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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.

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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]).

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.

Transgene and Institut Bergonié Present a Poster on the METROmaJX Trial (Oncolytic Virus Pexa-Vec + Metronomic Cyclophosphamide) at ESMO 2017 Congress

On September 7, 2017 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops viral-based immunotherapies, reported that the results of the Phase 1 part of the METROmaJX trial will be presented in a poster presentation at the annual congress of European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) (8-12 September 2017, Madrid, Spain) (Press release, Transgene, SEP 7, 2017, View Source [SID1234520416]). These Phase 1 trial results showed that the regimen associating intravenous infusion of Pexa-Vec (JX-594) with low-dose cyclophosphamide was well-tolerated with no dose limiting toxicity in patients with solid tumors. Following these positive results, the Phase 2 part of the trial is currently enrolling patients with soft tissue sarcoma (STS) and HER2 negative-breast cancer.

Abstract title: A phase Ib trial of JX-594 (Pexa-Vec), a targeted multimechanistic oncolytic vaccinia virus, in combination with low-dose cyclophosphamide in patients with advanced solid tumors

Poster number: 414P
Date and time: 11 September 2017, 1:15 pm
Location: Hall 8
Presenter: Pr Antoine Italiano, MD, PhD (Institut Bergonié)
The abstract can be downloaded from the ESMO (Free ESMO Whitepaper) website and from Transgene’s website (www.transgene.fr).

METROmaJX is a Phase 1/2 clinical trial evaluating the tolerability and efficacy of the co-administration of Pexa-Vec with metronomic cyclophosphamide (low doses given with high frequency) in patients with advanced solid tumors (NCT02630368).

The Phase 2 stage of the trial is currently enrolling patients with STS and HER2 negative-breast cancer. It will primarily assess the anti-tumor efficacy of this novel combination regimen.

Prof. Antoine Italiano is the principal investigator of the trial. Institut Bergonié is the sponsor of this trial, that is supported by INCa (French National Cancer Institute) within the frame of the CLIP² projects.

Pexa-Vec is a GM-CSF expressing vaccinia derived oncolytic virus. Cyclophosphamide is a chemotherapy. Metronomic administration involves giving low doses of the drug at a higher frequency and is known to have an immunomodulating activity. The combination of Pexa-Vec and cyclophosphamide aims at targeting two distinct steps in the immune response against cancer cells and has the potential to be significantly more effective than either product alone.

Regeneron and Sanofi Announce Cemiplimab (REGN2810) Has Received FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous Cell Carcinoma

On September 8, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma. Cemiplimab is an investigational human, monoclonal antibody targeting PD-1 (Press release, Regeneron, SEP 8, 2017, View Source [SID1234520414]).

Regeneron and Sanofi previously reported positive, preliminary results for cemiplimab from two expansion cohorts involving 26 advanced CSCC patients in a Phase 1 study of nearly 400 patients, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2017. EMPOWER-CSCC 1, a Phase 2, potentially pivotal, single-arm, open-label clinical trial of cemiplimab is currently enrolling patients with metastatic CSCC and locally advanced and unresectable CSCC. Cemiplimab was discovered using Regeneron’s proprietary VelocImmune technology that yields optimized fully-human antibodies, and is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. Pending data results, the companies anticipate submitting a biologics license application for cemiplimab with the FDA in the first quarter of 2018.

CSCC is the second most common type of skin cancer in the United States. Although CSCC has a good prognosis when caught early, it can prove especially difficult to treat when it progresses to advanced stages. Patients at this stage can be disfigured due to multiple surgeries to remove CSCC tumors on the head, neck and other parts of the body.1 CSCC is responsible for the most deaths among non-melanoma skin cancer patients.

Breakthrough Therapy designation serves to expedite the development and review of drugs that target serious or life- threatening conditions. Drugs qualifying for this designation must show credible evidence of a substantial improvement on a clinically significant endpoint over available therapies, or over placebo if there is no available therapy. The designation includes all of the Fast Track program features, as well as more intensive FDA guidance and discussion. The Breakthrough Therapy designation is distinct from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met.

Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.