On September 5, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will present at the H.C. Wainwright 26th Annual Global Investment Conference (Press release, Cidara Therapeutics, SEP 5, 2024, https://www.cidara.com/news/cidara-to-present-at-the-h-c-wainwright-26th-annual-global-investment-conference/ [SID1234646369]).

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Presentation details are as follows:

Event: H.C. Wainwright 26th Annual Global Conference
Date: Monday, September 9, 2024
Time: 7:00 am ET
Webcast: View Source

Cidara’s presentation will be available on-demand from the above date/time in the investors section on the Company’s website at www.cidara.com. The replay of the presentation will be available for 90 days.

On September 5, 2024 NextPoint Therapeutics, a clinical-stage biotechnology company developing a new class of precision immuno-oncology and tumor-directed therapeutics targeting the novel B7-H7 axis, reported that it has unveiled NPX372, a novel T cell engager (Press release, NextPoint Therapeutics, SEP 5, 2024, View Source [SID1234646385]). NPX372 further expands NextPoint’s multi-modal focus on the emerging B7-H7 axis in cancer therapy.

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B7-H7, also known as HHLA2, is an emerging immunomodulatory receptor upregulated in various solid tumor types, including colorectal carcinoma, non-small cell lung cancer, renal cell carcinoma, prostate cancer, and many others. Notably, this receptor is induced independently of PD-L1 or other B7 family members. Unlike other B7 family proteins that are expressed across a wide range of cell types, B7-H7 is primarily found on the epithelial cells of tumors, making it a unique and potentially specific target for tumor-directed therapies.

"T cell engagers have shown immense potential, but to date their application in solid tumors has remained a formidable challenge. NPX372 represents a significant advancement, aiming to redirect T cell-mediated immunity with high specificity by modulating key biological components, potentially offering more effective monotherapy treatment options for a range of solid tumors," said Tatiana Novobrantseva, PhD, Chief Scientific Officer of NextPoint Therapeutics.

NPX372 is a CD3 bispecific antibody with unique capabilities to redirect T cell-mediated cytotoxicity toward B7-H7-positive tumors. In addition to CD3 engagement, this antibody interacts with the B7-H7 immune axis to achieve added potency. Preclinical data highlight NPX372’s potent anti-tumor responses and a favorable safety profile at clinically relevant doses with no indication of cytokine release syndrome. This asset is part of NextPoint’s diverse portfolio of immunotherapies designed to target various tumor types. NextPoint is rapidly advancing the Investigational New Drug (IND) application for NPX372.

"NPX372 represents a significant advancement in our pursuit of precision immunotherapy," said Ivan Cheung, CEO of NextPoint Therapeutics. "As part of our ongoing immune checkpoint clinical programs, NPX267 and NPX887, we have developed a clinical biomarker for B7-H7 expression, which allows us to selectively target patients across various tumor types who may benefit from a potent T cell engager such as NPX372. This precision medicine approach allows us to potentially address solid tumors expressing B7-H7, tailoring treatments to those who will respond best. Our deep knowledge of B7-H7 biology drives our leadership in advancing innovative, transformative treatments that can make a meaningful difference in the lives of cancer patients."

On September 4, 2024 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported that James Dentzer, President and Chief Executive Officer of Curis, will participate at the following conferences (Press release, Curis, SEP 4, 2024, View Source [SID1234646338]):

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The H.C. Wainwright 26th Annual Global Investment Conference being held September 9 – 11, 2024. Presentation details are as follows:

Format: Company Presentation
Date: Wednesday, September 11, 2024
Time: 1:00 pm ET
H.C. Wainwright webcast
The 2024 Cantor Fitzgerald Global Healthcare Conference being held September 17 – 19, 2024. Presentation details are as follows:

Format: Fireside Chat
Date: Tuesday, September 17, 2024
Time: 3:05 pm ET
Cantor webcast
Webcasts will be also available on the Curis website at www.curis.com in the ‘Investors’ section.

On September 4, 2024 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported that the company and collaborators from the biopharma industry and leading cancer centers, including those within the Caris Precision Oncology Alliance (POA), will collectively present seven studies across a wide range of tumor types at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain from September 13-17, 2024 (Booth #608) (Press release, Caris Life Sciences, SEP 4, 2024, View Source [SID1234646354]). The findings demonstrate the power of Caris’ comprehensive multi-modal database to enable novel insights into cancer that could have profound effects on a patient’s diagnosis, prognosis, care plan and response to treatment.

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"The research being presented at this year’s ESMO (Free ESMO Whitepaper) Congress is a testament to Caris’ continued commitment to data-driven molecular innovation and the power of our ever-expanding network of collaborators to answer some of today’s pressing questions in precision oncology," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The findings underscore the critical role of comprehensive profiling in cancer care and the power of large clinico-genomic datasets to enable the identification of new biomarkers with clinical implications across diverse tumor types. Through extensive sequencing and data analysis efforts, we are unlocking new avenues for tailored therapies to revolutionize cancer treatment."

"Our comprehensive molecular profiling coupled with rich clinical data is enabling Caris to help clinicians make the best treatment choices, researchers to discover novel cancer biology, and the biopharmaceutical industry to develop the next breakthrough medicines," said Caris President David Spetzler, MS, PhD, MBA. "Our vast real-world evidence from over 689,000 cases, including over 550,000 with matched molecular data and outcomes, enables our team and research collaborators to better understand the biological hallmarks of cancers and how they impact clinical outcomes, paving the way for personalized therapies and improved patient outcomes."

Mini oral presentations include:

Metastatic hormone receptor-positive breast cancer outcomes in 628 patients with BRCA1, BRCA2, or PALB2 pathogenic variants: Real world data analysis of genomics and targeted therapy sequencing. (Abstract Number: 342MO)
September 15, 2024

Atlas of tertiary lymphoid structures in solid tumors: Genomic features and prediction of response to immunotherapy. (Abstract Number: 75MO)
September 16, 2024
Poster presentations include:

Impact of TLS Status on outcomes in patients with high TMB or MSI-high status treated with immune checkpoint inhibitors. (Abstract Number: 1051P)
September 14, 2024

Comparison of breast and gastric HER2 immunohistochemistry (IHC) scoring criteria in the assessment of endometrial endometrioid adenocarcinoma (EEA). (Abstract Number: 739P)
September 14, 2024

METPRO: Evaluating prognostic value of c-Met protein overexpression and concurrent biomarker presence. (Abstract Number: 1303P)
September 14, 2024

Genomic landscape & prognostic impact of HER2 low-expressing tumors. (Abstract Number: 126P)
September 15, 2024

Molecular and immunologic correlates of high PSMA/FOLH1 mRNA expression in prostate cancer (PC). (Abstract Number: 1653P)
September 15, 2024
Poster and abstract summaries highlighting the Caris research presented at ESMO (Free ESMO Whitepaper) 2024 will be available onsite at Caris’ Booth #608. The full abstracts will be available on the Caris website at the event’s conclusion.

The Caris POA includes 95 cancer centers, academic institutions, research consortia and healthcare systems, including 46 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients.

On September 5, 2024 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, which is taking place virtually and in-person in Barcelona, Spain from September 13 to 17 (Press release, Eisai, SEP 4, 2024, View Source [SID1234646370]).

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First presentation of results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating lenvatinib (LENVIMA), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC) will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium (NCT04246177(New Window); Presentation: #LBA3).

"The late-breaking data from the Phase 3 LEAP-012 trial add to a growing body of research that we have undertaken in hepatocellular carcinoma, reinforcing Eisai’s longstanding commitment to people living with this devastating disease," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "We are eager to share these findings at ESMO (Free ESMO Whitepaper), alongside our other research on lenvatinib monotherapy and in combination with pembrolizumab, and pipeline developments, as this crucial scientific exchange fuels our mission to accelerate progress in oncology and help improve the lives of patients and families affected by cancer."

Additionally, a Mini Oral presentation will feature real-world evidence for patients with radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) treated with lenvatinib monotherapy in Europe and Canada (Presentation: #1926MO). Research into the use of lenvatinib monotherapy in patients with HCC from the Phase 4 STELLAR study (Presentation: #964P) and from a real-world study utilizing the LINK (Liver cancer IN Korea) research network (Presentation: #972P) will be shared in poster presentations. An exploratory analysis from the Phase 3 LEAP-001 trial evaluating tumor response with lenvatinib plus pembrolizumab for patients with advanced or recurrent endometrial carcinoma will also be presented (NCT03884101(New Window); Presentation: #737P).

Research from Eisai’s pipeline includes a quality-of-life analysis from the Phase 3 EMERALD study in Japan evaluating either Eisai’s eribulin (HALAVEN) or a taxane in combination with trastuzumab and pertuzumab in patients with HER2-positive, locally advanced or metastatic breast cancer (NCT03264547(New Window); Presentation: #373P); findings from a Phase 1b dose-expansion cohort evaluating E7386 (a CBP/β-catenin interaction inhibitor) in combination with lenvatinib in patients with advanced endometrial carcinoma with progression following prior anti-PD-(L)1 immunotherapy and platinum-based chemotherapy (NCT04008797(New Window); Presentation: #738P); as well as presentations for BB-1701, an antibody drug conjugate which combines an anti-HER2 antibody with Eisai’s approved anticancer drug eribulin via its linker, in previously-treated patients with HER2-positive or HER2-low unresectable or metastatic breast cancer (NCT06188559(New Window); Presentation: #437TiP) and non-small cell lung cancer patients with HER2 mutation/amplification (Presentation: #1296P; presented by Bliss Biopharmaceutical Co., Ltd), respectively.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. Regular abstracts will be made available via the ESMO (Free ESMO Whitepaper) website on Monday, September 9, at 12:05 AM Central European Summer Time (CEST). Late-breaking abstracts accepted for presentation at ESMO (Free ESMO Whitepaper) as a Proffered Paper or Mini Oral will be published on the ESMO (Free ESMO Whitepaper) website at 12:05 AM CEST on the day of the presentation. Posters will be on display from 9:00 AM – 5:00 PM CEST on the day of their poster session.

Cancer Type Study/
Compound Abstract Title Abstract Type & Details
Lenvatinib Plus Pembrolizumab
Genitourinary Cancer LEAP-012 Transarterial chemoembolization (TACE) with or without lenvatinib (len) plus pembrolizumab (pembro) for intermediate stage hepatocellular carcinoma (HCC): phase 3 LEAP-012 study
Presidential Symposium
(Proffered Paper Session)
Presentation #LBA3
September 14, 2024
5:36-5:48 PM CEST

Endometrial Carcinoma
LEAP-001

Characterization of tumor response with lenvatinib plus pembrolizumab (LEN + Pembro) in the ENGOT-en9/LEAP-001 study
Poster Session
Presentation #737P
September 14, 2024

Lenvatinib
Differentiated
Thyroid Cancer Real-World Evidence
Radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) patients treated with lenvatinib monotherapy: real-world treatment patterns and clinical outcomes in Europe and Canada

Mini Oral Presentation
Presentation #1926MO
September 13, 2024
4:05-4:10 PM CEST

Gastrointestinal Cancer

Real-World Evidence

Efficacy and safety of lenvatinib vs. sorafenib in hepatocellular carcinoma: a multi-center real-world study from the LINK research network
Poster Session
Presentation #972P
September 16, 2024

STELLAR

Lenvatinib (L) and sorafenib (S) in patients (pts) with advanced or unresectable hepatocellular carcinoma (uHCC): an international, multicenter, phase 4 study (STELLAR)
Poster Session
Presentation #964P
September 16, 2024

Eribulin
Breast Cancer JBCRG-M06/ EMERALD
Quality-of-life outcomes in patients with HER2-positive, locally advanced or metastatic breast cancer treated with eribulin mesylate in combination with trastuzumab and pertuzumab in the phase 3 JBCRG-M06/EMERALD study

Poster Session
Presentation #373P
September 16, 2024

Pipeline
Endometrial Carcinoma E7386 Global, phase 1b dose-expansion cohort of E7386 + lenvatinib (LEN) in patients (pts) with advanced (a) endometrial cancer (EC) that progressed on platinum-based chemotherapy (CTx) and an anti-PD-(L)1 immunotherapy (IO)
Poster Session
Presentation #738P
September 14, 2024

Breast Cancer BB-1701 An open-label, multicenter, phase 2 study to evaluate the safety and efficacy of BB-1701, a novel antibody drug conjugate (ADC) targeting HER2, in previously treated patients (pts) with HER2+ or HER2-low unresectable or metastatic (M) breast cancer (BC)
Poster Session
Presentation #437TiP
September 16, 2024

Non-Small Cell Lung Cancer BB-1701 A phase 2 study to evaluate the efficacy and safety of BB-1701 in advanced or metastatic NSCLC patients with HER2 mutation/amplification (Presented by Bliss Biopharmaceutical Co., Ltd.)
Poster Session
Presentation #1296P
September 14, 2024　

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, pembrolizumab. Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across multiple clinical trials.

In May 2023, Eisai entered into a joint clinical trial collaboration agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd. (Headquarters: Zhejiang Province, China, "BlissBio"), for BB-1701, a HER2-targeting antibody drug conjugate (ADC), with option rights for a strategic collaboration. Eisai is currently investigating BB-1701 in a Phase 2 clinical trial in Japan and the United States for breast cancer, and BlissBio is investigating a Phase 1/2 clinical trial in the United States and China for HER2-expressing solid tumors.