On June 17, 2024 iTeos Therapeutics, Inc. (Nasdaq: ITOS) ("iTeos"), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, and its development partner GSK, reported to have initiated the first, global Phase 3 registration study of belrestotug + dostarlimab doublet versus placebo + pembrolizumab in patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non-small cell lung cancer (NSCLC) (Press release, iTeos Therapeutics, JUN 17, 2024, View Source [SID1234644400]).

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"With the initiation of the first Phase 3 study for belrestotug, we are entering a monumental stage in our journey to develop a world-leading oncology company. Nearly 70% of patients with first-line PD-L1 high non-small cell lung cancer rely upon a chemotherapy-free regimen. We believe belrestotug + dostarlimab are poised to potentially advance the therapeutic regimen in this setting and establish new benchmarks," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Based on our high-quality doublet exceeding its pre-defined efficacy criteria for clinically relevant activity in an interim assessment from the Phase 2 GALAXIES Lung-201 study, we believe initiating the Phase 3 program with this patient population will serve as the foundation to our broader strategy and marks our first step in building a franchise."

The randomized, double-blind, placebo-controlled, multicenter trial will enroll approximately 1,000 patients with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected NSCLC in North America, South America, Europe and Asia. The primary endpoints of the trial are progression free survival and overall survival. In the GALAXIES Lung-301 trial, patients will be randomized 1:1 to either an intravenous infusion of the belrestotug + dostarlimab doublet or placebo + pembrolizumab.

In May 2024, iTeos announced an interim assessment of the Phase 2 GALAXIES Lung-201 study of the belrestotug + dostarlimab doublet in previously untreated, locally advanced, or metastatic PD-L1 selected NSCLC exceeded pre-defined efficacy criteria for clinically relevant activity and showed an acceptable safety profile in line with the TIGIT:PD-1 class. Clinically meaningful tumor reduction was observed at every belrestotug + dostarlimab dose vs dostarlimab monotherapy.

On June 17, 2024 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP) (Press release, Northwest Biotherapeutics, JUN 17, 2024, View Source [SID1234644399]). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies. The license is the culmination of more than 2 years of discussions and negotiations.

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The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.

The DC based therapies include versions with tumor antigens loaded into the DCs and versions for intra-tumoral administration without pre-loading of antigens. Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials. The Company does not anticipate having to provide any funding or undertake any operational role for these trials.

As previously reported, over time the Company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies.

The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.

The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell. The portfolio in-licensed now includes the further work during the last 7 years at Roswell. Taken together, the Company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the Company’s own portfolio. The Company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies.

The Company believes that the infrastructure and systems it has developed, and experience it has gained, in producing and delivering personalized living-cell DC based therapies for large numbers of patients make it uniquely positioned to help accelerate the late-stage development of the licensed DC technologies. The Company’s 331-patient Phase 3 clinical trial remains one of the largest personalized cell therapy trials conducted to date, and the Company’s extensive experience treating compassionate use patients has added valuable ongoing "real world" experience.

"We are excited to join forces with Dr. Kalinski, one of the foremost experts on dendritic cell biology and therapies," commented Linda Powers, the Company’s CEO. "We also greatly appreciate the supportiveness of the institutions throughout the long process of working out the arrangements to keep the Kalinski portfolios intact and to license them to NWBio. In the immediate term, we will continue to focus intensively on pursuing the approval and commercialization of DCVax-L for glioblastoma, but we are excited to begin working on growth opportunities with the licensed technologies as well."

The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale. If all of the milestones are met, the payments would be approximately $2.3 million. The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking).

On June 17, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell its ordinary shares and pre-funded warrants (Press release, UroGen Pharma, JUN 17, 2024, View Source [SID1234644396]). In connection with the proposed offering, UroGen also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of ordinary shares (including those underlying pre-funded warrants) offered in the public offering. There can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering. All of the ordinary shares and pre-funded warrants to be sold in the proposed offering will be offered by UroGen.

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TD Cowen and Guggenheim Securities are acting as joint book-running managers for the proposed offering. Oppenheimer & Co. is acting as lead manager for the proposed offering. Ladenburg Thalmann is acting as co-manager for the proposed offering.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, filed with the Securities and Exchange Commission (the "SEC") and declared effective on November 29, 2022. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement (when available) and accompanying prospectus may be obtained by contacting TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, telephone: (212) 518-5548, email: [email protected].

This press release shall not constitute an offer to sell or the 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 registration or qualification under the securities laws of any such state or other jurisdiction.

On June 17, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) by the Independent Data Monitoring Committee (IDMC) (Press release, Sellas Life Sciences, JUN 17, 2024, View Source [SID1234644395]). The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. Based on a detailed analysis of all unblinded data, the IDMC projects with a high level of confidence that the interim analysis (60 events) will occur by the fourth quarter of 2024.

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"We are encouraged with another positive review and the IDMC’s recommendation to continue the Phase 3 REGAL trial in AML without any modifications," said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. "The committee’s review did not raise any safety or futility concerns, further strengthening our confidence in the potential of GPS as a safe and effective treatment option for AML patients. This is the first time the IDMC has provided guidance regarding the timing of the expected interim analysis, by the fourth quarter of this year, based on their thorough analysis of the REGAL trial data."

"As a principal investigator from a high enrolling REGAL study site, I am of course delighted to learn that the interim analysis, a key milestone, is upcoming," said Panagiotis Tsirigotis, MD, Professor of Medicine at the University of Athens and Chief of Leukemia at Attikon University Hospital. "What makes me equally and perhaps even more excited is that now with the REGAL study enrollment completed and upcoming efficacy read-out, I am looking forward to the potential expansion of GPS into other settings, beyond maintenance of second remissions in patients with AML, as it could function as a treatment modality in patients in first remission as well as post bone marrow transplant."

REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific, and biostatistics experts responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the study’s validity, scientific and clinical merits. The IDMC charter provides for periodic reviews of safety, efficacy, and futility in addition to the interim and final analyses.

On June 17, 2024 Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, reported that investigators at the University of Texas MD Anderson Cancer Center’s Leukemia department presented clinical data on seclidemstat in patients with MDS and CMML at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress (Press release, Salarius Pharmaceuticals, JUN 17, 2024, View Source [SID1234644394]). The meeting was held in Madrid and virtually from June 13-16, 2024.

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Seclidemstat is a novel oral, reversible, targeted LSD1 inhibitor. The poster was presented by Guillermo Montalban-Bravo, M.D. on June 14th, and is available on Salarius’ website, in the Investors, Events and Presentations section.

The objective of this investigator-initiated Phase 1/2 dose-escalation study is to evaluate the safety, tolerability, maximum tolerated dose and overall response of seclidemstat in combination with azacitidine in adult patients with higher-risk MDS or CMML who previously failed or relapsed after hypomethylating agent therapy. As of May 2024, 16 patients were enrolled in this study with 14 patients evaluable for efficacy.

As presented at EHA (Free EHA Whitepaper), of the 14 evaluable patients for efficacy, 6 (43%) had an objective response including 1 complete response, 3 marrow complete responses, 1 marrow complete response plus hematological improvement and 1 hematologic improvement. The median overall survival was 18.5 months (95% CI, range 6.1-30.9 months), median event-free survival was 7.2 months (95% CI, range 6.3-8.2 months) and median follow-up time was 18.9 months (95% CI, range 0-48 months) from treatment initiation. As reported, overall survival after failing therapy with hypomethylating agents typically is 4-6 months.

15 patients were evaluable for toxicity, with a dose-limiting toxicity observed in 1 patient in the 750mg BID cohort. Per protocol, the cohort was expanded to 3 additional patients. Based upon reported data, Salarius believes adverse events observed were manageable.

The Phase 1 dose-escalation portion of this study will evaluate up to six dose levels of seclidemstat. Cohort 5 (dose level 750mg BID seclidemstat in combination with azacitidine) is currently enrolling and cohort 6, the final cohort, will receive 900mg BID seclidemstat in combination with azacitidine. The maximum tolerated dose, which will inform the Phase 2 portion of the study, has not yet been reached.

"We are encouraged by these promising results at this early stage of the study when seclidemstat is combined with azacitidine at doses below what we believe will be the recommended Phase 2 dose," said William McVicar, Ph.D., Chairman of the Salarius Pharmaceuticals Board of Directors. "Patients who have failed prior treatments including hypomethylating agents have a poor prognosis and are in desperate need of new treatment options. With a 43% overall response rate, median overall survival of 18.5 months and median event-free survival of 7.2 months, we agree with the investigators that these results show promising early signs of activity in a high-risk MDS and CMML treatment failure population."