On June 12, 2024 Sibylla Biotech and The University of Texas MD Anderson Cancer Center reported a strategic collaboration agreement to discover and develop novel small-molecule cancer therapies known as Folding Interfering Degraders (FIDs), which disrupt the proper folding of target proteins and lead to their degradation (Press release, Sibylla Biotech, JUN 12, 2024, View Source [SID1234644287]).

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Under the agreement, Sibylla and MD Anderson will jointly conduct discovery and development work from target identification through drug candidate nomination on selected proteins, with the potential to continue further pre-clinical and clinical development. The collaboration brings together Sibylla’s Pharmacological Protein Inactivation by Folding Intermediates Targeting (PPI-FIT) technology with the drug development expertise and capabilities of MD Anderson’s Therapeutics Discovery division.

"The Sibylla team is committed to expanding the applications of our PPI-FIT technology and FIDs to provide new treatment options for hard-to-treat indications. This collaboration builds upon the progress we have achieved to date and the applicability of our technology and know-how," said Lidia Pieri, PhD, MBA, Co-Founder and Chief Executive Officer of Sibylla Biotech. "We value the opportunity to work with MD Anderson’s team of drug development experts in order to foster our vision of treating patients with high unmet medical need."

Sibylla’s proprietary PPI-FIT technology is used to discover and develop FIDs, small molecules that induce the degradation of target proteins by interfering with the folding pathway. Notably, PPI-FIT can be applied to target proteins currently considered "undruggable" due to the absence of suitable pockets in their native state.

"Folding interfering degraders represent an exciting new modality to target key cancer drivers, and we look forward to opportunities to advance compelling candidates forward as novel therapeutic options," said Tim Heffernan, Ph.D., vice president and head of Therapeutics Discovery at MD Anderson. "By aligning Sibylla’s innovative PPI-FIT technology with our drug development engine, we hope to create impactful new medicines that will expand options for patients in need of more effective therapies."

By uniting scientists, clinicians and drug development experts together within MD Anderson, the institution’s Therapeutics Discovery division is designed to eliminate the bottlenecks slowing traditional drug discovery. Seamless integration with MD Anderson physicians allows Therapeutics Discovery to develop impactful cancer therapies inspired directly by patient needs and clinical insights.

Once a drug candidate is nominated, Sibylla and MD Anderson may consider further drug development, translational, and clinical activities to advance the candidate to patients in need.

On June 12, 2024 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated biopharmaceutical company, reported it has entered into a placement agency agreement for the purchase and sale of 3,753,558 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $1.065 per share (or $1.064 per pre-funded warrant in lieu thereof) (Press release, TONIX Pharmaceuticals, JUN 12, 2024, View Source [SID1234644288]). The closing of the public offering is expected to take place on or about June 13, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the 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 June 12, 2024 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, reported that it has commenced an underwritten public offering of up to $350,000,000 of shares of its common stock and, in lieu of issuing common stock to certain investors, pre-funded warrants to purchase shares of its common stock (Press release, Ultragenyx Pharmaceutical, JUN 12, 2024, View Source [SID1234644289]). In addition, the company is expected to grant the underwriters of the offering an option for a period of 30 days to purchase up to an additional $52,500,000 of shares of common stock at the public offering price, less the underwriting discount.

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The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. J.P. Morgan, Goldman Sachs & Co. LLC, BofA Securities and TD Cowen are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became automatically effective on February 21, 2024. This offering is being made solely by means of a prospectus supplement and accompanying prospectus. When available, copies of the preliminary prospectus supplement and the accompanying prospectus related to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at [email protected]; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; BofA Securities, NC1-002-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; and TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected].

This press release shall not constitute an offer to sell or the 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 June 12, 2024 Lantern Pharma Inc., (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, reported that the Japan Patent Office (JPO) has issued a Certificate of Patent for patent application no. 2021-513267 / registration no. 7489966 directed to Lantern Pharma’s drug candidate LP-284 ((+)N-hydroxy-N-(methylacylfulvene)urea) (Press release, Lantern Pharma, JUN 12, 2024, View Source [SID1234644291]). The Certificate of Patent entitled "Illudin Analogs, Uses Thereof, and Methods for Synthesizing the Same" covers molecule LP-284, including claims covering the new molecular entity. A Certificate of Patent is issued after JPO examinations have confirmed the merits of a patent request. Lantern values the broad protection this latest patent provides.

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"The addition of a JPO-issued patent for LP-284 to our intellectual property portfolio strengthens the future of this novel therapeutic for the commercial market and expands the potential for LP-284 to positively impact outcomes for patients with unmet needs in non-Hodgkin’s lymphomas," said Panna Sharma, CEO and President, Lantern Pharma. "It also supports the use of Lantern’s AI technologies to accelerate the development of novel cancer therapies."

Lantern previously received a similar patent on LP-284 from the US Patent and Trademark Office (USPTO) in April 2023, with an expiry in early 2039. Lantern anticipates receiving similar or same patent rights for LP-284 in Europe, China, Australia, Canada, and Korea.

LP-284 has already seen significant success in its progress in the United States. In 2023, the FDA cleared an investigational new drug (IND) application for LP-284, and Lantern Pharma began enrolling patients for a first-in-human Phase 1 clinical trial evaluating LP-284 in patients with relapsed or refractory non-Hodgkin’s Lymphoma (NHL), including mantle cell lymphoma (MCL) and double hit lymphoma (DHL) and other high-grade B-cell lymphomas (HGBL) as well as other select solid tumors and sarcomas. In mid-March 2024, Lantern announced that the first two patients had been dosed in the Phase 1 clinical trial.

MCL accounts for up to ~5,800 cases of NHL in Japan each year. In the U.S. and Europe, MCL and DHL are diagnosed in a combined ~9,000 patients each year. Nearly all patients diagnosed with MCL will relapse after treatment and LP-284 represents a potential improved novel therapeutic option for treatment of relapsed or recurrent NHL.

LP-284 has also been granted an Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of HGBL, and another for the treatment of MCL. LP-284 is the second drug candidate from Lantern Pharma to receive such designation from the FDA. LP-184— a novel therapeutic in clinical development for the potential treatment of malignant gliomas, pancreatic cancer, and atypical teratoid rhabdoid tumors (ATRT)— has also been granted an ODD by the FDA, along with a Rare Pediatric Disease Designation.

On June 12, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its TOPO1i anti-CLDN18.2 ADC (R&D code: IBI343), for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy (Press release, Innovent Biologics, JUN 12, 2024, View Source [SID1234644292]). Previously, IBI343 has already received FDA approval of its IND application for the treatment of PDAC.

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At the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting, Innovent reported the preliminary Phase 1 results of IBI343 in advanced PDAC patients who have received at least one prior line of treatment. In the 6 mg/kg dose group, among the 10 evaluable PDAC patients with CLDN18.2 1/2/3+≥60%, the overall response rate (ORR) was 40% (link).

Dr. Hui Zhou, Senior Vice President of Innovent, said, "Pancreatic cancer is highly malignant and difficult to diagnose early. At present, the treatment of advanced pancreatic cancer is still based on systemic chemotherapy. The clinical options for the second-line treatment are particularly limited, with response rate of only 6%-16%, and median survival period of only about 3-6 months. There are urgent clinical needs to be met. As the world’s first CLDN18.2 ADC to obtain FTD certification in this difficult-to-treat cancer, IBI343 single-agent therapy shows encouraging efficacy and tolerable safety in the late-line treatment of patients with advanced pancreatic cancer. We will continue to confirm its efficacy and safety in this disease in subsequent clinical trials, and also explore IBI343 in combination therapy and other solid tumors including gastric cancer."

Fast Track Designation (FTD) is a rapid review process designed to facilitate the clinical development of a drug that may treat serious conditions and fulfill an unmet medical need. According to regulations, drug candidates that obtain FTD qualifications will have more opportunities to communicate with the FDA during subsequent drug development and review processes, which will help speed up the clinical development and approval of the drug.

About Pancreatic Ductal Adenocarcinoma

Pancreatic cancer is one of the most malignant tumors of the digestive system, with a 5-year survival rate of about 10% [i]. In recent years, the incidence of pancreatic cancer has increased, but the early diagnosis rate is still low, seriously endangering human life and health. At present, the treatment of advanced pancreatic cancer is still based on systemic chemotherapy. Currently, the first-line treatment options mostly use fluorouracil (5-FU) or gemcitabine-based chemotherapy. In the second-line treatment, clinical options are very limited, mainly alternatives to the first-line regimen, and the median survival period is only about 3 to 4 months[ii], [iii]. Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. Among them, CLDN18.2 is normally buried in the gastric mucosa, but the development of malignancy leads to disruption of tight junctions and exposure of CLDN18.2 epitopes on the membrane of tumor cells[iv]. CLDN18.2 is present in 50% to 70% of pancreatic cancer patients, making it a highly scrutinized target[v].

About IBI343 (Claudin18.2 ADC)

IBI343 is a recombinant human anti-Claudin 18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the Claudin 18.2-expressing tumor cells, which causes the Claudin 18.2-dependent ADC internalization to occur. Following lysosomal processing of the ADC, the active drug (TOP1i) is liberated, which results in DNA damage and eventually apoptosis of the tumor cells. The free drug can also diffuse through the plasma membrane and effectively eliminate neighboring cells, leading to a "bystander killing effect". As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric cancer and pancreatic cancer.

In May 2024, The National Medical Products Administration (NMPA) of China granted breakthrough therapy designation (BTD) to IBI343 for use as a single agent in patients with claudin 18.2–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who experienced disease progression following 2 prior lines of systemic treatment. The multi-center Phase 3 trial of IBI343 for this indication is in preparation.