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)

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.

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

On October 3, 2017 Siamab Therapeutics, Inc., a biopharmaceutical company developing novel cancer immunotherapies, reported the presentation of new preclinical data for its novel anti-Sialyl-Tn (STn) antibodies and antibody drug conjugates (ADCs) that show inhibition of tumor progression in in vivo and in vitro patient derived xenograft (PDX) ovarian cancer models with complete regression in some treatment arms (Press release, Siamab Therapeutics, OCT 3, 2017, View Source [SID1234520772]). The data were presented in a poster presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Addressing Critical Questions in Ovarian Cancer Research and Treatment Meeting, held October 1-4, 2017 in Pittsburgh, Pennsylvania. ST1, Siamab’s lead antibody program targeting STn, is in late stage preclinical development for the treatment of solid tumors.

Siamab is developing monoclonal antibody (mAb) therapeutics that target cancer cell surface glycans called tumor-associated carbohydrate antigens (TACAs), a novel class of cancer-specific antigens found on the cell surface of many solid tumors. TACAs are implicated in immune suppression, chemoresistance, and a cancer stem cell (CSC) phenotype. The elevated presence of STn, a key TACA observed in the majority of ovarian tumors, is associated with metastatic disease, poor prognosis, and reduced overall survival. Elevation of STn expression is linked to chemotherapy resistance and enables tumors to evade the host immune system. Siamab has also identified the presence of STn on myeloid-derived suppressor cells, which are major regulators of immune response in cancer and influence the tumor microenvironment by suppressing T cells. STn is a major reported constituent of two established CSC biomarkers, CD44 and MUC1, which reside on both CSCs and mature malignant cells in some cancer types.

In the poster presentation, titled Targeting the Tumor-Associated Carbohydrate Antigen STn with Humanized anti-Sialyl-Tn Monoclonal Antibody-drug Conjugates Inhibits Ovarian Cancer Tumor Growth in vitro and in vivo,” Siamab scientists and collaborators reported data demonstrating anti-tumor effect in vitro utilizing humanized anti-STn ADCs as well as inhibition of tumor progression in vivo in both cell line- and PDX ovarian cancer models with complete regressions observed in some treatment groups. In a chemo-naïve ovarian PDX model, 75% of animals given ST1 are completely tumor free at 52 days post treatment as compared to control-treated animals. In a chemoresistant ovarian PDX model, tumors regressed by more than 50% in 75% of the animals in the ST1 group as compared to control-treated animals. No significant weight loss was observed for any of the treatment groups, indicating the therapy was well tolerated by all the groups. A decrease in STn expression was noted in the tumors following treatment, indicating that Siamab’s anti-STn ADC was depleting the mAb-targeted STn+ tumor cells. In addition, researchers utilized the STn-selective antibodies to develop both tissue- and serum-based biomarker assays with the potential to become companion diagnostics.

“Our research findings show that tumor-associated carbohydrate antigens, and in particular STn, have the potential to offer a unique approach to targeting cancer cells,” said Jeff Behrens, president and chief executive officer of Siamab. “STn is not only an intriguing cancer biomarker and therapeutic target, but

manipulating STn biology offers the potential to have significant immune re-engagement and anti-metastatic therapeutic benefits. These data demonstrate that high-affinity, STn-selective humanized mAbs show promise as therapies for ovarian tumors, as well as tools for patient stratification and pharmacodynamic biomarker assessments.”

Ovarian cancer is the leading cause of death from gynecological malignancies in the United States. The current standard of care is tumor debulking followed by chemotherapy. This treatment results in approximately 70% of patients achieving an initial complete clinical response. However, many of these patients will unfortunately relapse with chemoresistant disease developing in part due to the presence of CSCs within the tumor. Ovarian CSCs have been shown to be resistant to chemo- and radiotherapy.