On May 23, 2024 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that company management will participate in the following investor conferences (Press release, Tyra Biosciences, MAY 23, 2024, View Source [SID1234643639]):

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TD Cowen’s 5th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper), May 28-29, 2024: Todd Harris, CEO of TYRA, will participate in a fireside chat on Tuesday, May 28, 2024, at 1:00 pm ET.
Jefferies Global Healthcare Conference, June 5-6, 2024: TYRA management will participate in one-on-one meetings with investors during the conference.
45th Annual Goldman Sachs Global Healthcare Conference, June 10-13, 2024: Todd Harris, CEO of TYRA, will present on Wednesday, June 12, 2024, at 8:40 am ET. TYRA management will also participate in one-on-one meetings with investors during the conference.
A live and archived webcast of the presentations will be available via the For Investors page on the Investor section of the TYRA website.

On May 23, 2024 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported that it has been accepted for a poster presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held from May 31 to June 4, 2024, in Chicago, Illinois (Press release, OncoHost, MAY 23, 2024, View Source [SID1234643638]). The presentation will highlight the ability of the company’s PROphet platform to predict clinical benefit from immune checkpoint inhibitor (ICI)-based therapies across various cancer indications.

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"ICIs represent a key treatment modality for a growing number of cancer types, but a gap exists in the availability of predictive tests that can accurately identify patients likely to benefit from these therapies. Our PROphet platform offers a solution," said Ofer Sharon, MD, CEO at OncoHost. "This research highlights the adaptability of PROphet as we work to provide treatment guidance for multiple indications. I am proud of our team’s commitment to improving outcomes for cancer patients worldwide and the ongoing impact of our work in the oncology field."

PROphet is a novel and robust predictive computational model that analyzes and identifies proteomic profiles in pre-treatment blood plasma by combining bioinformatics, system biology, proteomic pattern recognition and machine learning. PROphetNSCLC, the first indication for which the platform was developed, predicts clinical benefit from first-line PD-1/PD-L1 inhibitor-based therapies in patients with metastatic non-small cell lung cancer (mNSCLC), offering guidance in choosing between ICI monotherapy and ICI-chemotherapy combination.

For this observational study, pre-treatment plasma samples and clinical data were collected from patients with metastatic melanoma and HPV-related cancers undergoing treatment with PD-1/PD-L1 inhibitor-based therapies. HPV-related cancers included anogenital squamous cell carcinoma, cervical carcinoma, and head and neck squamous cell carcinoma. The presentation will showcase the findings which demonstrate the potential of the PROphetNSCLC test in predicting ICI response for indications beyond just NSCLC, underscoring the promise of PROphet in advancing precision medicine.

The study was conducted in collaboration with Sidney Kimmel Medical College at Thomas Jefferson University, Yale School of Medicine, and the Center for Immuno-Oncology, Center for Cancer Research of the National Cancer Institute.

"We are excited to present our latest findings at ASCO (Free ASCO Whitepaper) 2024," said Itamar Sela, Ph.D., VP R&D at OncoHost and co-author of the study. "This study showcases the versatility of the PROphet platform in predicting benefit from immune-checkpoint inhibitors not only in NSCLC, but also in melanoma and HPV-related cancers. By leveraging the power of plasma-based proteomic analysis, PROphet offers a non-invasive and efficient method to guide treatment decisions and optimize patient care."

Poster Presentation Details
Session: Developmental Therapeutics—Immunotherapy
Abstract #: 2568
Poster Bd #: 47
Title: A plasma-based proteomic platform for predicting clinical benefit from immune checkpoint inhibitors in multiple cancers.
Presenter: Itamar Sela, Ph.D., VP R&D at OncoHost
Date/Time: 6/1/2024, 9:00 AM-12:00 PM CDT

The abstract is available on the ASCO (Free ASCO Whitepaper) website.

On May 23, 2024 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that clinical and biomarker data from its ST101 Phase 2 study in GBM will be delivered during an oral presentation on June 1, 2024 at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Sapience Therapeutics, MAY 23, 2024, View Source [SID1234643637]).

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ST101 is a first-in-class antagonist of C/EBPβ, currently being evaluated in patients with recurrent and newly diagnosed GBM in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279).

Sapience’s Chief Medical Officer, Abi Vainstein-Haras, MD, stated, "We are encouraged by ST101’s clinical and biomarker data for patients with glioblastoma. This novel therapy has the potential to be a new treatment opportunity for this devastating disease, and we are honored to be presenting these promising results in an oral presentation at ASCO (Free ASCO Whitepaper) 2024. We are committed to bringing new hope to patients battling glioblastoma and look forward to advancing ST101 through clinical development."

Dr. Fabio M. Iwamoto, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Irving Medical Center, and Principal Investigator of the ST101-101 clinical study added, "Current treatments for recurrent glioblastoma offer limited hope for patients. I’m enthusiastic about the potential of ST101. It represents a novel approach with the potential to extend survival, both as a standalone therapy and in combination with existing treatments. Importantly, ST101’s safety profile suggests it could be well-tolerated, potentially offering a significant benefit for patients battling this aggressive disease."

Oral presentation details and abstract highlights include:

Abstract Title: "Efficacy and biomarker analysis of phase 2 (P2) and window-of-opportunity (WoO) cohorts of patients with glioblastoma (GBM) treated with ST101, an inhibitor of the transcription factor C/EBPβ"
Abstract Number for Publication: 2011
Session Type and Title: Clinical Science Symposium – Advancing Trial Design: Illuminating Tumor Evolution in Central Nervous System Cancer
Date and Time: 6/1/2024, 3:00 PM-4:30 PM CDT
Presenting Author: Fabio M. Iwamoto, MD, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Irving Medical Center

ST101 has the potential to be a well-tolerated treatment option for patients with GBM

Outcome data to be presented from multiple cohorts of GBM patients
Main study: monotherapy in recurrent GBM
Window-of-Opportunity Study: mono/combination-therapy in GBM
Biomarker data to be presented from Window-of-Opportunity study cohorts
ST101 crosses the BBB and penetrates tumor tissue as shown by IHC
Target (C/EBPβ) engagement and degradation shown by IHC
Modulation of the tumor immune microenvironment to promote anti-tumor activity
Data supports continued clinical development of ST101 as a backbone treatment in combination with standard of care and immune-oncology agents.
The slide presentation described here will be made available on the Sapience Therapeutics website following the conference.

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in patients with newly diagnosed and recurrent GBM (ndGBM and rGBM) in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279). In an ongoing window-of-opportunity sub-study, ST101 is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in ndGBM, with patients receiving ST101 before and after surgical resection. ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and orphan designations for glioma from the U.S. FDA and the European Commission.

On May 23, 2024 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, reported new nonclinical data demonstrating the significantly higher intratumoral drug concentration, stronger inhibition of mTOR targets and greater antitumor activity of nab-sirolimus compared to intravenous and oral mTOR inhibitors in a xenograft model (Press release, Aadi Bioscience, MAY 23, 2024, View Source [SID1234643636]). These data will be available as an abstract and published in the Journal of Clinical Oncology supplement to coincide with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 – June 4, 2024.

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"Our goal at Aadi is to unlock the full power of mTOR inhibition by combining nanoparticle albumin bound (nab) technology with sirolimus to improve delivery, stability, solubility and targeting," said Loretta Itri, MD, Chief Medical Officer at Aadi. "With superior findings across key markers, these important nonclinical data add to our growing body of evidence that nab-sirolimus may overcome limitations of previous therapies, including both orally and intravenously delivered mTOR inhibitors, with the potential to play an important therapeutic role in difficult-to-treat cancers."

Abstract details and highlights include:

Title: Antitumor activity of nab-sirolimus versus mTOR inhibitors temsirolimus, sirolimus, and everolimus in A549 NSCLC xenografts
Lead Author: Shihe Hou
Abstract: View Source

Despite the broad importance of the mTORC1 pathway in cancer cell growth and survival, mTOR inhibitors (mTORis) temsirolimus, sirolimus and everolimus have limited clinical application in the cancer setting.
In A549 xenografts, nab-sirolimus resulted in significantly greater suppression of tumor growth compared with IV temsirolimus and oral sirolimus and everolimus.
Average intratumoral drug concentrations 24 hours after IV mTORi treatment were significantly higher with nab-sirolimus (420-539 ng/g) compared with temsirolimus (34.9 ng/g) and its active metabolite (13.2 ng/g); similarly, tumor uptake of nab-sirolimus greatly exceeded that of sirolimus and everolimus at steady-state.
We believe these results support further clinical evaluation of nab-sirolimus as a single agent or in combination with other therapeutic agents.
In addition, Aadi will present a trials-in-progress poster on its Phase 2 trial in advanced or recurrent endometrioid-type endometrial cancer (EEC), a difficult-to-treat mTOR-driven cancer. Endometrial cancer is the most common cancer of the female reproductive organs and one of the few cancers with increasing mortality. There are an estimated 10,000 cases of EEC diagnosed annually.

Poster details and abstract highlights include:

Title: A phase 2, open-label, single-arm, prospective, multicenter study of nab-sirolimus plus letrozole in advanced or recurrent endometrioid endometrial cancer
Presenting Author: Lauren Dockery, MD, MS
Session Title: Poster Session – Gynecologic Cancer
Abstract Number: TPS5640
Date/Time: Monday, June 3rd, 9:00 am – 12:00 pm

This is a Phase 2 open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus and letrozole in patients with advanced or recurrent endometrioid endometrial carcinoma, exploring the potential for this combination to produce additive anti-tumor activity in patients with EEC.
Dysregulation of mTOR signaling is implicated in the pathology of EEC, in which >80% harbor PTEN or PI3K/AKT/mTOR pathway alterations.
Prior clinical studies with mTOR inhibitors and letrozole in endometrial cancer patients have yielded promising results.
Alternative treatment options for patients with advanced or recurrent EEC remain necessary despite recent pivotal data demonstrating improved outcomes with immunotherapy plus chemotherapy.

On May 23, 2024 Rutgers Cancer Institute and RWJBarnabas Health reported that its Clinicians and scientists will lead sessions and present their latest discoveries from their innovative cancer research program at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in Chicago (and online) from May 30-June 4 (Press release, Rutgers Cancer Institute of New Jersey, MAY 23, 2024, View Source [SID1234643635]). A total of 49 accepted abstracts and presentations will cover cutting-edge topics, including two oral sessions highlighting the National Surgical Quality Improvement Program (NSQIP) audit of enhanced recovery after surgery protocols for radical cystectomy, as well as social vulnerability and clinical trial enrollment’s role in the next frontier of health equity.

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"Our world-renowned integrated network of researchers and clinicians at Rutgers Cancer Institute and RWJBarnabas Health continues to innovate and investigate strategies that will achieve the best possible outcomes for our patients. This is reflected in the dynamic lineup of presentations featured at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, underscoring our team’s commitment and dedication," said Steven K. Libutti, MD, FACS, Director, Rutgers Cancer Institute and Senior Vice President, Oncology Services, RWJBarnabas Health. "As New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center and the leading cancer program in the state, we are at the forefront of advancing cancer research and care to conquer a disease that impacts so many. We look forward to sharing our array of recent advancements and findings at this year’s meeting."

The research accepted for presentation at ASCO (Free ASCO Whitepaper) includes one late-breaking abstract, oral and poster sessions as well as publication-only abstracts highlighting data in numerous types of cancer, including breast, colorectal, lymphoma, and lung.

Highlights of the accepted abstracts include the following:

Findings from a study that assesses how social vulnerability impacts clinical trial enrollment and explores the interaction between race and social vulnerability among patients with one of the top five cancers – breast, prostate, lung, colorectal and pancreas. Findings confirm that neighborhood social vulnerability is a barrier to trial enrollment, even more so among Black patients.
Utilization of enhanced recovery after surgery (ERAS) protocols for radical cystectomy has been associated with improved postoperative recovery and shorter hospital stays. This study was designed to assess the impact of increasing compliance to ERAS components on postoperative outcomes in patients who underwent radical cystectomy. Researchers reviewed 3,708 patients from the National Surgical Quality Improvement Program database who underwent radical cystectomy from 2019 – 2021.
Updates from CTEP 10492, a Phase 1/1b study investigating the AKT inhibitor ipatasertib with chemoradiation to treat locally advanced head and neck squamous cell carcinoma (HNSCC). The primary objective of this study is to determine the maximum tolerated dose and recommended Phase 2 dose of ipatasertib in combination with definitive chemoradiation therapy (CRT) in locally advanced HNSCC based on dose-limiting toxicities. This phase 1/1b study will be the first to establish safety and preliminary efficacy of ipatasertib combined with standard of care definitive CRT for HNSCC.
Data from a Phase 3 clinical trial evaluates the efficacy and safety of odronextamab plus CHOP vs rituximab plus CHOP in previously untreated diffuse large B-cell lymphoma (DLBCL) patients. OLYMPIA-3 is a Phase 3, randomized, open-label, multicenter study of O-CHOP vs. R-CHOP in patients with previously untreated DLBCL and intermediate- or high-risk features. The primary endpoints of the study are the incidence of dose-limiting toxicities, and incidence and severity of treatment-emergent adverse events as well as progression-free survival by independent central review.
CIPHER (NCT05333874), a single institution pilot study, evaluated whether trend of circulating tumor DNA (ctDNA) testing during neoadjuvant therapy (NAT) can serve as an early indicator of treatment response and inform disease management in the adjuvant setting. The study included 35 patients with stage II-III triple negative and HER2+ breast cancer and longitudinal ctDNA testing performed during standard of care NAT.
The full list of presentations at this year’s 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting can be found here.