On January 3, 2023 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, reported the clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for HST-1011, the Company’s investigational small molecule allosteric inhibitor of casitas B-lineage lymphoma-B (CBL-B) (Press release, HotSpot Therapeutics, JAN 3, 2023, View Source [SID1234625763]). This represents the first IND filing for HotSpot. The Company expects to initiate the Phase 1/2 study of HST-1011 in the first quarter of 2023, with an initial focus on the evaluation of HST-1011 as monotherapy in patients with advanced solid tumors who are relapsed or refractory to anti-PD(L)1 therapy.

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"Clearance of our first IND is an important step forward for our Smart Allostery platform and our mission to produce a pipeline of differentiated product candidates for clinically meaningful, yet historically difficult-to-drug, targets," said Tim Reilly, Ph.D., Chief Development Officer of HotSpot Therapeutics. "Despite tremendous advances in the field of immuno-oncology (I-O), a significant unmet need persists for patients with tumors that either do not respond to or relapse following treatment with existing immunotherapies. With robust preclinical data supporting the potential of CBL-B inhibition to create an immunostimulatory tumor microenvironment and in turn, address the underlying factors that serve as a basis for poor response, we believe the therapeutic advancement of CBL-B inhibition represents a significant turning point for I-O."

About HST-1011
HST-1011 is an investigational orally bioavailable, selective, small molecule allosteric inhibitor of CBL-B, an E3 ubiquitin protein ligase critically involved in immune cell response. Because CBL-B functions as a master regulator of effector cell (T cell and natural killer cell) immunity, its inactivation removes its endogenous negative regulatory functions to substantially enhance anti-tumor immunity. Preclinical data has demonstrated HST-1011’s ability to bind to and inhibit a natural hotspot on CBL-B, yielding the activation and propagation of a targeted anti-tumor immune response. Enabled by HotSpot’s proprietary Smart Allostery platform, HST-1011 is designed with tight binding, low nanomolar potency, a slow dissociation rate from the target to enable sustained pharmacology, and greater selectivity for CBL-B relative to C-CBL.

On January 3, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will webcast its corporate presentation at the 41st Annual J.P. Morgan Healthcare Conference (Press release, Jazz Pharmaceuticals, JAN 3, 2023, View Source [SID1234625762]). Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update on Monday, January 9, 2023, at 3:45 p.m. PST / 11:45 p.m. GMT.

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A live audio webcast of the presentation may be accessed via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. A replay of the webcast will be available on the website for 30 days following the conference.

On January 3, 2023 Valo Health, Inc. ("Valo"), the technology company using human-centric data and artificial intelligence (AI) powered computation to transform the drug discovery and development process, reported that it will participate in the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, January 9th – 12th (Press release, Valo Health, JAN 3, 2023, View Source [SID1234625761]).

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David Berry, M.D. PhD, Valo’s CEO and founder, is scheduled to present on Tuesday, January 10, 2023 at 2:30 PM PT (5:30 PM ET) in the Golden Gate Room (31st Fl) at the Westin St. Francis in San Francisco.

Valo’s management, investor relations and business development leadership will be attending and available throughout the conference for meetings.

On January 3, 2023 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for cancer, fibrosis and inflammation, reported that the company is presenting at Biotech Showcase 2023 (Press release, Bridge Biotherapeutics, JAN 3, 2023, View Source [SID1234625760]).

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Pavel Printsev, Director of Business Development of Bridge Biotherapeutics, will provide an overview of the company as well as an introduction to its pipeline with the focus on oncology, fibrosis, and inflammatory diseases. He will also introduce the company’s strong commitment to support innovative sciences in the industry across the world.

"We are glad to be able to give an in-person corporate presentation at this year’s Biotech Showcase. In addition to the presentation, we look forward to the opportunity to discuss our progress and partnering ambitions for therapies that are addressing serious diseases with no viable treatment options," stated Pavel Printsev, Director of Business Development of Bridge Biotherapeutics.

"We are delighted that Bridge Biotherapeutics will be joining us in San Francisco and presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is a prime occasion for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of drug discovery."

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry’s largest gatherings and busiest weeks.

This year, registered Biotech Showcase attendees can view the company presentation live. Also, attendees can view recorded presentations at their convenience with 24×7 on-demand access, when scheduling does not allow viewing during the main event week. The presentation slide will be uploaded on the company’s website: www.bridgebiorx.com/en after the session.

Date & Time: Tuesday, January 10, 2023, 2:00 P.M. (Pacific Time)
Place: Hilton San Francisco Union Square; Yosemite A

On January 3, 2023 Burning Rock (NASDAQ/LSE: BNR), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, reported that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally (Press release, Burning Rock Biotech, JAN 3, 2023, View Source [SID1234625759]).

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Under the FDA’s Breakthrough Devices Program, the Breakthrough Device Designation is granted to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions such as cancer. This program is designed to provide patients and healthcare providers with timely access to medical devices granted the designation by speeding up their development, assessment, and review.

OverC MCDBT is intended for early detection of multiple cancer types (esophageal, liver, lung, ovarian, and pancreatic cancers) in adults of either sex, aged 50-75 years old, at average risk for cancer. OverC MCDBT demonstrated a 69.1% of sensitivity and 98.9% of specificity in the case-control study, THUNDER, and will be further validated in prospective interventional studies among asymptomatic population. Test results of "Detected" with the top one or two predicted tissues of origin of cancer-associated signals may indicate the presence of cancer and should be followed up by diagnostic tests suggested by qualified healthcare professionals in accordance with professional guidelines. Test results of "Undetected" do not rule out the presence of cancer, and individuals should continue with guideline-recommended standard of care screening tests.

Compared with conventional cancer screening methods, liquid biopsy has the potential to increase detection efficiency and enable early diagnosis and treatment, thus improving patients’ survival and quality of life while reducing social burden of the disease. Burning Rock started development of multi-cancer early detection technology based on DNA methylation in 2016, and the technology and validation data have been presented at ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) and other medical conferences, as well as journals such as Nature Biomedical Engineering [1], demonstrating high specificity, sensitivity, and accuracy in predicting the tissue of origin. In May 2022, Burning Rock received CE mark for its OverC MCDBT manufactured in both the US and China facilities. Today, the FDA Breakthrough Device Designation granted for OverC MCDBT would pave the way for a clearer registration path through confirmative performance validation and utility establishment.

Mr. Yusheng Han, founder and CEO of Burning Rock, said, "We are very excited that our cfDNA methylation multi-cancer early detection technology has received FDA Breakthrough Device Designation. For cancer, early diagnosis and treatment are the key to the long-term survival of patients. Liquid biopsy-based early detection technology will be an important supplement to the current cancer screening methods, especially for ovarian cancer, pancreatic cancer and other cancers that have no effective screening methods up to now. Burning Rock has also launched two prospectively collected case-control studies, PREDICT and PRESCIENT, with more than 10,000 subjects to be enrolled, to continue developing OverC MCDBT to cover more cancer types. With our promising clinical research data, we believe that over time our collective effort is going to make significant impact towards the improvement of cancer patients’ lifespan and quality of life."