On May 14, 2018 BMG Pharma S.r.l., an innovative specialty pharmaceutical company, reported the European regulatory approval for its GelX product to be used for the prevention of oral mucositis (Press release, BMG PHARMA, MAY 14, 2018, View Source [SID1234526593]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

This new regulatory approval for GelX is the first for a medical product to be used for both the treatment and prevention of oral mucositis in cancer patients.

The approval is based on clinical data, (conducted under Good Clinical Practice(GCP) principles) from 149 adult and paediatric patients showing unique results with 99,3% of patients experiencing prevention or remission of oral mucositis during cancer therapy.

This new approval will allow patients to receive cancer treatment with a significantly reduced chance of developing oral mucositis during that treatment and to reduce the grade of oral mucositis, allowing the opportunity for normal eating and drinking.

Marco Mastrodonato, Founder and CEO of BMG Pharma S.r.l. commented– "We achieved a unique milestones by giving the opportunity to cancer patients to prevent Oral Mucositis in both adults and children which will allow them to continue with a complete nutritional program while under cancer treatment. GelX will be available through its partners to over 1.1m patients in the 7 major markets, suffering from oral mucositis as a side-effect of cancer and transplants treatment.’’

GelX Oral Gel and GelX Oral Spray are proprietary products of BMG Pharma Srl, which thanks to their innovative formula alleviate pain in cancer patients, offering unique solutions for chemotherapy & radiation induced oral mucositis.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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

Tweet this
"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].