CellCeutix has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, CellCeutix, SEP 8, 2017, View Source [SID1234520459]).

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On September 8, 2017 Sanofi and Regeneron Pharmaceuticals, Inc. 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[i], Anchor[ii] (Press release, Sanofi, SEP 8, 2017, View Source [SID1234520415]). Cemiplimab is an investigational human, monoclonal antibody targeting PD-1.
Sanofi and Regeneron 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 for metastatic CSCC and locally advanced and unresectable CSCC. Cemiplimab is being jointly developed by Sanofi and Regeneron 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.[iii] CSCC is responsible for the most deaths among non-melanoma skin cancer patients.ii
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.[iv]
Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.

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SurVaxM is a first-of-its-kind, patented peptide mimic immunotherapeutic vaccine (immunotherapy) that targets survivin, a cell-survival protein present in 95 percent of glioblastomas and many other cancers. It is engineered to recognize survivin-expressing cancer cells as foreign and stimulate patients’ own immune response to control tumor growth and recurrence.

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While vaccines are typically thought of as ways to prevent diseases, vaccines can also be used in a therapeutic mode (e.g., to treat cancer). SurVaxM is delivered through simple subcutaneous injection.
Malignant Glioma (GBM):

SurVaxM demonstrated safety and tolerability in a Phase I study in patients with recurrent or progressive malignant glioma (brain tumors). View press release

SurVaxM has now entered a Phase II clinical trial in adults with newly diagnosed glioblastoma. at leading cancer centers: Roswell Park Cancer Institute, Cleveland Clinic and Dana-Farber Cancer Institute. Please visit the Clinical Trials page for more information.

Although SurVaxM was first tested in brain cancer, survivin is present in most cancers, including multiple myeloma, melanoma, ovarian, renal, lymphoma, prostate and breast cancers. Thus SurVaxM could have broad applicability to these cancers.
Multiple Myeloma:

A Phase I clinical trial evaluating SurVaxM in combination with REVLIMID(lenalidomide) as a maintenance therapy for adults with multiple myeloma has been initiated with support from Celgene (marketer of REVLIMID). Please visit the Clinical Trials page for more information.

MimiVax has an exclusive license to globally commercialize SurVaxM, as well as an extensive worldwide patent portfolio for SurVaxM and other products in development.

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]).

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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.

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]).

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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."