On October 11, 2023 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 that its partner GenFleet Therapeutics (Shanghai), Inc. has dosed the first patient in a Phase Ib/II trial evaluating SLS009 (GFH009) in relapsed/refractory Peripheral T-cell Lymphomas (PTCL) (Press release, Sellas Life Sciences, OCT 11, 2023, View Source [SID1234635858]). The open-label, single-arm trial will enroll up to 95 patients to evaluate safety and efficacy and, based on the results, may serve as a registrational study. This initial PTCL study is fully funded by GenFleet and is being conducted in China.

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"SLS009 is a novel and highly selective CDK9 inhibitor which, to date, has shown tremendous therapeutic promise across multiple blood cancers," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are pleased with the initiation of the Phase Ib/II trial of SLS009 in the underserved PTCL patient population. Collaborating with GenFleet amplifies the potential of our highly selective CDK9 inhibitor in multiple indications and reflects our joint commitment to delivering this groundbreaking treatment to cancer patients globally. While our primary efforts are focused on acute myeloid leukemia (AML) in the United States, we remain fully supportive and deeply involved in the PTCL study and will make further development decisions for this indication as we obtain initial data for this Phase Ib/II study from our partner."

SLS009 demonstrated favorable safety/tolerability and promising clinical efficacy in the recently completed dose-escalation portion of the Phase I trial in relapsed/refractory hematological malignancies. Complete or partial responses were observed in AML and lymphoma patients among which four PTCL patients (36.4%) achieved clinical responses.

In March 2022, SELLAS and GenFleet Therapeutics (Shanghai), Inc. entered into an exclusive license agreement that grants rights to SELLAS for the development and commercialization of SLS009 (GFH009), a highly selective small molecule CDK9 inhibitor, across all therapeutic and diagnostic uses worldwide outside of Greater China (mainland China, Hong Kong, Macau, and Taiwan).

On October 11, 2023 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported that it will present updated Phase 1 data from the ongoing Phase 1/2 PYNNACLE study of PC14586 in a late-breaking poster session at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 11-15, 2023, in Boston, Massachusetts (Press release, PMV Pharma, OCT 11, 2023, View Source [SID1234635856]). The poster will contain updated clinical data from the study as of September 5, 2023.

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The abstract, containing data with a May 1, 2023 cutoff, was published today and is available for conference registrants on the AACR (Free AACR Whitepaper)-NCI-EORTC 2023 Conference app.

Poster presentation details:

Title: Updated Phase 1 results from the PYNNACLE Phase 1/2 study of PC14586, a selective p53 reactivator, in patients with advanced solid tumors harboring a TP53 Y220C mutation
Session Date and Time: 12:30 PM – 4:00 PM ET on Thursday, October 12, 2023
Session Title: Poster Session A
Lead Author: Alison M. Schram, M.D., Memorial Sloan Kettering Cancer Center
Abstract Number: LB_A25
Additional PC14586 Presentations at AACR (Free AACR Whitepaper)-NCI-EORTC Conference

The updated PYNNACLE clinical trial data will also be discussed by Leila Alland, M.D., Chief Medical Officer of PMV Pharma, during the Chemistry in Cancer Research Town Hall at 6:00 PM ET on Friday, October 13, 2023, and by Aparna Parikh, M.D, M.S., Director of the Global Cancer Care Program at Mass General Hospital Cancer Center, as part of Concurrent Session 8: Targeted and Immunotherapy Approaches Against p53 at 10:00 AM ET on Saturday, October 14, 2023.

KOL Webinar

PMV will host a KOL webinar via webcast on Thursday, October 12, 2023 at 4:00 PM ET to review the data and to provide a regulatory update. The event will feature presentations by Dr. Parikh and by PMV management.

To register for the event please click here.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE study is evaluating PC14586 in patients with advanced solid tumors harboring a p53 Y220C mutation. The primary objective of the Phase 1 portion of the trial is to determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PC14586 when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers will also be assessed. Phase 2 will be an expansion study with the primary objective of evaluating the efficacy of PC14586 at the RP2D in patients with TP53 Y220C advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.

On October 11, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, reported interim safety and immune response data for the first-in-human Phase 1/2 clinical trial evaluating PDS0301, a novel investigational tumor-targeting, antibody-conjugated Interleukin 12, in combination with current standard-of-care (SOC) chemotherapy, docetaxel, to treat metastatic castration sensitive (mCSPC) and castration resistant (mCRPC) prostate cancer (Press release, PDS Biotechnology, OCT 11, 2023, View Source [SID1234635855]). The data will be featured in an oral presentation by Ravi A. Madan, MD, Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research of the National Cancer Institute, an Institute of the National Institutes of Health, at the 11th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2023) in Athens, Greece.

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"We are encouraged by the preliminary data from the Phase 1/2 clinical trial evaluating PDS0301 in combination with docetaxel for patients with metastatic prostate cancer which has the potential to improve treatment outcomes for patients with advanced and refractory prostate cancers that have spread to other parts of the body," said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech.

Eighteen patients (11 with mCSPC and 7 with mCRPC) with a median age of 69 years (range 39-82) were evaluated for clinical activity and toxicity. Three dose levels of PDS0301 (8.0 mcg/kg, 12.0 mcg/kg, and 16.8 mcg/kg) in combination with docetaxel (75 mg/m2) were administered every three weeks beginning with the second cycle of treatment. The dose-limiting toxicity (DLT) window spanned the 6 weeks after initiating docetaxel. While all doses of PDS0301 were well-tolerated, the 12.0 mcg/kg dose of PDS0301 with chemotherapy provided the best combination of immune response and tolerability.

Interim data highlights to be presented at Cytokines 2023 include:

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Decrease in PSA levels was seen in all patients at all three tested doses of PDS0301 and ranged from -4% to -100%.

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All doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia.

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Administration of the combination was associated with decreases in T reg cells and increases in activated natural killer (NK) cells, memory CD8 T cells, proliferating CD4 and CD8 T cells and cytokines INF-γ and Interleukin 10 (IL-10).

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The changes in immune responses with the combination were independent of the PDS0301 dose.

"The interim data show that adding PDS0301 to docetaxel was associated with increases in peripheral activated natural killer cells, central memory CD8, proliferating CD4 and CD8 cells in addition to cytokines interferon-gamma and Interleukin 10 as well as decreases in T regulatory cells," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "As the first clinical study to evaluate docetaxel and an immunocytokine, we were pleased to see that the combination can be administered every 3 weeks and look forward to its continued evaluation and impact on clinical outcomes for the treatment of metastatic prostate cancer."

For patients interested in enrolling in this clinical trial, please contact NCI’s toll-free number: 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], or visit View Source using the identifier NCT04633252.

About PDS0301
PDS0301 is a novel investigational tumor-targeting antibody drug conjugate of Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells and natural killer (NK) cells in the tumor microenvironment. PDS0301 is given by subcutaneous injection and is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.

On October 11, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard to treat tumors and viruses, reported that Walter Klemp, President and Chief Executive Officer and Jonathan Foster, Executive VP and Chief Financial Officer of Moleculin, will participate at the Virtual Investor Ask the CEO Conference on Tuesday, October 24, 2023 at 12:00 PM ET (Press release, Moleculin, OCT 11, 2023, View Source [SID1234635854]).

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The "Ask the CEO" conference is intended to provide the investment community with access to ask their questions directly to management. Investors and interested parties will have the opportunity to submit questions live during the event. Questions can also be pre-submitted leading up to the event through virtualinvestorco.com/asktheceo-mbrx. Participating companies will answer as many questions as possible during the event.

A live video webcast of the event will be available on the Events page of the Investors section of the Company’s website (moleculin.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On October 11, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its President and CEO, Robert E. Hoffman will present at the 8th Annual Dawson James Small Cap Growth Conference on Thursday, October 12, 2023 at 10:30 am ET (Press release, Kintara Therapeutics, OCT 11, 2023, View Source [SID1234635853]).

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