On January 17, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported a licensing agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers (Press release, UroGen Pharma, JAN 17, 2024, View Source [SID1234639293]).

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UGN-103, UroGen’s RTGel technology combined with medac’s licensed mitomycin, is a next-generation formulation that is planned to follow the anticipated U.S. Food and Drug Administration approval and launch of UGN-102. UGN-103 is expected to provide advantages related to production, cost, supply, and product convenience if approved. UroGen plans to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC.

"The strategic alliance with medac fortifies our commitment to continuously innovate novel, non-surgical treatments for patients with urothelial cancers, including LG-IR-NMIBC," said Liz Barrett, President and CEO of UroGen. "The 80 mg formulation of mitomycin from medac is specifically designed to be mixed with our RTGel technology, which may provide advantages for patients looking for non-surgical treatments for urothelial cancer. With medac’s intellectual property protection for this next-generation mitomycin formulation lasting until June 2035 and our pending U.S. patent applications, we foresee potential intellectual property protection until December 2041."

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024 and an FDA decision in 2025.

On January 17, 2024 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company that employs a suite of innovative technologies to develop best-in-class radiopharmaceuticals for the treatment and monitoring of cancers, reported the close of its $50M Series B financing, bringing the total raised to date to over $90 million (Press release, Ratio Therapeutics, JAN 17, 2024, View Source [SID1234639292]). The latest round witnessed continued participation from Series A leads Schusterman and Duquesne and welcomed among others PagsGroup, Bristol Myers Squibb and the Center for Technology Licensing at Cornell University.

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This financing will expand the applications of company’s proprietary technology platforms, Trillium and Macropa, to develop novel best in class fit-for-purpose radiopharmaceuticals. Additionally, the funding will drive the clinical development of the company’s fibroblast activation protein-alpha (FAP) targeted radiopharmaceutical therapeutic.

"This funding advances Ratio’s technology platforms and will help launch clinical trials for our FAP-targeted radiotherapeutic which aims to treat a broad array of solid-tumor cancers," said Dr. Jack Hoppin, Ratio’s Chairman and Chief Executive Officer. "We are grateful to our investors for their confidence in our technology. We have filed two INDs and completed enrollment in both radiation dosimetry studies in support of two of our corporate partnerships. Now we have the backing to move our first therapeutic candidate into clinical trials by the end of this year."

"The FAP-targeted therapeutic program has the potential to provide much needed treatment to patients with multiple types of cancer," said Dr. Mey Boukenna of PagsGroup, the Boston-based family office of Stephen Pagliuca. "With Ratio’s unique assets and technology, and Drs. Babich and Hoppin standing as pioneers in the radiopharmaceutical field, we believe they are very well positioned to advance novel radiopharmaceutical cancer treatments and diagnostics into the clinic."

About Trillium and Macropa

Ratio Therapeutics’ fully integrated proprietary R&D platforms, Trillium and Macropa, harness the tumor-killing power of alpha particles. The tunable nature of the platforms enables the efficient and timely development of numerous novel radiopharmaceuticals for a broad range of high unmet need in solid tumors, while addressing the trifecta of typical challenges seen with most radiopharmaceuticals: delivery, safety and efficacy. Trillium is a pharmacokinetic modulation platform that can be altered to bind to any antigen-specific target, while Macropa is a best-in-class Actinium-225 chelator. The combination of these platforms enables the tumor-killing power of alpha particles with potential for first- and best-in-class radiopharmaceuticals.

On January 17, 2024 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors (Press release, Kineta, JAN 17, 2024, View Source;utm_medium=rss&utm_campaign=kineta-provides-update-on-its-ongoing-phase-1-2-vista-101-clinical-trial-of-kva12123-in-patients-with-advanced-solid-tumors [SID1234639291]). KVA12123, Kineta’s novel VISTA blocking immunotherapy, cleared the first four monotherapy dose levels and the first cohort in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). KVA12123 was well tolerated with no dose limiting toxicities (DLT) or cytokine related adverse events at any dose level. Additionally, KVA12123 demonstrates robust and dose proportional induction of pro-inflammatory biomarkers required for strong anti-tumor activity, demonstrating on target effects of blocking VISTA.

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"We are encouraged with the efficacy-related biomarker data that demonstrate on-target activity of KVA12123 in our Phase 1/2 clinical trial. Additionally, the safety profile supports advancing to higher doses in the monotherapy and combination cohorts of the study," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "We believe KVA12123 continues to show its potential as a next-generation immunotherapy that may overcome immunosuppression in the tumor microenvironment. The clinical study is progressing on time, and we anticipate fully enrolling the Phase 1 portion of the trial by April 2024."

In the VISTA-101 trial (NCT05708950), a total of 18 patients have been dosed with KVA12123. 15 patients with advanced solid tumors were enrolled in the first four monotherapy dose-escalation cohorts, where subjects received either 3, 10, 30 or 100 mg of KVA12123 by intravenous (IV) infusion every two weeks. Additionally, 3 patients were enrolled in the initial combination cohort with 30 mg KVA12123 and 400mg of pembrolizumab. Primary objectives of the Phase 1/2 study are to evaluate the safety and tolerability of KVA12123 and to determine the recommended Phase 2 dose (RP2D). Patients enrolled in the study were heavily pretreated with multiple prior lines of therapy including chemotherapy, radiation, and immunotherapy. Approximately half of the enrolled patients failed prior checkpoint inhibitor therapy. Dosing of the 300 mg monotherapy and 100 mg in combination with pembrolizumab cohorts have been initiated.

Safety Profile
In the first four monotherapy cohorts and initial cohort in combination with pembrolizumab, KVA12123 was well tolerated at all doses and no DLTs were observed. During Phase 1, the study is closely monitoring the proinflammatory IL-6 and TNFα cytokines that are associated with cytokine release syndrome (CRS). No evidence of CRS-associated cytokine induction has been observed at any dose level with KVA12123 in the initial cohorts.

Biomarkers
KVA12123 demonstrated dose proportional induction of pro-inflammatory biomarkers including CXCL10, CCL2, CCL3 and CCL4 that are required for strong anti-tumor activity. Consistent increases in anti-tumor non-classical monocytes, NK cells, helper (CD4+) and cytotoxic (CD8+) T cells in the blood were also observed. These key pro-inflammatory myeloid derived cytokines and chemokines are involved in immune cell activation and recruitment in the tumor microenvironment (TME).

Pharmacokinetics and Receptor Occupancy (RO)
To guide the recommended Phase 2 dose (RP2D) decision, Kineta developed a proprietary assay to evaluate VISTA RO on immune cells from patients in the clinical trial. KVA12123 achieved a greater than 90% VISTA RO at the 30 and 100 mg doses. Furthermore, pharmacokinetic analyses demonstrated a greater than dose-proportional increase in drug exposure across all evaluated doses, consistent with target-mediated drug disposition at lower doses.

"We are pleased to see the compelling safety data of KVA12123 and lack of CRS-associated cytokine induction. The drug has been very well tolerated in patients," said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. "These data are encouraging and consistent with the results from our preclinical models."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On January 17, 2024 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported the commencement of an underwritten public offering of its ordinary shares (Press release, Immatics, JAN 17, 2024, View Source [SID1234639290]). The offering is subject to market conditions and other factors, 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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Jefferies, BofA Securities and Leerink Partners are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on August 9, 2021. The offering will be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement related to the offering has been filed with the SEC and is available free of charge by visiting EDGAR on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained free of charge from

Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, telephone: (877) 821-7388, email: [email protected];
BofA Securities, Attention: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, telephone: (800) 294-1322, email: [email protected];
Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: (800) 808-7525, ext. 6105, email: [email protected].

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 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

On January 17, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported that management will be participating in the following investor conference (Press release, Gritstone Bio, JAN 17, 2024, View Source [SID1234639289]):

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B. Riley Securities’ 4th Annual Oncology Conference (Fireside Chat)
Date and Time: Thursday, January 18, 2024 at 1:30pm ET
Presenter: Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer

A live webcast of the fireside chat will be available via View Source An archived replay will be accessible for 30 days following each event.