On October 11, 2018 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and 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 a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational PI3K delta inhibitor, in combination with BeiGene’s zanubrutinib, an investigational BTK inhibitor, for the treatment of patients with B-cell malignancies (Press release, MEI Pharma, OCT 11, 2018, View Source;p=irol-newsArticle&ID=2371323 [SID1234529862]).

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"We are excited to be working with BeiGene to explore the potential of ME-401 in combination with zanubrutinib," said Robert Mass, M.D., chief medical officer of MEI Pharma. "Combinatorial approaches to fighting difficult to treat cancers historically have proven to be important in the delivery of better treatments to patients, and we believe that the data observed to date for ME-401, with its unique pharmaceutical properties, and for zanubrutinib support the evaluation of the combination for the treatment of patients with various B-cell malignancies."

"Zanubrutinib is a potentially differentiated BTK inhibitor that is being globally developed in a number of B-cell malignancies both as a monotherapy and in combination. We look forward to exploring this interesting combination in patients with B-cell malignancies," commented Jane Huang, M.D., chief medical officer, hematology, at BeiGene.

Under the terms of the clinical collaboration agreement, MEI will amend its ongoing Phase 1b trial to include evaluation of ME-401 in combination with zanubrutinib in patients with B-cell malignancies.

Study costs will be shared equally by the parties, and MEI will supply ME-401 and BeiGene will supply zanubrutinib. MEI will retain full commercial rights for ME-401 and BeiGene will retain full commercial rights for zanubrutinib.

About ME-401
ME-401 is an investigational oral phosphatidylinositol 3-kinase ("PI3K") delta inhibitor; PI3K delta is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancer cells. ME-401 displays high selectivity for the PI3K delta isoform and has distinct pharmaceutical properties from other PI3K delta inhibitors. It is being clinically evaluated in patients with various B-cell malignancies. MEI is initiating a Phase 2 study to evaluate the efficacy, safety, and tolerability of ME-401as a single agent in patients with follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. The Phase 2 study is intended to support an accelerated approval marketing application with the U.S Food and Drug Administration.

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B cell malignancies.

On October 11, 2018 Incyte Corporation (Nasdaq:INCY) reported that it has scheduled its third quarter 2018 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, October 30, 2018 (Press release, Incyte, OCT 11, 2018, View Source [SID1234529863]).

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The schedule for the press release and conference call/webcast is as follows:

Q3 2018 Press Release: October 30, 2018 at 7:00 a.m. ET

Q3 2018 Conference Call: October 30, 2018 at 8:00 a.m. ET

Domestic Dial-In Number: 877-407-3042

International Dial-In Number: 201-389-0864

Conference ID Number: 13683637

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13683637.

The live webcast with slides can be accessed at www.incyte.com under For Investors, Events and Presentations and will be available for replay for 30 days.

On October 11, 2018 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release third-quarter 2018 financial results before the market opens on Thursday, October 25, 2018, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, OCT 11, 2018, View Source [SID1234529864]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 8341499.

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A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the site three hours after the live call and will be available through Thursday, November 1, 2018, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 8341499.

On October 11, 2018 Kitov Pharma (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company, reported the appointment of Gil Efron as the Company’s new Deputy Chief Executive Officer and Chief Financial Officer (Press release, Kitov Pharmaceuticals , OCT 11, 2018, View Source [SID1234530234]). Simcha Rock, who has served as Kitov’s Chief Financial Officer since 2013, will retire from that position following a transition with Mr. Efron, and will continue to serve on the Company’s Board of Directors and as a strategic advisor.

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"On behalf of the entire Board and management team at Kitov, I am immensely grateful to Simcha Rock for his dedication and valuable contributions to Kitov since its inception, including playing a key role in the growth of our business and leading our initial public offering on the NASDAQ. I am deeply appreciative that Simcha will remain with Kitov to help facilitate a smooth leadership transition, and we are pleased to continue to benefit from his expertise and strategic advice. We all wish him all the best in his retirement," stated Kitov CEO, Isaac Israel. "We are fortunate to be able to welcome Gil Efron, a highly regarded and seasoned public company executive, into the Deputy CEO and CFO position."

Gil Efron brings over 25 years of experience in public company and financial management positions. Most recently, he served as Deputy CEO and CFO of Kamada, a NASDAQ and TASE dual-listed plasma-derived protein therapeutics company. Previously, he was CFO of NASDAQ listed RRsat Global Communications LTD where he led its listing on NASDAQ; prior to that Mr. Efron served in various finance executive positions. Mr. Efron holds a BA degree in Economics and Accounting and an MA degree in Business Administration from the Hebrew University of Jerusalem, and was granted a certified public accountant’s license in Israel.

"Gil has proven his leadership and business acumen in the biotech space. He played a key role in building Kamada into a leading, profitable, international biopharmaceutical company with over $100 million in annual revenues, where he led Kamada’s IPO on NASDAQ," Isaac Israel said.

"Following the recent FDA approval of our lead drug, Consensi, Kitov is well positioned to benefit from Gil’s experience and skills in growing biotech companies from the clinical trial phase into successful commercialization networks and profitability," Isaac Israel concluded.

Gil and Simcha will work together in the coming months until the complete transition of responsibilities, which is planned by year-end.

On October 11, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported program updates for its G100 intratumoral TLR4 agonist and CMB305 cancer vaccine programs in development for the treatment of cancer (Press release, Immune Design, OCT 11, 2018, View Source [SID1234530255]).

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The company has completed a portfolio review and determined that, given advances in G100 and its broad potential, new CMB305 data, and existing capital, it should focus on accelerating and expanding the development of G100.

G100 has a unique mechanism of action that differs from current therapies in lymphoma. It triggers an immune-mediated anti-tumor effect with a favorable safety profile that could position G100 as a pillar of chemo-free regimens for the treatment of lymphomas and beyond.
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Immune Design’s first goal is to develop G100 in combination with pembrolizumab in follicular lymphoma patients who have received three prior lines of systemic therapy. These patients may represent an unmet medical need, which may allow for an accelerated approval path in this indication.

The company will evaluate the clinical activity based on Objective Response Rate (ORR) in an open label setting.

To accelerate enrollment, Immune Design plans to use both an open IND and submit a new IND for this specific unmet medical need population, as requested by the FDA.

The data from both INDs would be combined in a potential BLA filing.

Based on existing ORR data, approximately 100 patients may be required. The final sample size will be adapted depending on the ORR observed in the initial patients.
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Given its broad potential reach, Immune Design’s second goal is to evaluate G100 beyond late-stage follicular lymphoma.

Immune Design intends to evaluate G100 in earlier-stage follicular lymphoma patients in combination with rituximab, the backbone treatment for lymphomas in multiple lines of therapy.

The company also plans to explore G100 in combination with other agents in both indolent and aggressive lymphomas that are known to express TLR4.

Finally, the company plans to evaluate the safety and efficacy of G100 in solid tumors, initially through supporting investigator-sponsored studies.

Based on a recent review of the CMB305 program, including an early analysis of the ongoing Phase 2 study that showed the combination of CMB305 and Tecentriq (atezolizumab) is not likely to show a survival benefit in relapsed synovial sarcoma patients, the company has decided to discontinue the SYNOVATE trial. Immune Design will seek external collaborations to explore the continued development of CMB305 in sarcoma.

This portfolio prioritization and an associated company re-structuring extends Immune Design’s cash runway into 2021, which enables significant potential value creation from the focus on, and expanded development of, G100.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss these program updates.

The live call may be accessed by dialing (844) 266-9538 for domestic callers and (216) 562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the Immune Design website at View Source and will be archived there for 30 days. A telephone replay of the call will be available for five days by dialing (855) 859-2056 for domestic callers or (404) 537-3406 for international callers and entering the conference code 7095731.

An archived copy of the webcast will be available on Immune Design’s website beginning approximately two hours after the conference call. Immune Design will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.