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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Third Rock Ventures Launches Rheos Medicines with $60 Million in Series A Funding to Harness Immunometabolism to Develop Precision Medicines for Immune-mediated Diseases

On March 22, 2018 Rheos Medicines, Inc. was launched with $60 million in Series A financing backed by Third Rock Ventures, LLC. Rheos is pioneering immunometabolism as a novel approach to tune metabolic pathways in immune cells to treat disease (Press release, Rheos Medicines, MAR 22, 2018, View Source [SID1234532790]). The company will translate recent breakthroughs in the understanding of immune cell metabolism to develop precision medicines for immune-mediated diseases.

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The number of patients with immune-mediated diseases is large and growing in Western society, with an estimated 7-10 percent of the population with autoimmune diseases1 and 5-7 percent of the population with immune-mediated inflammatory diseases.2 Despite recent advances in treatment, there remains a significant unmet need. Understanding how variations in immune cell metabolism underlie patient heterogeneity provides an opportunity to bring precision treatments to patients.

New, in-depth understanding of immune cell physiology based upon research by leading academic scientists, including Rheos’s founders, points to cellular metabolism as a key driver of immune cell response. Rheos’s product engine takes a fundamentally novel approach to immune-mediated diseases by encompassing the full range of immune cells and their functions, and how they are regulated by cellular metabolism. In addition, by identifying new therapeutic targets and related biomarkers, the Rheos engine will address patient heterogeneity inherent to many immune-mediated diseases.

"The emerging field of immunometabolism offers a tremendous opportunity to set a higher standard for how immune-mediated diseases are treated. This opens an opportunity for Rheos to direct our medicines to a new aspect of disease pathogenesis by targeting the underlying cellular metabolism of immune cells," said Abbie Celniker, PhD, Chief Executive Officer of Rheos. "By building on the discoveries of our founders, Rheos is developing a biomarker and drug discovery engine that will allow us to address disease biology and patient variability by ‘tuning’ immune cells in select patient populations with precision medicines."

Rheos Product Engine and Pipeline

Rheos has developed a product engine that offers unprecedented insight into the drivers of immune-mediated diseases by characterizing how different immune cell types impact disease progression in different patient subpopulations. By simultaneously identifying new drug targets and characterizing biomarkers of disease, the Rheos product engine enables a precision medicine approach to treatment of immune-mediated diseases. Using the latest technological advances– including DNA sequencing, transcriptional and metabolomic profiling – along with incorporating primary patient samples, the Rheos product engine is an integrated immune cell metabolism and physiology platform.

Central to this product engine is a proprietary Immune Cell Encyclopedia (ICE), which maps the metabolic pathways used by different types of immune cells to regulate their fate and function in disease and in health. The initial focus of Rheos’s product pipeline is on therapeutics that target CD4 and CD8 T cell subtypes, which are involved in diseases such as inflammatory bowel disease, psoriasis, vitiligo and in immuno-oncology applications. These immune cell subtypes are critical to disease pathogenesis, and Rheos’s product engine is providing insight into how these cells drive immune response in disease.

"I have firsthand experience treating patients with immune-mediated diseases based on my years in clinical practice, and it is exhilarating to apply the wealth of expertise and technology at Rheos to create new treatments and address these patient needs," said Larry Turka, MD, Chief Scientific Officer and co-founder of Rheos. "I am excited to work with the talented team at Rheos and use our product engine to translate the powerful science of immunometabolism into the reality of new treatments that can make a lasting difference for the millions of patients with immune-mediated diseases."

Expert team of immunometabolism scientists and immune disease clinicians

The Rheos leadership team includes recognized leaders in immunometabolism, target discovery, translational medicine and company building. Company leaders include Abbie Celniker, PhD, interim Chief Executive Officer; Cary Pfeffer, MD, interim Chief Business Officer; Laurence Turka, MD, Chief Scientific Officer; Edward Driggers, PhD, Chief Technology Officer; Ryan Cohlhepp, PharmD, Senior Vice President, R&D Strategy and Operations; Brian Albrecht, PhD, Vice President, Drug Discovery; and Hozefa Bandukwala, PhD, Senior Director, Head of Discovery Biology.

Rheos’s internal team is working alongside a founding team of leading scientists whose discoveries opened the field of immunometabolism and clinicians with deep understanding of immune-mediated diseases. The company’s scientific founders are:

Richard Flavell, PhD, Sterling Professor of Immunobiology, Yale University; Investigator, Howard Hughes Medical Institute. Flavell is a world-renowned immunologist who pioneered the use of transgenic mouse models to study autoimmune and inflammatory diseases. Richard is a member of the National Academy of Sciences, National Academy of Medicine (USA), and a Fellow of the Royal Society.
Edward Pearce, PhD, Senior Group Leader, Max Planck Institute of Immunobiology and Epigenetics; Faculty of Biology, University of Freiburg. Edward Pearce is a pioneer in understanding how macrophage and dendritic cell metabolism influences the function of those cells.
Erika Pearce, PhD, Director, Max Planck Institute of Immunobiology and Epigenetics. Erika Pearce is a world leader in T cell metabolism and understanding how different metabolic pathways tune T cell function and fitness.
Ken Smith, MD, PhD, Professor of Medicine and Head of the Department of Medicine, University of Cambridge. Smith is an international expert in identifying biomarkers which predict prognosis in patients with autoimmune disease.
William St. Clair, MD, Professor of Medicine and Immunology, Duke University Medical Center. Dr. St. Clair is a former President of the American College of Rheumatology, he has extensive experience in translational immunology and the design and implementation of trials in autoimmune diseases.
Laurence Turka, MD, CSO, Rheos Medicines. Turka is former President of the American Society of Transplantation, a leader in the fields of T cell costimulation and regulatory T cell biology. Prior to joining Rheos, Laurence was the Harold and Ellen Danser Professor of Surgery and Professor of Medicine at Harvard Medical School and Massachusetts General Hospital.

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."

BIOCRYST PHARMACEUTICALS AND IDERA PHARMACEUTICALS TO PRESENT AT THE 17TH ANNUAL NEEDHAM HEALTHCARE CONFERENCE

On March 22, 2018 BioCryst Pharmaceuticals, Inc. ("BioCryst") (NASDAQ:BCRX), and Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ:IDRA), reported they will be presenting at the 17th Annual Needham Healthcare Conference on Tuesday, March 27, 2018 at 12:15 P.M. E.T. The conference is being held at the Westin New York Grand Central Hotel (Press release, Idera Pharmaceuticals, 22 22, 2018, View Source [SID1234524951]).

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