On April 27, 2022 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, reported that clinical trial investigator, Alexander I Spira, MD, PhD, FACP, Co-Director of the Virginia Cancer Specialists (VCS) Research Institute and Director of the Thoracic and Phase I Program, will present a Trials in Progress Poster for HFB200301 on Sunday, June 5 from 8:00 AM to 11:00 AM CT at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting held June 3 – 7, 2022, in Chicago, IL (Press release, HiFiBiO Therapeutics, APR 27, 2022, View Source [SID1234613029]).

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"HFB200301 is an anti-TNFR2 antibody that induces T cell and natural killer cell activation, demonstrated in preclinical models. The unique mechanism of action indicates that HFB200301 functions as a bridge between innate and adaptive immunity" said Dr. Alexander Spira. "We are excited to have VCS medical staff and patients to be a part of this Phase I clinical study (NCT05238883). Our hospital’s clinical strength combined with HiFiBiO’s innovative DIS approach will hopefully accelerate the clinical development of HFB200301 for cancer patients."

"We look forward to sharing the clinical study for HFB200301, a first-in-class cancer therapeutic targeting TNFR2 as well as our DIS indications selection strategy," said Luigi Manenti, MD, Chief Medical Officer of HiFiBiO Therapeutics. "With strong in-vivo efficacy as a monotherapy and in combination with anti-PD-1 in preclinical models, we believe it has significant potential in DIS selected tumor types including EBV+ gastric cancer, PD-L1+ pleural mesothelioma and clear cell renal cell carcinoma."

Details on the poster presentation are as follows:

Title: Phase I study of HFB200301, a first-in-class TNFR2 agonist monoclonal antibody in patients with solid tumors selected via Drug Intelligent Science (DIS)
Abstract Number: TPS2670
Poster Session: Developmental Therapeutics – Immunotherapy
Session Date and Time: Poster Session 3 – Sunday, June 5 at 8:00 AM – 11:00 AM CT

The abstract will be available through the ASCO (Free ASCO Whitepaper) Meeting Library at View Source on May 26, 2022.

HFB200301 (TNFR2)
HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2 and induces the activation of CD4 T cells, CD8 T cells and NK cells. In vivo, HFB200301 demonstrates potent antitumor activity as a single agent and in combination with anti-PD-1. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select indications who may benefit the most from HFB200301 treatment.

On April 27, 2022 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and biologic cancer therapeutics, reported that it will present a poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3-7 in Chicago, Illinois (Press release, Inspirna, APR 27, 2022, View Source [SID1234613028]).

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Poster Presentation Details
Title: Phase 1b study of RGX-202-01, a first-in-class oral inhibitor of the SLC6A8/CKB pathway, in combination with FOLFIRI and bevacizumab (BEV) in second-line advanced colorectal cancer (CRC)
Date and time: Saturday, June 4, 2022, 8:00 a.m. CDT
Session: Gastrointestinal Cancer—Colorectal and Anal
Abstract ID: 3579

On April 27, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported that it will present a poster featuring data on AL101 in adenoid cystic carcinoma (ACC) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to take place June 3-7, 2022 in Chicago, Illinois (Press release, Ayala Pharmaceuticals, APR 27, 2022, View Source [SID1234613027]).

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Details of the poster presentation are as follows:

Abstract Title: Results of ACCURACY: A phase 2 trial of AL101, a selective gamma
secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid
cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut)
Abstract Number: 6046
Session Title: Head and Neck Cancer
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
The ongoing Phase 2 ACCURACY clinical trial is an open-label, single-arm, multi-center study to assess the clinical activity of AL101 using radiographic assessments of patients with R/M ACC demonstrating disease progression within 6 months prior to dosing. The company will present safety, efficacy, PK and PD data from the 4mg and 6mg AL101 cohorts in the trial.

About Adenoid Cystic Carcinoma (ACC)

ACC is a rare malignancy of the secretory glands including salivary glands, accounting for about 10% of all salivary gland tumors with an annual incidence of 3,400 in the U.S. There is currently no approved standard of care for patients with recurrent/metastatic ACC. Patients with locoregional disease undergo surgery and radiation therapy, with recurring disease treated by chemotherapy. ACC is an immunologically "cold" tumor that is refractory to chemotherapy, with a recurrence rate of about 60% after initial surgery. The Notch pathway has been determined to be an oncogenic driver of ACC and its dysregulation plays a key role in tumorigenesis and correlates with a distinct pattern of metastasis and a poor prognosis.

About AL101

AL101 is an investigational small molecule Gamma Secretase Inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in the Phase 2 ACCURACY clinical studies in patients with adenoid cystic carcinoma (ACC). AL101 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL101 from Bristol-Myers Squibb Company in November 2017. AL101 was granted U.S. FDA Fast Track Designation and Orphan Drug Designation for the treatment of ACC.

On April 27, 2022 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that a poster describing the design of the Phase 1/2 trial of AU-007 will be presented during a Trials in Progress session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Aulos Bioscience, APR 27, 2022, View Source [SID1234613026]). AU-007 is a monoclonal antibody computationally designed by Biolojic Design that is highly selective for the CD25-binding portion of IL-2. The ASCO (Free ASCO Whitepaper) meeting will take place virtually and at McCormick Place in Chicago, Illinois, from June 3-7, 2022.

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Details of the Aulos poster presentation are as follows:

Title: Trial in progress: A phase 1-2, first-in-human, open label, dose escalation and expansion study of AU-007, a monoclonal antibody that binds to IL-2 and inhibits IL-2Rα binding, in patients with advanced solid tumors.

Abstract: TPS2671

Session Type/Title: Poster Session/Developmental Therapeutics—Immunotherapy

Session Date and Time: Sunday, June 5, 2022, 8:00 a.m.-11:00 a.m. CDT

Presenter: Jim Vasselli, M.D., Chief Medical Officer, Aulos Bioscience

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

Aulos is evaluating AU-007 in an open label, first-in-human Phase 1/2 clinical trial designed to assess the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. To learn more about the clinical trial program, visit ClinicalTrials.gov (NCT05267626).

On April 27, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing therapeutics that combine both targeted and immune-mediated mechanisms, reported that two abstracts were accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022 at the McCormick Place Convention Center in Chicago, IL (Press release, Tempest Therapeutics, APR 27, 2022, View Source [SID1234613025]). The results of the Phase 1 monotherapy and Phase 1 combination therapy studies with TPST-1120, a potential first-in-class PPARα antagonist, received an invitation for an oral presentation. The trial results will be presented on the podium by Mark Yarchoan, a clinical investigator from Johns Hopkins School of Medicine.

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In addition, the trials-in-progress abstract for TPST-1495, a potential first-in-class EP2/EP4 prostaglandin receptor dual antagonist, was accepted for a poster presentation.

"We are thrilled that ASCO (Free ASCO Whitepaper) recognized our two novel clinical programs and accepted the abstracts for presentation," commented Stephen Brady, chief executive officer of Tempest. "This will be the first presentation of clinical data from a Tempest program, and we are encouraged by the results from our completed Phase 1 study with TPST-1120, and excited about the ongoing first-line randomized study in patients with hepatocellular carcinoma."

Our abstracts will be released on Thursday, May 26, 2022 at 5:00 p.m. EDT on ASCO (Free ASCO Whitepaper).org/abstracts. We expect to also include data from the additional TPST-1120 patients enrolled after abstract submission.

Presentation details:

Title: A phase 1 study of TPST-1120 as a single agent and in combination with nivolumab in subjects with advanced solid tumors.

Session Typer/Title: Oral Abstract Session, Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Tuesday, June 7, 2022; 9:45 a.m. – 12:45 p.m. CDT
Abstract Number: 3005

Title: A phase 1 study of TPST-1495 as a single agent and in combination with pembrolizumab in subjects with solid tumors

Session Type/Title: Poster Session, Developmental Therapeutics – Immunotherapy
Session Date and Time: Sunday, June 5, 2022; 8:00 a.m. – 11:00 a.m. CDT
Abstract Number: TPST2696