On May 14, 2018 Allogene Therapeutics, Inc. (Allogene), a biotechnology company with a mission to catalyze the next revolution of cell therapy through the advancement of allogeneic CAR T therapies for blood cancers and solid tumors, reported a poster presentation highlighting preclinical research for its allogeneic pipeline programs (Press release, Allogene, MAY 14, 2018, View Source [SID1234526594]). The presentation will occur during the 21st ASGCT (Free ASGCT Whitepaper) Annual Meeting, which is taking place in Chicago May 16-19, 2018.

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Presentation Details:

Title: Development of an In Vitro Cynomolgus Macaque Allogeneic CAR T Cell Platform: Working towards a Reliable In Vivo Allogeneic Model to Assess Safety and Efficacy (Poster No. 131)
Category: Cancer – Targeted Gene & Cell Therapy I
Session Date & Time: Wednesday, May 16, 2018 at 5:30 PM – Stevens Salon C, D
Authors: Diego A. Vargas-Inchaustegui1, Rory Dai1, Alexandre Juillerat2, Christopher Do1, Kris Poulsen1, Thomas Pertel1, Barbra Sasu1

1Allogene Therapeutics, Inc., South San Francisco, CA,
2Cellectis, Inc., New York, NY

In April 2018, Allogene announced that it had acquired Pfizer’s allogeneic CAR T portfolio which included the rights to 16 preclinical CAR T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier, UCART19, an allogeneic CAR T therapy that is being developed for treatment of CD19-expressing hematological malignancies. In partnership with Servier, UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase 1.

On May 14, 2018 Immatics, a leading company in the field of cancer immunotherapy, reported the appointment of Stephen Eck, M.D., Ph.D. as Chief Medical Officer (CMO) at Immatics US, Inc. (Houston, Texas), effective immediately (Press release, Immatics Biotechnologies, MAY 14, 2018, View Source [SID1234569553]).

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Stephen Eck is a hematologist and oncologist with more than 25 years experience in academia and industry. He began his professional career at the University of Pennsylvania where he was Director of the Gene Therapy Program, and has since held a number of leaderships roles in oncology drug and biomarker development at prominent pharmaceutical companies. Prior to joining Immatics, Stephen Eck served as Vice President and Global Head of Oncology Medical Sciences at Astellas Pharma, and previously held senior roles at Pfizer and Eli Lilly.

Dr. Harpreet Singh, CEO and President of Immatics US, said: "Stephen’s appointment will further strengthen our cell therapy programs and global development capabilities. He brings significant experience in both early and late-stage development, as well as new drug approvals, in oncology and cancer immunotherapies, which will be invaluable to us as we progress our clinical and pre-clinical programs."

Dr. Stephen Eck, Chief Medical Officer of Immatics US, said: "Immatics has truly impressed me as having one of the most innovative approaches in immuno-oncology. I am thrilled to be joining the Company at this very exciting time in its history, and as T-cell therapies move to become more widely used in cancer therapeutics. Immatics’ unique approach gets at the root cause of prior failures in the treatment of solid cancers by addressing novel, highly-specific cancer targets and mobilizing billions of activated T cells against these."

Whilst at Astellas Pharma, Stephen Eck worked closely with The University of Texas MD Anderson Cancer Center, a key collaborator of Immatics, on a number of clinical trials, joint collaborations and external advisory committees. Notably, he is a member of MD Anderson’s Moon Shots Program advisory board. Additionally, he is a Fellow of the American Association for the Advancement of Science, and is Chairman of the Board of Directors of the Personalized Medicine Coalition. Stephen Eck has a Ph.D. in Chemistry from Harvard University and an M.D. degree from the University of Mississippi School of Medicine."

On May 14, 2018 Immunicom, Inc., a medical technology company developing revolutionary non-pharmaceutical approaches for treating cancer and autoimmune diseases, reported the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Immunopheresis therapy, which is based on a proprietary technology that selectively removes immune inhibitors from a patient’s bloodstream potentially enabling their natural immune system to more-effectively attack cancer tumors (Press release, Immunicom, MAY 14, 2018, View Source [SID1234637423]).

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To achieve Breakthrough Device designation, a technology must demonstrate compelling potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.
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The FDA’s intent in granting this specific designation to qualified devices is to collaboratively facilitate expediting the device’s assessment and review processes through more interactive communication and planning with the FDA; ensuring proper data collection, efficient clinical study design, senior management engagement of Agency personnel, and priority review of applicable filings.

In contrast to immunotherapy pharmaceuticals and biologicals that introduce foreign compounds and material into a patient’s body, and which are often accompanied by negative side effects, Immunicom’s patented technology is based on a "subtractive" approach that is intended to potentially limit treatment-associated adverse effects. By removing immune system inhibitors from the blood without introducing new substances, Immunicom’s therapeutic approach has been shown in preliminary preclinical studies to enhance anti-cancer immune system response without causing unwanted side effects.
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Immunicom’s blood-filtering device technology is the first step in execution of a broader corporate strategic vision. "We are very pleased with FDA’s granting of Breakthrough Device designation for Immunopheresis, our initial immunotherapy product for treating late/end stage IV cancer patients with metastatic solid tumors," said Amir Jafri, CEO of Immunicom, "This significant milestone will enable us to more efficiently pursue device regulatory approval and address critical unmet patient needs sooner, while also continuing our commitment to invest in other exciting treatment options in our product pipeline."

On May 14, 2018 Medigene AG (MDG1, Frankfurt, Prime Standard), Germany, reported the significant expansion of its successful strategic alliance with bluebird bio, a leader in gene and cell therapies, focusing on the research and development of T cell receptor-modified T cell (TCR-T) immunotherapies for the treatment of cancer (Press release, MediGene, MAY 14, 2018, View Source [SID1234526577]).

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"We are delighted to broaden this outstanding collaboration for the joint research and discovery of TCR lead candidates designed for the treatment of multiple cancer indications. Medigene is contributing its unique TCR technology platform, which encompasses multiple innovative screening and assessment tools to identify and characterize specific, non-modified TCRs to selected target antigens in a highly competitive timeframe." said Dolores J. Schendel, Chief Executive Officer and Chief Scientific Officer, Medigene . "The expansion of this alliance further validates the efficiency and quality of Medigene’s TCR platform technology."

"As we continue to build our leadership in immuno-oncology, we value Medigene’s TCR technology platform which enables us to tackle intracellular tumor antigens not addressable by CAR Ts," said Philip Gregory, Ph.D., Chief Scientific Officer, bluebird bio, "Our expanded collaboration will help us broaden our pipeline of TCR lead candidates for potential future clinical development."

Under the revised terms of the agreement, the number of target antigen/MHC restriction combinations for the discovery of specific TCR lead candidates by Medigene will be increased from four to six. As part of this contractual expansion, Medigene will receive an additional one-time payment of USD 8 million. R&D funding for all work performed by Medigene in this collaboration will grow proportionally to address the broader scope of the collaboration. In addition, the aggregate amount of all potential development and commercial milestones as well as royalty payments has been significantly increased in line with the extended number of TCR projects. If successfully developed and marketed through several indications and markets, Medigene could receive up to USD 250 million in milestone payments per TCR program in addition to tiered royalty payments on net sales up to a double-digit percentage. Following the amendment of the agreement, Medigene anticipates receiving an additional payment of USD 1 million associated with the first collaboration project under the agreement.

Based on the terms of the agreement signed in September 2016, Medigene is responsible for the discovery of TCRs for each target antigen selected by bluebird bio using its TCR technology platform. Following the collaborative non-clinical development, bluebird bio will assume sole responsibility for pre-clinical¬ and clinical development and commercialization of the TCR-T cell product candidates and will receive an exclusive license for the intellectual property covering the selected TCRs.

As a result of the payments mentioned above, Medigene improves the Company’s cash burn guidance for 2018 and now anticipates a cash usage of EUR 16-19 million instead of EUR 21-25 million for the full year. Revenue, R&D expense and EBITDA guidance for 2018 will not change substantially as a result of this expansion of the agreement. Full financial guidance will be provided in Medigene’s 6-months report 2018.

On May 14, 2018 TP Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company developing oncology therapies with a focus on addressing current drug resistance, reported the appointment of Athena M. Countouriotis, M.D., as Executive Vice President and Chief Medical Officer (Press release, TP Therapeutics, MAY 14, 2018, View Source [SID1234526596]).

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TP Therapeutics Appoints Athena Countouriotis, M.D., as EVP and Chief Medical Officer

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"The Board and I are extremely delighted to have Athena join us as Executive Vice President and Chief Medical Officer," said Dr. J. Jean Cui, founder, President, and Chief Scientific Officer of TP Therapeutics, Inc. "Athena brings extensive and in-depth oncology clinical development experience to TP Therapeutics."

"Athena has a history of success in oncology drug development, including the kinase inhibitor area which TP focuses on, and we are thrilled that she is joining us," commented Dr. Carl Gordon of OrbiMed and director at TP Therapeutics.

"I am very excited to join TP Therapeutics at this critical time and help drive the strategy of our initial asset TPX-0005 (Ropotrectinib) in ALK/ROS/NTRK driven malignancies. I look forward to working closely with Dr. J. Jean Cui and our team as we unveil the Phase 1 clinical data with Ropotrectinib at an upcoming medical conference and we continue to expand our pipeline," added Dr. Countouriotis.

Dr. Countouriotis has 15 years of experience within oncology. Before joining TP Therapeutics, Dr. Countouriotis served as Senior Vice President and Chief Medical Officer at Adverum Biotechnologies and previously at Halozyme Therapeutics. Prior to that, she was Chief Medical Officer at Ambit Biosciences leading the development of Quizartinib through the Company’s initial public offering and acquisition by Daiichi Sankyo. Dr. Countouriotis also worked within Pfizer and Bristol-Myers Squibb in various leading clinical development roles for Sutent, Mylotarg, Bosulif, and Sprycel. Dr. Countouriotis holds an M.D. from Tufts University School of Medicine, completed her pediatric residency at the University of California, Los Angeles, and did additional training at the Fred Hutchinson Cancer Research Center in the Pediatric Hematology/Oncology program.

About TPX-0005 (Ropotrectinib)

TPX-0005 (Ropotrectinib) is a potent and orally bioavailable investigational small molecule kinase inhibitor for ALK, ROS1, and TRK family. The clinical benefits of targeting ALK, ROS1, or TRK fusion kinase have been demonstrated with multiple kinase inhibitors already approved for the treatment of ALK+ non-small cell lung cancer (NSCLC), in addition to crizotinib for ROS1+ NSCLC, and larotrectinib and entrectinib in clinical studies for TRK+ cancers. The successes of these therapies are overshadowed by the development of acquired resistance. The acquired solvent front mutations including ALK G1202R, ROS1 G2032R, TRKA G595R and TRKC G623R render a common clinical resistance to the current ALK, ROS1, and TRK inhibitors. TPX-0005 (Ropotrectinib) is a potent kinase inhibitor against wildtype and mutated ALK, ROS1 and TRK family kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple line treatments. Ropotrectinib may provide new opportunity to inhibit the abnormal signaling of ALK, ROS1, or TRK family in solid malignancies, and overcome multiple resistance mechanisms seen in refractory patients. TPX-0005 (Ropotrectinib) is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1, NCT03093116). For additional information about TPX-0005 (ropotrectinib) trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can also contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email [email protected].