Kite, a Gilead Company, And Sangamo Therapeutics Announce Collaboration To Develop Next-Generation Engineered Cell Therapies For The Treatment Of Cancer

On February 22, 2018 Kite, a Gilead Company (Nasdaq: GILD) and Sangamo Therapeutics, Inc. (Nasdaq: SGMO) reported the companies have entered into a worldwide collaboration using Sangamo’s zinc finger nuclease (ZFN) technology platform for the development of next-generation ex vivo cell therapies in oncology (Press release, Sangamo Therapeutics, FEB 22, 2018, View Source [SID1234524155]).

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Kite will use Sangamo’s ZFN technology to modify genes to develop next-generation cell therapies for autologous and allogeneic use in treating different cancers. Allogeneic cell therapies from healthy donor cells or from renewable stem cells would provide a potential treatment option that can be accessed directly within the oncology infusion center, thus reducing the time to infusion for patients.

Under the terms of the agreement, Sangamo will receive an upfront payment of $150 million and is eligible to receive up to $3.01 billion in potential payments, aggregated across 10 or more products utilizing Sangamo’s technology, based on the achievement of certain research, development, regulatory and successful commercialization milestones. Sangamo would also receive tiered royalties on sales of potential future products resulting from the collaboration. Kite will be responsible for all development, manufacturing and commercialization of products under the collaboration, and will be responsible for agreed upon expenses incurred by Sangamo.

"This collaboration between Kite and Sangamo brings together two leading platforms to develop best-in-class cell therapies in oncology," said Sandy Macrae, President and Chief Executive Officer of Sangamo. "We are excited by Kite’s commitment to driving innovation in this field and look forward to working together to realize the full promise of cell therapy in treating cancer."

"The emergence of gene editing as a tool to edit immune cells holds promise in the development of therapies with potentially improved safety, efficacy and efficiency," said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. "We believe Sangamo’s zinc finger nucleases provide the optimal gene editing platform, and we look forward to working with Sangamo to accelerate our efforts to develop next-generation autologous cell therapies, as well as allogeneic treatments that can be accessed more conveniently in the hospital setting for people living with cancer."

This transaction is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions. A Current Report on Form 8-K describing the proposed transaction in more detail will be filed by Sangamo, and this press release is subject to further detail provided in Sangamo’s 8-K.

Sangamo Conference Call
Sangamo will host a conference call today, February 22, 2018 at 8:00 a.m. ET, which will be open to the public, to discuss the details of the collaboration and the Company’s fourth quarter and full year 2017 business and financial results. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A replay of the webcast will also be available for one week after the call.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 4392918. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 4392918.

Quest Diagnostics To Speak At The Raymond James 39th Annual Institutional Investors Conference

On February 22, 2018 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, announced that it is scheduled to speak at the Raymond James 39th Annual Institutional Investors Conference in Orlando. Mark Guinan, Executive Vice President and CFO will discuss the company’s vision, goals and two-point strategy to accelerate growth and drive operational excellence (Press release, Quest Diagnostics, FEB 22, 2018, View Source [SID1234524651]). The presentation is scheduled for Tuesday, March 6, 2018 at 1:05 p.m. Eastern Time.

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Quest Diagnostics Incorporated logo. (PRNewsFoto/Quest Diagnostics Incorporated)

The presentation will be webcast live during the conference and will be available to registered investors on the following site: View Source and to the public on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within one hour after the conclusion of the live event and will remain available until March 13, 2018.

Loxo Oncology Fourth Quarter and Year End 2017 Conference Call

On February 22, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, will announce financial results for the fourth quarter and full year ended December 31, 2017 on March 1, 2018 before the Nasdaq market open. At 8:00 a.m. ET that day, Loxo Oncology management will host a conference call to discuss these financial results, in addition to recent updates on development and corporate activities (Press release, Loxo Oncology, FEB 22, 2018, View Source [SID1234524241]).

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To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 7395447. A replay will be available shortly after the conclusion of the call and archived on the company’s website for 30 days following the call.

Moleculin Announces Conference Call to Discuss Recent Discovery of New Molecule and Business Update on Wednesday, February 28, 2018

On February 22, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported it will host a conference call to discuss the recent discovery of a new molecule for cancer treatment and provide a business update (Press release, Moleculin, FEB 22, 2018, View Source [SID1234524141]). The call will be at 4:30 p.m. ET on Wednesday, February 28, 2018.

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Participants can dial (800) 860-2442 or (412) 858-4600 to access the conference call, or can listen via a live Internet web cast, which is available in the Investor Relations section of the Company’s website at www.moleculin.com. A replay of the call will be available by visiting www.moleculin.com for the 90 days after the call or by calling (877) 344-7529 or (412) 317-0088, confirmation code 10117548, through March 7, 2018.

Daiichi Sankyo Initiates Phase 1 Study of DS-1062 in Patients with Advanced Non-Small Cell Lung Cancer

On February 22, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported the first patient has been dosed in a phase 1 study assessing the safety and tolerability of DS-1062, an investigational TROP2-targeting antibody drug conjugate (ADC), in patients with unresectable advanced non-small cell lung cancer (NSCLC) who are refractory to or have relapsed following standard treatment or for whom no standard treatment is available (Press release, Daiichi Sankyo, FEB 22, 2018, View Source [SID1234524126]).

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With the discovery of driver genes and introduction of targeted therapies, there has been improvement in patient outcomes for certain types of NSCLC. However, for patients with unresectable advanced NSCLC, there is still a need for new therapeutic strategies as the five-year survival rates for patients with advanced stages of NSCLC are low.1

DS-1062 is designed to target and deliver chemotherapy inside cancer cells expressing trophoblast cell-surface antigen 2 (TROP2), which is overexpressed in many cancers including NSCLC.2 Overexpression of TROP2 is a driver in cancer growth and has been associated with decreased patient survival, increased tumor aggressiveness, metastasis, and drug resistance in several tumor types.3

"We are initially focusing on evaluating DS-1062 in patients with advanced NSCLC with potential expansion into other tumor types depending on the results of this early critical test in a study designed to provide evidence supporting unique properties of this particular TROP2 ADC construct," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "With the initiation of this study of DS-1062, we move our third ADC into the clinic and continue to investigate the potential of the smart delivery of chemotherapy in various cancers including lung, breast and gastric cancer."

About the Study
The phase 1, open-label study will investigate the safety and tolerability of DS-1062 in patients with unresectable advanced NSCLC who are refractory to or have relapsed following standard treatment or for whom no standard treatment is available. The first part of the study (dose escalation) will assess the safety and tolerability of increasing doses of DS-1062 to determine the maximum tolerated dose and recommended dose for expansion. The second part of the study (dose expansion) will evaluate the safety and tolerability of DS-1062 at the recommended dose for expansion. Study endpoints include safety, pharmacokinetics, objective response rate, duration of response, disease control rate, time to response, progression-free survival, overall survival, biomarker analysis and immunogenicity. This portion of the study is expected to enroll approximately 40 patients with unresectable advanced NSCLC in the United States and Japan.

Following the outcome of both the dose escalation and dose expansion parts of the study in patients with unresectable advanced NSCLC, there may be two additional expansion cohorts opened for other solid tumors where high expression of TROP2 is frequently observed. For more information about the study, please visit ClinicalTrials.gov.

About DS-1062
Part of the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise, DS-1062 is an investigational TROP2-targeting ADC. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, DS-1062 is a smart chemotherapy comprised of a humanized anti-TROP2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered. DS-1062 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: DS-8201, an antibody drug conjugate (ADC) for HER2-expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/

refractory acute myeloid leukemia (AML) with FLT3-ITD mutations; and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.