On September 21, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that three posters showcasing new data from the company’s Afirma Genomic Sequencing Classifier (GSC) will be presented at the 2023 American Thyroid Association (ATA) Annual Meeting being held in Washington, DC from September 27 to October 1 (Press release, Veracyte, SEP 21, 2023, View Source [SID1234635317]). Together, these abstracts offer novel insights into the molecular underpinnings of thyroid nodules and tumors based on whole-transcriptome RNA sequencing data from thyroid nodules analyzed with the Afirma GSC.

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"As we enter a new era in the personalized diagnosis and management of thyroid nodules and cancer, it is more important than ever to advance the science around this cancer so we can ultimately characterize each patient’s individual molecular profile," said Joshua Klopper, MD, Veracyte’s medical director for Endocrinology. "The abstracts to be presented by our clinical research colleagues at the ATA meeting show that the Afirma GSC platform can be used to glean new insights about thyroid nodules and thyroid cancer preoperatively. We believe that Afirma-based whole-transcriptome analysis will help drive cancer research and unlock findings that may ultimately be used in clinical care."

The following late-breaking posters will be presented at the 2023 ATA Annual Meeting (all times ET):

Title: Leveraging RNA Sequencing for Pre-Operative Immunophenotyping of BRAFV600E+ Thyroid Nodules
Presenter: Jarod Olay, M.S., UCLA David Geffen School of Medicine
Poster #: 502
Date/Time: September 28; 10:00 a.m. – 10:30 a.m. and 11:35 a.m. – 12:45 p.m.
Title: Molecular Assessment of Isthmus Thyroid Carcinomas

Presenter: Sina Jasim, M.D., Washington University in St. Louis
Poster #: 501
Date/Time: September 28; 10:00 a.m. – 10:30 a.m. and 11:35 a.m. – 12:45 p.m.
Title: Sodium Iodide Symporter (NIS) Expression in Cytologically Indeterminate and Malignant Thyroid Nodules

Presenter: Prasana Santhanam, M.B.B.S., M.D., The Johns Hopkins University School of Medicine
Poster #: 515
Date/Time: September 28; 10:00 a.m. – 10:30 a.m. and 11:35 a.m. – 12:45 p.m.

These abstracts will later be published as an online supplement to Thyroid, the official journal of the ATA.

On September 21, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that it will present new preclinical data from SNS-101, a clinical-stage conditionally active, human monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), at the Seventh Annual CRI-ENCI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival, held on September 20 – 23, 2023 in Milan, Italy (Press release, Sensei Biotherapeutics, SEP 21, 2023, View Source [SID1234635316]).

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"We believe these data further support the potential best-in-class PK and safety profile of SNS-101 and its ability to effectively target VISTA, a promising, but difficult-to-drug immune checkpoint," said Edward van der Horst, Ph.D., Chief Scientific Officer of Sensei Biotherapeutics. "Restricting drug activity to low pH conditions, such as those found in the acidic tumor microenvironment, allowed us to safely dose SNS-101 in our multi-dose NHP study at increasing levels while maintaining linear elimination kinetics and displaying no target-mediated drug disposition or adverse effects. Paired with new mechanistic data showing SNS-101 can shift immunosuppressive macrophages towards an anti-tumor phenotype, we believe SNS-101 could provide a transformative treatment option for patients. We look forward to sharing data from our ongoing clinical trial later this year."

Presentation Highlights:

SNS-101 displayed linear elimination kinetics and no target-mediated drug disposition or adverse effects in a multi-dose GLP toxicology study in cynomolgus monkeys evaluating SNS-101 doses of 1, 10 and 100 mg/kg.
In MC38 tumor-bearing mice, SNS-101 alone and in combination with an anti-PD-1 antibody shifted the cytokine expression profile of immunosuppressive myeloid cells in the tumor microenvironment to an anti-tumor, M1 phenotype. The expression of anti-tumor cytokines was correlated with a reduction in tumor size.
Sensei is evaluating SNS-101 in a Phase 1/2 clinical trial in patients with advanced solid tumors, and expects to report initial monotherapy pharmacokinetic and safety data by year-end 2023. Topline monotherapy and initial combination data are anticipated in 2024.

The full poster is available for viewing on Sensei’s website and will be on display at the conference during Poster Session A, being held today, September 21, 2023, from 12:30 pm to 2:00 pm CET.

On September 21, 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 positive topline data for the patient group with relapsed/refractory (r/r) lymphomas from the Phase 1 dose-escalation trial of its CDK9 inhibitor, SLS009 (GFH009) (Press release, Sellas Life Sciences, SEP 21, 2023, View Source [SID1234635315]).

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All primary and secondary study objectives, including safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD), were successfully achieved. The recommended Phase 2 Dose (RP2D) for lymphoma patients has been established at the highest dose level evaluated of 100 mg, administered as a once-weekly infusion. The maximum tolerated dose (MTD) was not reached. A dose-limiting toxicity occurred in one out of five patients treated at the 100 mg dose level. No dose-limiting toxicities were observed at any other dose level, and there were no unexpected toxicities across the study.

"We are excited to share strong topline data from the Phase 1 trial of SLS009 in lymphoma patients, building upon the promising results in the cohort of patients with acute myeloid leukemia (AML) which we reported earlier this year," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "The data demonstrate meaningful anti-tumor activity and clinical responses as a monotherapy. Based on its favorable therapeutic profile, SLS009 continues to emerge as a potential treatment for patients with hematologic malignancies who have exhausted available treatment options. Our partner, GenFleet Therapeutics, plans to advance GFH009 (SLS009) into Phase 2 clinical studies in China for patients with peripheral T-cell lymphoma (PTCL) later this year."

A total of 52 r/r lymphoma patients were enrolled. Of these, 24 received two bi-weekly doses (BIW), while 28 were administered weekly doses (QW). Among the 52 r/r lymphoma patients, 15 were diagnosed with PTCL, with 6 of them receiving the BIW regimen and 9 the QW regimen.

The dose-escalation trial investigated a range of doses from 2.5 mg to 100 mg, employing two dosing regiments: once-weekly infusions (QW) and twice-weekly infusions (BIW).

Key findings from the study include :

Efficacy:

Among 34 evaluable r/r lymphoma patients, five (14.7%) achieved a clinical response with a reduction in tumor burden of up to 62%.
An additional seven patients (20.6%) achieved stable disease (SD) resulting in an overall disease control rate of 35.3%.
In the subgroup of PTCL patients, four out of 11 (36.4%) evaluable patients achieved a clinical response.
Safety:

There were no drug-related fatalities at any dose level, and the drug was well tolerated.
In patients treated with the BIW regimen, no significant safety events appeared to be dose-dependent.
In patients receiving the QW regimen, ≥ G3 treatment-related adverse events (TRAEs) occurred, primarily hematologic events, at higher dose levels.
Non-hematologic toxicities were rare across all dose levels with five out of 52 patients (9.6%) experiencing higher grade toxicities, including hypokalemia (3/52 patients, 5.8%), upper respiratory tract infection (1/52 patients, 1.9%) and increase in bilirubin (1/52 patients, 1.9%).
Maximum Tolerated Dose (MTD) was not reached with only 1/5 patients at the highest dose level studied (100 mg) experiencing a dose-limiting toxicity (DLT).
No dose-limiting toxicities were observed at any other dose level, and there were no unexpected toxicities across the study.
Pharmacokinetic (PK) Data: Exposure parameters (Cmax and AUC) increased in an approximately proportional manner with the dose range of 30 mg~60 mg QW. The exposure of 100 mg was the highest, and the mean plasma concentration remained above IC90 for the longest time period (nearly 50 hours).

Pharmacodynamic (PD) Data: Desired levels of suppression in peripheral blood were achieved, leading to a decrease in MCL1 or MYC biomarkers in all (100%) studied patients. Biomarker suppression was dose-dependent in patients receiving QW dosing. The biomarkers studied included MYC and MCL1 with SLS009 administration resulted in biomarkers suppression across dose levels in both administration regimens (BIW and QW) and a dose-dependent decrease in QW groups. 100mg QW DL resulted in the longest sustained inhibition of both MCL1 and MYC.

The totality of the r/r lymphoma data will be presented at a major medical conference.

For more information on the Phase 1 study of SLS009 in r/r AML and r/r lymphomas, please visit ClinicalTrials.gov and reference Identifier NCT04588922.

On September 21, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported that it will present a poster titled: "Phase 1 Study of CM24 in Combination with Nivolumab in Patients with Advanced Pancreatic Cancer – Survival, Potential Biomarker and Effect on Neutrophil Extracellular Traps (NETs)" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Pancreatic Cancer, on September 28, 2023 at 4:40 pm ET in Boston (Press release, Purple Biotech, SEP 21, 2023, View Source [SID1234635314]). New biomarker data presented at the AACR (Free AACR Whitepaper) conference will be shared via a press release by Purple Biotech subsequent to the poster presentation.

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On September 21, 2023 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, reported that Russell Trenary, President and CEO of Outlook Therapeutics will participate in a panel presentation at the 2023 Cantor Fitzgerald Global Healthcare Conference being held in New York, NY on Tuesday, September 26, 2023 at 1:35 PM ET (Press release, Outlook Therapeutics, SEP 21, 2023, View Source [SID1234635313]).

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In addition to the panel presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A live video webcast of the panel presentation will be accessible on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). A webcast replay will be archived for 90 days following the event.