May 2024 – Page 42 – 1stOncology™: Cancer Intelligence Service

Iovance Biotherapeutics to Present at Upcoming Conferences and Events

On May 24, 2024 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that senior leadership plans to present at the following conferences and events (Press release, Iovance Biotherapeutics, MAY 24, 2024, View Source [SID1234643678]):

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TD Cowen 5th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper)
Fireside Chat: May 28, 2024 at 3:00 p.m. ET
Virtual
Iovance ASCO (Free ASCO Whitepaper) Investor/Analyst Event
Presentation and Key Opinion Leader Panel Discussion: May 31, 2024 at 7:15 p.m. ET
Chicago, IL and Virtual
Jefferies Global Healthcare Conference
Fireside Chat: June 6, 2024 at 9:30 a.m. ET
New York, NY
Goldman Sachs Global Healthcare Conference
Fireside Chat: June 10, 2024 at 2:40 p.m. ET
Miami, FL
Iovance 2024 Annual Meeting
June 11, 2024 at 11:00 a.m. ET
Virtual
The live and archived webcasts will be available at View Source

Inhibrx Inc. Stockholders Approve Sale of INBRX-101 to Sanofi

On May 24, 2024 Inhibrx, Inc. (Nasdaq: INBX) ("Inhibrx," or the "Company") reported that, at a special meeting (the "Special Meeting"), the Company’s stockholders approved the sale to Sanofi of all the assets and liabilities primarily related to INBRX-101, an optimized, recombinant alpha-1 antitrypsin ("AAT") augmentation therapy currently in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency ("AATD") (Press release, Inhibrx, MAY 24, 2024, View Source [SID1234643677]). Immediately prior to the closing of the merger, all non-101 assets and liabilities, including INBRX-105, INBRX-106, INBRX-109, Inhibrx’s non-101 discovery pipeline and its corporate infrastructure, will be spun out from the Company into a new publicly traded company, Inhibrx Biosciences, Inc. ("New Inhibrx").

The final voting results will be filed in a Current Report on Form 8-K with the U.S. Securities and Exchange Commission ("SEC").

Subject to the terms of the definitive agreements announced on January 23, 2024, Sanofi will acquire all outstanding shares of Inhibrx through a merger with an indirect wholly owned subsidiary of Sanofi (the "Merger"), and in turn, each Inhibrx stockholder (a) as of the date of the closing of the Merger will receive: (i) $30.00 per share in cash and (ii) one contingent value right per share, representing the right to receive a contingent payment of $5.00 in cash upon the achievement of a regulatory milestone and (b) as of May 17, 2024, will receive one SEC-registered, publicly listed, share of New Inhibrx per every four shares of Inhibrx common stock held. In addition, in connection with the transactions, Sanofi will assume and retire Inhibrx’s outstanding third party debt, and New Inhibrx will be funded with at least $200 million in cash, with Sanofi retaining an equity interest in New Inhibrx of 8% of outstanding shares of New Inhibrx common stock as of the date of the distribution of New Inhibrx shares.

The Company expects to announce consummation of the transactions within the coming days, subject to the satisfaction or waiver of certain customary closing conditions. Upon closing of the transactions, Inhibrx’s common stock will be delisted from The Nasdaq Global Market and deregistered under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Inhibrx will no longer file periodic reports with the SEC on account of the Company’s common stock.

IN8bio to Present at International Society for Cell & Gene Therapy (ISCT) 2024

On May 24, 2024 IN8bio, Inc. (Nasdaq: INAB) a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported multiple presentations at the International Society for Cell & Gene Therapy 2024, to be held May 28th to June 1st in Vancouver, Canada (Press release, In8bio, MAY 24, 2024, View Source [SID1234643676]).

"ISCT is a scientific gathering renowned for fostering groundbreaking ideas and innovation in cellular therapies," said Dr. Kate Rochlin, Chief Operating Officer of IN8bio. "Our presentations represent a significant and meaningful step in our proprietary manufacturing platform towards the advancement of gamma-delta T cell therapeutics. We will demonstrate how our manufacturing process influences cellular product characteristics and our ability to generate a robust and reproducible final product. Our DeltEx gamma-delta T cell platform has enabled the development of multiple investigational candidates which are now moving into multi-center Phase 2 clinical trials and designed to target and potentially eradicate cancer cells to help improve patient outcomes."

Details of the poster presentations are provided below, and reprints will be accessible following the sessions on the IN8bio website at View Source

INB-400 DeltEx drug resistant immunotherapy (DRI) multi-center clinical trial product logistics management
Poster: #816
Session: Poster Networking Reception #1
Date/Time: May 29th, at 7pm-8:30pm PDT
Presenter: Guoling Chen, Senior Director Quality Operations, IN8bio

Healthy donor vs. Patient manufactured autologous DeltEx DRI product; TCR Repertoire sequencing
Poster: #850
Date/Time: May 29th, at 7pm-8:30pm PDT
Session: Poster Networking Reception #1
Presenter: Mariska ter Haak, Senior Director Analytical Development, IN8bio

HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting

On May 24, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL and online (Press release, Hutchison China MediTech, MAY 24, 2024, View Source [SID1234643675]).

Results will be presented from the registration Phase II study of fruquintinib combined with sintilimab in 98 second-line or above patients with endometrial cancer ("EMC") with pMMR status by central laboratory analysis, which supported the New Drug Application (NDA) filed in China. The primary endpoint was objective response rate ("ORR") per RECIST v1.1, assessed by an independent review committee. The combination showed meaningful efficacy improvements in advanced EMC patients with pMMR status, regardless of prior bevacizumab treatment, with a manageable safety profile. The median follow-up time was 15.7 months. The ORR in 87 efficacy evaluable patients was 35.6% including two complete responses. Disease control rate ("DCR") was 88.5%, and duration of response was not reached, with 80.7% remaining in response after nine months. Amongst the 98 patients, median progression-free survival (PFS) was 9.5 months, and median overall survival (OS) was 21.3 months. Further details are available in the abstract link below.

Following the initial data of the FRUTIGA Phase III study of fruquintinib in second-line gastric cancer published during the February 2024 ASCO (Free ASCO Whitepaper) Plenary Series session, further updated efficacy data in key subgroups, and quality of life data will be presented at this year’s ASCO (Free ASCO Whitepaper) annual meeting. In addition, further data from the FRESCO and FRESCO-2 Phase III colorectal cancer studies, the study of surufatinib combinations in small cell lung cancer, and initial clinical data for the ERK1/2 inhibitor HMPL-295 will be presented.

Details of the presentations, including links to available abstracts, are as follows:

Abstract title

Presenter / Lead author

Presentation details

Exact Sciences Demonstrates Continued Leadership in Early Cancer Diagnosis and Improved Health Outcomes for Patients with Multiple Data Presentations at ASCO®

On May 24, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present 10 abstracts highlighting the breadth and depth of the company’s screening and diagnostic portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31 – June 4, 2024, in Chicago, Ill (Press release, Exact Sciences, MAY 24, 2024, View Source [SID1234643673]). Presentations will include new data confirming both the predictive and prognostic value of the Oncotype DX Breast Recurrence Score test in racially and ethnically diverse patients. Exact Sciences will also present data on its approach to multi-cancer early detection (MCED) across multiple tumor types, plus additional real-world evidence showing optimized screening adherence strategies for the Cologuard test as well as high adherence rates for repeat screenings.

"Exact Sciences’ growing evidence shows that earlier and more personalized treatment interventions lead to greater success for people living with cancer. Therefore, effective cancer screening and diagnostic tools are critical to improving patient outcomes," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology at Exact Sciences. "These data presented at ASCO (Free ASCO Whitepaper) support our goal to set new screening and diagnostic standards through rigorous innovation and real-world data collection across cancer care. We are committed to continuing to develop high-quality tests that meet the needs of all patients, regardless of race, age, or ethnicity."

Precision Oncology
New data from two studies evaluating Recurrence Score results showed that the Oncotype DX Breast Recurrence Score test predicted breast cancer survival across different racial and ethnic groups. The first study confirmed that the test is prognostic for breast cancer-specific mortality and predictive of chemotherapy benefit across racial and ethnic groups in lymph node-negative patients, following propensity score-adjusted analyses. This real-world study of more than 171,000 patients with nonmetastatic, hormone receptor-positive, HER2-negative breast cancer with a Recurrence Score result from the SEER database also showed that the Recurrence Score result was predictive of chemotherapy benefit across all node-positive patients. In the study, non-Hispanic Black patients were shown to have a higher Recurrence Score result and chemotherapy usage compared to other groups. Exploratory analyses of the RxPONDER trial showed that while the test remained prognostic across racial and ethnic groups, non-Hispanic Black patients had higher proliferation axis scores, suggesting that differences in tumor biology may help explain differences in breast cancer outcomes.

Screening
New data suggests benefits of multi-cancer early detection (MCED) in identifying cancers earlier, with patients having a shorter time to diagnosis and fewer late-stage (Stage IV) diagnoses. In a modeling analysis, when MCED was evaluated across 12 different cancer types, it resulted in fewer Stage IV diagnoses relative to diagnosis through usual care, with 38% of Stage IV reductions attributed to cancers without recommended screening guidelines.

Exact Sciences will also share real-world evidence showing high adherence and three-year repeat rate of the Cologuard test. It will also share data demonstrating success with using different digital outreach approaches to help improve screening adherence, leading to high screening completion rates for the Cologuard test across different patient populations.

Data presentations across Exact Sciences’ Precision Oncology and Screening portfolio at ASCO (Free ASCO Whitepaper) 2024:

Precision Oncology

Abstract 515: Recurrence Score Gene Axes Scores by Race and Ethnicity in the RxPONDER Trial
Presenter: Y. Abdou, MD
Session: Rapid Oral Abstract Session
Date/time: Friday, May 31, 3:39 PM – 3:45 PM CDT
Key findings: This study analyzed Recurrence Score gene axis scores and their associations with outcomes to understand the differences in underlying tumor biology among different racial and ethnic groups. Recurrence Score gene axis scores differed by race/ethnicity, with Non-Hispanic Black patients exhibiting higher proliferation axis scores than other groups. This could partially explain the poorer outcomes observed in this population in the RxPONDER trial. These findings highlight the importance of tumor biology and support further investigation into the intricate factors contributing to disparities in outcomes to address them effectively.

Abstract 533/Poster Bd 125: Updated SEER database study of 21-gene assay to assess breast cancer-specific mortality and benefit of chemotherapy by race and ethnicity
Presenter: E. Diego, MD
Session: Poster Session
Date/time: Sunday, June 2, 9:00 AM CDT
Location: Hall A
Key findings: Real-world evidence from the SEER registries in over 145,000 patients with breast cancer confirms that the Oncotype DX Breast Recurrence Score test is prognostic of breast cancer-specific survival across all racial and ethnic groups and predictive of chemotherapy benefit across most groups. This study was performed to further understand the racial and ethnic disparities identified in the TAILORx and RxPONDER phase 3 trials, which used the Oncotype DX test to identify patients with node-negative or node-positive breast cancer who may or may not benefit from chemotherapy. This latest SEER analysis provides further confidence in the prognostic value of the Oncotype DX test regardless of race or ethnicity.

Abstract 508: Development and validation of RSClin N+ tool for hormone receptor-positive (HR+), HER2-negative (HER2-) node-positive breast cancer
Presenter: L. Pusztai, MD, PhD, FASCO
Session: Oral Abstract Session
Date/time: Monday, June 3, 5:24 PM – 5:35 PM CDT
Location: Hall B1
Key findings: The RSClin N+ tool model delivers improved estimates of prognostic risk and absolute chemoendocrine therapy benefit over clinical or genomic data alone for patients with node-positive, HR+/HER2- breast cancer and could be used in patient counseling. Building upon the success of the RSClin tool, the N+ version of the RSClin tool integrates the Recurrence Score result with clinicopathologic factors, stratified by menopausal status, to further enhance its prognostic and predictive value for patients with node-positive disease.

Abstract 576/Poster Bd 168: Evaluating Ki67 and Oncotype DX Recurrence Score during neoadjuvant treatment with letrozole/abemaciclib or chemotherapy in highly proliferative HR+/HER2- breast cancer patients participating in the GEICAM CARABELA trial.
Presenter: A. Guerrero, MD
Session: Poster Session
Date/time: Sunday, June 2, 9:00 AM CDT
Location: Hall A
Key findings: Highly proliferative breast cancer tumors (Ki67 ≥40%) or those with high Recurrence Score results (>25) showed lower residual cancer burden after neoadjuvant chemotherapy treatment versus neoadjuvant letrozole plus abemaciclib. These data confirm the predictive value of Ki67 and Recurrence Score risk assessments and suggest that relying solely on letrozole/abemaciclib as a systemic treatment for these tumors may be insufficient. This is an exploratory analysis from the CARABELA phase 2 trial, which is comparing the efficacy of neoadjuvant chemotherapy vs. neoadjuvant letrozole/abemaciclib treatment in patients with HR+/HER2- breast cancer who are at high/intermediate risk (stage II-III, Ki67≥20%).

Abstract 565: Combination of predicted sensitivity to endocrine therapy (SET2,3 index) and the Recurrence Score in node-positive breast cancer: independent validation in the PACS-01 trial
Presenter: F.M. Penault-Llorca, MD, PhD
Session: Poster Session
Date/time: Sunday, June 2, 9:00 AM CDT
Location: Hall A
Key findings: Combining the Oncotype DX Breast Recurrence Score test with the Sensitivity to Endocrine Therapy (SET2,3) index, a biomarker-based assessment designed to assess a tumor’s response to hormonal therapy, successfully enhanced the prognostic value for patients with node-positive breast cancer. These are data from an independent, blinded validation analysis of the PACS-01 trial, which evaluated sequential adjuvant epirubicin-based and docetaxel chemotherapy for patients with node-positive breast cancer.

Abstract 10584/Poster Bd 111: Clinical and economic benefit of genomic testing strategies to guide the treatment of patients with HR+/HER2- breast cancer in the US
Presenter: B. Heald, MS
Session: Poster Session
Date/time: Monday, June 3, 1:30 PM CDT
Location: Hall A
Key findings: Using a testing strategy that combines both the Oncotype DX Breast Recurrence Score test and germline genetic testing (GGT), which identifies potentially pathogenic cancer variants, can help optimize treatment decisions in early HR+/HER2- breast cancer and improve patient outcomes at reduced costs, according to this health economic modeling study.

Screening

Abstract 11135/Poster Bd 330: Time-to-diagnosis and peri-diagnostic healthcare utilization between screen- and non-screen detected cancers: Evidence from SEER-Medicare
Presenter: X. Cao, PhD
Session: Poster Session
Date/time: Monday, June 3, 9:00 AM CDT
Location: Hall A
Key findings: Effective cancer screening programs successfully shortened the time to diagnosis and reduced the frequency of stage 4 diagnoses for patients with breast or colorectal cancer detected through screening. This retrospective SEER registry analysis reinforces that effective cancer screening technologies have the potential to improve patient outcomes by enabling earlier detection when treatment options are typically most successful.

Abstract 11076/ Poster Bd 271: Effect of multi-cancer early detection testing on late-stage cancers: A modeling study
Presenter: J. Chhatwal, PhD
Session: Poster Session
Date/time: Monday, June 3, 9:00 AM CDT
Location: Hall A
Key findings: In a 50-year modeling simulation, MCED testing resulted in 1,323 fewer Stage IV (24%) cancer diagnoses overall compared to usual care. Thirty-eight percent of these Stage IV reductions were attributable to screening for cancers without recommended guidelines, underscoring the potential of novel MCED strategies to help catch cancers earlier and initiate treatment interventions sooner.

Abstract e15632: Real-world multi-target stool DNA adherence in an underserved and vulnerable prison patient population.
Presenter: J. Kasselman
Session: Publication Only
Date/time: N/A
Location: N/A
Key findings: Among incarcerated persons, mt-sDNA yielded high adherence rates (95.3%) and short completion times (average of 20 days) in this difficult-to-reach population. These data further demonstrate the importance of efforts to uncover patient, provider, and system-level benefits that may be obtained through broader adoption of this highly accessible screening approach in this challenging healthcare setting.

Abstract e15633: Real-world multi-target stool DNA longitudinal adherence for colorectal cancer re-screening in a large, national population
Presenter: M. Greene
Session: Publication Only
Date/time: N/A
Location: N/A
Key findings: In a real-world longitudinal analysis of 481,748 patients, adherence to repeat colorectal cancer (CRC) screening with the Cologuard test remained high (83.6%), and patients who underwent repeat screening once were more likely to continue with a third lifetime Cologuard screening. These data suggest high perceived patient confidence in Cologuard, further reinforcing its potential to help close the CRC screening gap for average-risk individuals.

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Month: May 2024

Iovance Biotherapeutics to Present at Upcoming Conferences and Events

Inhibrx Inc. Stockholders Approve Sale of INBRX-101 to Sanofi

IN8bio to Present at International Society for Cell & Gene Therapy (ISCT) 2024

HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting

Exact Sciences Demonstrates Continued Leadership in Early Cancer Diagnosis and Improved Health Outcomes for Patients with Multiple Data Presentations at ASCO®