On April 14, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported the presentation of three posters at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper), taking place April 14-19, 2023, in Orlando, FL (Press release, Aadi Bioscience, APR 14, 2023, View Source [SID1234630112]).

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The presentations at AACR (Free AACR Whitepaper) 2023 include: a trials-in-progress (TIP) poster for the ongoing PRECISION 1 trial, a registrational directed tumor agnostic study for patients with solid tumors driven by TSC1 or TSC2 alterations; results on the anti-tumor activity of nab-sirolimus in combination with KRAS-G12C inhibitors in xenograft models; and results of a biomarker analysis from the AMPECT trial correlating response to nab-sirolimus with TSC1 and TSC2 inactivating alterations, which includes previously reported response data from AMPECT.

Abstracts and poster presentation details are below:

Title: "Phase 2, multicenter, open-label basket trial of nab-sirolimus for patients with inactivating alterations in TSC1 or TSC2 (PRECISION I)"
Date and Time: Monday, April 17, 2023, 9:00 AM – 12:30 PM
Session Title: Phase II and Phase III Clinical Trials in Progress
Presentation Number: CT057

Abstract highlights:

nab-Sirolimus is a novel albumin-bound mTOR inhibitor (mTORi) approved in the US for adult patients with advanced malignant PEComa.
Eligible patients are ≥12 years old and mTORi-naïve, possess malignant solid tumors with TSC1 or TSC2 inactivating alterations (confirmed by central review of sequencing reports), and have received appropriate standard treatments, as determined by the investigator.
Available data from the AMPECT exploratory analysis and an expanded access program suggest acceptable efficacy and safety of nab-sirolimus, an mTORi with enhanced antitumor activity, in patients with solid tumors harboring inactivating alterations in TSC1 and/or TSC2.
nab-Sirolimus 100 mg/m2 will be given weekly intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary endpoint is overall response rate per independent radiographic review (IRR) using RECIST v1.1. Other endpoints include duration of response, time to response, progression-free survival by IRR, overall survival, patient-reported quality of life, and safety.
Enrollment began in March 2022. Collaboration with leading next-generation sequencing vendors will expedite the identification of patients with qualifying TSC1 or TSC2 mutations; study access will be facilitated through a "just-in-time" approach to trial location activation.
Based on the prevalence of TSC1 or TSC2 inactivating alterations, the most frequent tumor types expected are bladder, hepatobiliary, endometrial, soft tissue sarcoma, ovarian, and esophagogastric.
Title: "Synergistic anti-tumor activity of nab-sirolimus in combination with KRAS inhibitors (KRASis) sotorasib and adagrasib in KRAS G12C NSCLC and bladder cancer xenografts"
Date and Time: Tuesday, April 18, 2023, 1:30 – 5:00 PM
Session Category: Clinical Research Excluding Trials
Session Title: Combination Therapies for Cancer
Presentation Number: 5484

Abstract highlights:

KRAS is frequently mutated in non-small cell lung cancer (NSCLC) and other tumor types, with KRAS G12C mutation representing ~12% of patients with NSCLC. Sotorasib and adagrasib are approved for the treatment of KRAS­ G12C NSCLC. Mutations in KRAS may lead to mTORC1 activation, and mTOR may contribute to adaptive resistance to KRASis.
This study investigated the antitumor activity of nab-sirolimus in combination with KRASis in KRAS G12C NSCLC and bladder xenograft models.
nab-sirolimus in combination with either sotorasib or adagrasib showed greater tumor growth inhibition, a higher meaningful tumor regression rate and synergistic antitumor activity vs single agent therapy.
A multicenter, single-arm, open-label Phase 1/2 clinical study is planned to determine the recommended Phase 2 dose, safety, tolerability, and efficacy for the combination of adagrasib and nab-sirolimus in patients with KRAS G12C tumors.
Title: "Biomarker analysis from AMPECT correlating response to nab-sirolimus with TSC1 and TSC2 inactivating alterations"
Date and Time: Wednesday, April 19, 2023, 9:00 AM – 12:30 PM
Session Category: Clinical Research Excluding Trials
Session Title: Late-Breaking Research: Clinical Research 3
Presentation Number: LB288

Abstract Highlights:

An exploratory biomarker analysis was performed on samples from patients enrolled in the AMPECT study, a Phase 2, multicenter, open-label trial in advanced malignant PEComa (NCT02494570).
A variety of pathogenic inactivating alterations were observed in TSC1 and TSC2 genes, though TSC2 mutations were most commonly frameshift mutations; no recurring mutations were observed.
A tumor-agnostic study (PRECISION 1: NCT05103358) is now recruiting patients with pathogenic inactivating TSC1 or TSC2 alterations to further examine these biomarker findings.
Full session and meeting details are available through the AACR (Free AACR Whitepaper) Annual Meeting planner: AACR (Free AACR Whitepaper) Annual Meeting 2023 | Meetings | AACR (Free AACR Whitepaper). Each poster will be made available following the date of presentation at AACR (Free AACR Whitepaper), on the investor relations page of the Aadi website at www.aadibio.com

On April 14, 2023 Geneius Biotechnology, Inc., an immuno-oncology company developing a best-in-class personalized RNA-enabled T cell therapy platform that generates a robust immune response to solid and liquid cancers, reported that the company will present a poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 14-19, 2023, in Orlando, Florida (Press release, Geneius Biotechnology, APR 14, 2023, View Source [SID1234630111]).

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The abstract will be available on the AACR (Free AACR Whitepaper) meeting website. The poster will be available online at www.geneiusbiotech.com following the presentation.

Poster Presentation Details

Abstract 4067 – RNA primed SMAR-T cells against multiple driver mutations, all HLA’s, designed for first line therapy
Date/Time: Tuesday, April 18, 2023, 9:00 AM – 12:30 PM ET
Session: Adoptive Cell and Natural Killer Cell Therapy
Presenter: Alfred E. Slanetz, Ph. D.
Location: Orange County Convention Center, Poster Section 22, Poster Board 19

About RNA primed SMAR-T cells

SMAR-T is an RNA-enabled T cell therapy targeting multiple driver mutations to extend immunotherapy to the 95% of solid tumor patients who currently don’t have an effective anti-PD1 immunotherapy. Anti-PD1 (Keytruda and Opdivo) provides great benefit to patients whose cancers have high mutational burden by recruiting new T cells from the blood into the tumor and unleashing those previously dormant T cells. Geneius’s treatments deliver a high dose of these cells, whose T cell receptors (TCRs) are "educated" using our proprietary RNA technology to create multiple TCRs recognizing multiple cancer driver mutations in the context of all HLA for the 95% of patients whose tumors have low of mutational burden. SMAR-T expands T cells reactive to multiple driver mutations from the blood with all of the T cell phenotypes for an ideal cancer therapy. The "ultimate TCR-T": SMAR-T uses the entire repertoire of T-cell receptors and HLA in a parallel system targeting multiple, specific cell-surface and internal driver mutations. However, unlike current TCR-T, SMAR-T works with every patient’s HLA, recognizes multiple peptides, is cost effective to manufacture and has no cross-reactivity.

SMAR-T cells kill tumor cells but not normal cells, needing only one amino acid difference to distinguish a cancer mutation from normal. In a single closed system production run, we produce SMAR-T to target greater than 20 driver mutations efficiently and cost effectively in a disposable bioreactor. T cells targeting multiple mutations prevent the cancer from "escaping" therapy by a cell not expressing a particular mutation and allows the T cell product to combat heterogenous solid tumors. Our key product is SMAR-T targeting solid tumors starting with Melanoma, Lung and Pancreatic cancer. We collaborate with Yale (CT) and Mount Sinai (NY/NJ) to conduct clinical trials and phase I manufacturing with clinical data anticipated in 2024.

On April 14, 2023 Biological Dynamics, a life sciences company focused on developing and commercializing exosome isolation technology for earlier disease detection, will present data showing how the company’s ExoVerita platform can be utilized for early detection of lung and pancreatic cancers at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Orlando, Fl., April 14-19 (Press release, Biological Dynamics, APR 14, 2023, View Source [SID1234630110]). A case study of early pancreatic cancer management will also be discussed at the meeting. Biological Dynamics’ will exhibit its technology and early cancer detection assays at booth #1368.

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"We are developing a clinical tool to enable early disease detection in order to improve patient survival outcomes for the most challenging cancers," said Harmeet Dhani, MD, MSc, Medical Director at Biological Dynamics. "Pancreatic and lung cancers are two of the deadliest cancers in the U.S., as they are often diagnosed in late stages, making treatment more difficult and lowering survival chances. Our data clearly demonstrate the ExoVerita platform, with its assay applications, can detect important cancers earlier than standard of care approaches using a new generation of biomarkers and technology. Surveillance of high cancer risk individuals with these new methods should proceed."

Two posters will be presented on April 19 from 9 am to 12:30 pm EDT, including:

"Pancreatic ductal adenocarcinoma (PDAC) early detection," which shows that in 105 pathologically confirmed PDAC cases (Stage 1 = 39; Stage II = 66) and 545 controls, the ExoVita Pancreas assay detected cancer at stages 1 and 2 with 93% sensitivity and 91% specificity. The assay is performed on the ExoVerita platform, which isolates and analyzes EVs, including exosomes found in patient blood samples.
"Liquid biopsy for lung cancer based on extracellular vesicles," presenting data from a pilot study evaluating 143 pathologically confirmed lung cancer cases and 491 controls using a stratified cross-validation approach. Results show that Biological Dynamics’ lung assay, performed on the ExoVerita platform, detected cancer with an overall sensitivity and specificity of approximately 91%.
The poster featuring a case study titled "Early detection of high-grade IPMN using extracellular vesicles – a successful patient story" will be presented on April 16 from 1:30 pm to 5 pm EDT. The case study highlights how the ExoVita Pancreas test (available as a laboratory developed test) can be used as part of a diagnostic workup to aid earlier detection of a high-grade precursor malignant lesion in a patient with acute pancreatitis and no radiographic evidence of lesions found on standard-of-care diagnostic imaging.

Biological Dynamics’ patented ExoVerita platform targets and isolates exosomes which carry informative biomarkers. Assays, like ExoVita, that run on the platform can detect specific, blood-based exosome protein biomarkers, enabling high-sensitivity detection of cancer in its early stages. The presented data suggest the potential for the company’s technology and assays to become an integral component of surveillance for and early detection of cancers.

On April 14, 2023 OncoOne, a biotechnology company focused on discovering precision medicines for cancer and autoimmune diseases, reported two poster presentations highlighting new preclinical data from its oxMIF-targeting drug candidate pipeline at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, held from April 14-19, in Orlando, Florida (Press release, OncoOne, APR 14, 2023, View Source [SID1234630109]). The presentations will feature updated analyses for lead antibody candidate ON203 and first preclinical data from the company’s pre-targeted radioimmunotherapy program, ON-05, both of which demonstrated promising anti-tumor effects. ON203 and ON-05 target the oxidized macrophage migration inhibitory factor (oxMIF), a central regulator of innate immune cells in the tumor microenvironment (TME).

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"MIF’s disease-specific isoform oxMIF is an exciting target for cancer therapy across a range of drug modalities. The positive impact on the tumor microenvironment and the anti-tumor effects we are seeing with ON203, particularly in ex-vivo patient tumoroids, and the first presented data from our PreTarg-it program ON-05 clearly show the potential of this approach. We look forward to further investigating the individual benefits of each of our programs in a range of solid tumor indications," said Randolf Kerschbaumer, Ph.D., CEO of OncoOne.

Alexander Schinagl, Ph.D., CTO of OncoOne added: "We are pleased to see that our PreTarg-it program, ON-05, demonstrated such promising initial preclinical results including significant tumor regression. Our goal at OncoOne is to develop the right drug modality for each indication to broadly explore the value of oxMIF as a target for patients living with solid tumors."

Dr. Jennifer Guerriero, Assistant Professor at Harvard Medical School and Member of OncoOne’s Scientific Advisory Board added: "The preclinical ON203 data is especially encouraging given that it was collected from actual patient tumor material treated with the antibody. These ex-vivo data are extremely value-building for OncoOne as the company approaches the clinic because they provide more accurate analyses beyond what can be generated using standard animal models alone."

Data Summary and Presentation Details ON203
The poster entitled "Targeting the oxidized form of macrophage migration inhibitory factor (oxMIF) with antibody ON203 activates the tumor microenvironment" summarizes new preclinical results evaluating the anti-tumor and TME-modulating effects of the next-generation anti-oxMIF antibody ON203 in human tumoroids which retain an intact TME and are isolated from colorectal adenocarcinoma patients. The data build on and strengthen the excellent tumor penetration, tumor retention and reduced tumor proliferation preclinical data shown in previously analyzed mouse models. As outlined in the poster, ON203 demonstrated tumor cell killing effects in four out of five ON203-treated CRC tumoroids with substantial stimulation effects on immune cells. In responding tumoroids, ON203 activated Natural Killer (NK) and NK T cells (upregulation of Granzyme B and CD107a) and supported an anti-tumor M1 like polarization along with macrophage activation (upregulation of CD16 and HLA-DR). These preclinical data highlight the potential of ON203 to significantly modulate the TME towards immune-stimulating functions in tumor material collected from patients.

The poster #2974 will be presented on Monday April 17th in the poster session "Immunology / Therapeutic Antibodies 3 / Section 24 – Poster Board 21," from 1:30 PM to 5:00 PM ET.

Data Summary and Presentation Details PreTarg-it ON-05
The second poster, titled "Pretargeted radioimmunotherapy with a novel anti-oxMIF/HSG bispecific antibody and a 177Lu-loaded HSG radioligand results in significant tumorregression in murine models of cancer" presents the first preclinical data of OncoOne’s pre-targeted radioimmunotherapy program, ON-05. The PreTarg-it program ON-05 combines an anti-oxMIF/HSG bispecific antibody with a sequentially administered radioligand with high affinity for the bispecific antibody. By pre-targeting the tumor with the bispecific antibody, it can accumulate within the tumor prior to administering the radioactive payload reducing the radiation burden on normal tissues. The study results demonstrated the ability of the anti-oxMIF/HSG bispecific antibody to penetrate and accumulate in the tumor tissue with fast clearance in the circulation. In conjunction with the 177Lu-loaded HSG radioligand significant tumor growth inhibition and survival benefits were demonstrated in colorectal cancer and pancreatic cancer mouse models indicating PreTarg-it ON-05 as a novel therapeutic option for patients living with hard-to-treat tumors.

The poster #585 will be presented on Sunday, April 16th in the poster session "Experimental and Molecular Therapeutics / Targeting the Tumor Microenvironment / Section 20 – Poster Board 19," from 1:30 PM to 5:00 PM ET.

Both posters will be available on OncoOne’s website upon conclusion of the AACR (Free AACR Whitepaper) 2023 Annual Meeting.

About oxMIF
The founders of OncoOne discovered a disease-related isoform of the macrophage migration inhibitory factor (MIF), which they named "oxMIF" (oxidized MIF). OxMIF is generated by a post-translational modification of MIF in inflammatory processes and tumorigenesis. Unlike MIF, oxMIF can only be detected in inflamed tissue and solid tumors but not in healthy tissues. The post-translational modification leads to a structural transformation that exposes epitopes in the MIF homotrimer that are otherwise inaccessible to antibodies in the center of the trimer. Targeting oxMIF as the disease related isoform of MIF overcomes previous significant challenges associated with targeting MIF, making it an ideal candidate for therapeutic intervention in an array of high-need indications.

On April 14, 2023 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported the company will present one poster concerning Phase 1 clinical results for BAT1006 at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting taking place April 14 – April 19, 2023 in Orlando, Florida (Press release, BioThera Solutions, APR 14, 2023, View Source [SID1234630108]).

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The poster, entitled "A Phase I study of BAT1006, a Novel Anti-HER2 Antibody, in Patients with Locally Advanced/Metastatic Solid Tumors," will highlight Phase I clinical data demonstrating the safety and efficacy of BAT1006 in HER2-positive cancer patients. An abstract of the presentation will be available on AACR (Free AACR Whitepaper) website on the day of the presentation.

Presentation details are as follows:

Session Title:

Phase I Clinical Trials

Session Time:

Tuesday Apr 18, 2023 9:00 AM – 12:30 PM

Location:

Orange County Convention Center, Poster Section 46

Poster Board Number:

2

Abstract Number:

CT189

Copies of the poster will be made available on the Company’s website after they are presented.

About BAT1006

BAT1006 is a HER2 extracellular domain II-targetd monoclonal antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) effect aiming for HER2-positive locally advanced/metastatic solid tumors. After the dose escalation trial, dose expansion study of BAT1006 and combination therapy with other HER2-based therapy such as BAT8010 ADC will be initiated for the treatment of HER2-positive cancers.