On January 18, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its fourth-quarter and full-year 2018 financial results on Wednesday, Feb. 20, 2019 (Press release, Valeant, JAN 18, 2019, View Source [SID1234532780]). Bausch Health 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 Bausch Health website prior to the start of the call.

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Conference Call Details

Date:

Wednesday, Feb. 20, 2019

Time:

8:00 a.m. EST

Webcast:

View Source

Participant Event Dial-in:

+1 (888) 317-6003 (United States)

+1 (412) 317-6061 (International)

+1 (866) 284-3684 (Canada)

Participant Passcode:

4514727

Replay Dial-in:

+1 (877) 344-7529 (North America)

+1 (412) 317-0088 (International)

+1 (855) 669-9658 (Canada)

Replay Passcode:

10127646 (replay available until Feb. 27, 2019)

On January 18, 2019 Obsidian Therapeutics, a biotechnology company developing cell therapies with pharmacologic operating systems, reported a strategic collaboration with Celgene Corporation (NASDAQ: CELG) for the discovery and development of novel, regulated cell therapies that utilize Obsidian’s Destabilizing Domain (DD) technology (Press release, Obsidian Therapeutics, JAN 18, 2019, View Source [SID1234532782]). Specifically, the collaboration is based on Obsidian’s DD technology for the controlled expression of two immunomodulatory factors, IL12 and CD40L, that have the potential to augment the power of adoptive cell therapies but require precise control to optimize their therapeutic benefit.

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This multi-year collaboration provides Celgene with the exclusive option to in-license worldwide rights for cell therapy candidates that incorporate DD-regulated IL12 or CD40L for the treatment of cancer. The collaboration includes an upfront payment and equity investment by Celgene, and potential future milestone and royalty payments.

"Obsidian’s technology has the potential to unlock the activity of cell therapy in a number of new settings, particularly against solid tumor malignancies, and this is a prime example of the new technologies that we see enabling broader applications for CAR-T and cell therapies for the treatment of cancer," said Robert Hershberg, MD, PhD, Executive Vice President, Business Development & Global Alliances for Celgene Corporation. "We value the innovation that the Obsidian team can bring and we look forward to working together to bring powerful new immunotherapies to patients."

This strategic agreement is Obsidian’s first collaboration with a major pharmaceutical company to deploy its DD technology. Obsidian’s technology enables integration and precise pharmacologic control of potent new activities in cell therapies and offers additional capabilities to Celgene’s portfolio of cellular immunotherapies for cancer.

"This collaboration focuses the Obsidian team on product development, accelerates the advance of our innovative technology toward clinical applications, and positions us to expand our own platform and portfolio," said Michael Gilman, PhD, CEO of Obsidian. "We are thrilled to be partnering with Celgene and will benefit from their capabilities in the development and commercialization of cancer medicines. We share an ambitious vision of the potential for cell therapy to benefit patients with cancer and look forward to working together with the Celgene team to realize it."

About Obsidian’s Destabilizing Domain Technology

Obsidian is developing cell therapies that incorporate Destabilizing Domains (DDs) to regulate expression of immunomodulatory factors, thereby providing precise pharmacologic control of the potent activity of these agents to optimize their safety and efficacy in engineered cell therapies. DDs are small, human protein domains that confer conditional stability to a fused payload protein that is engineered into a cell or gene therapy product. In the absence of a specific small-molecule ligand, the fusion protein is rapidly degraded, whereas in the presence of the ligand the fusion protein becomes stable and functional. Obsidian uses this approach to equip engineered cell therapies with controllable functions that can be precisely and dynamically tuned by the administration of small-molecule medicines that are currently approved, readily available, and can be dispensed by the treating physician.

On January 17, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that a poster entitled "Phase 1 Results from the Phase 1/3 FIGHT Study Evaluating Bemarituzumab and mFOLFOX6 in Advanced Gastric/GEJ Cancer" was presented today at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium in San Francisco (Press release, Five Prime Therapeutics, JAN 17, 2019, View Source [SID1234532709]). The poster (Board J1, Abstract #91) can be found online at Five Prime Therapeutics Scientific Publications.

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"Gastric cancer with FGFR2b overexpression or FGFR2 gene amplification is associated with a poor prognosis for patients with advanced disease," said Helen Collins, M.D., senior vice president and chief medical officer of Five Prime. "We completed the Phase 1 safety lead-in and saw no dose-limiting toxicities with the combination of bemarituzumab and mFOLFOX6. Additionally, we are encouraged to see evidence of clinical activity with the combination. The FIGHT Phase 3 study is currently enrolling patients worldwide with newly diagnosed advanced gastric and gastroesophageal junction cancer whose tumors overexpress FGFR2b with the goal of providing a better first-line treatment option for these patients."

The Phase 1 portion of the study achieved the primary objective of determining a recommended dose of bemarituzumab in combination with mFOLFOX6 to initiate the Phase 3 portion of the FIGHT trial. Key inclusion criteria for the Phase 1 patient population included: adults with incurable GI cancer for whom mFOLFOX6 was an appropriate therapy, an ECOG score of 0-1, and evaluable disease by RECIST v1.1. The patient population was not selected for FGFR2b status or limited to patients without prior chemotherapy treatment for advanced or metastatic disease. At the time of publication, 2 patients with gastric/esophageal cancer were confirmed to be FGFR2 positive with 1 achieving a PR and the other demonstrating a complete metabolic response.

FIGHT Trial

In December 2017, Five Prime initiated the Phase 1 portion (NCT03343301) of the Phase 1/3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) global registrational trial. The Phase 1 safety lead-in portion of the trial was designed to identify a recommended dose of bemarituzumab in combination with the modified FOLFOX6 standard-of-care chemotherapy regimen (mFOLFOX6) to support the initiation of the Phase 3 portion of the trial.

The Phase 3 portion of the FIGHT trial will evaluate bemarituzumab in combination with mFOLFOX6 versus placebo plus mFOLFOX6 in approximately 550 patients with gastric cancer (GC) or gastroesophageal junction (GEJ) cancer whose tumors overexpress FGFR2b. The Phase 3 portion of the trial began in September 2018 and will include more than 250 sites in the U.S., Europe and Asia.

The primary endpoint of the FIGHT trial is overall survival (OS) with secondary endpoints of progression-free survival (PFS), objective response rate (ORR), safety and pharmacokinetic (PK) parameters.

Previous Bemarituzumab Trial Results

Data from a Phase 1 clinical trial of single-agent bemarituzumab were presented at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting. Bemarituzumab demonstrated single-agent activity and an acceptable safety profile in heavily pretreated patients with metastatic gastric cancer whose tumors overexpress FGFR2b.

Efficacy:

In 21 treated patients with late-line GC/GEJ and high FGFR2b overexpression:
ORR was 19.0% with 4 confirmed PRs
Disease control rate at 6 weeks: 57.1%
Median duration of response was 15.4 weeks
Safety:

Bemarituzumab was well tolerated
There were no dose-limiting toxicities
Maximum tolerated dose was not reached during dose escalation
Unmet Need in GC and GEJ

GC, including GEJ cancer, is the fifth most common cancer worldwide and third leading cause of cancer death. The presence of FGFR2 gene amplification or FGFR2b overexpression is associated with a worse prognosis and is present in 10% of patients with GC/GEJ.

Current first-line chemotherapy treatments prolong survival by approximately 6 months compared to best supportive care, but median OS remains poor with literature-reported ranges of approximately 10 to 11 months and PFS from 5 to 5.6 months. An unmet medical need exists in the treatment for GC/GEJ since few treatment options following progression are available after first-line chemotherapy.

Companion Diagnostic Development for FGFR2b

Five Prime is using companion diagnostics to identify FGFR2b overexpression using an IHC test and FGFR2 gene amplification using ctDNA analysis. Five Prime will use both assays to select patients for the FIGHT trial to identify the estimated 10% of patients with gastric and GEJ tumors that would qualify for the trial.

About Bemarituzumab

Bemarituzumab is a first-in-class, isoform-selective, humanized monoclonal antibody in clinical development as a targeted immunotherapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. Bemarituzumab has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Clinical results to date suggest that the specificity of bemarituzumab avoids the dose-limiting toxicities that have been seen with less selective pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs, including FGFR2.

On January 17, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the achievement of a new development milestone in its collaboration with Eli Lilly and Company ("Lilly") (Press release, Zymeworks, JAN 17, 2019, View Source;Submission [SID1234532710]). In accordance with Zymeworks’ 2014 licensing and collaboration agreement with Lilly, Zymeworks will receive a milestone payment of US$8.0 million for Lilly’s submission of an IND application for an immuno-oncology bispecific antibody enabled by Zymeworks’ proprietary Azymetric platform.

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"We believe that Lilly’s submission of a second IND on an Azymetric bispecific drug candidate within a six-month period is further evidence that Zymeworks’ platform technologies are enabling our global pharmaceutical partners to accelerate drug development into the clinic," said Ali Tehrani, Ph.D., President and Chief Executive Officer of Zymeworks. "As one of our first collaborators, Lilly’s successes demonstrate the ease of use, productivity and promise of our proprietary platforms, especially for advancing therapeutic programs into the clinical setting."

Under its two licensing and collaboration agreements with Lilly, Zymeworks has granted Lilly worldwide licenses to research, develop, and commercialize multiple bispecific therapeutics directed towards Lilly’s targets. To date, Zymeworks has received multiple equity investments, an upfront licensing payment and multiple research and development milestone payments under these agreements. Zymeworks is also eligible to receive further development and commercial milestone payments and tiered royalties on global product sales.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. This unique technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

On January 17, 2019 Adaptive Biotechnologies, an immune driven-medicine company, reported that Palmetto GBA, a Medicare Administrative Contractor (MAC) and leader in assessing diagnostic technologies through its MolDX program, has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL) (Press release, Adaptive Biotechnologies, JAN 17, 2019, View Source [SID1234532711]). clonoSEQ is the first and only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in myeloma and ALL using DNA from a patient’s bone marrow sample. The Medicare coverage for clonoSEQ is aligned with the assay’s FDA label and with clinical practice guidelines in myeloma and ALL and includes assessing MRD at multiple time points throughout therapy to monitor treatment response and help predict patient outcomes. The article, also posted by the MAC Noridian, is effective immediately and enables national coverage of Medicare patients undergoing clonoSEQ testing.

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"Availability of sensitive, specific and standardized MRD testing is increasingly crucial to the delivery of optimal patient care in both multiple myeloma and ALL," said Nikhil Munshi, M.D., Director of Basic and Correlative Science at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. "Medicare coverage for the clonoSEQ Assay will help ensure that eligible patients across the U.S. have access to a highly advanced option for MRD assessment to support more personalized treatment decisions across their course of care."

MRD refers to the remaining number of cancer cells that are present in a patient’s body during and after treatment and may eventually lead to recurrence of the disease. Cancer treatment guidelines for myeloma and ALL call for MRD testing to assess disease burden throughout the course of care to help monitor for remission, detect relapse, determine response to treatment and predict patient outcomes. Controlled trials have shown that even the smallest amounts of residual disease significantly predict a patient’s long-term clinical outcomes.

"This is great news for patients. The establishment of favorable Medicare coverage for clonoSEQ soon after FDA authorization further demonstrates the clinical relevance of MRD assessment and underscores the benefit that this test delivers in the management of myeloma and ALL patients," said Charles Sang, senior vice president, Adaptive Diagnostics. "clonoSEQ is a highly sensitive and standardized MRD test that enables more cost-effective care by assessing the effectiveness of therapy, monitoring remission and identifying relapse in lymphoid blood cancers, serving as a critical tool to help clinicians decide if a patient should initiate, pause or discontinue a potentially costly treatment regimen."

clonoSEQ testing has been used in 25 of the 28 of the National Comprehensive Cancer Network (NCCN) centers in the U.S., and Adaptive is working diligently with community practice leaders to increase use in the community setting. As MRD assessment becomes standard practice for patient management across a range of blood cancers, it is essential that clinicians and patients have access to a highly accurate, sensitive and standardized MRD assessment tool. Having satisfied the analytical and clinical validation requirements of the FDA and met the bar for clinical utility required by Medicare, the clonoSEQ Assay addresses this need.

Adaptive continues to work closely with third-party payers to obtain coverage of clonoSEQ for eligible patients in need. With Medicare coverage in place, Adaptive is strongly positioned to expand commercialization of clonoSEQ in 2019. The company is committed to pursuing regulatory approval for additional potential indications for clonoSEQ in other blood cancers and sample types, including blood-based MRD assessment.

The clonoSEQ coverage decision can be found here.

About the clonoSEQ Assay

The Adaptive Biotechnologies clonoSEQ Assay has been granted De Novo designation by the FDA as an in vitro diagnostic (IVD) to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. It identifies and quantifies specific DNA sequences found in malignant cells, allowing clinicians to monitor patients for changes in disease burden during and after treatment. This robust assay provides sensitive and accurate measurement of residual disease that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and detect potential relapse. The clonoSEQ Assay is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers.

clonoSEQ was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk novel devices for which there is no legally marketed predicate device.

For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary