On May 29, 2024 ConcertAI, the leader in oncology predictive and generative AI SaaS and Real-World Data (RWD) Solutions for clinical research, reported the results of the study to be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting 2024 utilizing its real-world oncology dataset (Press release, ConcertAI, MAY 29, 2024, View Source [SID1234643807]). The study, conducted in cooperation with Merck & Co., Inc., and AstraZeneca, has found earlier treatment with oliparib monotherapy may improve duration of therapy and overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC).

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This real-world analysis indicates many mCRPC patients with homologous recombination repair gene mutation (HRRm) are receiving several lines of therapy prior to olaparib, even when novel hormonal agents (NHA) are used prior to mCRPC. HRRm+ patients with confirmed mCRPC diagnosis, age ≥21 years, treated with olaparib monotherapy (post May 19, 2020) and prior to abiraterone or enzalutamide were abstracted from electronic medical records in the ConcertAI Oncology Dataset with PC diagnosis between 1990 and 2023. Frequency of patients who progressed from metastatic hormone-sensitive PC (mHSPC) and from non-metastatic CRPC (nmCRPC) to mCRPC and treatment patterns prior to mCRPC were summarized.

Jeff Elton, PhD, CEO of ConcertAI stressed, "This study underscores the potential of real-world data to support specific treatment decisions and improved patient outcomes. By analyzing our vast dataset of de-identified patient records, we were able to provide compelling evidence that earlier treatment with oliparib can significantly extend the duration of therapy and overall survival for patients with metastatic castration-resistant prostate cancer. This reinforces our core mission of transforming data housed in electronic health records into actionable insights that directly benefit patient care."

This study will be presented at a poster session at the ASCO (Free ASCO Whitepaper) Annual Meeting 2024 on Sunday, June 2, between 9:00 am and 12:00 pm. Please visit poster #460 to learn more during that time. Alternatively, please visit the ConcertAI booth number 12045 at any time during exhibit hall hours.

On May 29, 2024 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases and cancer, reported that Chris Kirk, Co-founder and Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 5, 2024, at 12:30 pm ET in New York, NY (Press release, Kezar Life Sciences, MAY 29, 2024, View Source [SID1234643824]).

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A webcast of the panel discussion will be available on the "Events & Presentations" section of the Company’s website at www.kezarlifesciences.com. Following the event, an archived webcast will be available on the Kezar website for 90 days.

On May 28, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported that members of its senior management team will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 11:30 a.m. Eastern Time (Press release, Abeona Therapeutics, MAY 28, 2024, View Source [SID1234643723]). The Company will also participate in one-on-one investor meetings at the conference.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the fireside chat will be available on the Investors section of the Abeona website under "Events" at View Source The webcast will be archived for 30 days.

On May 28, 2024 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the presentation of updated data from the completed dose escalation part and first data from the ongoing expansion part of Study 1100, a US Phase 1 study evaluating NBTXR3 followed by anti-PD-1 in patients with recurrent or metastatic head and neck cancer (n=68) at the 2024 Annual Meeting of the American Society for Clinical Oncology (Press release, Nanobiotix, MAY 28, 2024, View Source [SID1234643739]). The data will be presented by Study 1100 Coordinating Investigator Colette Shen, MD, PhD, during a poster presentation session that begins at 10:00 AM EDT / 4:00 PM CEST on Sunday, June 2nd, 2024.

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ABSTRACT #6035: Early signs of efficacy in patients with anti-PD-1 naïve (n=33) and anti-PD-1 resistant (n=35) HNSCC treated with NBTXR3/SBRT in combination with nivolumab and pembrolizumab in the phase 1 trial Study 1100
Colette Shen1, Jessica Frakes2, Trevor Hackman1, Jiaxin Niu3, Jared Weiss1, Jimmy Caudell2, George Yang2, Tanguy Seiwert4, Paul Chang5, Septimiu Murgu5, Siddharth Sheth1, Shetal Patel1, Kedar Kirtane2, David Rolando6, Pavel Tyan6, Omar I. Vivar6, Zhen Gooi5, Aditya Joolori5, Ari Rosenberg5

Nanobiotix Investor Call

Nanobiotix will host a conference call and webcast featuring Nanobiotix chief executive officer and chairman of the executive board, Laurent Levy, following the poster session on Sunday June 2nd, 2024, at 12:00 PM EDT / 6:00 PM CEST.

Details for the call are as follows:

Audio-only dial-in link: click here

Webcast link: click here

Participants can use the audio-only link above to register and obtain dial-in instructions to listen to the presentation via phone and ask questions during the Q&A session, or participants can use the webcast link to register and listen and watch the slide presentation online; the replay version will be available under the same webcast link shortly after the presentation and will be archived on the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior to the event start. Participants are invited to email their questions in advance to [email protected].

1University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA; 2Moffitt Cancer Center, Tampa, Florida, USA; 3Banner MD Anderson Cancer Center, Gilbert, Arizona, USA; 4Johns Hopkins Medicine, Baltimore, Maryland, USA; 5The University of Chicago, Chicago, Illinois, USA; 6Nanobiotix, SA, Paris, France

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV.

On May 28, 2024 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, reported that it has entered a clinical collaboration with MEDSIR (www.medsir.org), a Spanish and US-based, international and innovative research organization in clinical oncology (Press release, MedSIR, MAY 28, 2024, View Source [SID1234643756]). The study will evaluate the safety and efficacy of Debio 0123 (Debiopharm’s investigational, potential best-in-class WEE1 inhibitor) together with sacituzumab govitecan (Trodelvy; an antibody-drug conjugate [ADC] owned and commercialized by Gilead Sciences, Inc. [Gilead]). Sites for this Phase 1b/2 investigator-initiated trial in patients with previously treated advanced breast cancer will be opened in Europe, UK, and the USA.

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Hormone receptor-positive (HR+)/HER2- is the most common type of breast cancer and it accounts for 70% of all breast cancers. It groups estrogen-receptor (ER) and/or progesterone-receptor (PR) expressing cells. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%. As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy. For patients treated with single-agent chemotherapy, the prognosis remains poor [1]. Despite having a more favorable outcome than other breast cancer subtypes like HER2-positive and triple-negative breast cancers (TNBC), relapse still occurs and there remains a high unmet medical need for this patient population [2-3]. TNBC is an aggressive type of breast cancer that accounts for 10-15% of all breast cancers. It is called "triple negative" as it does not express ER, PR or HER2 receptors. Because of its aggressive nature, TNBC has a high risk of metastasis either at diagnosis or at time of relapse after initial curative therapy, which explains the poor prognosis many TNBC patients face. Compared to other types of breast cancer, the relapse rate as well as the mortality rate in the 5 years after diagnosis is significantly higher [4-5].

"It’s great to see companies like Debiopharm that are open to investigating novel combination strategies to support breast cancer patients. I look forward to seeing potential benefits for patients" Dr. Tim Robinson, Principal Investigator, University of Bristol.

Sacituzumab govitecan is a Trop-2-directed ADC currently approved globally for patients with 2L metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer The clinical trial will enroll patients with HR[+]/HER2[-] metastatic breast cancer and metastatic TNBC, and will be sponsored by MEDSIR, and fully funded by Debiopharm. Gilead will provide supply of sacituzumab govitecan.

"We are honored to develop this Investigator Sponsor Trial (IST) in collaboration with Debiopharm and Gilead to explore new approaches to breast cancer treatment. Together, we’re committed to advancing patient care and fostering important partnerships in the oncology field. I believe our work with Debio 0123 and sacituzumab govitecan holds great promise for patients" said Dr. Javier Cortés, MEDSIR Senior Scientific Lead.

The foundations for this clinical trial were set by the promising preclinical data suggesting an existing synergy between Debiopharm’s Debio 0123 and Gilead’s sacituzumab govitecan. These results will be disclosed at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting 2024 under the title "Anti-tumor activity of Debio 0123 in combination with sacituzumab govitecan in preclinical models of breast cancer" [6].

About Debio 0123

Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, allowing cells to repair their DNA before resuming their cell cycle. WEE1 inhibition, particularly in combination with DNA damaging agents, induces an overload of DNA breaks. In conjunction with abrogation of other checkpoints such as G1, the compound pushes the cells through cell cycle without DNA repair, promoting mitotic catastrophe and inducing apoptosis of cancer cells. Currently investigated in clinical trials for solid tumors in monotherapy and combination, Debio 0123 is being developed to respond to high unmet needs of patients living with the burden of difficult-to-treat cancers.