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RedHill Biopharma to Present at the BioNetwork 2017 Partnering Summit

On October 10, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported that Mr. Adi Frish, RedHill’s Senior VP Business Development and Licensing, will present a corporate overview at the BioNetwork 2017 Partnering Summit, on Monday, October 23, 2017, at 12:20 pm PDT , at the Ritz-Carlton Hotel, Laguna Niguel, CA (Press release, RedHill Biopharma, OCT 10, 2017, View Source [SID1234520823]).

A copy of the presentation to be made by Mr. Frish will be available on the Company’s website and may be viewed at: View Source

Genmab and Seattle Genetics to Initiate New Study of Novel Antibody-Drug Conjugate Tisotumab Vedotin in Cervical Cancer

On October 10, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (NASDAQ: SGEN) reported a decision to start a Phase II study of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer (Press release, Genmab, OCT 10, 2017, View Source [SID1234520822]). The study could provide the basis for a regulatory application for approval. Tisotumab vedotin consists of a tissue factor (TF)-targeted antibody linked to the cell-killing agent monomethyl auristatin E (MMAE). TF is a protein expressed on a broad range of solid tumors. The Phase II trial is single arm and includes about 100 patients with recurrent or metastatic cervical cancer who relapsed or progressed after standard of care treatment. The companies plan to start enrolling patients by the first half of 2018.

“We are very pleased to see the clinical development of tisotumab vedotin progress in patients with cervical cancer — an area with a strong unmet medical need. The study provides an opportunity for accelerated registration. We look forward to the continuing development of this promising first-in-class antibody-drug conjugate,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

“Standard therapies for previously treated recurrent and/or metastatic cervical cancer generally result in response rates of less than 15 percent and a median overall survival of six to eight months,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Based on promising data from the Phase I/II clinical trial of tisotumab vedotin in recurrent and/or metastatic cervical cancer and feedback from the Food and Drug Administration (FDA) on the planned trial, we and Genmab are advancing the program into a potentially registrational study for these patients with high unmet medical need.”

About the Phase II study

The single arm, multicenter Phase II study (GCT1015-04) of tisotumab vedotin monotherapy is expected to enroll about 100 patients with recurrent or metastatic cervical cancer who have experienced disease progression on or after platinum containing chemotherapy and who have received or are ineligible for bevacizumab. The primary endpoint of the study is overall response rate (ORR) as assessed by independent review of RECIST v1.1 criteria. The main secondary endpoints are duration of response (DoR) and safety.

About Cervical Cancer

Cervical cancer originates in the cells lining the cervix, which connects the uterus to the birth canal. About 13,000 women are expected to be diagnosed with cervical cancer in the US in 2017, with an estimated 4000 deaths.1 Globally, it was estimated that 527,000 people would be diagnosed and 265,000 would die from the disease in 2012, the vast majority of these patients being in the developing world.2 Routine medical examinations and the human papillomavirus (HPV) vaccine have had a positive impact on the incidence of cervical cancer in the developed world. Despite these advances, women are still diagnosed with cervical cancer, which can have a devastating impact, particularly in the recurrent or metastatic setting. Standard therapies for previously treated recurrent/metastatic cervical cancer generally result in response rates of less than 15 percent and a median overall survival of 6 to 8 months.3-10

About Tisotumab Vedotin

Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human antibody that binds to tissue factor (TF) and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE). TF is a protein involved in tumor signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF was selected as a target for an ADC approach. Tisotumab vedotin is being evaluated in ongoing Phase I/II clinical studies for solid tumors and a Phase II trial in recurrent and/or metastatic cervical cancer is planned to start by the first half of 2018. Tisotumab vedotin is being co-developed by Genmab and Seattle Genetics, under an agreement in which the companies share all future costs and profits for the product on a 50:50 basis.

IMCHECK THERAPEUTICS OBTAINS 1M€ FROM BPIFRANCE TO CONTRIBUTE TO THE DEVELOPMENT OF A NOVEL THERAPEUTIC ANTIBODY IN IMMUNO-ONCOLOGY

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.

ARMO BioSciences Appoints Immuno-Oncology Industry Veteran Joseph Leveque, M.D., as Chief Medical Officer

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]).

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.

Clovis Oncology Submits Supplemental New Drug Application for Rucaparib as Maintenance Treatment for Patients with Platinum-Sensitive Recurrent Ovarian Cancer

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.

"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.