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Immune Design Announces Program Updates & Portfolio Prioritization for G100 and CMB305

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.

Clinical Genomics to Attend AAFP’s Family Medicine Experience (FMX) in New Orleans to Promote InSure® ONE for Colorectal Cancer Screening Programs

On October 11, 2018 Clinical Genomics, the manufacturer of the InSure ONE fecal immunochemical test (FIT), is reported to discuss the new American Cancer Society (ACS) Colorectal Cancer Screening Guidelines with Family Medicine Physicians (Press release, Clinical Genomics, OCT 11, 2018, View Source [SID1234530236]).

In the new guidelines published in May 2018, ACS now recommends that starting at age 45 years, adults with an average risk of colorectal cancer undergo regular screening with either a high-sensitivity stool-based test or a structural (visual) examination, depending on patient preference and test availability. Six testing options are recommended, including FIT annually and colonoscopy every 10 years. According to the ACS, the reason for lowering the age range was based on the marked increase in colorectal cancer amongst younger adults. The ACS reported a 51% increase among those individuals under the age of 55 between 1994 and 2014.

InSure ONE, a convenient at-home collection FIT, intended to detect blood in stool, is easy to use, and may improve compliance for screening programs. Unlike other FITs, InSure ONE simply requires a sample of water from the toilet bowl following a single bowel movement. Sample collection is completed in minutes using a long-handled brush and does not require the user to collect, handle, or smear fecal matter.

"Clinical Genomics is dedicated to the prevention of colorectal cancer by providing a test that patients will more likely use," said Tadd S. Lazarus, M.D., Chief Medical Officer of Clinical Genomics. "The simple elegance of the InSure ONE brush method provides patients with an easy alternative to other tests that require collecting an entire bowel movement in a container or smearing fecal matter on a card." Dr. Lazarus added, "This simplicity of collection gives physicians peace of mind that their patients will comply with the new colorectal cancer ACS guidelines."

Clinical Genomics will be providing further information and samples of the easy-to-use InSure ONE FIT at booth 627 from October 10th through October 12th.

Iovance Biotherapeutics, Inc. Announces Proposed Public Offering of Common Stock

On October 11, 2018 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA) ("Iovance" or "Company"), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering (Press release, Iovance Biotherapeutics, OCT 11, 2018, View Source [SID1234530235]). All of the shares in the offering are to be sold by Iovance. Iovance intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares of common stock at the public offering price, less the underwriting discounts and commissions.

Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel, to fund its commercial manufacturing capabilities and facilities, to fund its ongoing clinical trials for its current product candidates, including its on-going Phase 2 clinical trials of LN-144, TIL for the treatment of metastatic melanoma, and LN-145, TIL for the treatment of cervical and head and neck cancers, to fund its planned clinical trials for its current product candidates, including its ongoing Phase 2 clinical trial of LN-145 for the treatment of non-small cell lung cancer, or NSCLC, in collaboration with MedImmune, and its ongoing Phase 2 clinical trials of LN-145 as an early-line therapy alone or in combination with pembrolizumab in melanoma, head and neck cancer, and NSCLC, and for other general corporate purposes. Additional indications may be explored with the use of proceeds.

Jefferies LLC is acting as sole book-running manager for the offering.

The shares of common stock described above are being offered by Iovance pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). The offering may be made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor New York, New York, 10022, by telephone at (877) 821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Kitov Appoints Gil Efron as Deputy Chief Executive Officer and Chief Financial Officer

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.

"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.

Incyte to Report Third Quarter Financial Results

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 [SID1234530094]).

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

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Q3 2018 Press Release:

October 30, 2018 at 7:00 a.m. ET
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Q3 2018 Conference Call:

October 30, 2018 at 8:00 a.m. ET
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Domestic Dial-In Number:

877-407-3042
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International Dial-In Number:

201-389-0864
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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.