GT BIOPHARMA HIRES FORMER PFIZER CMO/VICE PRESIDENT AND SENIOR DIRECTOR OF ONCOLOGY RESEARCH AS CHIEF MEDICAL OFFICER

On September 7, 2017 GT Biopharma Inc. (OTCQB: OXISD) reported the appointment of Dr. Raymond Urbanski, the former business unit Chief Medical Officer and senior director of oncology research and development with Pfizer Inc. (PFE), as its new Chief Medical Officer (Press release, GT Biopharma , SEP 7, 2017, View Source [SID1234539539]).

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!

Dr. Urbanski will oversee development of key products in GT Biopharma’s product pipeline, including its platform targeted immunotherapy BiKE and TriKE technologies as well as its newly acquired Central Nervous System pipeline.

Dr. Urbanski spent eight years with Pfizer and held several positions with the company, including Vice President/CMO of the Established Products Business Unit, senior medical director of oncology clinical R&D, senior medical director of breast cancer products and medical director of diversified products.

He brings extensive experience in developing and overseeing clinical studies, including phase 3b and phase 4 studies (including line extensions) for sunitinib (Sutent), exemestane (Aromasin), irinotecan (Camptosar), epirubicin (Ellence), axitinib, IGF1R inhibitor, and tremelimumab.

In addition to his role with Pfizer, Dr. Urbanski served as Chief Medical Officer of Mylan Inc., Chief Medical Officer of Metabolex Inc., and Senior Director of US Medical Affairs for Aventis.

GT Biopharma Executive Chairman Anthony J. Cataldo said the appointment of Dr. Urbanski as Chief Medical Officer is a key development that comes at an exciting time for the Company.

"We announced on Tuesday the completion of our acquisition/merger of Georgetown Translational Pharmaceuticals, Inc., the elimination of all debt and a suite of neurological products that are late stage and close to market. Along with this, we have retained a world class CEO in Dr. Kathleen Clarence-Smith in the process. Her resume speaks for itself," Mr. Cataldo said.

"Now we complete our executive management team with another world class executive in Dr. Raymond Urbanski as our new CMO. His expertise in oncology assets and quick-to-market 505(b)2 products is timely for GT Biopharma Inc. Ray’s big pharma and biotech expertise is custom made for the assets of GT Biopharma. He will be instrumental in helping to guide our highly sought after oncology BiKE and TriKE platform technologies to commercial success. We are excited to have our "Dream Team" in place," Mr. Cataldo said.

Dr. Kathleen Clarence-Smith, Chief Executive Officer of GT Biopharma, said she is pleased that Dr. Urbanski is joining the GT Biopharma team.

"We have known each other for many years. He is not only highly experienced in drug development but hardworking and respected by his teams," Dr. Clarence-Smith said. "I admire his dedication to successfully getting product candidates over the finish line, and rapidly through the regulatory process, as attested by several approved NDAs, sNDAs, and BLAs. Ray’s expertise in the development of both oncology and neurology drugs is the perfect fit for GT Biopharma."

Dr. Urbanski said he believes his background will prove valuable at GT Biopharma, and he looks forward to pursuing the company’s promising oncology and Central Nervous System pipeline.

"My rise at Pfizer was rapid, as I went from a Medical Director to the Head of a business unit at the largest pharmaceutical company in the world in under 4 years. I have been involved in all phases of drug development from discovery through FDA phase 4 clinical trials and fast to market FDA 505 (b)(2) licenses. This included an abundance of Oncology assets," Dr. Urbanski said. "I believe it is my breadth of knowledge, experience and proven record of success that brings true value to GT Biopharma."

Bristol-Myers Squibb Completes Previously Announced Acquisition of IFM Therapeutics

On September 7, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that it has completed the previously announced planned acquisition of IFM Therapeutics (Press release, Bristol-Myers Squibb, SEP 7, 2017, View Source [SID1234523239]).

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!

The transaction includes full rights to IFM’s preclinical STING (stimulator of interferon genes) and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer. IFM’s STING agonist program includes a lead asset that accelerates the company’s efforts against this target, while the NLRP3 agonist program includes a potential first-in-class pipeline candidate. A newly formed entity will be established by the current shareholders of IFM – IFM Therapeutics LLC – and it will retain IFM’s current personnel and facilities, as well as its remaining research programs, which include an NLRP3 antagonist program focused on curbing immune responses that lead to inflammatory diseases and fibrosis.

Celgene Provides Update on the Fusion™ Clinical Program

On September 7, 2017 Celgene Corporation (NASDAQ:CELG) reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on five trials and a full clinical hold on one trial in the Celgene FUSION program (Press release, Celgene, SEP 7, 2017, View Source [SID1234520404]). The trials are testing IMFINZI (durvalumab), an anti-PD-L1 antibody, in combination with immunomodulatory and chemotherapy agents in blood cancers such as multiple myeloma, chronic lymphocytic leukemia and lymphoma.

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!

The decision by the FDA was based on risks identified in other trials for an anti-PD-1 antibody, pembrolizumab, in patients with multiple myeloma in combination with immunomodulatory agents. In the FUSION program, the Company has not discerned, at this time, an imbalance in the risk benefit profile; however, the clinical holds allow for additional information to be collected to further understand the risk benefit profile of the program.

Patients enrolled in the trials on partial clinical hold who are receiving clinical benefit from treatment as determined by the investigator, may remain on treatment. Patients enrolled in the trial on full clinical hold will be discontinued from treatment. No new patients will be enrolled into the listed trials.

The trials placed on partial clinical hold are:

MEDI4736-MM-001: A Phase IB Multicenter, Open-Label Study to Determine the Recommended Dose and Regimen of Durvalumab Either as Monotherapy or in Combination with Pomalidomide with or without Low-Dose Dexamethasone in Subjects with Relapsed and Refractory Multiple Myeloma
MEDI4736-MM-003: A Phase II, Multicenter, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Subjects with Relapsed and Refractory Multiple Myeloma
MEDI4736-MM-005: A Phase II, Multicenter, Single-Arm, Study to Determine the Efficacy for the Combination of Durvalumab Plus Daratumumab in Subjects with Relapsed and Refractory Multiple Myeloma That Have Progressed While on Current Treatment Regimen Containing Daratumumab
MEDI4736-NHL-001: A Phase I/II, Open-label, Multi-center Study to Assess the Safety and Tolerability of Durvalumab as Monotherapy and in Combination Therapy in Subjects with Lymphoma or Chronic Lymphocytic Leukemia. The only arm in this trial for which enrollment is suspended is the arm with the durvalumab, REVLIMID and rituximab combination.
MEDI4736-DLBCL-001: A Phase II, Open-label, Multicenter Study to Evaluate the Safety and Clinical Activity of Durvalumab in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) or with Lenalidomide Plus R-CHOP (R2 CHOP) in Subjects with Previously Untreated, High Risk Diffuse Large B Cell Lymphoma
The trial placed on full clinical hold is:

MEDI4736-MM-002: A Phase Ib Multicenter, Open-label Study to Determine the Recommended Dose and Regimen of Durvalumab in Combination with Lenalidomide with and without Low-dose Dexamethasone in Subjects with Newly Diagnosed Multiple Myeloma
The trials that will continue to enroll are:

MEDI4736-MDS-001: A Randomized, Multicenter, Open-label, Phase II Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination with Durvalumab in Previously Untreated Subjects with Higher-Risk Myelodysplastic Syndromes or in Elderly ( > = 65 Years) Acute Myeloid Leukemia Subjects Not Eligible for Hematopoietic Stem Cell Transplantation
CC-486-MDS-006: A Phase II, International, Multicenter, Randomized, Open-label, Parallel Group to Evaluate the Efficacy and Safety of CC-486 Alone in Combination with Durvalumab in Subjects with Myelodysplastic Syndromes Who Fail to Achieve an Objective Response to Treatment with Azacitidine for Injection or Decitabine
In April 2015, Celgene entered into a strategic collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, to develop and commercialize IMFINZI for hematologic malignancies. The use of IMFINZI in combination with other agents for the treatment of patients with hematologic malignancies is not approved by the FDA, and the safety and efficacy of those combinations have not been established.

Vividion Therapeutics Appoints Diego Miralles, M.D., Chief Executive Officer

On Sept. 7, 2017 Vividion Therapeutics, a newly established biotechnology company using revolutionary proteomics and chemistry platforms to discover and develop novel small molecule therapeutics, reported the appointments of Diego Miralles, M.D., as Chief Executive Officer and Richard Heyman, Ph.D. as member of the Board of Directors (Press release, Vividion Therapeutics, SEP 7, 2017, View Source [SID1234520719]).
Dr. Miralles brings extensive scientific leadership and drug development experience to Vividion spanning two decades and includes leading biotech and pharmaceutical companies.
“We are delighted to have Diego join our company. Throughout his career he has demonstrated a longstanding commitment to improving patient care, and he brings the strong business and scientific leadership we need to maximize the enormous potential of our platforms,” said Tom Daniel, Chairman of the Board of Directors. “We believe we can transform the way in which small molecules are discovered and can address targets that until now have remained undruggable.”
“I’m excited about the potential for Vividion to revolutionize drug discovery and address many unmet medical needs. Patients are waiting,” said Dr. Miralles.
Dr. Miralles most recently served as President of Adaptive Therapeutics, a new division of Adaptive Biotechnologies launched in 2016. Prior to that, Dr. Miralles served as the Global Head for Johnson & Johnson Innovation. During his career at Johnson & Johnson, he founded the Johnson & Johnson Innovation Centers and JLABS, a best-in-class corporate incubator for entrepreneurs in the healthcare and life sciences industries. Dr. Miralles also headed an entrepreneurial team within the Janssen Pharmaceutical Companies of Johnson & Johnson that created integrated care businesses and enabling technologies to transform the healthcare experience, improve outcomes and reduce healthcare costs. He headed the Janssen Research and Early Development unit in La Jolla, California focused in pharmaceutical discoveries and early proof of concept clinical development. Dr. Miralles joined Johnson & Johnson as VP of Clinical Development at Tibotec in Belgium, where he was involved in the development and approval of several drugs including PREZISTA and INTELENCE.

Prior to Johnson & Johnson, Dr. Miralles held research and development positions at Trimeris and Triangle Pharmaceuticals and was an Assistant Professor at Duke University Medical Center, serving as a scientist and an Infectious Disease physician. He is currently an Adjunct Professor in the Department of Pharmacology at the University of California San Diego. Dr. Miralles received his M.D. from the Universidad de Buenos Aires, Argentina, completed his internal medicine residency at the Mayo Clinic, and was a fellow in Infectious Diseases at Cornell University-New York Hospital.

Dr. Heyman is former CEO of Seragon Pharmaceuticals, which was acquired by the Roche, and Aragon Pharmaceuticals, which was purchased by Johnson & Johnson. He was a cofounder and Chief Scientific Officer of X-Ceptor Therapeutics, which was acquired by Exelixis. He has served as Vice President of Research at Ligand Pharmaceuticals. He is the author or inventor on more than 120 publications and patents. Dr. Heyman currently serves on the Board of Directors for ORIC Pharmaceuticals, the Salk Institute for Biological Studies, UCSD Moores Cancer Center, Gritstone Oncology and Metacrine Inc. He was an NIH postdoctoral fellow at the Salk Institute, working with Dr. Ronald Evans. Dr. Heyman received a Ph.D. in pharmacology from the University of Minnesota.

About Vividion Therapeutics
Vividion Therapeutics, Inc. is a biotechnology company focused on developing innovative therapeutics that treat major unmet clinical needs using the first platform for proteome-wide ligand and target discovery. The company’s cutting-edge platform was spun out of the labs of Vividion’s scientific founders, a team of experts in chemical biology and synthetic chemistry from The Scripps Research Institute in La Jolla, CA. Vividion is committed to advancing and applying its pioneering synthetic and proteomic chemistry platforms to create therapeutics that will make a transformative difference in patients. For more information, please visit www.vividion.com.

TRACON Pharmaceuticals Announces Completion of Enrollment in Randomized Phase 2b TRAXAR Study of TRC105 and Inlyta® in Renal Cell Carcinoma

On September 7, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported that it has completed enrollment in the randomized Phase 2b TRAXAR study of TRC105 and Inlyta (axitinib) in patients with advanced or metastatic renal cell carcinoma (RCC) (Press release, Tracon Pharmaceuticals, SEP 7, 2017, View Source [SID1234520430]).

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!

TRACON expects to report top-line progression-free survival (PFS) data from the study later this year, with the exact timing driven by the number of progression events or deaths (from any cause) that define PFS. The study is expected to yield between 80 and 110 events as confirmed by the study’s independent central review committee at the time of data readout, which is expected to provide between 70% and 80% power to detect an improvement in PFS from 4.8 months with Inlyta to 7.2 months with the combination of TRC105 and Inlyta. PFS will also be assessed in patients with predefined levels of two soluble biomarkers that correlated with response in the Phase 1b portion of the trial, osteopontin and TGF-β receptor III.

"The completion of enrollment in the TRAXAR study represents an important step in the development of TRC105 and keeps us on track to deliver top-line data later this year," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "The TRAXAR study provides a strong example of the depth of the TRACON product development platform as we have efficiently conducted the study at more than 50 sites located in Europe and the United States."

About the TRAXAR Phase 2b Clinical Trial in RCC

The Phase 2b TRAXAR clinical trial is a multicenter, open-label, randomized clinical trial of TRC105 in combination with Inlyta versus Inlyta alone in patients with advanced or metastatic RCC. The primary endpoint of the Phase 2b study is progression-free survival and the trial enrolled 150 patients who failed one prior VEGF inhibitor in the study. Patients may have also failed one prior mTOR inhibitor and one prior immunotherapy. For additional information on this clinical trial, please visit www.clinicaltrials.gov, identifier NCT01806064.

About TRC105 (carotuximab)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in one Phase 3 and multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumors in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.