On December 20, 2018 Gritstone Oncology reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to GRANITE-001 for the treatment of colorectal cancer (Press release, Gritstone Oncology, DEC 20, 2018, View Source [SID1234564162]). GRANITE-001 is a personalized immunotherapy containing patient-specific neoantigens identified by Gritstone’s proprietary EDGETM artificial intelligence platform as the most relevant neoantigens to drive a tumor-specific T-cell attack.

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"Colorectal cancer remains a major contributor to cancer deaths and has not yet proved very amenable to first generation immunotherapy," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. "We believe GRANITE-001 has the potential to be a valuable therapeutic option for these patients through its highly personalized design. The ability to leverage tumor markers, or neoantigens, specific to a patient’s own tumor cells in the development of a personalized immunotherapy is regarded as the next frontier of cancer therapy. We look forward to continuing our productive dialogue with the FDA under their Fast Track program as we seek to advance GRANITE-001 expeditiously for the potential benefit of patients."

The FDA grants Fast Track designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives Fast Track designation can benefit from early and frequent communication with the agency, in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more quickly.

Ongoing Phase 1/2 Clinical Study
GRANITE-001 in combination with immune checkpoint blockade is being evaluated in a Phase 1/2 clinical study called GO-004 for the treatment of patients with common solid tumors, including metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal cancer, and bladder cancer. The Phase 1 study includes two parts: in part A patients receive an adenovirus-based prime with escalating doses of an RNA-based boost vaccinations in combination with anti-PD-1 therapy; and in part B patients receive the prime and the boost vaccinations at the selected dose in combination with both anti-PD-1 and anti-CTLA-4 immuno-modulatory antibodies.

About GRANITE-001
GRANITE-001 is Gritstone Oncology’s lead, personalized tumor-specific immunotherapy product candidate. It is engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T-cells) against mutation-derived tumor-specific neoantigens, or TSNA, identified for each patient through the company’s proprietary EDGE artificial intelligence platform. GRANITE-001 consists of two components, first a priming adenoviral vector followed by monthly boosting with an RNA vector, each containing the same 20 patient-specific TSNA.

On December 20, 2018 Kleo Pharmaceuticals Inc., a unique immuno-oncology company developing next-generation bispecific compounds designed to emulate or enhance the activity of biologics, reported that its Chief Executive Officer, Douglas J. Manion M.D. FRCP(C), will present at Biotech Showcase 2019 to be held January 6-9, 2019, at the Hilton San Francisco Union Square (Press release, Kleo Pharmaceuticals, DEC 20, 2018, View Source [SID1234532185]).

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Dr. Manion will present an overview of Kleo’s development strategy for its pipeline of small molecule and synthetic peptide compounds that function similar to highly complex biologics, while offering multiple potential advantages. The overview will also outline Kleo’s key value drivers including the three proprietary technology platforms that drive in-house drug development and partnership opportunities, the multiple in-house and collaborative channels through which it is building its immuno-oncology pipeline, and its discovery collaboration with PeptiDream.

Kleo is well-funded to achieve multiple preclinical and early clinical milestones following the November 2018 closing of an oversubscribed $21 million Series B financing to advance its first clinical candidates through IND-enabling studies and into the clinic in 2020.

Details of Kleo’s presentation are as follows:

Event:

Biotech Showcase 2019
Date: Monday, January 7, 2019
Time: 10:45 a.m. (Pacific Time)
Location:Franciscan B Ballroom; Hilton San Francisco Union Square

On December 20, 2018 SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that Saqib Islam, Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 7, 2019, at 10:30 a.m. Pacific Standard Time (Press release, SpringWorks Therapeutics, DEC 20, 2018, View Source [SID1234532200]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On December 20, 2018 Rakuten Aspyrian, a biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy platform, reported that it has raised an additional $134 million in a second tranche of its Series C financing, bringing the total amount raised to $284 million (Press release, Rakuten Aspyrian, DEC 20, 2018, View Source [SID1234532217]). New investors include the SBI Group, Japan and Rakuten Inc. Rakuten Aspyrian has raised approximately $372 million in equity since it was founded in 2015.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"My unwavering confidence in the vision and potential of Rakuten Aspyrian’s Photoimmunotherapy platform has grown tremendously and was the impetus behind my further financial investment in the company," said Mickey Mikitani, CEO of Rakuten Aspyrian. "Our entire organization is committed to developing treatments for cancer patients and we will continue pressing forward with our corporate mission of conquering cancer."

"We are excited to support Rakuten Aspyrian, and strongly believe in the potential of its Photoimmunotherapy platform, which the company is studying in clinical trials for the selective destruction of cancer cells with minimal effects on normal cells developed by Dr. Hisataka Kobayashi of the Center for Cancer Research at the National Institutes of Health," said Mr. Yoshitaka Kitao, representative director, president & CEO of SBI Holdings.

The Series C financing supports the advancement of Rakuten Aspyrian’s proprietary investigational compound, ASP-1929 Photoimmunotherapy, currently in Phase 3 development for the treatment of patients with recurrent local regional head and neck squamous cell carcinomas (HNSCC), and new proof-of-concept Phase 1/2 studies in additional solid tumors to be initiated in early 2019. The financing will also support manufacturing processes to support the initial launch and commercialization of ASP-1929 if approved in the United States, Japan and Europe. The company also announced that it has established its corporate headquarters in San Mateo, California, where it will expand clinical, commercial and corporate functions.

"With this financing, we have expanded our team and footprint: We have established our corporate headquarters in San Mateo, California, where we will execute on our goal of building a full-fledged pharmaceutical company, and will continue advancing a number of our photoimmunotherapy programs in various cancer types," said Takashi Toraishi, Ph.D., President and Chief Operating Officer of Rakuten Aspyrian. "In addition, proceeds from this financing will support continued development of our lead program, ASP-1929, which we recently announced has entered into a global, pivotal Phase 3 clinical trial for head and neck cancer. We thank our generous investors for their belief and support of Rakuten Aspyrian as we continue executing on our mission."

About ASP-1929 Photoimmunotherapy
ASP-1929, a conjugate of cetuximab and IRDye 700DX, targets epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck squamous cell carcinomas, esophagus, lung, colon, pancreas and other cancers. This first-in-class therapy targets cancer cells, after which the compound is locally activated with red light using a proprietary investigational laser and fiber optics. The local activation of the tumor-selective conjugate targets the tumor but not surrounding normal tissues and structures. ASP-1929 received Fast Track designation by the U. S. Food and Drug Administration for the treatment of HNSCC.

Interim results of a Phase 1/2 trial in patients with HNSCC showed a clinically meaningful improvement in the objective response rate, and potential improvements in progression free survival and overall survival when compared to historical data for the standard of care treatments currently available to this patient population. Top line results of the ASP-1929 Phase 1/2 trial are expected in the first quarter of 2019.

ASP-1929 is an investigational compound that is not approved for any use in any country.

On December 20, 2018 Myovant Sciences (NYSE: MYOV), a leading clinical-stage biopharmaceutical company focused on women’s health and endocrine diseases, reported that Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences, will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, Myovant Sciences, DEC 20, 2018, http://investors.myovant.com/news-releases/2018/12-20-2018-133012290 [SID1234532186]). The presentation will begin at 9:00 a.m. PT on Tuesday, January 8, 2019 at the Westin St. Francis, followed by a Q&A session at 9:30 a.m. PT.

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The company’s presentation will be webcast live and will be accessible from the Events page under the Investors and Media section of the Myovant website at www.myovant.com. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 30 days following the conference.