On February 7, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported dosing of the first 2 patients in its IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab Combination Phase 1b/2a Clinical Trial in patients with advanced solid tumors (Press release, Immix Biopharma, FEB 7, 2023, View Source [SID1234626918]). Initial clinical data from this combination trial is anticipated to be released on a rolling basis beginning in 1H 2023. IMX-110 + Beigene/Novartis anti-PD-1 tislelizumab combination treatment is designed to enhance response to solid tumors by turning immunologically "cold" tumors "hot". In ImmixBio prior IMX-110 + anti-PD-1 preclinical experiments, a 50% improvement (63-day median survival) was produced by IMX-110 + anti-PD-1 in a genetic (KPC) pancreatic cancer mouse model in which mice develop their own pancreatic cancer and have an intact immune system, compared to a 4-drug combination of 2 chemotherapies and 2 immunotherapies (anti-PD-1/anti-CD40/nab-paclitaxel/gemcitabine) in the same genetic pancreatic cancer mouse model (42-day median survival) according to Winograd et al., 2015.

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"We are thrilled to kick-off this important milestone working with our partner BeiGene," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We believe the combination of IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab will have a synergistic effect that could bolster responses and expand the population of cancer patients benefiting from these therapies."

About IMX-110

The U.S. Food and Drug Administration ("FDA") approved orphan drug designation ("ODD") for IMX-110 in soft tissue sarcoma. The FDA also approved Rare Pediatric Disease Designation ("RPDD") for IMX-110 for the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children. RPDD qualifies Immix Biopharma to receive fast track review, and a priority review voucher ("PRV") at the time of marketing approval of IMX-110. PRV holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA. IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. Learn more at www.immixbio.com/iMX-110

On February 7, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the company will participate in the virtual SVB Securities Global Biopharma Conference, February 14 – 16, 2023 (Press release, Hookipa Pharma, FEB 7, 2023, View Source [SID1234626917]).

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Corporate Presentation: Tuesday, February 14, 2023 at 10:00 AM EST

The webcast of the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

On February 7, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported the launch of the OncoExTra therapy selection test in the United States (Press release, Exact Sciences, FEB 7, 2023, View Source [SID1234626916]). OncoExTra is a next-generation sequencing (NGS), comprehensive DNA and RNA based genomic test providing doctors and their patients a complete molecular picture of the patient’s cancer. The test provides reliable and actionable results personalized to each patient.

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"The OncoExTra test substantially enhances our ability to characterize and understand solid tumors, giving our patients the best chance at treating their cancer successfully," said Dr. Stephen Gruber, MD, PhD, MPH, vice president of the City of Hope National Medical Center and Director, Center for Precision Medicine at City of Hope. "With this test, I have a much better picture of my patient’s cancer, allowing me to prescribe the most effective treatment for their specific solid tumor."

The majority of eligible cancer patients do not receive comprehensive genomic profiling (CGP) to help understand their disease and guide treatment. Personalized medicine, powered by CGP, helps oncologists understand the unique biology of each patient’s tumor and prescribe treatments determined to offer the best outcomes.

"Exact Sciences continues to build its leadership in cancer diagnostics by offering innovative tests addressing clinical needs at every step of patient cancer care," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are proud to add OncoExTra to our growing portfolio of cancer solutions across the cancer-care continuum, and deliver new levels of tumor-specific information and insights to doctors and patients that guide vital treatment decisions to achieve the best outcomes."

The OncoExTra test uses NGS to assess the tumor’s RNA and DNA, providing actionable information to inform treatment decisions and uncover variants possibly missed by only evaluating DNA. The OncoExTra test works by profiling the entire exome and the transcriptome across approximately 20,000 genes. The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has updated its guidelines to recommend RNA-based fusion testing for patients with no actionable information provided by a standard DNA, multigene panel test. OncoExTra also analyzes all National Comprehensive Cancer Network (NCCN) recommended genes for patients with solid tumors and provides expertly curated, intuitive reports. The OncoExTra test uses matched tumor-normal sequencing, which also limits false positives and allows physicians to make clinical decisions based on somatic variants detected. Medicare covers the OncoExTra test and doctors can order the test for all advanced solid tumors. The sales team that helps educate oncologists on Oncotype tests will also bring OncoExTra to market; most oncologists have ordered Oncotype tests and they can now order both products from a single Exact Sciences portal, streamlining the management and treatment for both early stage and late-stage patients.

The OncoExTra test includes information on targetable mutations and fusions, immuno-oncology signatures and clinical trial options. Healthcare providers can also order immunohistochemical (IHC) panels and individual stains concurrently, allowing them to receive all actionable tumor information from Exact Sciences.

On February 7, 2023 Ensysce Biosciences, Inc. (NASDAQ:ENSC) (the "Company"), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, reported that it has closed its previously announced registered direct offering for the purchase and sale of 3,571,431 shares of the Company’s common stock at a purchase price of $0.84 per share of common stock in a registered direct offering priced at-the-market under NASDAQ rules (Press release, Ensysce Biosciences, FEB 7, 2023, View Source [SID1234626915]).

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In addition, in a concurrent private placement, the Company issued warrants to purchase up to 3,571,431 shares of common stock. The warrants have an exercise price of $0.715 per share, are exercisable immediately following issuance and will have a term of five and one-half years from the issuance date.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering were approximately $3.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include funding capital expenditures and working capital and repaying indebtedness.

The shares of common stock described above (but not the warrants issued in the concurrent private placement or the shares of common stock underlying such warrants) were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-269157) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on January 17, 2023. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering have been filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On February 7, 2023 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the SVB Securities Global Biopharma Conference on Thursday, Feb. 16, 2023. Ilya Yuffa, executive vice president and president, Lilly International, will participate in a virtual fireside chat at 12 p.m., Eastern time (Press release, Eli Lilly, FEB 7, 2023, View Source [SID1234626914]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.