On December 10, 2018 Merck KGaA, Darmstadt, Germany, a leading science and technology company, which operates its healthcare business in the U.S. and Canada as EMD Serono, reported that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to M7824, the first regulatory designation for the bifunctional immunotherapy, for the treatment of biliary tract cancer (BTC) (Press release, Merck KGaA, DEC 10, 2018, View Source [SID1234531987]). The FDA orphan drug designation follows the recent presentation of the first clinical data for M7824 in BTC at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) congress in October. M7824 is an investigational bifunctional immunotherapy designed to combine co-localized blocking of the transforming growth factor-β and anti-PD-L1 immune escape mechanisms.

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BTC is a collective term for a group of rare and aggressive gastrointestinal cancers, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder carcinoma (GBC).[1] Approximately 16,000 cases of BTC are estimated to occur every year in the US and collectively these cancers present late in the majority of patients. [1],[2] Treatment options are limited and the median survival rate in the advanced setting is less than one year, objective tumor response with commonly used chemotherapy is typically less than 10% with short duration of response. [1],[3],[5]

"Biliary tract cancer is a rare, notoriously hard-to-treat tumor where existing treatment approaches, such as surgery or chemotherapy, are either not viable or simply don’t deliver acceptable patient outcomes," said Luciano Rossetti, Head of Global Research & Development at the Biopharma business of Merck KGaA, Darmstadt, Germany. "As the first regulatory designation for M7824, Merck KGaA, Darmstadt, Germany is excited about the potential of this new class of immunotherapy in a number of challenging cancers and settings."

The first clinical data for M7824 in BTC, presented at the ESMO (Free ESMO Whitepaper) congress in October, demonstrated clinical activity in Asian patients who had progressed after platinum-based first-line treatment. The ORR among the total of 30 patients was 20%, as assessed by IRC, and responses were observed across PD-L1 levels with a duration of response ranging from 8.3 months to 13.9+ months. Grade 3 or higher TRAEs were experienced by 10 patients (33.3%) and the most common Grade 3 TRAEs were rash (10%) and lipase increase (10%).

FDA Orphan Drug Designation (ODD) is granted to medicines intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US, or those that affect more than 200,000 people but are unlikely to recover the costs of developing and marketing the drug. Medicines that meet the FDA’s ODD criteria qualify for a number of incentives to help support advancement.

M7824 is an investigational bifunctional immunotherapy that combines a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein. Designed to combine co-localized blocking of the two immunosuppressive pathways, M7824 is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses. M7824 is an important part of a novel combination approach that seeks to harness the power of the immune system and address the tremendously complex nature of difficult-to-treat tumors. To-date, more than 670 patients with various types of solid tumors have been treated across the program with M7824. In addition to BTC, M7824 is being studied in solid tumor indications, including non-small cell lung, HPV associated tumors and gastrointestinal cancers, such as gastric cancer, esophageal squamous cell carcinoma and esophageal adenocarcinoma.

About M7824

M7824 is an investigational bifunctional immunotherapy that is designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein. M7824 is designed to combine co-localized blocking of the two immunosuppressive pathways – targeting both pathways aims to control tumor growth by potentially restoring and enhancing anti-tumor responses. M7824 is currently in Phase I studies for solid tumors, as well as a trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced NSCLC. The multicenter, randomized, open-label, controlled study is evaluating the safety and efficacy of M7824 versus pembrolizumab as a monotherapy treatment.

About the FDA Orphan Designation

FDA orphan drug designation is granted to drugs intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US, or those that affect more than 200,000 people, but are unlikely to recover the costs of developing and marketing the drug. Orphan drug designation by the FDA qualifies the sponsor for incentives provided for in the Orphan Drug Act, which can include protocol assistance for clinical trials, prescription drug user fee waivers, tax incentives and seven years of market exclusivity. The granting of an orphan drug designation does not alter the standard regulatory requirement to establish the safety and effectiveness of a drug through adequate and well-controlled studies to support approval. The orphan drug designation for M7824 applies only to BTC.

About Biliary Tract Cancer (BTC)

BTC is a collective term for a group of rare and aggressive gastrointestinal cancers, including intrahepatic cholangiocarcinoma (iCC), extrahepatic cholangiocarcinoma (eCC), and gallbladder carcinoma (GBC).[1] Surgery is the only curative treatment, but most patients present with advanced disease and therefore have a limited survival.[1] Approximately 140,000 cases of BTC are estimated to occur annually world-wide.[2] However, incidence of BTC varies in different parts of the world: the incidence of cholangiocarcinomas is rising in the Western world, with reports of up to 2 in 100,000[4]. By contrast, in Asian countries, the incidence is much higher.[4] GBC also has an incidence of 2 in 100,000, but is much more prevalent in parts of South America.[4]
Collectively these cancers present late in the majority of patients and long-term outcomes for resectable patients are poor with median survival in the advanced setting less than 1 year.[1],[3]

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On December 10, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its Board of Directors has named Daniel O’Day Chairman of the Board and Chief Executive Officer, effective March 1, 2019. Mr. O’Day is currently the CEO of Roche Pharmaceuticals (Press release, Gilead Sciences, DEC 10, 2018, View Source;p=irol-newsArticle&ID=2380022 [SID1234531986]). He has held the position since 2012, and prior to that led Roche Diagnostics. His career spans three decades of diverse leadership roles across North America, Asia Pacific and Europe.

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The Board has also appointed Gregg Alton as interim Chief Executive Officer for the period of January 1, 2019 until Mr. O’Day’s start date of March 1, 2019. Mr. Alton has held a number of executive positions at Gilead over the past 20 years, with experience in legal, medical affairs, policy and commercial. He previously served as general counsel and in August of this year, was appointed Chief Patient Officer.

"Following a comprehensive search, the Board became convinced that Dan is the right leader to bring Gilead into the future," said John C. Martin, PhD, Chairman, Gilead Sciences Board of Directors. "He is uniquely qualified to take on this role given his track record of success in highly scientific and competitive therapeutic areas, deep understanding of the evolving healthcare environment around the world, and unwavering commitment to driving innovation across all aspects of a business, which will serve Gilead and our stakeholders well. Additionally, Dan brings expertise and values that are aligned with our organization, and I, along with Gilead’s entire Board, am confident in his ability to work alongside our talented leadership team and deliver on our ambitious goals."

After joining Roche Pharmaceuticals in 1987, Mr. O’Day held various positions in the United States before moving to Roche headquarters in Switzerland in 1998. During his time in Switzerland, he held leadership roles in Global Marketing and Lifecycle Management. In 2001, he moved to Tokyo to become Head of Corporate Planning for Roche Pharmaceuticals in Japan and later moved to Denmark to serve as General Manager. He became President of Roche Molecular Diagnostics in California in 2006 and subsequently returned to Roche headquarters to lead the Diagnostics Division before assuming his current position. He is a member of the corporate executive committee of F. Hoffmann La Roche AG and a member of the boards of Shanghai Roche Pharmaceuticals Ltd., Roche (China) Holding, Roche Pharma Schweiz AG, Genentech, Inc., Chugai Pharmaceuticals Co., Ltd., Flatiron Health, Inc., and Foundation Medicine, Inc. Additionally, he has served as a member of the board of the European Federation of Pharmaceutical Industries and Associations. Mr. O’Day holds a Bachelor of Science in Biology from Georgetown University in Washington, D.C. and an MBA from the Columbia Business School at Columbia University in New York.

"I have long admired Gilead for its work to develop medicines that have fundamentally changed the way HIV and viral hepatitis are treated. The company has successfully grown into a global organization, providing access to people around the world, while maintaining its focus on innovative science," said Mr. O’Day. "Together with the Board, leadership team and Gilead’s 11,000 employees, I look forward to building on this in ways that I believe will – in keeping with Gilead’s mission – transform the lives of millions of individuals."

As previously announced, Dr. Martin will step down from the company’s Board of Directors, effective March 1, 2019, Mr. O’Day’s first day of employment. Also as previously announced, John F. Milligan, PhD, will step down from his role as President and Chief Executive Officer and as a member of the Board at the end of 2018.

On December 10, 2018 Enzo Biochem, Inc. (NYSE:ENZ), an integrated diagnostics and therapeutics company, reported operating results for the first fiscal quarter ended October 31, 2018, in addition to providing an update on the company’s development of lower cost products, platforms and services for the diagnostics and therapeutics markets (Press release, Enzo Biochem, DEC 10, 2018, View Source [SID1234531984]).

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Recent Developments

Optimizing diagnostic processes towards FDA clinical trials on Enzo’s proprietary and affordable open system platform capable of high throughput to meet the needs of clinical laboratories of all sizes. Enzo’s platform includes automation-compatible reagent systems and associated products for sample collection and processing to further drive costs down for diagnostic testing. Enzo’s programs also include manufacturing and assembly of all components required for each step in the diagnostic process for integration into an open platform. Focusing on molecular diagnostics, immunohistochemistry and ELISA platforms which consist of a significant percentage of the cost of goods for clinical laboratories. The Company’s programs encompass all steps from research and development to manufacturing, translation, clinical trials, to FDA approval.

To address the tightening reimbursement paradigm, Enzo is expanding its approach to centralize lab to lab reference services providing margin improvement, expanding its specialized testing menu to the Company’s clientele, developing opportunities with institutional clients, and expanding its geographical reach. To support Enzo’s strategic approach, it recently obtained a license from the State of Connecticut allowing Enzo to open a new free standing clinical laboratory in the state. The new facility expands Enzo’s geographical reach, allowing it to expand its Lab-to-Lab reference services in the Northeast. It will also enable Enzo to open additional patient service centers in collaboration with commercial insurance providers to address this large patient population need. Enzo is already designated an in-network provider for three health insurance providers in New England.

·Impact of diagnostic reimbursements pressures on clinical laboratories is now more widely evident throughout the industry, irrespective of laboratory testing volume. Enzo’s early recognition of the industry challenges has driven the development of the Company’s innovative, expanding line of cost effective, highly efficient platforms and reagents, as well as establishment of a nationally available reference laboratory incorporating these advances.

·Reported on publication in recent Journal of Lipid Research of a preclinical study by scientific collaborators involving a company-developed proprietary Sphingosine Kinase 1 inhibitor drug candidate effective in reversing resistance to the breast cancer drug tamoxifen, potentially a first line treatment for estrogen receptor-positive breast cancer patients. With more than 50% of patients who initially respond to tamoxifen ultimately failing therapy due to development of resistance, these results suggest that SK1-I may have potential in the treatment of tamoxifen-resistant breast cancers. Enzo research results, as well as those of its collaborators, show that SK1-1 may address significantly unmet medical needs in the treatment of multiple oncology indications and immune-related disorders, warranting further development anticipated in the coming year.

·Continuing to build one of the most comprehensive intellectual property estate in the industry with recently awarded patent for optimizing real time nucleic acid detection processes

·Completed purchase of previously announced additional 36,000-square foot commercial facility in Farmingdale, NY, adjacent to the Company’s current Long Island campus. A renovation underway will add needed infrastructure to produce and distribute Enzo’s expanding low cost, open architecture diagnostic platform products and broaden related services, including automation-compatible reagent systems and associated products for sample collection and processing through to analysis. This new facility will also include GMP manufacturing capabilities.

Barry Weiner, President, Comments:

"In the few weeks since we last reported on fiscal 2018 results and commented on how we viewed the inevitable consequences of PAMA reimbursement reductions, estimated by some to be at least $2 billion industry wide, we are seeing industry wide impact today. With these developments, Enzo’s strategy to provide low-cost, efficient and high capacity diagnostic solutions has become even more important and critical for an industry being challenged to maintain high quality services, while being paid less for work performed. Our investment and focus on development of cost effective products should assist in the improvement of our financial performance in the future.

"Also, we believe that it will prove to be a beneficial solution for a large number of independent and hospital labs adversely affected by lower reimbursement rates. For some time, Enzo has recognized the inevitable negative impact of both Medicare reimbursement reductions, along with more stringent policies of private payors, and the inflexible high pricing of products associated with closed end diagnostic systems. Our unique operating structure, coupled with innovative product development make Enzo uniquely positioned to provide unique laboratory solutions for our industry.

"In this environment, our strategy to build upon our deep knowledge and experience to develop an extensive line of products and services that are inexpensive, highly efficient and utilizing open ended architecture is now also a commercially available alternative as a service.

"Enzo is moving quickly to capitalize on opportunities that lie ahead. We continue to expand our comprehensive menu of tests for the market. Our commercialization efforts are well underway, which we believe will address the economic challenges we see throughout the industry and to create future value for our shareholders. The industry challenges play to our strengths as a developer and provider of unique platforms and reagents. In addition, due to our expanded Farmingdale campus, our ability to

provide clinical laboratories anywhere in the U.S. with reference diagnostic services utilizing our tools will prove highly attractive and economical, as well as rewarding, for them and for Enzo."

"In light of the significant reimbursement changes that have impacted Enzo and other clinical laboratories in this quarter, Enzo has taken a number of steps to adjust its operations to this new paradigm. These actions include tightening billing and client services practices, expanding our reference laboratory services menu of tests, and hiring sales professionals in new geographical regions. Most importantly, our vertically integrated structure allows Enzo to move quickly to position our broader lab to lab reference service. "

First Quarter Operating Results

Total revenues were $21.3 million, compared to $26.9 million in the prior year, a decrease of $5.6 million. Clinical services revenues were $14.3 million, compared to $19.5 million in the prior year, a decrease of $5.2 million, largely due to reduced insurance reimbursement payments and mix of testing, which were reimbursed at higher than average rates, in the prior year. Total diagnostic testing volume, measured by the number of accessions, decreased 5% year over year, again due to lower high-value testing, partially offset by an increase in esoteric testing, including Enzo’s AmpiProbe woman’s health panel which has increased in volume each quarter since its launch last fiscal year. Product and royalty revenue was $7.0 million compared to $7.3 million in the prior year. The decline year over year was the result of elimination of product royalties due to expiration of the agreement in April 2018.

Clinical services revenues for the three months ended October 31, 2017 have been restated to reflect adoption of new revenue recognition rules on a full retrospective basis. Under the new rules, Enzo reports uncollectible balances associated with patient responsibility as a reduction in net revenues; historically these amounts were separately classified in operating expenses as a provision for uncollectable accounts receivable, and amount to $0.6 million and $0.8 million in the three months ended October 31, 2018 and 2017, respectively.

Consolidated gross margins were 33% compared with 42.6% in the prior year. Clinical services gross margins were 23.3% compared to 38.4% a year ago. Gross margins in the current year were negatively impacted by lower reimbursement revenue from Clinical Services, as noted above. Clinical products gross margin was 53% compared to 52% in the prior year period.

Operating expenses totaled $13.0 million, up 8% compared to $12.0 million a year ago. The increase reflected legal fee expenses in anticipation of a patent infringement and contract related trial, where Enzo is plaintiff, slated to occur next calendar year. Total legal expenses were $1.3 million compared to $0.4 million in the prior year. Selling and general administrative expenses (SG&A) as well as research and development (R&D) expenses were slightly higher year over year in support of the Company’s growth strategies.

The GAAP and Non-GAAP net loss was $6.0 million compared to $0.6 million a year ago. The GAAP and non-GAAP net loss per share was $0.13, compared to $0.01 a year ago. EBITDA was a loss of $5.5 million compared to $0.1 million a year ago.

Total cash and cash equivalents at October 31, 2018 were $52.8 million compared to $60.0 million at July 31, 2018. Cash used in operations was $6.2 million during the first quarter of fiscal 2019 and cash used for investing activities, principally capital expenditures, was $1.0 million. Working capital at October 31, 2018 was over $57.3 million.

Conference Call

The Company will conduct a conference call Tuesday, December 11, 2018 at 8:30 AM ET. The call can be accessed by dialing (888) 459-5609. International callers can dial (973) 321-1024. Please reference PIN number 3927608.

Interested parties may also listen over the Internet at: View Source

To listen to the live call, individuals should go to the website at least 15 minutes early to register, download and install any necessary audio software. Any pop up blocker installed on your PC should be disabled while accessing the webcast. A rebroadcast of the call will be available starting approximately two hours after the conference call ends, through December 25, 2018. The replay of the conference call can be accessed by dialing (855)-859-2056. (International callers can dial (404) 537-3406) and, when prompted, use the same PIN number 3927608.

Adjusted Financial Measures

To comply with Regulation G promulgated pursuant to the Sarbanes-Oxley Act, Enzo Biochem attached to this news release and will post to the Company’s investor relations web site (www.enzo.com) any reconciliation of differences between GAAP and Adjusted financial information that may be required in connection with issuing the Company’s quarterly financial results.

The Company uses EBITDA as a measure of performance to demonstrate earnings exclusive of interest, taxes, depreciation and amortization. Adjustments to EBITDA are for items of a non-recurring nature and are reconciled on the table provided. The Company manages its business based on its operating cash flows. The Company, in its daily management of its business affairs and analysis of its monthly, quarterly and annual performance, makes its decisions based on cash flows, not on the amortization of assets obtained through historical activities. The Company, in managing its current and future affairs, cannot affect the amortization of the intangible assets to any material degree, and therefore uses EBITDA as its primary management guide. Since an outside investor may base its evaluation of the Company’s performance based on the Company’s net loss not its cash flows, there is a limitation to the EBITDA measurement. EBITDA is not, and should not be considered, an alternative to net loss, loss from operations, or any other measure for determining operating performance of liquidity, as determined under accounting principles generally accepted in the United States (GAAP). The most directly comparable GAAP reference in the Company’s case is the removal of interest, taxes, depreciation and amortization.

We refer you to the tables attached to this press release which includes reconciliation tables of GAAP to Adjusted net income (loss) and EBITDA to Adjusted EBITDA

On December 10, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported it will present data on its investigational anti-PD-1 antibody tislelizumab at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress, being held December 13-16 in Geneva, Switzerland (Press release, BeiGene, DEC 10, 2018, View Source;p=RssLanding&cat=news&id=2380046 [SID1234531983]).

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Mini Oral Presentation:

Title: A Phase 1A/1B trial of Tislelizumab, an Anti-PD-1 Antibody (Ab), in Patients (Pts) With Advanced Solid Tumors
Presentation #: 70O
Session: Mini Oral Session (ID37)
Location: Room A, Geneva Palexpo
Date: Saturday, December 15
Time: 08:30 CET
Presenter: Chia-Chi Lin, M.D., Ph.D., National Taiwan University Hospital
Poster Presentation:

Title: Tislelizumab, an Anti-PD-1 Antibody, in Patients With Urothelial Carcinoma (UC): Results From an Ongoing Phase 1/2 Study
Presentation #: 76P
Session: Poster display session (ID 9)
Location: Foyer, Geneva Palexpo
Date: Friday, December 14
Time: 12:30 CET
Lead Author: Shahneen Sandhu, M.D., Peter MacCallum Cancer Centre-East Melbourne, East Melbourne, Victoria, Australia
About Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Discovered by BeiGene scientists, tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. The new drug application (NDA) for tislelizumab in China for patients with R/R cHL has been accepted by the China National Medical Products Administration (NMPA, formerly known as CFDA) and granted priority review status. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumors in the United States, Europe, Japan and the rest of world outside Asia

On December 10, 2018 CBT Pharmaceuticals (CBT), Inc., a U.S. and China-based innovative pharmaceutical company, and Strata Oncology, Inc., a precision oncology company, reported that the companies have entered into an agreement to drive patient enrollment in CBT’s ongoing Phase 1/2 trial of CBT-101 in cancer patients with c-Met dysregulated malignancies including non-small cell lung cancer (Press release, CBT Pharmaceuticals, DEC 10, 2018, View Source [SID1234531982]). Under the terms of the agreement, Strata will exclusively refer Met-amplified, Met-mutation and Met-fusion advanced cancer patients identified through the Strata Trial for enrollment consideration into CBT’s clinical development program for CBT-101.

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"Partnerships with innovative pharmaceutical companies like CBT, who share our vision for biomarker-driven drug development, are essential to our mission to accelerate development of promising precision therapies for cancer patients," said Dan Rhodes, Ph.D., CEO of Strata Oncology. "This marks the eighth study in Strata’s portfolio of pharma-sponsored precision trials which are available to eligible advanced cancer patients at our partner health systems."

The Strata Trial is a genomic screening protocol providing comprehensive tumor molecular profiling to advanced cancer patients at no cost, and proactive enrollment support for a portfolio of pharma-sponsored precision therapy trials. Tumor profiling through the Strata Trial is provided as part of routine care to solid tumor patients across the Strata Precision Oncology Network, a network of 14 leading health systems representing more than 100,000 new cancer patients annually. This large network of trial-ready health systems with fully pre-screened advanced cancer populations enables rapid and predictable enrollment of precision therapy trials.

Gavin Choy, Chief Operating Officer of CBT Pharmaceuticals, stated, "One of our goals at CBT is to develop selective medicines in cancer populations driven by a particular mutation. By partnering with Strata’s extensive oncology network and genomic screening capabilities, we can accelerate the development of CBT-101 by broadening patient access to our investigational therapy and targeting the patients who may derive the most benefit."

About CBT-101

CBT-101 is a novel, small molecule drug that targets the epithelial to mesenchymal transition (EMT) pathway that is dysregulated in several tumors. It is a specific inhibitor of the c-Met receptor. CBT-101 has demonstrated tumor inhibitory effect in a variety of human primary c-Met amplified gastric, hepatic, pancreatic and lung cancer xenograft animal models with c-Met fusions, mutations or amplifications. Visit clinicaltrials.gov for additional information on the ongoing trial: NCT03175224.