On June 13, 2024 Zumutor Biologics Inc. "Zumutor", a Boston-based clinical stage Oncology Company developing first-in-class monoclonal antibody molecules targeting innate immunological pathways, reported that the first patient was dosed in its Phase 1 clinical trial, with ZM008 (Press release, Zumutor Biologics, JUN 12, 2024, View Source [SID1234644293]). The dose escalation trial is evaluating ZM008 in patients with advanced solid tumors, as a single agent and in combination with pembrolizumab.

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ZM008 is a novel fully human IgG1 monoclonal antibody against LLT1 (CLEC2D), which disrupts the interaction of LLT1-CD161 between NK cells and tumor cells. ZM008-mediated NK cell activation and subsequent T cell activation will modify the immune infiltrate in the tumor microenvironment driving eventual antitumor effects. The mode of action of ZM008 is to convert the ‘cold’ or less immune responsive cancers (TME) into ‘hot’ or highly immune responsive tumors. This approach could provide significant benefits to patients resistant to available immunotherapy treatments.

"While immunotherapy has made a significant and positive impact on patient outcomes, there remains a significant unmet need. ZM008 is a first-in-class antibody that could help patients, both as a single agent as well as in combination with anti-PD-1 directed therapy. We are pleased to participate in the study and are optimistic that early clinical activity may be observed in this heavily pre-treated patient population based on clinical evaluation and translational data," commented Dr. Ildefonso Ismael Rodriguez, MD, Principal Investigator at NEXT Oncology.

Understanding the Trial Design

The ZM008-001 trial is an open-label, first-in-human, multicenter, Phase 1 dose escalation trial of ZM008 administered alone or combined with Pembrolizumab. The trial will assess the safety, pharmacokinetics, establish the maximum tolerated dose, pharmacodynamic biomarkers, and initial antitumour activity of ZM008. The study will recommend the Phase 2 dose.

In stage 1A, increasing doses of ZM008 will be administered to patients with solid tumors, without standard therapeutic options. This will be followed by stage 1B, where ZM008 will be given in combination with the anti PD1 drug, Pembrolizumab. Multiple solid cancer indications will be enrolled: non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), prostate cancer, colorectal cancer (CRC), high-grade serous ovarian cancer (HGSOC), and others. Clinical responses and detailed translational studies will be performed, to evaluate the activation of the immune system, safety and patient benefits, after ZM008 monotherapy and combination therapy.

Knowing the Criteria

The ZM008-001 clinical trial is for adults, aged 18 or older, with advanced metastatic solid tumors. Patient must have adequate hematologic, renal and hepatic functions. Patients with a history of auto-immune reactions and toxicities with previous anti-cancer therapies (irAEs) are not eligible. ZM008 will be administered intravenously once every three weeks. This trial requires multiple visits to NEXT Oncology sites for lab tests, safety evaluations, and other follow-up appointments each month.

"Advancing our first novel drug ZM008 into clinical development is an important inflection point for Zumutor and underscores the power of our Antibody discovery engine, INABLR, supporting the immuno-oncology pipeline," said Maloy Ghosh, PhD, Chief Scientific Officer at Zumutor Biologics. "We are excited to enroll patients in this first-in-human Phase 1 study, focused on advanced solid tumor patients. Activation of immune pathways, by targeting this novel mechanism with ZM008, will be a viable option for patients to fight advanced solid cancers."

"We are looking forward to see safety and efficacy data from the ZM008-001 clinical trial," said Kavitha Iyer Rodrigues, Founder/CEO of Zumutor. "There is such a tremendous unmet need for patients suffering from multiple solid cancers. We are eager to see this novel monoclonal antibody advance through clinical trials and hope it will one day be available for these patients in need."

"ZM008 is a very exciting molecule. The preclinical work, including the ex-vivo studies, have shown remarkable activity both as a single agent and in combination with pembrolizumab. We are hoping this will translate to beneficial activity in patients and are thankful to the trial sites for joining us in developing ZM008," said Dr. Debasish Roychowdhury, MD, Medical Oncologist.

Additional information on this clinical trial will be updated on www.clinicaltrials.gov (NCT06451497).

For questions or to enroll in this study, the patient’s treating physician can contact Jordan Georg. Phone: 210-580-9521

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.

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 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 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.