On May 14, 2018 Atossa Genetics Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported it will host a corporate conference call to discuss the Company’s business on Wednesday, May 16, 2018 at 4:30 EDT (Press release, Atossa Genetics, MAY 14, 2018, http://ir.atossagenetics.com/news/detail/853/atossa-genetics-to-host-corporate-conference-call-wednesday-may-16-2018-at-4-30pm-edt [SID1234526576]). The call is being provided so that stockholders and potential investors can hear directly from senior management about the Company’s business with a focus on recent developments.

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Due to expected high call attendance, participants are asked to preregister for the call through the following link: View Source Please note that registered participants will receive their dial in number upon registration and will dial directly into the call without delay. Those without internet access or who are unable to pre-register may dial in by calling: 1-844-824-3830 (domestic), 1-412-317-5140 (international) and Canada Toll Free: 1-855-669-9657. Callers should ask to be joined into the Atossa Genetics call.

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 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].

On May 14, 2018 GT Biopharma Inc. (OTCQB: GTBP)(Euronext Paris GTBP.PA) reported the promotion of Dr. Raymond W Urbanski MD, PhD to the position of President and Chief Medical Officer effective immediately. Dr. Urbanski will report to Shawn Cross, the Company’s Chief Executive Officer (Press release, GT Biopharma , MAY 14, 2018, View Source [SID1234539531]).

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"I am pleased to announce the promotion of Dr. Urbanski to President and Chief Medical Officer. The combination of Ray’s experience as a practicing physician and subsequently experience in industry, where he has served in key leadership positions including serving as the Chief Medical Officer of one of Pfizer’s business units and as the Chief Medical Officer of Mylan. His training, depth of knowledge and experience as well as his organizational acumen has been invaluable as we prepare GT Biopharma for our next stage of growth," said Shawn M. Cross, Chairman and Chief Executive Officer of GT Biopharma. "In addition to pushing forward our pre-clinical and clinical product candidates, Ray has played a critical role in advancing other company initiatives including recruiting experienced members to our scientific advisory board and board of directors, implementing internal processes and procedures, which are less visible but very important, as progress towards certain goals including a NASDAQ up-listing, among others. In short, I am delighted to have Ray as a senior member of our leadership team."

Since joining the company in October 2017 Dr. Urbanski has been instrumental in driving key milestones and initiatives including the transitioning the first TriKE IND from the University of Minnesota to GT Biopharma while engaging the FDA in preparation for human clinical testing to begin in 2H 2018; implementing processes to expedite the identification and development of future tumor antigen targets; driving forward our Bi-specific Antibody Drug Conjugate platform which included the formation of our Antibody-Drug Conjugate Clinical Advisory Board. Dr. Urbanski has also been a major factor in developing a strong working relationship with the University of Minnesota, Masonic Cancer Center, the epicenter of innovation for the TriKE and TetraKE platforms.

Dr. Urbanski also represents the company at key international meetings such as ASH (Free ASH Whitepaper) and the upcoming ASCO (Free ASCO Whitepaper) conferences, attending investor conferences and recruiting top tier Scientific Advisory Board members and consultants.