On March 22, 2018 AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, reported that after consulting with the U.S. Food and Drug Administration (FDA), it will not seek accelerated approval for Rova-T in third-line relapsed/refractory (R/R) small cell lung cancer (SCLC) based on magnitude of effect across multiple parameters in this single-arm study (Press release, AbbVie, MAR 22, 2018, View Source [SID1234525398]).

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"We continue to believe Rova-T has potential for patients with small cell lung cancer and other DLL3-expressing cancers," said Mike Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "Although the results from the study were not what we hoped for, we look forward to receiving data from the ongoing Phase 3 studies in the first- and second-line settings and remain committed to developing Rova-T for the treatment of patients with small cell lung cancer."
Summary of Investigator Assessed Best Overall Response Rate, Independent Review Committee (IRC) Assessed Objective Response Rate, Duration of Response and Overall Survival in Third-Line SCLC Patients with High DLL3 Expression (N = 177)*

*Data represent 74 percent of the TRINITY study population with high DLL3 expression
a Best overall response is defined as a subject with a response of complete response (CR) or partial response (PR) at any time prior to receiving any subsequent anticancer therapy.
b Objective response is defined as a subject with a response of complete response (CR) or partial response (PR) prior to receiving any subsequent anticancer therapy, with confirmation of CR or PR at least 4 weeks (28 days) from the initial determination per RECIST v1.1.
­­c Based on Kaplan-Meier estimate.

In the study, the most common treatment-emergent adverse events were fatigue (38 percent), photosensitivity reaction (36 percent), pleural effusion (32 percent), edema peripheral (31 percent), decreased appetite (30 percent), nausea (26 percent), dyspnea (25 percent), thrombocytopenia (25 percent), constipation (22 percent), vomiting (17 percent), anemia (17 percent), hypoalbuminemia (16 percent), and cough (16 percent). Grade three and higher severe toxicities ≥ 5 percent were thrombocytopenia (11 percent), photosensitivity reaction (7 percent) and pleural effusion (5 percent)
.
About the Phase 2 TRINITY Study
TRINITY is a multicenter, open-label, single-arm, Phase 2 study of Rova-T in DLL3-expressing small cell lung cancer (SCLC) patients with relapsed/refractory (R/R) disease after receiving at least two previous regimens, including at least one platinum-based regimen. The primary objective was to investigate the efficacy of Rova-T as third-line and later treatment for R/R DLL3-expressing SCLC. Secondary objectives included assessment of safety and tolerability, pharmacokinetics, RECIST-assessed progression-free survival, duration of response and clinical benefit rate.

About Rovalpituzumab Tesirine (Rova-T)
Rova-T is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3)[1], which is expressed in more than 80 percent of small cell lung cancer (SCLC) patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue.[2] Rova-T combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells while minimizing toxicity to healthy cells. Rova-T is under investigation as a third-line treatment in SCLC.[2] The expression of DLL3 suggests Rova-T may be useful across multiple tumor types, including metastatic melanoma, glioblastoma multiforme and some prostate, pancreatic and colorectal cancers.[2]
Rova-T is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

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 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 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."

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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