On September 21, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that it has commenced an underwritten public offering of its common stock and, in lieu of common stock, Leap intends to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock (Press release, Leap Therapeutics, SEP 21, 2021, View Source [SID1234590060]). All shares of common stock and pre-funded warrants to be sold in the offering will be offered by Leap. Leap intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the securities offered in the public offering. The offering is subject to market, regulatory, and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Piper Sandler & Co., Raymond James & Associates, Inc. and Mizuho Securities USA LLC will act as book-running managers for the offering. Robert W. Baird & Co. Incorporated will act as lead manager for the offering.

Leap intends to use the net proceeds from the offering to fund: (i) the continued development of DKN-01; (ii) manufacturing of clinical trial material; and (iii) general corporate purposes, including working capital and other general and administrative expenses.

The securities will be issued pursuant to an effective shelf registration statement on Form S-3 (File No. 333-248797) that was previously filed by Leap with the Securities and Exchange Commission (the "SEC") on September 14, 2020 and declared effective by the SEC on October 16, 2020. A preliminary prospectus supplement and the related prospectus will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN, 55402, by telephone at (800) 747-3924, or by e-mail at [email protected]. These documents may also be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by e-mail at [email protected]; or from Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY, 10020, by telephone at (212) 205-7600, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 21, 2021 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., Chairman and Chief Executive Officer, and John Poyhonen, President and Chief Commercial Officer, will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 1:20 pm ET (Press release, Heron Therapeutics, SEP 21, 2021, View Source [SID1234590059]).

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A live webcast of the fireside chat will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the event will be archived on the site for 60 days.

On September 21, 2021 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," or "the Company"), an international healthcare solutions company targeting oncological, COVID-19 and dry eye disease (DED) diagnostics, reported that it has appointed Joseph Tauber, MD as Chief Medical Officer and Chairman of its Medical Advisory Board (Press release, AXIM Biotechnologies, SEP 21, 2021, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-appoints-joseph-tauber-md-chief-medical-officer-and-chairman-of-its-medical-advisory-board [SID1234590057]).

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With over 30 years of clinical experience, Dr. Tauber is an internationally recognized authority in the field of ocular surface diseases including dry eye and meibomitis management. He is an entrepreneurial private

AXIM Chief Medical Officer and Chairman of its Medical Advisory Board

practice ophthalmologist with extensive experience as a clinical trials researcher and business consultant to global health product companies and institutional investors. Dr. Tauber has served on numerous scientific advisory boards and as the Ophthalmology representative at institutional investor-focused conferences.

"Dr. Tauber is arguably among the world’s leading authorities on dry eye and ocular surface disease, including researching the causes, treating, and diagnosing patients with dry eye disease," said John W. Huemoeller II, AXIM Biotech Chief Executive Officer. "Our goal is to build a powerful diagnostic company, which begins with assisting doctors to diagnose DED faster and more efficiently than alternative methods. We are honored and excited to have such a distinguished ophthalmic DED professional to help guide our strategy and future innovations to capture a larger share of the growing Dry Eye Disease market."

Joseph Tauber, MD Summary Bio
Dr. Tauber is the founder and CEO of Tauber Eye Center, a practice focused on corneal disease, uveitis and ocular immunology and complex corneal surgical procedures as well as Medical Director of Saving Sight, the US’ third largest eye bank.

Dr. Tauber has been centrally involved in virtually every significant dry eye development project during the past 25 years. He has served as a Principal Investigator in over 140 multicenter clinical trials including those that led to the approval of all four medications currently approved by the FDA for the treatment of dry eye – Restasis, Xiidra, Cequa and Eyesuvis. He has been avidly involved in research for nearly three decades, and a principal investigator in over 140 research studies across a broad range of eye conditions, including high-risk corneal transplantation, inflammation and allergic eye diseases, corneal infectious diseases and numerous ocular surface conditions.

Dr. Tauber received his doctorate from Harvard Medical School, residency training in internal medicine at Beth Israel Hospital and in ophthalmology at Tufts-New England Medical Center, and fellowship training in Ocular Immunology and in Corneal Diseases and Surgery at the Massachusetts Eye & Ear Infirmary, all in Boston, Massachusetts.
Dr. Tauber has also written eight book chapters and over 80 peer-reviewed articles in the fields of ocular surface and immunologic disease for prestigious medical journals as Ophthalmology, Investigative Ophthalmology and Visual Science, Journal of Cataract and Refractive Surgery and Cornea. He has been awarded the Heed Ophthalmic Foundation Fellowship Award and a National Eye Institute Individual NRSA Award.

Dry Eye Disease Market
Recent estimates of the prevalence of dry eye disease are that over 26 million people in the United States and over 300 million globally suffer with dry eye disease. The prevalence is growing in both young and old adults, making it more urgent that clinicians are better able to diagnose and treat DED. As many as two-thirds of patients with symptoms of dry eye have never been diagnosed by their physician. Diagnosing DED is a challenge because of the multifactorial nature of the disease, with symptoms similar to other ocular surface conditions. It is well known that there is often a discordance between signs and symptoms, highlighting the need for more sensitive and accurate diagnostic tools.

On September 21, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical need, reported that the China National Intellectual Property Administration has granted a new patent covering DUET-02, one of three key CpG-STAT3 inhibitors comprising the Duet Platform (Press release, Scopus BioPharma, SEP 21, 2021, View Source [SID1234590056]).

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The new patent covers the compound and composition, including phosphorothioated oligodeoxynucleotide, and methods of use for CpG-STAT3ASO, Duet’s CpG-STAT3 Antisense inhibitor.

Alan Horsager, Ph.D., President and Chief Executive Officer of Duet and President — Immuno-Oncology for Scopus, stated, "This is an important milestone for Duet Therapeutics as we continue to build our patent portfolio. The Chinese biotech market is an important and integral part of the global biotech industry. As referenced in a September 2021 Reuters article, the combined market value of Chinese biotech firms listed in Hong Kong, on Shanghai’s STAR board, and on Nasdaq had a combined value of approximately $180 billion as of May 2021, compared to just $1 billion in 2016. This rapid growth has been driven by an increasing number of Chinese biotechs raising significant amounts of capital in IPOs over the last several years."

Dr. Horsager added, "Duet continues to receive inbound inquiries regarding the Duet Platform from interested companies in Asia, including China. We believe China, as well as Asia more broadly, will be a key market for immuno-oncology therapeutics. The new patent positions Duet Therapeutics, a wholly-owned subsidiary of Scopus, to pursue opportunities arising from China’s burgeoning biotech market."

The new patent strengthens the patent portfolio for DUET-02. DUET-02 is also covered by a granted patent in the United States. Additionally, patent applications for DUET-02 are in process for the European Union, Canada, and Japan.

The patent granted in China, entitled "Compounds and Compositions Including Phosphorothioated Oligodeoxynucleotide, and Methods of Use Thereof," relates to the isolated compound, including a phosphorothioated oligodeoxynucleotide (ODN) sequence conjugated to an antisense oligonucleotide sequence (ASO), compositions of such a compound, and method of treatment of cancer and autoimmune diseases (with or without stimulating immune response), method of immune stimulation, and method of reducing activity of STAT transcription factor, by one of the disclosed compounds or compositions.

About the Duet Platform

Duet Therapeutics integrates the immunotherapy assets of Scopus and Olimmune, creating the Duet Platform. Olimmune was acquired by Scopus in June 2021. Duet is a wholly-owned subsidiary of Scopus.

The Duet Platform is comprised of three distinctive, complementary CpG-STAT3 inhibitors:

• RNA silencing CpG-STAT3siRNA ("DUET-01")
• Antisense CpG-STAT3ASO ("DUET-02")
• DNA-binding inhibitor CpG-STAT3decoy ("DUET-03")
DUET-01 is in a Phase 1 clinical trial, as a monotherapy, for B-cell non-Hodgkin lymphoma. Duet expects to file two INDs for DUET-02 in Q4 2022 in genitourinary and head & neck cancers, with Phase 1 clinical trials beginning in Q1 2023 in the United States. Duet is also evaluating combination therapies with checkpoint inhibitors.

On September 21, 2021 858 Therapeutics reported that stealth mode with a $60 million Series A financing led by founding investor Versant Ventures, with participation from NEA, Cormorant Asset Management and Logos Capital (Press release, 858 Therapeutics, SEP 21, 2021, View Source [SID1234590053]). Proceeds are being used to develop a portfolio of small molecules directed against novel therapeutic targets in oncology, including proteins that regulate RNA and the innate immune response.

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858’s founding team includes CEO Jeffrey Stafford, Ph.D., CSO James Veal, Ph.D., and VP of Biology Gretchen Bain, Ph.D. They previously held leadership roles at three other San Diego-based discovery companies co-founded by Versant including Jecure Therapeutics, Quanticel Pharmaceuticals and Amira Pharmaceuticals. Jecure developed therapies against innate immunity targets to treat serious inflammatory diseases and was acquired by Genentech in 2018. Quanticel developed DNA-modulating drug candidates and was acquired by Celgene in 2015. Amira developed anti-fibrotic small molecules and was acquired by Bristol-Myers Squibb in 2011.

The management team has been responsible for the discovery of over 20 drug candidates that have advanced into clinical trials, including the approved drugs VotrientTM (pazopanib) and NesinaTM (alogliptin).

858’s lead programs focus on the emerging fields of RNA modulation and innate immune pathways in cancer and expand upon insights from over 10 years of work by the founders at predecessor companies. Behind these, the company is pursuing emerging cancer targets in other pathways.

"The launch of 858 builds on our long-standing relationship with Versant in San Diego and leverages our prior experiences in both nucleic acid metabolism and innate immunity," said Dr. Stafford. "We are also pleased to have such strong support from NEA, Cormorant, and Logos as we develop an internal pipeline of precision oncology drug candidates."

RNA modulation as a broad and untapped field

There is an increasing appreciation that RNA modifications play a large role in numerous forms of cancer due to their direct influence on gene expression, tumorigenesis and immune-sensing pathways. Until now, however, it has been challenging to address many of these enzyme targets because of a dearth of assays and challenges in creating chemical matter with drug-like properties.

858 has built a platform to assess the impact of RNA-modifying proteins on disease biology and has generated a pipeline of small molecules against priority targets. The platform includes a suite of proprietary in vitro biochemical and biophysical assays, as well as cellular assays.

To accelerate the development of its pipeline, 858 has acquired Gotham Therapeutics for undisclosed terms. Gotham is a pioneer in the field of RNA biology, translating novel biological discoveries from the lab of Samie Jaffrey, M.D., Ph.D., co-founder of Gotham and now an advisor to 858.

"We are confident that 858 is well-positioned to capitalize on recent scientific discoveries in the field of RNA modification and translate them into a pipeline of drug candidates," said Clare Ozawa, Ph.D., Managing Director at Versant and an 858 board member. "Moreover, we are very pleased to again be working with Jeff, Jim, and Gretchen on a new company, given their proven track records in achieving successful outcomes for patients, employees and investors."

Operating plans

The Series A proceeds will allow 858 to enter the clinic with its lead candidates that have potential to treat cancers that are resistant to current therapies. 858 is headquartered in San Diego and will maintain lab operations both in San Diego and New York City. With this financing, the company plans to expand its team to about 40 people within the next 18 months. In addition, the 858 team will engage leading academic scientists who have made important contributions in the field and can bring specialized know-how to the company.

"858’s discovery platform provides a unique opportunity to interrogate this novel area of biology and make an impact for patients with intractable forms of cancer," said Ali Behbahani, M.D., general partner at NEA and an 858 board member. "We look forward to working with management to translate these recent discoveries into a pipeline of important therapeutics."