Takeda for development and commercialization. Specific financial terms of the transaction were not disclosed.

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According to the agreement, scientists from both companies will work together to discover antibodies against Takeda’s targets using HiFiBiO Therapeutics’ single-cell screening capabilities. Takeda will be responsible for the preclinical and clinical development of the discovered antibodies.

"Takeda is a world leader in oncology, gastroenterology and neuroscience therapeutics," said Liang Schweizer, PhD, President and CEO, HiFiBiO Therapeutics. "This multi-target partnership further validates our ongoing commitment to these types of open-innovation collaborations to better address unmet medical needs around the world."

With its focus on developing antibodies for immune modulation, HiFiBiO Therapeutics is actively progressing its own internal projects, while also establishing multiple open-innovation partnerships with leading pharmaceutical and biotechnology companies, as well as academic institutions. These innovative partnerships utilize the proprietary CelliGO platform and continue to generate a robust pipeline of novel antibody drugs for several complex diseases.

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.