Scientific Review Committee Meets on OncBioMune’s Phase 2 Prostate Cancer Clinical Trial

On March 22, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported that the Company received comments from a recent meeting of the Scientific Review Committee (SRC) responsible for reviewing the planned Phase 2 clinical trial of ProscaVax for early-stage prostate cancer to be hosted at a teaching hospital of Harvard University Medical School in Boston, MA (Press release, Oncbiomune, MAR 22, 2018, View Source [SID1234525392]).

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The SRC had minimal comments regarding the protocol, for which OncBioMune and investigators are presently making the suggested revisions.

"We greatly appreciate the knowledge and expertise of the SRC to request minor revisions to the protocol, advice that we believe is highly supportive of the clinical trial," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We don’t foresee any problems in responding to the comments and making adjustments in the protocol in the upcoming days and look forward to moving one step closer to initiating the trial."
ProscaVax is OncBioMune’s lead immunotherapy candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF). The Company has successfully completed a Phase 1a clinical trial of ProscaVax in hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA. The planned Phase 2 study at the teaching hospital of Harvard University Medical School is being designed to treat prostate cancer patients in the "active surveillance" group, representing the first-ever clinical study of a therapeutic vaccine for patients in this group to the Company’s knowledge. Active surveillance is a disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking any intervention measures, such as surgery or radiotherapy.

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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Caladrius Biosciences 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, Caladrius Biosciences, 2018, MAR 22, 2018, View Source [SID1234524943]).

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Celyad Reports 2017 Financial and OperatingResults and Expected Key Milestones for 2018

On March 22, 2018 Celyad Reported 2017 Financial and OperatingResults and Expected Key Milestones for 2018 (Press release, Celyad, MAR 22, 2018, View Source(3).pdf [SID1234532496]).

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BerGenBio to present overview of phase II clinical trial portfolio combining bemcentinib with KEYTRUDA at 3rd Annual Immuno-Oncology Summit Europe

On March 22, 2018 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors as a potential cornerstone of combination cancer therapy, reported that the Company will be presenting an overview of the three ongoing phase II trials combining the Company’s selective AXL inhibitor bemcentinib with the anti-PD-1 therapy KEYTRUDA at the 3rd Annual Immuno-Oncology Summit Europe, London, UK, today at 10:05-10:35 GMT (Press release, BerGenBio, MAR 22, 2018, View Source [SID1234525082]).

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The presentation will be delivered by Dr Julia Schoelermann, Assoc. Director Business Development & Partnering, and the presented slides are available on the Company’s website: www.bergenbio.com.

The talk will discuss the preclinical rationale for the studies and summarise clinical data to date.

Evotec OAI and Rigel Pharmaceuticals Enter Into Medicinal Chemistry Agreement To Identify A New Class of Anti-Cancer Compounds Called Ubiquitin Ligase Inhibitors

On March 22, 2018 Evotec OAI AG, Hamburg, Germany (Neuer Markt: EVT), a supplier of integrated high-value added drug discovery services, and Rigel Pharmaceuticals Inc., a drug discovery and development company (Nasdaq: RIGL), reported the signing of a medicinal chemistry agreement for the optimisation of small molecules focused on inhibitors of ubiquitin ligases (Press release, Evotec, MAR 22, 2018, View Source;announcements/press-releases/p/evotec-oai-and-rigel-pharmaceuticals-enter-into-medicinal-chemistry-agreement-to-identify-a-new-class-of-anti-cancer-compounds-called-ubiquitin-ligase-inhibitors-4642 [SID1234525393]). Ubiquitin ligases are involved in cell division and the progression of certain cancers. Research on this target class is an important new area in the field of oncology. Rigel is a leader in the field of ubiquitin ligases and their applications in oncologic, inflammatory and viral diseases.

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Under the terms of the agreement, Evotec OAI will use their leading-edge integrated drug discovery platform to select and synthesise lead compounds with optimised properties for Rigel to screen against their target proteins, and to identify novel scaffolds from Evotec OAI’s portfolio of validated chemistries, with the aim of identifying an IND candidate in 12 months. Initially, Evotec OAI’s molecular modelling expertise and computational platform will be used to perform SAR (structure activity relationship) analysis including pharmacophore modelling and in silico docking studies on selected Rigel small molecule drug leads. These proprietary compounds have been identified as most active in Rigel’s anti-cancer programme on ubiquitin ligases. This information will be used to select and synthesise the additional lead compounds.

Additionally, Evotec OAI will use their computational chemistry expertise to analyse Rigel’s corporate library and to identify additional scaffolds to increase the overall diversity of the library whilst retaining the drug and lead-like properties. Through the agreement, Rigel will also gain access to Evotec OAI’s lead discovery library for screening against the ligase and additional Rigel targets.

Rigel will provide funding to Evotec OAI for services conducted during this programme. In addition, Evotec OAI may receive future milestone payments if discovery projects meet defined goals and products are commercialised.

"We look forward to building a partnership with Rigel in their very exciting area of ubiquitin ligase research," said Mario Polywka, Chief Operating Officer of Evotec OAI. "Using our world class drug discovery platform will enable us to assist Rigel in accelerating their drug discovery programme."

"Rigel has built a very strong capability in ubiquitin ligase research and drug development, including the design of numerous biochemical and cellular assays to analyze the biology and proteomics of ligases, a robust and efficient high throughput screening program, a focused chemistry program with promising initial chemical hits and an experienced preclinical oncology development team," said James M. Gower, Rigel’s President and Chief Executive Officer. "This collaboration marks our second this month in the area of ubiquitin ligases, and Evotec’s expertise in computational and medicinal chemistry will contribute greatly to our ability to rapidly identify a clinical candidate in this promising new area of research."