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Nimbus Therapeutics and Celgene Enter Long-Term Strategic Immunology Alliance to Develop Programs for Patients with Autoimmune Disorders

On October 3, 2017 Nimbus Therapeutics, a biotechnology company applying deep computational expertise throughout drug discovery and development, reported the initiation of a long-term strategic alliance with Celgene Corporation (NASDAQ: CELG) in immunology (Press release, Nimbus Therapeutics, OCT 3, 2017, View Source [SID1234527305]).

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Under the terms of the agreement, Celgene will receive an option to acquire each program in the alliance up through a clinical inflection point. Nimbus will receive an upfront payment and potential downstream milestone payments for each program Celgene chooses to acquire. Nimbus will retain full control of research and development activities for each program prior to the program’s option point. Financial terms will remain undisclosed until Celgene acquires a program.

The Nimbus programs covered under the alliance include a preclinical effort targeting Tyk2 (tyrosine kinase 2), a signal-transduction kinase for key pro-inflammatory cytokine receptors, including IL-23, IL-12 and type-I interferons. Because of its central role in the inflammatory response, Tyk2 is a high-potential target for the treatment of autoimmune disorders including rheumatoid arthritis, lupus, Crohn’s disease, psoriasis and multiple sclerosis. The alliance also covers Nimbus’ preclinical small-molecule STING (stimulator of interferon genes) antagonist program, which seeks to block the role played by STING in the activation of the innate immune system in lupus and other interferonopathies. Nimbus will continue to own and develop its small-molecule STING agonist program for immuno-oncology, which is not part of the agreement.

"Celgene is committed to the continued growth of our expanding immunology and inflammation pipeline, and believes that the Nimbus immunology programs, including their efforts on Tyk2 and STING antagonists, represent important additions as we work to create the next generation of drug candidates for patients with autoimmune disorders," said Rupert Vessey, F.R.C.P., D.Phil., Executive Vice President and President, Global Research and Early Development, of Celgene.

Robert Plenge, M.D., Ph.D., Vice President, Research and Early Development, and Head, Inflammation and Immunology Thematic Center of Excellence, of Celgene, added, "We are excited about the potential of the Nimbus immunology targets, which are based on compelling human genetic data. Moreover, Nimbus’ robust in silico-based approach is very promising."

"We are thrilled to partner with Celgene and its world-renowned inflammation and immunology team to fuel the rapid advancement of these important potential therapeutic programs for patients," said Donald Nicholson, Ph.D., Chief Executive Officer of Nimbus. "In addition, our agreement with Celgene accelerates our growth as a company back into the clinic, while also expanding the breadth of our pipeline."

Valeant Will Release Third-Quarter 2017 Financial Results On November 7

On October 03, 2017 Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) (“Valeant”) reported that it will release its third-quarter 2017 financial results on Tuesday, Nov. 7, 2017 (Press release, Valeant, OCT 3, 2017, http://ir.valeant.com/news-releases/2017/10-03-2017-120126880 [SID1234520901]). Valeant will host a conference call and live web cast at 8:00 a.m. EST to discuss the results and provide a business update. All materials will be made available on the investor relations section of the Valeant web site prior to the start of the call.
Conference Call Details
Date:
Tuesday, Nov. 7, 2017
Time:
8:00 a.m. EST
Webcast:
http://ir.valeant.com/events-and-presentations
Participant Event Dial-in:
(844) 428-3520 (North America)

(409) 767-8386 (International)
Participant Passcode:
91700211
Replay Dial-in:
(855) 859-2056 (North America)

(404) 537-3406 (International)
Replay Passcode:
91700211 (replay available until Jan. 7, 2018)

Strata Oncology, Inc. Announces Partnership with UCSF to Launch Stratify Prostate™ Initiative to Expand Access to Precision Medicine Clinical Trials for 10,000 Men with Metastatic Prostate Cancer

On October 3, 2017 Strata Oncology, Inc. (Strata), a precision oncology company, reported a collaboration with the University of California San Francisco (UCSF) to launch Stratify Prostate a unique initiative focused on expanding access to tumor sequencing nationwide for men with advanced prostate cancer and to dramatically accelerate enrollment into relevant targeted therapy trials (Press release, Strata Oncology, OCT 3, 2017, View Source [SID1234520844]).

With the launch of this new initiative, eligible metastatic prostate cancer patients anywhere in the United States can now receive no-cost NGS testing via enrollment in the Strata Trial, an observational study sponsored by Strata, to study the impact of sequencing on clinical trial enrollment. The larger Strata Trial is available to advanced cancer patients with solid tumors and lymphomas, including prostate cancer. The Strata Trial was launched in February of 2017 at select clinical research sites, providing no-cost tumor sequencing to help identify trial candidates for targeted therapies. Stratify Prostate allows physicians who are not affiliated with these investigative centers to offer their eligible patients with advanced prostate cancer access to tumor sequencing.

As part of the collaboration, UCSF physicians and researchers will play a leading role in driving success of Stratify Prostate, and will use insights gained from the initiative to catalyze new advances in prostate cancer.

“We are pleased to launch the Stratify Prostate initiative in collaboration with Strata Oncology. This is a terrific example of how UCSF clinicians and researchers provide patients with the most up to date information and treatment options,” said Eric Small, MD, deputy director of UCSF’s Helen Diller Family Comprehensive Cancer Center.

The StrataNGS Test is a 90-gene targeted assay focused on actionable genetic alterations, sequences DNA and RNA on limited archival or fresh biopsy material, and has a turnaround time of less than 10 business days. Testing is performed in Strata’s high-throughput CLIA-certified lab in Ann Arbor, MI.

“We are excited to partner with UCSF to deliver on the promise of precision medicine for men with advanced prostate cancer. Our shared goal is to provide advanced patients the opportunity to be tested without the worry of cost or location. With innovations like Stratify Prostate and the larger Strata Trial, our aim is to establish highly efficient ways for physicians and their patients to get actionable genetic information and real-time connections to targeted therapies,” said Dan Rhodes, Ph.D., CEO of Strata.

The first clinical trials targeted in Stratify Prostate are TRITON2 and TRITON3, evaluating Clovis Oncology’s PARP inhibitor rucaparib in metastatic castration-resistant prostate cancer. Rucaparib was given accelerated approval by the FDA in late 2016 for the treatment of patients with deleterious BRCA mutation associated advanced ovarian cancer. Additional trials for prostate cancer targeted therapy will be evaluated for inclusion in Stratify Prostate.

Stratify Prostate is open to physicians and patients nationwide. Interested participants should visit www.stratifyprostate.com to learn more.

Celyad reports a first complete response in a relapsed refractory AML patient in the THINK trial. First ever morphologic complete response (MLFS1) with gene-engineered T cells without prior pre-conditioning chemotherapy for a patient with relapsed refractory acute myeloid leukemia (AML).

On October 3, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a pioneer in the discovery and development of CAR-T cell therapies, reported exciting early clinical results of the first dose-level in the hematological arm of its THINK trial (THerapeutic Immunotherapy with CAR-T NKG2D) (Press release, Celyad, OCT 3, 2017, View Source [SID1234520787]).

Christian Homsy, CEO of Celyad comments: “We are pleased to have demonstrated the first objective clinical response of CYAD-01 (a.k.a. CAR-T NKG2D) as this is the very first time a relapsed, refractory AML patient has reached a MLFS with gene-engineered T cells without pre-conditioning lymphodepletion nor additional other concurrent treatment to CYAD-01 administration. This success further reinforces our confidence in our approach and the validity of NKG2D ligands as a target. We will now use the collected data to move forward with the next stage of our product development: reinforcing responses in as many clinical settings as possible.”

At the first dose-level 3×108 CYAD-01 T cells were administered without any prior conditioning chemotherapy to a cohort of three patients with hematologic cancer (two with AML and one with Multiple Myeloma, MM). One AML patient has achieved a MLFS after administration with CYAD-01 at the H. Lee Moffitt Cancer Center and Research Institute (Florida, USA).

Dr. David Sallman, Assistant Member in the Malignant Hematology Department of Moffitt Cancer Center, comments “The results announced today regarding CYAD-01 provide the first clinical validity of CYAD-01 as a tumor-specific antigen-receptor and AML as a disease sensitive to gene-engineered cell therapies. As antigen targeting offers significant challenges in AML, this outcome brings hope for the further use of gene-engineered T cells for patients with AML that have run out of therapeutic options. It’s all the more striking that this outcome was observed without any prior lymphodepletion highlighting the potential of using a physiologic antigen-receptor.”
AML is a blood cancer characterized by a rapid increase of abnormal white blood cells in the bone marrow, which in turn affects the production of normal blood cells. More than

• 1 MLFS for Morphological Leukemia-Free Status

www.celyad.com | 1
LOGO Press Release
3 October 2017
07:00 am CEST

Regulated Information
Inside Information

20,000 people in the US and almost as many people in Europe are diagnosed every year with this type of blood cancer. As AML’s incidence increases with age and as population ages, it is expected that a growing number of people might be affected by this type of cancer.

Dr. Frédéric Lehmann, Vice President Clinical Development and Medical Affairs at Celyad adds: “With this first objective and ongoing response, obtained without additional treatments such as lymphodepletion, CYAD-01 confirms the potential to treat relapsed refractory AML, one of the deadliest cancers with a median overall survival of less than 4 months. The concept of CAR-T cells with the NKG2D receptor is now progressing to further validation.”
The THINK trial, conducted in the US and in Europe, includes two stages: a dose escalation and an extension stage. The dose escalation is being conducted in parallel in solid cancers (colorectal, pancreatic, ovarian, triple negative breast and bladder) and in hematologic (AML and MM) cancer groups, while the extension phase will evaluate in parallel each tumor type independently. The dose escalation design includes three dose levels adjusted to body weight: up to 3×108, 1×109 and 3×109 CYAD-01. At each dose, the patients receive three successive administrations, two weeks apart, of CYAD-01 at the specified dose. To date, 14 patients have been dosed in the THINK trial. One Grade Three and one Grade Four event have been observed, both resolved within 72 hours. No dose limiting toxicities (DLT) nor deaths related to the investigational product have been reported.
Celyad’s management will host a conference call at 2pm CEST/8am EDT on Friday October 6, 2017

Conference Call Details

A conference call will be held on Friday October 6, 2017 at 2:00pm (CEST) / 8:00am (EDT) to provide an update on Celyad’s clinical strategy. Christian Homsy, Chief Executive Officer, and Patrick Jeanmart, Chief Financial Officer, will deliver a brief presentation followed by a Q&A session.

Participants are asked to call the assigned numbers approximately five minutes before the conference call begins.
The call can be accessed by dialling the numbers below and using the passcode: 95148855

International: +44 (0) 2071 928338
Belgium: 02 793 3847
France: 0170700781
UK: 0800 2796619
US: 1 877 8709135

Vium Awards Grant to OncoSynergy to Further Preclinical Research in Ovarian Cancer Model

On October 3, 2017 Vium reported the selection of OncoSynergy, a UCSF oncology therapeutics spinout, as the first recipient of its "Next Generation Disease Model Grant" of $100,000 worth of research services (Press release, OncoSynergy, OCT 3, 2017, View Source [SID1234520773]). The companies will collaborate on a study of OncoSynergy’s lead drug candidate OS2966 to facilitate development of an optimized and clinically relevant experimental model of malignant ascites (MA), a complication of metastatic ovarian cancer (OC) associated with poor prognosis. The study will be the first to collect in-depth quality of life (QOL) metrics using an established experimental model of MA.

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OncoSynergy has already demonstrated efficacy of OS2966, its lead monoclonal antibody therapeutic candidate designated as an Orphan Drug by the U.S. Food and Drug Administration (FDA), in multiple models of OC, including alleviation of clinical signs of MA. The new study will therefore use Vium’s Smart Housing to increase the therapeutic window to more closely model disease progression in humans, thereby yielding more accurate measurement of disease metrics and improved tracking of QOL measures.

"We are pleased to collaborate with OncoSynergy and to fund this innovative study in a disease area with high unmet research and treatment needs," said Vium Chief Scientific Officer David Hutto, Ph.D, DVM, DACVP. "It’s a great match for Vium, as it allows us to apply our fully automated, low-touch technology and novel digital metrics to continuously assess changes in ovarian cancer-related malignant ascites — signs that would be difficult to evaluate using traditional methods."

"We believe the ability to continuously collect multimodal data noninvasively will be a game-changer for oncology studies, in which the current standard for decades has been binary," commented W. Shawn Carbonell, MD, Ph.D, co-founder and CEO of OncoSynergy. "We are excited to work with Vium to develop this novel and more humane approach to studying animal models of orphan malignancies such as ovarian cancer and glioblastoma, as these diseases are our main focus."