On May 26, 2022 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported that the Company will present a Trials in Progress poster presentation for its second broad immune stimulation program, RTX-224, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually from June 3-7, 2022 (Press release, Rubius Therapeutics, MAY 26, 2022, View Source [SID1234615100]).

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The Trials in Progress poster presentation will summarize the proposed mechanism of action of RTX-224, preclinical observations to date and the clinical trial design, including the translational medicine approach, for the ongoing Phase 1/2 clinical trial of RTX-224 for the treatment of patients with select advanced solid tumors, including cutaneous melanoma, head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer and urothelial cancer.

Poster Title: A Phase 1/2 Study of RTX-224, an Engineered Red Blood Cell Expressing 4-1BB Ligand and Membrane-Bound IL-12, for the Treatment of Patients with Select Advanced Solid Tumors
Session Title: Developmental Therapeutics—Immunotherapy
Abstract Number: TPS2680
Date and Time: Sunday, June 5, 2022, 8:00-11:00 a.m. CDT

About the RTX-224 Phase 1/2 Clinical Trial

This is a Phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study to determine the safety and tolerability, pharmacokinetics, maximum tolerated dose and a recommended Phase 2 dose and dosing regimen of RTX-224 in adult patients with certain relapsed/refractory or locally advanced solid tumors including non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma, urothelial (bladder) carcinoma and triple-negative breast cancer. The trial will also assess pharmacodynamic changes in immune cell populations relative to baseline and anti-tumor activity. The study will include a monotherapy dose escalation phase followed by an expansion phase in specified tumor types during the Phase 2 portion of the trial.

About RTX-224

RTX-224 is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to express hundreds of thousands of copies of 4-1BB ligand (4-1BBL) and interleukin-12 (IL-12) on the cell surface. RTX-224 is designed to broadly stimulate the immune system by activating and expanding NK and CD8+ memory T cells and is expected to produce a broad and potent anti-tumor T cell response, an innate immune response and generate anti-tumor activity in those tumor types with known sensitivity to T cell killing, including tumor types with high mutational burden, PD-L1 expression and/or known responsiveness to checkpoint inhibitors.

On May 26, 2022 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported multiple presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from June 3 to June 7, 2022 (Press release, Replimune, MAY 26, 2022, View Source [SID1234615099]).

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Details for the presentations are as follows:

Data presentation

Updated results from the skin cancer cohorts from an ongoing Phase 1/2 multi-cohort study of RP1, an enhanced potency oncolytic HSV, combined with nivolumab (IGNYTE)

Session Title: Melanoma/Skin Cancers
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 146
Abstract: 9553
Trial in progress presentations

A randomized, controlled, open-label, phase 2 study of cemiplimab ± RP1 in patients with advanced cutaneous squamous cell carcinoma (CERPASS)

Session Title: Melanoma/Skin Cancers
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 184a
Abstract: TPS9593
An open-label, multicenter, phase 1b/2 study of RP1, a first-in-class, enhanced potency oncolytic virus in solid organ transplant recipients with advanced cutaneous malignancies (ARTACUS)

Session Title: Melanoma/Skin Cancers
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 187a
Abstract: TPS9597
A phase 1 trial of RP2, a first-in-class, enhanced potency oncolytic HSV expressing an anti-CTLA-4 antibody as a single agent and combined with nivolumab in patients with advanced solid tumors

Session Title: Developmental Therapeutics Immunotherapy
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Location: McCormick Place, Exhibit Hall A, Poster 339b
Abstract: TPS2704
An open-label, multicenter, phase 1 study of RP3 as a single agent and in combination with nivolumab in patients (pts) with solid tumors

Session Title: Developmental Therapeutics Immunotherapy
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Location: McCormick Place, Exhibit Hall A, Poster 340a
Abstract: TPS2705
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial is enrolling 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall survival (OS) as secondary endpoints. The study is being conducted under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi.

Libtayo is a registered trademark of Regeneron.

About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo. There are 4 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional cohorts are in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors and anti-PD(L)-1 failed non-small cell lung cancer, or NSCLC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb Company. Opdivo is a registered trademark of Bristol-Myers Squibb Company.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

May 26, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the Jefferies Healthcare Conference. Steve Rusckowski, Chairman, CEO and President and Jim Davis, CEO-elect, will discuss the company’s vision, goals, and capital deployment strategies (Press release, Quest Diagnostics, MAY 26, 2022, View Source [SID1234615098]). The presentation is scheduled for Friday, June 10, 2022, at 11:00 a.m. Eastern Time.

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The presentation and Q&A session will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 24 hours after the conclusion of the live event and will remain available until August 10, 2022.

On May 26, 2022 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that it will present a Trials in Progress poster related to its ADVANCED-1 Phase 1 trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, Illinois and virtually from June 3 through June 7, 2022 (Press release, Protara Therapeutics, MAY 26, 2022, View Source [SID1234615097]). The ADVANCED-1 study is evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC).

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"There is a significant need for new treatment options for patients with NMIBC, one of the most recurrent and difficult to treat cancers," said Jathin Bandari, M.D., Chief Medical Officer of Protara Therapeutics. "Based on its mechanism of action, and promising clinical data from its predecessor therapeutic OK-432, we believe that TARA-002 may address this pressing area of high unmet need. We look forward to continuing to advance this trial and exploring TARA-002’s full potential in NMIBC."

Details of the poster presentation are as follows:

Title: A Phase 1a/b safety study of intravesical instillation of TARA-002 in adults with high-grade non-muscle invasive bladder cancer (ADVANCED-1)
Abstract Number: TPS4620
Session Title: Genitourinary Cancer—Kidney and Bladder
Session Date and Time: Saturday, June 4, 2022, from 2:15 PM – 5:15 PM EDT
Location: In-Person & Online | McCormick Place, Hall A

ADVANCED-1 is a Phase 1 dose-finding, open-label trial (NCT05085977 and NCT05085990) evaluating TARA-002 in treatment-naïve and treatment-experienced NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumors (Ta). In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability and preliminary signs of anti-tumor activity of TARA-002, with the goal of establishing a recommended dose for a planned Phase 2 clinical trial.

A copy of the abstract is available at View Source

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and LMs for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan and Taiwan by Chugai Pharmaceutical Co., Ltd.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins (IL)-2, IL-6, IL-8, IL-10, IL-12, interferon (IFN)-gamma, tumor necrosis factor (TNF)-alpha, granulocyte colony-stimulating factor, and granulocyte-macrophage colony-stimulating factor, are secreted by immune cells to induce a strong local inflammatory reaction and destroy the abnormal cells.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

May 26, 2022 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP; "PMV Pharma"), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported the online publication of the abstract for its lead program, PC14586, accepted as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting being held June 3-7, 2022 in Chicago, Illinois (Press release, PMV Pharma, MAY 26, 2022, View Source [SID1234615096]).

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The published abstract describes preliminary outcomes from 29 patients, including 21 efficacy evaluable, from the ongoing Phase 1/2 PYNNACLE trial of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. These initial data from our Phase 1/2 tumor agnostic study enrolled patients across multiple tumor types over a broad range of doses. The preliminary clinical pharmacokinetics data showed dose proportional increases in Cmax and AUC. In addition, the safety profile was encouraging as PC14586 was well-tolerated.

The oral presentation at ASCO (Free ASCO Whitepaper) containing updated data from the trial will be presented by Ecaterina Ileana Dumbrava, M.D., of the University of Texas MD Anderson Cancer Center. PC14586 is a first-in-class precision oncology small molecule investigational therapy that selectively targets the p53 Y220C mutation in solid tumors.

"Patients whose tumors carry a p53 mutation are known to have a poor prognosis. The patients who were enrolled in our study had very limited or no other standard treatment options available to them. Early efficacy and safety data from this Phase 1/2 trial provide the potential of a p53 therapy," said David Mack, Ph.D., President and CEO, PMV Pharma. "We look forward to Dr. Dumbrava’s presentation of these data at ASCO (Free ASCO Whitepaper) and continuing to progress the PC14586 development program."

Details of the oral presentation are as follows:

Investor Event

PMV Pharma will host an investor event via webcast on June 7, 2022, at 6:30 PM CDT to discuss the PC14586 Phase 1 data. The event will feature a presentation by Dr. Dumbrava who will review the data presented at ASCO (Free ASCO Whitepaper) 2022. To listen to the webcast and view the accompanying slide presentation, please refer to the Events and Presentations section of the PMV Pharma website.

About PC14586

PC14586 is a first-in-class, small molecule p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. For more information about the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).