DAC Selects Evotec as Strategic Partner for a Drug Discovery Collaboration on the HSP90 Cancer Target

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]

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."

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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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.

ARCA biopharma Announces Fiscal Year 2017 Financial Results and Provides Corporate Update

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]).

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"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.