On October 31, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary technology and products to kill tumors and increase immune system recognition of solid cancers, reported that the first patient has been dosed with a combination of INT230-6, the Company’s lead investigational product, and Keytruda (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy (Press release, Intensity Therapeutics, OCT 31, 2019, View Source [SID1234550127]). The combination is being studied in a series of cohorts within IT-01, Intensity’s ongoing Phase 1/2 international clinical study (NCT03058289).

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The first part of the combination cohort of IT-01 expects to enroll approximately six patients with different types of advanced solid tumors in order to test safety of the combination. The second part will evaluate the safety and efficacy of the combination in several Phase 2 cohorts of patients with different types of cancer, including cancers that are not immunogenic.

"Bringing INT230-6 into human testing in combination with Keytruda is a major milestone for Intensity Therapeutics," commented Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "Our preclinical and clinical data to date have already demonstrated good safety for INT230-6 as a single agent, with evidence of patient benefit and immune activation in highly refractory cancer patients. We believe the immune activation potential of INT230-6 can be increased when combined with Keytruda, and are excited to have initiated human testing of the combination."

"Our Phase 1/2 study will continue to accrue patients with multiple tumor types in the INT230-6 monotherapy portion while concurrently exploring this combination," said Ian B. Walters, MD, Chief Medical Officer of Intensity Therapeutics. "We are optimistic that our trial design enables us to quickly evaluate safety and efficacy. Tumor types of interest in the Phase 2 cohorts include pancreatic, cholangiocarcinoma, and non and microsatellite unstable colorectal cancer, which are all difficult to treat and historically nonresponsive to a PD1/PDL1 antibody alone. Physicians desperately need improved treatments for these patients and evidence of tumor response in any one of these patient populations would be validation of our approach of releasing tumor antigens derived from the patient’s own tumors to enable an immune attack on the cancer, an effect that can be amplified by blocking a checkpoint signal."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRxSM technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, releasing tumor antigens and recruitment of immune cells to the tumor. Results generated by the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-challenges of the initial cancer and resistance to other cancers. The NCI and Intensity collaborative research, published in July 2019, showed that there was also strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy.

On October 31, 2019 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T-cell therapies to treat cancers, reported a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting, November 6-10, 2019, in National Harbor, Maryland (Press release, Eureka Therapeutics, OCT 31, 2019, View Source [SID1234550143]). The presentation will highlight the company’s proprietary ARTEMIS antibody T-cell receptor (AbTCR) platform used to develop ET140202 for the treatment of hepatocellular carcinoma (HCC), the most predominant type of liver cancer. ET140202 features ARTEMIS T-cell receptors engineered with a TCR-mimic antibody to target the alpha-fetoprotein (AFP) peptide/ major histocompatibility complex (MHC) on HCC cancer cells.

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SITC Poster Presentation Details:

Title: ET140202 T-cell Therapy for the Treatment of Liver Cancer is Built upon a Novel Antibody-T cell Receptor (AbTCR) ARTEMIS T-cell Platform

Poster Presentation Date: Saturday, November 9, 2019

Poster Presentation Time: 12:35 – 2:05 pm EST and 7:00 – 8:30 pm EST

Presenter: Jun Cui, Ph.D.

Poster Number: P166

Abstract Category: Cellular Therapies

Location: Poster Hall (Prince George AB)

On October 31, 2019 The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD, ‘Breakthrough Device Designation’ for the CYTOTRON – a CE marked, whole-body therapeutic medical device (Press release, Shreis Scalene Sciences, OCT 31, 2019, View Source [SID1234550159]). "We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance (Breakthrough Devices Program), to enable the marketing submission, with the clinical datasets needed to support it," said Prof. Meena Augustus, Co-Founder CEO & CSO of Shreis. The company’s designation request stated that "The Cytotron is intended to be used to cause degeneration of uncontrolled growth of tissues. It is indicated for treating protein-linked, abnormally regenerating disorders such as neoplastic disease, by selectively targeting and enabling tissue apoptosis, allowing extended progression-free survival, with pain relief, palliation, improved quality and dignity of life. It is indicated for the treatment of solid tumors of the breast, liver, and pancreas."

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Dr. Rajah Vijay Kumar D.Sc., Inventor of the Cytotron and Shreis’ technology partner, at Scalene Cybernetics Ltd (SCL), and the Scalene Center for Advanced Research & Development (S-CARD), located in Bengaluru, India, said, "The clinical trial with this non-invasive, tissue engineering platform technology called Quantum Magnetic Resonance Therapy (QMRT) could eventually help to establish the Cytotron as an integral adjunct to existing standards of care in the cancer armamentarium."(Cytotron Publication, 2016)

"We are very encouraged by the breakthrough designation that will expedite review of an Investigational Device Exemption and future marketing application by the FDA, " said Rayol John Augustus Ph.D., Founder-President and COO of SSS-LLC. The diligent support of Dr. R.V. Kumar D.Sc., the dedicated efforts of Emergo by UL based in Austin, Texas, the Shreis’ regulatory team, the staff of SCL and S-CARD, helped ensure a favorable decision by the FDA.

Shreis, while actively pursuing collaborations for clinical trials in the current proposed indications for use, intend to also submit a request for Breakthrough designation in other solid tumors such as adult and pediatric brain tumors, lung cancer, and other life-limiting diseases.

On October 31, 2019 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, reported that the Company will report third quarter 2019 financial results and provide a business update on Thursday, November 7, 2019 (Press release, Savara, OCT 31, 2019, View Source [SID1234550182]). Savara management will host a conference call/webcast with an accompanying slide deck at 4:30 p.m. Eastern Time (ET)/1:30 p.m. Pacific Time (PT).

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Shareholders and other interested parties may access the call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and requesting the "Savara Inc." call. A live webcast of the call can be accessed on the Investors page of Savara’s website at View Source

Approximately one hour after the call, a telephone replay will be available and will remain available through November 14, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10135923. A webcast replay will be available on the Investors page of Savara’s website and will remain available for 30 days.

On October 31, 2019 Tmunity Therapeutics, in pursuit of its vision to save and improve lives by delivering the full potential of next-generation T-cell immunotherapy, reported that it closed a $75 million Series B financing (Press release, Tmunity Therapeutics, OCT 31, 2019, View Source [SID1234550201]). The financing was led by Andreessen Horowitz (also known as "a16z"), a venture capital firm that backs bold entrepreneurs building the future through technology and includes participation from a16z’s Cultural Leadership Fund. Joining the Series B financing are Westlake Village BioPartners, Gilead Sciences, The University of Pennsylvania, Be The Match BioTherapies and BrightEdge, the philanthropic impact fund of the American Cancer Society.

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The proceeds from the Series B will continue to fund ongoing and planned research, clinical development of product candidates, the continued build-out of the Company’s proprietary, vertically-integrated viral vector and cell therapy product manufacturing, working capital and other general purposes. Since inception, Tmunity has raised $231 million.

"We are fortunate to be funded by impressive investors who share our commitment to patients and our vision to dramatically change the way cancer is treated," said Usman "Oz" Azam, MD, President and Chief Executive Officer of Tmunity. "We see ourselves leading the innovation of the future of oncology treatment by uniting our foundational competences in cell therapy with expertise in building new constructs, translating them and getting them into the clinic."

As part of the Series B financing, Jorge Conde, General Partner at a16z, will join the Company’s Board of Directors. Mr. Conde leads a16z’s investments that are at the cross section of biology, computer science and engineering.

"To win the war on cancer, we need smarter weapons. Tmunity’s founders Carl June and Bruce Levine invented CAR-T, one of the most profound breakthroughs against cancer in recent history. Together with Oz Azam, who with his team, brought the first CAR-T therapy to market, the company has built a pioneering platform that has produced an unrivaled therapeutic pipeline with programs already in human clinical trials for both solid and liquid tumors. This is the dream team to deliver on the bold and promising mission to cure disease using engineered T-cells," said Conde.