On September 14, 2020 New preclinical research from The University of Texas MD Anderson Cancer Center and BridgeBio Pharma, Inc. affiliate Navire Pharma, Inc., reported that finds that the novel SHP2 inhibitor IACS-13909 is able to overcome multiple therapeutic-resistance mechanisms in non-small cell lung cancer (NSCLC), suggesting a possible new approach to treating cancers that have developed resistance to the targeted EGFR inhibitor osimertinib (Press release, MD Anderson, SEP 14, 2020, View Source [SID1234565159]).

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The data is published today in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). IACS-13909 is a potent and selective allosteric SHP2 (Src homology 2 domain-containing phosphatase) inhibitor developed through collaboration between Navire and MD Anderson’s Therapeutics Discovery division. Based on these data, Navire plans to launch a clinical study of SHP2 inhibitors by the end of 2020 at multiple US sites, including MD Anderson.

IACS-13909 was initially discovered as an SHP2 inhibitor by a team of scientists in MD Anderson’s Institute for Applied Cancer Science (IACS) and Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platforms, both engines within the Therapeutics Discovery division.

"Tyrosine kinase inhibitors, like osimertinib, appear initially effective in suppressing tumor growth, but multiple mechanisms of resistance can develop while a patient is still receiving treatment," said Nancy Kohl, Ph.D., a senior author of the study and member of Navire’s scientific advisory board. "This study shows that IACS-13909’s ability to inhibit a protein downstream of multiple signaling pathways is a promising approach in overcoming these common tumor-resistance mechanisms."

Osimertinib is a targeted EGFR inhibitor used as a front-line option for treating patients with NSCLC harboring specific EGFR mutations. However, NSLCs frequently develop osimertinib resistance over time, either through additional mutations in EGFR that block activity of the drug, or by activating compensatory signaling pathways.

SHP2 is a protein that acts downstream in these pathways, and it is required for full activation of the MAPK signaling pathways, which is known to fuel tumor growth, proliferation and survival.

"Our findings show that IACS-13909 is capable of suppressing tumor cell proliferation in vitro and causing tumor regression in vivo for lung cancers harboring a variety of activated kinases as the oncogenic driver," said lead author Yuting Sun, Ph.D., co-project lead and senior research scientist with TRACTION at MD Anderson. "These data suggest that targeting SHP2 could provide a viable strategy for overcoming osimertinib resistance occurring through a variety of mechanisms."

These results were consistent when IACS-13909 was used as a single agent and in combination with osimertinib in vivo. The combination treatment in vitro led to prolonged, more durable responses in tumors that were sensitive to osimertinib and stimulated tumor regression in osimertinib-resistant models.

"Through our collaboration with the Therapeutics Discovery team at MD Anderson, we continue to uncover SHP2’s critical role in activating multiple different pathways related to cancer’s onset and growth," said Eli Wallace, chief scientific officer of oncology at BridgeBio, Navire’s parent company. "This study further supports the very reason that Navire was founded – to develop novel SHP2 insights into targeted medicines for patients in need. We look forward to advancing our lead SHP2 inhibitor into the clinic later this year."

The ongoing research is supported by Navire through a global licensing and development agreement, and the Therapeutics Discovery division is supported in part by MD Anderson’s Moon Shots Program. MD Anderson has an institutional financial conflict of interest with Navire, and the research is managed according to MD Anderson’s Institutional Conflict of Interest Management and Monitoring Plan. A complete list of study co-authors and their disclosures can be found with the full paper here.

On September 14, 2020 University of Louisville reported that Cancer remains one of the most difficult and deadly challenges in human health, affecting Kentuckians at a higher rate than residents of any other state and killing more than 600,000 people each year in the U.S. alone (Press release, University of Louisville, SEP 14, 2020, View Source [SID1234565083]). In recent decades, therapies that engage the immune system to treat cancer have given hope to millions of cancer patients.

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Building on more than two decades of success in cancer research, the University of Louisville is poised to advance immunotherapy with a grant of $11.5 million from the National Institute of General Medical Sciences to establish the Center for Cancer Immunology and Immunotherapy (CCII). The new center will develop and improve strategies that use the immune response to fight cancer. The five-year grant also will allow UofL to establish the CCII as a National Institutes of Health-designated Center of Biomedical Research Excellence (CoBRE) to support young investigators and develop additional basic, translational and clinical research at the UofL Health – James Graham Brown Cancer Center.

"One of the university’s Grand Challenges is to advance the health of all people," said UofL President Neeli Bendapudi. "Through this center, our cancer researchers will grow the field of immunotherapy, saving the lives of many more patients with cancer in the future."

"Our mission is to harness the power of the immune system to eradicate cancer," said Jason Chesney, director of the Brown Cancer Center. "The University of Louisville, UofL Health and the Brown Cancer Center have been at the forefront of the clinical development of a new generation of immunotherapies that have been proven to increase the survival of cancer patients. This grant from the federal government leverages our existing strengths in cancer immunology and clinical trials to accelerate the development of new immunotherapies that will translate into lives saved across the globe."

Cancer survivor Jeff Habermel received two different immunotherapies at Brown Cancer Center in the course of treatment for three different cancers, including metastasized melanoma.

"I consider myself very fortunate to have the type of care that Dr. Chesney and Dr. (Donald) Miller and the whole staff provide at the Brown Cancer Center. We have a world-class facility right in our backyard," Habermel said. "I truly feel I am the luckiest man in the world to live in a time when we have such technologies and such amazing abilities to treat cancer in these ways."

The newest cancer treatments often are available at Brown Cancer Center through clinical trials before they are available anywhere else. One such treatment is CAR T-cell therapy, in which a patient’s own immune cells known as T cells are modified in the lab to more effectively attack cancer cells. UofL announced the creation of the Dunbar CAR T-Cell Program at UofL in October.

"Our leading-edge cancer program improves access for patients in our region, giving them the opportunity to benefit from life-saving immunotherapies through clinical trials," said Tom Miller, CEO of UofL Health. "Thousands of our cancer patients – our neighbors and family members – are alive today because of this early focus on drugs that activate immunity against cancer."

Researchers within the CCII will build on expertise and resources gained from previous research at UofL to develop better cancer immunotherapies. This will be achieved in part by enabling talented junior investigators who have not yet obtained major funding to advance their research and subsequently obtain major grant awards of their own.

"One of the major goals of the center is to cultivate the next generation of cancer scientists in immunology and immunotherapy," said Jun Yan, professor, director of the CCII and chief of the UofL Division of Immunotherapy. "Starting in year two, we will call for pilot projects that will bring in more researchers and investigators to work on immunotherapy and immunology."

The young researchers are provided funding, mentorship and access to sophisticated facilities to advance their research. Once CCII-supported researchers obtain their own funding they rotate out, allowing new investigators to come in to the program.

"It’s training a cohort of new investigators who will have their own large grants and expertise," said Paula Bates, professor of medicine and co-investigator for the CCII along with John Trent. "We are building a critical mass of well-funded researchers in the area."

Senior UofL faculty members Robert Mitchell, Nejat Egilmez, Haribabu Bodduluri, Huang-Ge Zhang and Bing Li will serve as mentors and core directors for the CCII. In the first year of the program, four junior researchers at UofL are conducting projects to improve the effectiveness of immune therapies.

Chuanlin Ding is investigating the impact of chemotherapy on anti-tumor immunity in breast cancer order to discover effective combination regimens that improve conventional chemotherapy.
Qingsheng Li is exploring a method to improve immune checkpoint inhibitor therapy for non-small cell lung cancer. Immune checkpoint inhibitors are a type of immunotherapy that blocks proteins (checkpoints) made by immune system cells, such as T cells. The checkpoints can prevent T cells from attacking cancer cells.
Corey Watson is studying immune cells to determine which of these cells are beneficial to lung cancer patient outcomes and how they may help kill tumor cells.
Kavitha Yaddanapuddi is studying immune checkpoint inhibitor resistance in lung cancer patients. This will help in developing therapies that reduce resistance and improve treatment.

Kavitha Yaddanapuddi, (left) and Chuanlin Ding use a mass cytometer to help improve the effectiveness of cancer immunotherapies.
This grant may be extended for two additional five-year phases. A previous CoBRE program for cancer research at UofL was extended through all three phases, lasting 15 years. That program significantly expanded the contingent of both junior and senior investigators at UofL, including Chesney, Trent and others whose research was funded by the previous program.

"This type of funding has been truly transformative for this cancer center," Trent said. "The research for the current generation of immunotherapeutic checkpoint inhibitors was done more than 18 years ago. This grant’s research will feed into the clinical work in time. These grants lay the groundwork for the next generation of therapies."

To extend the impact of the CCII still further, Kosair Charities has provided an additional $200,000 to facilitate the discovery and development of immunotherapy drugs for children with cancer. This gift bridges the CCII and the UofL Kosair Charities Pediatric Oncology Research Program, allowing the CCII to focus also on immuno-oncology for children.

"Kosair Charities is proud to be the first community partner to support the UofL Center for Cancer Immunology and Immunotherapy," said Kosair Charities President Keith Inman. "The UofL Kosair Charities Pediatric Cancer Research Program will allow this new center to include crucial pediatric cancer research as well as expand the scope to all people living with cancer – children and adults alike."

On September 14, 2020 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase-based therapies with a first-in-class collagenase-based product marketed as XIAFLEX in North America, reported that Joseph Truitt, Chief Executive Officer, will present at the virtual Oppenheimer & Co. Fall Healthcare Life Sciences and MedTech Summit on Monday, September 21, 2020 at 4:10 p.m. ET (Press release, BioSpecifics Technologies, SEP 14, 2020, View Source;Co.-Fall-Healthcare-Life-Sciences-and-MedTech-Summit/default.aspx [SID1234565101]).

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A live webcast of the presentations may be accessed by visiting the Events and Presentations section of the BioSpecifics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

On September 14, 2020 Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") reported that the Company management will present at the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (Press release, Intech Pharmaceuticals, SEP 14, 2020, View Source;medtech-summit-301130396.html [SID1234565119]).

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Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

Date: September 21 – 23, 2020

Company Presentation: Monday, September 21, 2020 at 2:30 pm (ET)

Presenter: Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma

Format: Fireside Chat and One-on-One Investor Meetings

Mr. Meckler’s fireside chat will be webcast live and will be accessible through the Events section of Intec Pharma’s website at www.intecpharma.com, where it will also be archived for a period of time.

On September 14, 2020 Grail, a spin out of genome sequencing firm Illumina,reported that it filed a preliminary prospectus for a $100 million initial public offering (IPO) last week with the U.S. Securities and Exchange Commission (SEC) (Press release, BioSpace, SEP 14, 2020, View Source [SID1234565137]). This move precedes the company’s anticipated 2021 launch of a multi-cancer liquid biopsy screening test for use in asymptomatic individuals over the age of 50.

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The IPO will be used to fund new trials for its liquid biopsy test as well as a diagnostic aid for the test. Additionally, proceeds from the IPO will be used to advance other candidates and expand sales force and lab operations.

As of May 2020, the company has raised more than $1.9 billion in capital, thanks largely to support from third-party investors. These investors include ARCH Venture Partners, Sutter Hill Ventures and even Amazon.com founder Jeff Bezos via Bezos Expeditions. Illumina holds a 14.6% stake in the company with approximately 98.3 million shares.

Grail expects to launch their liquid biopsy product Galleri as a lab-developed test next year. Galleri relies on a targeted methylation sequencing panel to identify more than 50 types of cancer across different stages of disease. Additionally, the blood-based test is designed to help clinicians identify a cancer’s tissue of origin. The company is planning for commercialization of their product, and a premarket approval application for a next-generation version of the test has been scheduled for submission in 2023.

Clinical data, published in the Annals of Oncology, supported the test’s accuracy in identifying tissue of origin and specificity in detecting cancers across all stages. The study also found that the test featured a single false positive rate of <1%.

"The promising results from this independent validation data set demonstrate the robustness of the test performance, including its ability to detect multiple cancer types, and its generalizability to broader populations due to a low false positive rate," according to a statement made by study author and investigator Minetta Liu, MD, Research Chair and Professor, Department of Oncology, Mayo Clinic. "In addition, the high accuracy in identifying the anatomic origin of the primary cancer, in conjunction with detection of a positive cancer signal in the blood, will allow providers to efficiently direct next steps for each individual’s diagnostic work-up and subsequent clinical care."

Grail noted in the SEC filing that the company has not yet generated any revenues to date. In 2019, Grail incurred a net loss of $244.9 million, encompassing research and development costs of approximately $158.9 million as well as general and administrative costs of $80.9 million.

In the IPO filing, Guardant Health, Exact Sciences, Freenome, Thrive Earlier Detection and ArcherDX were named as Grail competitors. These competitor companies have also tested liquid biopsies in trials comprising more than 100,000 participants. In an effort to set itself apart from these companies, Grail said that it doesn’t believe they "would have the financial resources to invest in population-scale clinical trials and rigorous analytics to compete with" Grail’s products.

According to a statement made by Grail about the IPO registration, the number of shares to be offered as well as the price range for the offering have not been determined. The company, based out of Menlo Park, CA, applied for Nasdaq listing under stock symbol "GRAL."