On October 9, 2017 Clovis Oncology (NASDAQ: CLVS) reported that the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for rucaparib as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy (Press release, Clovis Oncology, OCT 9, 2017, View Source;p=RssLanding&cat=news&id=2305489 [SID1234520821]). The sNDA submission is based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.

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"The submission of the sNDA for rucaparib in the ovarian cancer maintenance setting just four months after we reported topline results marks an important milestone that brings Clovis closer to our ultimate goal of making rucaparib available to a broader population of women with advanced ovarian cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We believe that the ARIEL3 results demonstrate the potential of rucaparib to provide a new, much-needed therapeutic option for women with advanced ovarian cancer."

The phase 3 ARIEL3 clinical trial forms the basis of the rucaparib sNDA. ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) BRCA mutant; 2) HRD-positive; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3.

Clovis announced positive topline results from the ARIEL3 clinical trial in June 2017. The comprehensive dataset from the trial was presented at the 2017 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Conference in Madrid, Spain,i and subsequently published in The Lancet.ii

Clovis intends to file a Marketing Authorization Application (MAA) in Europe in early 2018 for the maintenance indication, upon receipt of a potential approval in Europe for the ovarian cancer treatment indication.

About the ARIEL3 Clinical Trial

The ARIEL3 pivotal study of rucaparib is a confirmatory randomized, double-blind study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance treatment to platinum-sensitive ovarian cancer patients can extend the period of time for which the disease is controlled after a complete or partial response to platinum-based chemotherapy. The study enrolled 564 patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer. To be eligible for the study, participants had to have received at least two prior platinum-based treatment regimens, been sensitive to the penultimate platinum regimen, and achieved a complete or partial response to their most recent platinum-based regimen. There were no genomic selection criteria for this study. Trial participants were randomized 2:1 to receive 600 milligrams of rucaparib twice daily (BID) or placebo.

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2016, rucaparib became the first PARP inhibitor approved by the U.S. Food and Drug Administration (FDA) as monotherapy for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more prior chemotherapies. During the fourth quarter of 2016, the Marketing Authorization Application (MAA) submission in Europe for rucaparib in the same ovarian cancer treatment indication was submitted and accepted for review. In October 2017, Clovis Oncology submitted a supplemental New Drug Application (sNDA) in the U.S. for a second line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data, and in early 2018, plans to file an MAA in Europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication. Ongoing studies include the TRITON2 and TRITON3 (Trial of Rucaparib In Prostate Indications) studies in metastatic castration-resistant prostate cancer (mCRPC), the ARIEL4 (Assessment of Rucaparib in Ovarian Cancer Trial) confirmatory study in relapsed ovarian cancer patient with BRCA mutations, and the ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled study of nivolumab and rucaparib Combination Switch Maintenance Following Front-Line Platinum-based Chemotherapy in Ovarian Cancer Patients) study is expected to begin before the end of 2017. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for rucaparib.

About Ovarian Cancer

According to the American Cancer Society, more than 22,400 women will be diagnosed with ovarian cancer in the U.S. in 2017. There are often no clearly identifiable initial symptoms, and in an estimated 80 to 85% of ovarian cancer cases, the cancer has spread to other parts of the body before a person is diagnosed and can be treated. Ovarian cancer ranks fifth in cancer deaths and causes more deaths than any other cancer of the female reproductive system.

On October 9, 2017 ARMO BioSciences, Inc., a late-stage immuno-oncology company, reported the appointment of Joseph Leveque, M.D. as Chief Medical Officer. An accomplished industry veteran, Dr. Leveque has significant experience in immuno-oncology drug development, with a focus on bringing novel therapies to patients living with cancer (Press release, ARMO BioSciences, OCT 9, 2017, View Source [SID1234520853]).

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Dr. Leveque will lead the ongoing and planned pivotal Phase 3 clinical trials of ARMO’s lead investigational immuno-oncology drug AM0010 (pegilodecakin, PEGylated Interleukin-10) as well as the plans to advance the Company’s pipeline, which includes an anti-PD-1 monoclonal antibody.

"Joe has been on the forefront of innovation in the immuno-oncology field and has successfully brought multiple drugs to patients," said Peter Van Vlasselaer, Ph.D., President and Chief Executive Officer of ARMO BioSciences. "After being involved in developing some of the most important breakthrough immuno-oncology drugs, Joe brings valuable experience to the company as we advance AM0010, which we believe may offer the next important breakthrough in this field. We are confident that Joe will help drive the full potential of this novel cancer therapy as well as our broader pipeline."

"Over the past decade, I was involved in the development and commercialization of the first generation of immuno-oncology (IO) therapeutics, including a CTLA-4 inhibitor, a PD-1 inhibitor, and a PD-L1 inhibitor," said Dr. Leveque. "I believe next-generation IO therapeutics like AM0010, used alone or in combination with other IO therapies or other novel approaches, have the promise to significantly advance the oncology field and provide renewed hope to cancer patients who have difficult-to-treat tumors."

Dr. Leveque has more than 20 years of experience in the biopharmaceutical industry leading teams in the successful development and commercialization of oncology therapeutics. Dr. Leveque was the Chief Medical Officer of EMD Serono, the North America subsidiary of Merck KGaA and the Vice President and Head of U.S. Medical Oncology at Bristol-Myers Squibb (BMS) where he was involved in the development and commercialization of the first generation of immuno-oncology (IO) therapeutics, including Bavencio, Opdivo and Yervoy. Prior to BMS, Dr. Leveque was the Vice President of Medical and Scientific Affairs at Onyx Pharmaceuticals, where he was involved in the development of Kyprolis and was recognized by the Multiple Myeloma Research Foundation as one of the top 15 innovators in multiple myeloma over the last 15 years. Earlier in his career, he served as Vice President of Medical and Scientific Affairs at Cephalon Oncology and a Medical Director at Amgen, where he worked on several therapeutic programs for solid tumor and hematological malignancies.

Dr. Leveque received a Bachelor of Arts and Sciences with an emphasis in biology from the Santa Clara University. He earned a Medical Doctorate from University of Texas School of Medicine in Houston and completed his post-graduate medical training in internal medicine at the Cedars-Sinai Medical Center, a teaching affiliate of UCLA. In addition, Dr. Leveque holds a Master in Business Administration from the Wharton School of the University of Pennsylvania.

On October 09, 2017 ImCheck Therapeutics, an emerging biopharmaceutical company developing a new generation of immunomodulatory antibodies against cancer and auto-immune diseases, reported a funding award of €930,000 from Bpifrance to contribute to the advancement of one of its novel immunotherapy program in cancer (Press release, ImCheck Therapeutics, OCT 9, 2017, View Source [SID1234522234]).

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The funding will be dedicated to conducting translational studies and launching the production of a novel therapeutic antibody active on both adaptive and innate immune cells and whose target remains confidential at this stage. These studies will be performed in partnership with several renowned international expert academic institutions and will aim at validating the clinical benefit of predictive biomarkers for future treatments as well as study the mechanism of action of the antibody in various hematological cancers (e.g. acute myeloid leukemia, lymphoma) and solid tumors (e.g. colorectal, pancreas, lung, gynecological cancers).

«We are delighted to benefit from the support of the French State as we are preparing for the entry of our antibody in its clinical development phases. ImCheck has a very ambitious development plan building on the discovery work of Daniel Olive’s team, notably on the control mechanisms of gamma-delta T-cells, an immune cell population drawing increasing attention» said Benjamin Charles, Chief Business Officer of ImCheck Therapeutics.

« Bpifrance supports several companies in the highly-innovative and highly-competitive field of immuno-oncology. ImCheck’s projects are highly-differentiated and very well-positioned. We are pleased to support them with this funding. » added Françoise Marchand, Project Innovation Officer at Bpifrance.

The Company plans to take this first antibody candidate into Phase 1 in 2019 and will apply for further additional non-dilutive funding, notably through the FUI program from Bpifrance.

«We hope to rapidly deliver this new generation of immunomodulators with the potential to overcome resistance to existing cancer immunotherapies. In parallel, we intend to develop the proper personalization tools to precisely identify & select responders to this new therapeutic agents» concluded Pierre d’Epenoux, CEO of ImCheck Therapeutics.

On October 9, 2017 Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), reported it was named Best CRO Providerat the World ADC Awards (Press release, PPD, OCT 8, 2017, View Source [SID1234520813]). This recognition acknowledges the excellence and dedication of PPD Laboratories professionals in supporting clients’ antibody-drug conjugate (ADC) research to develop new anticancer therapies.

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ADCs are complex biotherapeutic molecules, combining monoclonal antibodies with an attached payload of highly potent cytotoxic drugs. They are designed to target and destroy cancer tumor cells with high specificity and efficiency, while minimally impacting healthy cells. To date, PPD Laboratories’ experience includes more than 100 different ADC molecules.

PPD Laboratories has supported numerous ADC development programs since 2009, ranging from early development projects to preclinical good laboratory practice (GLP) and human clinical trials.

"This award is evidence that PPD Laboratories’ employees are at the leading edge of ADC research and are driven to help clients succeed in combating cancer," said Chris Fikry, M.D., executive vice president of PPD Laboratories for PPD. "In the past five years, the bioanalytical lab has completed more than 5,000 studies, providing vital pharmacokinetic, pharmacodynamic and immunogenicity data to support our clients’ efforts to develop new medicines to improve health."

PPD Laboratories’ scientists have extensive experience in bioanalytical testing utilizing diverse measurement technologies, including immunochemistry, chromatography-mass spectrometry, cell-based assays, flow cytometry and molecular genomics. PPD’s expertise includes small molecules, biologics, vaccines and biomarkers across a wide variety of therapeutic areas. In oncology, our largest therapeutic area, PPD Laboratories helped develop all of 2016’s top 20 cancer therapies.

The fourth annual World ADC Awards, which recognize distinction within ADC research, were held Sept. 21 in conjunction with the eighth annual World ADC San Diego Conference.

On October 6, 2017– Incyte Corporation (Nasdaq:INCY) and Cancer Support Community Delaware (CSCDE) reported the establishment of the Incyte Cancer Care Assistance Fund for Delaware which will provide emergency financial assistance for cancer patients, their caregivers and family members living in Delaware (Press release, Incyte, OCT 6, 2017, View Source;p=RssLanding&cat=news&id=2305148 [SID1234520802]).

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Through the Incyte Charitable Giving Foundation, Incyte has committed to providing a maximum of $100,000 each year to CSCDE over the next 5 years, beginning in 2018.

"We are very pleased to announce the creation of the Incyte Cancer Care Assistance Fund for Delaware with Cancer Support Community Delaware, an organization which, like Incyte, is dedicated to supporting patients with cancer and the local community," said Paula Swain, Executive Vice President of Human Resources and Chair of The Incyte Charitable Giving Foundation. "Today, as we celebrate the opening of our newly expanded headquarters in Wilmington, we reaffirm our commitment to Delaware and to the well-being of the communities we serve."
The fund will be administered by Cancer Support Community Delaware. Additional details about the Incyte Cancer Care Assistance Fund for Delaware will be made available in January 2018.

"Through the establishment of this fund, we aim to address the emergent needs that patients with cancer in Delaware face as they navigate their disease and its impact across all aspects of their lives," said Nicole Topkis Pickles, Executive Director of Cancer Support Community Delaware.