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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

On March 22, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or the "Company") reported the initiation of patient dosing in the new cohort of the TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase 1 clinical trial (Press release, Immutep, MAR 22, 2018, View Source [SID1234524958]). This clinical study is evaluating the combination of Immutep’s lead immunotherapy product candidate eftilagimod alpha ("efti" or "IMP321") with pembrolizumab (KEYTRUDA) in unresectable or metastatic melanoma patients in Australia.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The additional cohort consists of six patients that will receive 30 mg of efti in combination with pembrolizumab starting at cycle one of pembrolizumab. Patients will be treated for up to 12 months. Yesterday the first patient in this cohort received their first dose of the two drugs. Safety assessment is the main objective of this study.

"This additional cohort of the ongoing TACTI-mel clinical trial is very important to the clinical development of efti, especially in the light of our new collaboration study announced on 12th of March 2018, as we are now dosing efti at cycle one in combination with KEYTRUDA with the highest dose and for a 12-month duration," said Dr. Frédéric Triebel, Immutep’s Chief Scientific Officer and Chief Medical Officer. "We look forward to presenting additional data from the TACTI-mel study during the middle of this calendar year as we hope it will further support our hypothesis that combining an antigen-presenting cell activator (efti) with a checkpoint inhibitor (KEYTRUDA) results in a therapeutic synergy and a potential benefit over checkpoint inhibitor monotherapy."

About TACTI-mel

The ongoing TACTI-mel Phase I clinical trial is a multi-centre, open-label, dosing escalating (1, 6 or 30 mg of efti) study evaluating the combination of efti with pembrolizumab (for 6 months, starting at cycle 5) in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pemobrolizumab monotherapy. Each cohort of the study is comprised of six patients. As previously reported in December 2017, the last patient of the third cohort (30 mg) has been dosed, bringing the total number of patients recruited and dosed in the trial to 18. Preliminary data from the 1 and 6 mg cohorts were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2017 Annual Meeting in November 2017. As reported at SITC (Free SITC Whitepaper), anti-tumour activity (tumour reduction) was observed in 7/12 patients (58%) in the first two cohorts of the study. Prior to treatment with efti, all of these patients had either a suboptimal response or had disease progression when treated with pembrolizumab monotherapy. The TACTI-mel trial was expanded with the addition of a new cohort in February 2018.

About Eftilagimod Alpha

Eftilagimod alpha ("efti" or "IMP321"), a LAG-3Ig fusion protein, is a MHC class II agonist that activates antigen-presenting cells ("APCs") such as dendritic cells and monocytes (primary target cells) and then CD8 T-cells (secondary target cells). The activation of the dendritic cell network and the subsequent T cell recruitment at the tumour site with efti may lead to stronger anti-tumor CD8 T cell responses than observed

LOGO

with checkpoint inhibitor monotherapy, as in the case of the TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial (clinicaltrials.gov identifier NCT02676869). In combination with chemotherapy, the activation of the APC network with efti the day after injection of a single agent chemotherapy may lead to stronger cytotoxic cellular responses associated with an improved long-term Th1 (IFN-g) immune status, both parameters being essential for a potent immune response against the tumour, as in the case of the AIPAC (Active Immunotherapy PAClitaxel) Phase IIb clinical trial (clinicaltrials.gov identifier NCT02614833).

On March 22, 2018 ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, reported financial results for the year ended December 31, 2017 (Press release, Arca biopharma, MAR 22, 2018, View Source [SID1234525078]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"During 2017, we continued to make progress on our lead development program as we completed the GENETIC-AF clinical trial evaluating Gencaro as potentially the first genetically-targeted treatment for atrial fibrillation," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "We reported top-line Phase 2B results for the GENETIC-AF clinical trial in February 2018 and are requesting a meeting with the U.S. FDA for the second quarter of 2018 to review the data and future development plans."

2017 Summary Financial Results

Cash, cash equivalents and marketable securities totaled $11.8 million as of December 31, 2017, compared to $23.5 million as of December 31, 2016. The Company raised net proceeds of approximately $3.4 million in January 2018 from sales of its common stock under its "at-the-market" offering facility. ARCA believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through the end of 2018.

Research and development (R&D) expenses for the year ended December 31, 2017 totaled $14.1 million compared to $12.3 million for 2016. The $1.7 million increase in research and development expenses in 2017 as compared to 2016 was primarily due to increased expenses for the GENETIC-AF clinical trial. The Company expects R&D expenses in 2018 to be lower than 2017 as the GENETIC-AF clinical trial has been completed.

General and administrative (G&A) expenses for the year ended December 31, 2017 were $4.6 million compared to $4.3 million in 2016. ARCA expects G&A expenses in 2018 to be consistent with those in 2017 as it maintains administrative activities to support ongoing operations.

Total operating expenses for the year ended December 31, 2017 were $18.7 million compared to $16.6 million in 2016. The increase in total operating expenses for 2017 was primarily due to the increase in R&D expense due to the increased expense of the GENETIC-AF clinical trial.

Net loss was $18.5 million, or $1.77 per share, for 2017 compared to $16.4 million, or $1.81 per share, for 2016.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Sign up for OncBioMune email alerts at: View Source

On March 22, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that it filed a Registration Statement on Form F-1 with the U.S. Securities and Exchange Commission (SEC) for a proposed offering of ordinary shares in the form of American Depositary Shares ("ADSs") in the United States (Press release, MorphoSys, MAR 22, 2018, View Source [SID1234556339]). The final number of ADSs to be offered and the price for the offering have not yet been determined.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

MorphoSys’s ordinary shares are listed on the Prime Standard Segment in Frankfurt, Germany. Application has been made to list the ADSs to be offered in the proposed offering on the Nasdaq Global Market in the United States under the ticker symbol "MOR".

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Leerink Partners LLC, are acting as lead book-running managers, and Berenberg Capital Markets, LLC and JMP Securities LLC are acting as co-managers for the proposed ADS offering.

A Registration Statement relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. The securities may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective.

The securities referred to in this release are to be offered only by means of a prospectus. A copy of the preliminary prospectus, when available, can be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or by e-mailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by emailing [email protected].

This announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.