On June 4, 2021 Aadi Bioscience, Inc. ("Aadi"), a privately-held clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported preliminary data from its lead investigational product candidate, FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009), during the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting being held virtually from June 4-8, 2021 (Press release, Aadi Bioscience, JUN 4, 2021, View Source [SID1234583540]). The poster is entitled "Institutional experience with nab-sirolimus in patients with malignancies harboring TSC1 or TSC2 mutations".1

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Dr. Mark Dickson, Principal Investigator of the study at Memorial Sloan Kettering Cancer Center stated, "I am encouraged by the activity of nab-sirolimus in multiple solid tumor histologies with TSC1 or TSC2 inactivating alterations. These new data provide strong rationale for conducting a broader investigation of nab-sirolimus in a tumor-agnostic setting. If the observed activity were reproduced, this could represent a meaningful advance in treatment for these patients."

Analysis from Expanded Access Patient Subset

Eight patients with malignancies and neoplasms bearing TSC1 or TSC2 inactivating alterations and representing histologies other than malignant PEComa were treated in a multi-institution expanded access program (NCT03817515) with FYARRO at 100 mg/m2 on day one and day eight of a 21-day cycle. RECIST v1.1 criteria were used for response analysis. Data cutoff occurred in March 2021.

Patients had a median of 3.5 lines of prior therapy and 6 of 8 patients were mTOR inhibitor-naïve. Treatment duration for all patients ranged from 0.7 to 12.0+ months. Five of 8 patients continued on treatment as of the data cutoff and 3 of 8 patients discontinued. Reasons for discontinuation were progressive disease (2 patients) and an adverse event (1 patient with acute kidney injury possibly secondary to administration of contrast).

Of the 8 patients treated, 7 patients were evaluable for response analysis and 1 patient progressed before the first scan. Five of 8 patients (63%, 95% CI: 25%-92%) achieved a confirmed partial response (PR). Amongst the patients who were mTOR inhibitor-naïve, 5 of 6 (83%, 95% CI: 36%-99+%) achieved a confirmed PR. Duration of response at data cutoff ranged from 3.1 to 9.7+ months and 3 of 5 responders continue on treatment.

Treatment-emergent adverse events that were ≥30% included edema, infections, mucositis, and pain (71% each), nail changes and vomiting (57% each), and hypertension and nausea (43% each). The majority of events were grade one or grade two. Treatment-related serious adverse events were reported in 2 patients and included hyperglycemia and infection; and acute kidney injury possibly secondary to administration of contrast. Three of 8 patients had a dose reduction from 100 mg/m2 to 75 mg/m2.

Dr. Neil Desai, founder and chief executive officer of Aadi, stated, "We are pleased to have provided FYARRO to patients through our expanded access program. Based on the data in this initial group of patients, and patients in the AMPECT trial with PEComa, we are planning to move forward with a tumor-agnostic registrational trial to confirm FYARRO’s activity in solid tumors with TSC1 or TSC2 inactivating alterations with planned initiation by the end of 2021."

On June 4, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in a fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Virtual Conference, which will be webcast on Thursday, June 10, 2021 (Press release, Bristol-Myers Squibb, JUN 4, 2021, View Source [SID1234583557]). Chris Boerner, Ph.D., Executive Vice President, Chief Commercialization Officer and Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Global Drug Development, will answer questions about the company at 9:40 a.m. ET .

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Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

On June 4, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported data demonstrating the differentiation of balstilimab as an anti-PD-1 antibody as well as data from a Phase 1 clinical trial of AGEN2373, a CD137 agonist antibody, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021 from June 4 – 8, 2021 (Press release, Agenus, JUN 4, 2021, View Source [SID1234583573]).

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Agenus submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) on April 19, 2021 for the use of balstilimab in patients with recurrent or metastatic cervical cancer. This submission was based on data from a Phase 2 trial in patients with recurrent or metastatic cervical cancer. These data show a response rate of 20% in PD-L1 positive tumors and an overall response rate of 15%, with a median duration of response of 15.4 months. Balstilimab shows responses across histology subgroups and in populations of patients typically unresponsive to commercially available therapies, such as patients with PD-L1 negative tumors.

Preclinical studies using Agenus’ proprietary R&D VISION platform underscored these observed clinical data. VISION demonstrates that balstilimab may be superior to currently approved anti-PD-1 antibodies such as pembrolizumab and nivolumab. Balstilimab showed superior tumor killing in both PD-L1 positive and PD-L1 negative tumors compared to commercially available anti-PD-1 antibodies in these studies.

"We are encouraged by the initial performance of our VISION platform both for drug discovery and potential therapeutic predictive modeling. It has the potential to bring effective treatments to patients more rapidly," said Steven O’Day, MD, Chief Medical Officer of Agenus. "AGEN2373 continues to show no liver toxicity in the clinic, and we expect the anticipated combination trials to provide potential benefit to patients."

AGEN2373 is a CD137 agonist antibody designed to overcome limitations seen with first-generation CD137 agonist antibodies, particularly the development of liver toxicity. In this first-in-human study of AGEN2373 in patients with advanced solid tumors, no dose limiting toxicities were seen at doses up to 3 mg/kg; notably, no liver toxicity has been observed well above the threshold at which liver toxicity is usually seen with other CD-137 agonist antibodies. Five patients demonstrated stable disease out of 22 patients treated with AGEN2373 monotherapy, with prolonged stable disease observed in three of these patients. AGEN2373 is expected to provide benefit especially in combination therapy, and combination trials are in planning.

Presentation Details:

Abstract title: Differentiated activity profile for the PD-1 inhibitor balstilimab
Abstract number: 5529
Poster Session: Gynecologic Cancer
Presenting author: Cailin Joyce, PhD

Abstract title: Initial findings of the first-in-human Phase I study of AGEN2373, a conditionally active CD137 agonist antibody, in patients (pts) with advanced solid tumors
Abstract number: 2634
Poster Session: Developmental Therapeutics—Immunotherapy
Presenting author: Anthony Tolcher, MD

About balstilimab
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Balstilimab is currently in clinical trials as monotherapy and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an ongoing Phase 2 study for recurrent/metastatic cervical cancer. A Biologics License Application has been submitted to the U.S. Food and Drug Administration for the use of balstilimab to treat recurrent/metastatic cervical cancer.

About AGEN2373
AGEN2373 is a novel, fully human monoclonal conditionally active CD137 agonist antibody designed to selectively enhance CD137 co-stimulatory signaling in activated immune cells while mitigating side effects associated with systemic activation of CD137. CD137 (4-1BB) is a positive regulator of the immune system that is highly upregulated on activated T cells (adaptive immune cells) and NK cells (innate immune cells). AGEN2373 is currently in a Phase 1 clinical trial against solid tumors.

About VISION
VISION (VIrtual Systems for Immuno-ONcology) is an active learning platform that mimics a patient’s tumor microenvironment and immune system in order to define predictive biomarker signatures. VISION leverages advanced analytics to explore an immense range of drug-biology interactions not possible via traditional processes. Producing informative data feedback loops in real-time, VISION enables quicker validation of drug targets, faster optimized molecule design and drug candidate selection, and personalized treatment regimens based on biomarker signatures.

On June 4, 2021 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by Amgen to be a specialty pharmacy partner for LUMAKRAS (sotorasib), a new oral treatment for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy (Press release, Onco360, JUN 4, 2021, View Source [SID1234583589]).

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"Onco360 is honored to be selected as a specialty pharmacy provider for LUMAKRAS in partnership with Amgen," said Benito Fernandez, Chief Commercial Officer, Onco360. "The recent approval of LUMAKRAS unlocks the first FDA-approved treatment option for patients with previously treated advanced or metastatic KRAS G12C-mutant NSCLC. As a provider of this key treatment, Onco360 is committed to supporting the highly specialized needs of NSCLC patients."

ABOUT METASTATIC NON-SMALL CELL LUNG CANCER

According to the National Cancer Institute’s (NCI’s) Surveillance, Epidemiology, and End Results (SEER) program, 235,760 patients will be diagnosed with lung cancer in 2021, with a corresponding 131,880 deaths. When considering all stages and histologic subtypes of the disease, the five-year overall survival (OS) of lung cancer is 21.7%. Patients with Stage IV metastatic disease have a five-year OS of only 6.3%. Unfortunately, 56% of lung cancer patients have metastatic disease upon initial diagnosis. Up to 85% of lung cancer cases are classified as NSCLC.1 Approximately 13% of NSCLC patients have KRAS G12C mutations.2

LUMAKRAS is manufactured by Amgen, a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer. The FDA’s approval of LUMAKRAS comes as a result of a 124 patient subset of the Phase I/II CodeBreak 100 clinical trial (NCT03600883) which demonstrated that previously treated patients with metastatic KRAS G12C-mutant NSCLC experienced a 36% objective response rate (ORR) after LUMAKRAS ad

On June 4, 2021 Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, reported the results of a study focused on evaluating a novel biomarker approach for immunotherapy, utilizing its comprehensive genomic and transcriptomic profiling (CGTP) assay paired with real-world clinical data to predict pembrolizumab benefit in patients with advanced solid tumors (Press release, Strata Oncology, JUN 4, 2021, View Source [SID1234583607]). The data were shared during a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place virtually from June 4-8, 2021.

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The study found that PD-L1, PD-L2 and tumor mutation burden (TMB) from the CGTP test independently predicted pembrolizumab benefit in pan-solid tumors – and when combined in a multivariate signature score – predicted benefit better than PD-L1 or TMB alone. Across a dataset of over 20,000 advanced solid tumors, the Strata immune response score identified 12% of all patients across a range of solid tumor types that are outside of currently approved indications but predicted to benefit from immunotherapy. The multivariate signature, developed from the Strata clinical-molecular database and real-world data, also predicted pembrolizumab benefit relative to chemotherapy across solid tumors.

The study included 610 patients with advanced solid tumors with TMB and immune gene expression data from the Strata Oncology CGTP tissue test and documented pembrolizumab treatment outcomes. Pembrolizumab treatment benefit was assessed by time to next treatment (TTNT), which was validated against overall survival. Real-world TTNT was defined as time in months from therapy start to new treatment or death.

"Immune checkpoint inhibitors are approved in many solid tumor types, but current biomarkers for predicting response are imperfect," said Scott Tomlins, MD, PhD, Chief Medical Officer at Strata Oncology. "Currently a minority (20-30%) of patients are estimated to respond to PD-1/PD-L1 therapy so the development of biomarkers for predicting the efficacy of immune checkpoint inhibitors is urgent. Strata’s multivariate biomarker, derived from our genomic and transcriptomic profiling assay, may expand the pan-tumor treatable population beyond current biomarkers."

The full poster can be viewed at www.asco.org.

Poster details

Title: Comprehensive genomic and transcriptomic profiling (CGTP) to predict pembrolizumab benefit in patients with advanced solid tumors
Session: Developmental therapeutics – immunotherapy
Subtrack: Tissue-based biomarkers
Abstract #: 2609