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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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.

On March 22, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX 30) reported that DAC (a wholly owned subsidiary of Genextra SPA) has chosen Evotec as a strategic partner to identify small molecule therapeutics in a pharmaceutical discovery project on the HSP90 target, a key protein involved in a variety of oncogenic pathways in several cancer related diseases (Press release, Evotec, MAR 22, 2018, View Source;announcements/press-releases/p/dac-selects-evotec-as-strategic-partner-for-a-drug-discovery-collaboration-on-the-hsp90-cancer-target-4520 [SID1234525395]).

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Under the agreement, DAC will access compound intellectual property that Evotec has generated on this disease target through its internal R&D activities. The aim of the collaboration will be to take compounds identified by Evotec as being active against the target and further optimise them to the point of clinical development.

Using its proprietary fragment screening platform (High Throughput Fragment Screening, HTFS), Evotec identified novel fragments that interact with the HSP90 target from Evotec’s five thousand member fragment library. Active fragments were further characterised by co-crystallisation with the target protein. The X-ray crystal structures of the protein-ligand complexes identified a variety of binding modes some of which will give rise to novel approaches for inhibiting HSP90. Following due diligence DAC has decided to collaborate with Evotec with the aim of improving the potency and selectivity of the identified compounds. In the collaboration, which may run for an initial period of over 2 years, Evotec will use its medicinal chemistry, profiling and ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) expertise to generate lead molecules for further progression into clinical trials.

For its contributions to the discovery project Evotec will potentially receive single digit millions R&D service revenues and will also be eligible for additional preclinical and clinical milestone payments.

"We are delighted that DAC and Genextra, one of the most innovative and active biopharmaceutical companies in Italy, appreciated the value of the HSP90 inhibitors that we had identified using our novel approach to fragment screening and have selected us for this project. We are very excited about the potential for analogues of these compounds to be novel treatments for diseases that require inhibition of the HSP90 protein," said Dr Mark Ashton, Executive Vice President Business Development Services at Evotec. "This project represents another major milestone in our strategy to strengthen our collaborative relationships by providing our partners access to selected promising proprietary drug discovery assets discovered using our state-of-the-art platform."

"This project is an important extension of our lead discovery activities. From existing collaborations with Evotec, we remained positively impressed by Evotec’s medicinal chemistry capabilities and this, together with the results that Evotec had already generated against this disease target, convinced us to collaborate on this exciting project," commented Mr Paolo Fundarò, Chief Executive Officer of Genextra.

Contact: Anne Hennecke, Director, Investor Relations & Corporate Communications, Evotec AG, Phone: +49-40-56081-286, [email protected]

On March 22, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) reported that Evotec and Apeiron Biologics have entered into a research collaboration with the objective of developing immunomodulatory lead compounds for the treatment of cancer (Press release, Evotec, MAR 22, 2018, View Source;announcements/press-releases/p/evotec-and-apeiron-biologics-announce-collaboration-on-cancer-immunotherapy-5107 [SID1234525396]). Apeiron Biologics will contribute in vitro and in vivo pharmacology expertise to this collaboration while Evotec will be responsible for medicinal chemistry as well as chemical proteomics. The collaboration is based on the successful outcome of a phenotypic high throughput screen previously commissioned by Apeiron Biologics to Evotec.

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Dr Mario Polywka, Chief Operating Officer of Evotec, commented: ‘We look forward to continue working with Apeiron on this important project. The collaboration highlights the strength of Evotec’s phenotypic screening capabilities to identify novel mechanisms and hits in important therapeutic areas.’

Dr Hans Loibner, Chief Executive Officer of Apeiron Biologics, added: ‘We were excited about the outcome of the primary screen and look forward to refining the hit compounds in this collaboration applying our immunological know-how. There is no doubt that immunomodulatory compounds like these carry huge therapeutic and commercial potential.’

No financial details are disclosed.

ABOUT APEIRON Biologics AG
Apeiron is a mostly privately financed biotech company in Vienna that develops immunological/biological therapies against cancer. Its portfolio consists of five clinical projects (lead in phase III) as well as some preclinical approaches. The most advanced project APN311 is an antibody to treat the pediatric cancer neuroblastoma. The immunocytokine hu14.18-IL2 (APN301) is being developed clinically in neuroblastoma as well as in melanoma. Moreover, recombinant human superoxide dismutase is in clinical development, notably in a topical liposomal formulation (APN201) as a potent anti-inflammatory tissue-protective biologic. Two complementary approaches are pursued (APN401, APN411) that stimulate immune cells in a novel way to treat cancer more effectively. The recombinant human Angiotensin Converting Enzyme 2 (GSK2586881, previously APN01) was licensed out to GlaxoSmithKline in early 2010 and is currently investigated in a phase II trial in patients suffering from acute lung injury. Apeiron started operations in 2006 and has 23 employees as of today.

FORWARD LOOKING STATEMENTS – Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this report. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

On March 22, 2018 Array BioPharma Inc. (Nasdaq: ARRY) reported that detailed results of its pivotal Phase 3 COLUMBUS trial for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma were published in The Lancet Oncology (Press release, Array BioPharma, MAR 22, 2018, View Source;p=RssLanding&cat=news&id=2339334 [SID1234524945]). In the analysis of the primary endpoint, the median progression-free survival (mPFS) for patients treated with the combination of encorafenib, 450 mg daily, plus binimetinib, 45 mg twice daily (COMBO450) was 14.9 months versus 7.3 months for patients treated with vemurafenib, 960 mg twice daily [hazard ratio (HR) 0.54, 95% CI 0.41–0.71; p<0.0001].

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The manuscript entitled "Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial," was published online on March 21, 2018. Array previously announced top line results from this study in September 2016.

"A median progression-free survival of nearly 15 months with the combination of encorafenib and binimetinib is clinically meaningful for patients with advanced BRAF-mutant metastatic melanoma," said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School. "Further, a median overall survival of 33.6 months, compared to 16.9 months with vemurafenib monotherapy (HR of 0.61, 95% CI 0.47-0.79, p<0.001), a secondary endpoint not included in this publication, was recently announced. This further supplements the published data and shows that the combination of encorafenib and binimetinib may become a promising new therapy for patients with advanced BRAF-mutant metastatic melanoma."

As previously reported, the combination of encorafenib and binimetinib was generally well-tolerated. The median duration of treatment was 51.2 weeks (27.1-79.7) for encorafenib and 50.6 weeks (26.1-79.7) for binimetinib. The median dose intensity was 100% (93-100) of planned doses of encorafenib and 99.6% (80-100) of planned doses of binimetinib. The most common Grade 3/4 adverse events (AEs) seen in more than 5% of patients were increased gamma-glutamyltransferase (GGT) 9% (18/192 patients), increased creatine phosphokinase 7% (13), and hypertension 6% (11) in the encorafenib plus binimetinib group.

The U.S. Food and Drug Administration (FDA) is currently reviewing the New Drug Applications to support use of the combination of encorafenib and binimetinib for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The FDA set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2018 for both applications. In addition, the European Medicines Agency (EMA), as well as the Swiss Medicines Agency (Swissmedic) and the Australian Therapeutic Goods Administration (TGA), are reviewing the Marketing Authorization Applications for encorafenib and binimetinib.

An update from the COLUMBUS trial will be presented at an upcoming medical congress.

About Melanoma
Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates. [1, 2] There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma. [1, 3, 4]

About COLUMBUS
The COLUMBUS trial, (NCT01909453), is a two-part, international, randomized, open label Phase 3 trial evaluating the efficacy and safety of the combination of encorafenib and binimetinib compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAFV600 mutation. Prior immunotherapy treatment was allowed. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the trial. Patients were randomized into two parts:

In Part 1, 577 patients were randomized 1:1:1 to receive COMBO450, encorafenib, 300 mg daily (ENCO 300), or vemurafenib, 960 mg twice daily alone. The dose of encorafenib in the combination arm is 50% higher than the single agent maximum tolerated dose of 300 mg. A higher dose of encorafenib was possible due to improved tolerability when combined with binimetinib. The primary endpoint for the COLUMBUS trial was an mPFS comparison of the COMBO450 arm versus vemurafenib. mPFS is determined based on tumor assessment (RECIST version 1.1 criteria) by a Blinded Independent Central Review (BICR). Secondary endpoints include a comparison of the mPFS of COMBO450 arm to that of ENCO300 and a comparison of overall survival (OS) in patients treated in the COMBO450 arm to that of vemurafenib alone. Results from Part 1 of the COLUMBUS trial previously presented at the 2016 Society for Melanoma Research Annual Congress, showed that COMBO450 more than doubled mPFS in patients with advanced BRAF-mutant melanoma, with a mPFS of 14.9 months compared with 7.3 months observed with vemurafenib [HR 0.54, (95% CI 0.41-0.71, p<0.0001)]. In the secondary mPFS comparison of COMBO450 to ENCO300, ENCO300 demonstrated a mPFS of 9.6 months [HR 0.75, (95% CI 0.56-1.00, p=0.051)].
In Part 2, 344 patients were randomized 3:1 to receive encorafenib 300 mg plus binimetinib 45 mg twice daily (COMBO300) or ENCO300. Part 2 was designed to provide additional data to help evaluate the contribution of binimetinib to the combination of encorafenib and binimetinib.
As the secondary endpoint comparison of mPFS between the COMBO450 arm and ENCO300 arm in Part 1 did not achieve statistical significance, the protocol specified analysis of OS is descriptive.

About Encorafenib and Binimetinib
BRAF and MEK are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma and colorectal cancer. Encorafenib is a late-stage small molecule BRAF inhibitor and binimetinib is a late-stage small molecule MEK inhibitor, both of which target key enzymes in this pathway. Encorafenib and binimetinib are being studied in clinical trials in advanced cancer patients, including the Phase 3 BEACON CRC trial and the Phase 3 COLUMBUS trial.

Array BioPharma has exclusive rights to encorafenib and binimetinib in the U.S. and Canada. Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America. Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.