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 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.

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."

On September 7, 2017 AstraZeneca and MedImmune, its global biologics research and development arm, reported that they have been informed by partner Celgene that the US 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 programme (Press release, AstraZeneca, SEP 7, 2017, View Source [SID1234520401]). The trials are testing Imfinzi (durvalumab), an anti-PD-L1 agent, in combination with immunomodulatory agents, with or without chemotherapy, in blood cancers such as multiple myeloma, chronic lymphocytic leukaemia and lymphoma.

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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

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The decision by the FDA was based on risks identified in other trials for an anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma in combination with immunomodulatory agents. No imbalance has been observed in the FUSION programme; however, the clinical holds allow for additional information to be collected to further understand the risk benefit profile of the programme. The FDA has taken similar action with other combination trials in patients with multiple myeloma.

Patients enrolled in the trials on partial clinical hold who are receiving clinical benefit from treatment 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.

Other trials with Imfinzi in haematological malignancies and other tumour types continue unchanged.

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 patients 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 patients 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 patients 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 leukaemia. The only arm in this trial for which enrolment 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 patients 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 enrol are:

MEDI4736-MDS-001: A randomised, multicenter, open-label, Phase II trial 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 leukaemia subjects not eligible for haematopoietic stem cell transplantation
CC-486-MDS-006: A Phase II, international, multicenter, randomised, 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 to develop and commercialise durvalumab for haematologic malignancies. The use of durvalumab in combination with other agents for the treatment of patients with haematologic malignancies is not approved by the FDA, and the safety and efficacy of those combinations have not been established.