Sixteen Researchers from Florida Cancer Specialists & Research Institute Share Cancer Care Discoveries at 2024 ASCO® Annual Meeting

On May 29, 2024 Florida Cancer Specialists & Research Institute, LLC (FCS) physicians reported that it will present findings from multiple clinical studies that are contributing to global advancements in cancer care at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Florida Cancer Specialists & Research Institute, MAY 29, 2024, View Source;research-institute-share-cancer-care-discoveries-at-2024-asco-annual-meeting-302158316.html [SID1234643808]). Clinical research originating from trials conducted at the three FCS Phase 1 Drug Development Units and late-phase studies at FCS clinics throughout Florida are among those being published or presented during the five-day international gathering of oncology physicians and professionals.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Florida Cancer Specialists & Research Institute research featured in 37 presentations/publications at 2024 ASCO (Free ASCO Whitepaper).

"It is gratifying to see how FCS continues to expand the understanding of cancer worldwide," said FCS President & Managing Physician Lucio N. Gordan, MD. "Our clinical research efforts are patient centric. Each discovery enables us to target treatments with greater precision and impact for patients."

Manish Patel, MD, FCS director of drug development, notes that much of the clinical research being presented is focused on targeted treatments and biological combinations. Dr. Patel said, "The phase 1/2 trials offered at FCS provide patients early access to the most promising therapies and consistently lead to expedited FDA approvals that expand availability on a global scale."

Several FCS principal investigators are first authors of four abstracts that will be presented throughout the meeting:

Manish Patel, MD
Preliminary results from a phase 1 study of AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer
Safety and preliminary efficacy of EIK1001 in combination with atezolizumab in participants with advanced solid tumors.
Dr. Patel is a co-author of eight additional presentations
Judy Wang, MD, FCS associate director of drug development
Phase 1/2 study of NGM707, an ILT2/ILT4 dual antagonist antibody, in advanced solid tumors: Interim results from dose-escalation.
She also is first author of the published abstract, A novel oral microtubule inhibitor utidelone capsule (UTD2): A phase 1 clinical study to assess the tolerability, safety, and efficacy in advanced solid tumors, of which Dr. Manish Patel is a co-author.
Dr. Wang is also a co-author of six additional presentations
Maen Hussein, MD – NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Updated overall survival analysis with 29-month follow-up of NAPOLI 3.
FCS hematologist and medical oncologist Cesar Augusto Perez, MD will present an oral education session titled, "Emerging Data for Antibody Drug Conjugates in Head and Neck Squamous Cell Carcinoma."

The following FCS principal investigators will have their abstracts presented during oral presentations of research results and other clinical findings which they have co-authored:

Kapisthalam Kumar, MD, FACP – Are we bridging the gap? A ten-year probe into NIH grants for early-career and independent investigators in oncology.
Manish Patel, MD – Safety and preliminary efficacy of EIK1001 in combination with pembrolizumab in participants with advanced solid tumors
Vipul Patel, MD – Primary results from the phase 3 EVOKE-01 study of sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO).
Cesar Augusto Perez, MD, Amir Harandi, MD, MS – Phase 2 study of petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC)
Cesar Augusto Perez, MD – Updated phase 1 results of efficacy and safety of sigvotatug vedotin, an investigational ADC, in non-small cell lung cancer
FCS Associate Director of Drug Development Judy Wang, MD, Gail Lynn Shaw Wright, MD, FACP, FCCP, Fadi Kayali, MD — H3B-6545 in women with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (–) breast cancer (BC).
"We’re winning. We’re beating cancer," said Bradley Monk, MD, gynecologic oncologist and FCS medical director of late-phase clinical research. "Our discoveries through clinical trials are helping patients live longer and better lives." Dr. Monk is co-author of four presentations at ASCO (Free ASCO Whitepaper), including the results of the international phase 3 OUTBACK trial of racial disparities and survival outcome of patients with locally advanced cervix cancer.

Results from additional FCS co-authors will also be presented in various sessions, 26 in total, highlighting a variety of cancer types and treatment modalities:

Faithlore Gardner, MD
Todd Gersten, MD
Lucio N. Gordan, MD with FCS Senior Director of Partnerships, Managed Care Kiana Mehring
Joel Grossman, MD
Elizabeth Guancial, MD
"Our commitment to oncology research is stronger than ever and clearly demonstrated by sheer volume of abstracts presented by FCS researchers at this global symposium," stated FCS Chief Executive Officer Nathan H. Walcker. "The insights and breakthroughs revealed here fortify our resolve to tirelessly innovate and improve outcomes for patients worldwide."

FCS will be featured in 37 presentations and publications over the course of the conference. All abstracts and presentations are available to view at ASCO (Free ASCO Whitepaper) 2024 Annual Meeting.

The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO (Free ASCO Whitepaper) works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care.

View a full list of the FCS abstracts presented here: FLCancer.com/FCS-2024-ASCO-Presentations-052924.pdf

ConcertAI: ASCO 2024 study uses ConcertAI Oncology Dataset to find earlier treatment with oliparib monotherapy may improve duration of therapy and overall survival

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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Aadi Bioscience to Participate in the Jefferies Healthcare Conference

On May 29, 2024 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, reported participation in the Jefferies Healthcare Conference, taking place June 5-6, 2024, in New York. Dave Lennon, Ph.D., President and CEO, will participate in a fireside chat on Wednesday, June 5, 2024, from 2:00 PM – 2:25 PM EDT (Press release, Aadi Bioscience, MAY 29, 2024, View Source [SID1234643806]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The fireside chat will be webcast live on the IR pages of the Aadi Bioscience website and will be available for replay for approximately 30 days following each investor event.

Jazz Pharmaceuticals to Participate in Upcoming June Investor Conferences

On May 29, 2024 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that Company management will participate in the following investor conferences (Press release, Jazz Pharmaceuticals, MAY 29, 2024, View Source [SID1234643805]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Jefferies Global Healthcare Conference on Thursday, June 6, 2024

Fireside chat at 11:00 a.m. PT / 2:00 p.m. ET / 7:00 p.m. IST
Goldman Sachs 45th Annual Global Healthcare Conference on Wednesday, June 12, 2024

Fireside chat at 7:40 a.m. PT / 10:40 a.m. ET / 3:40 p.m. IST
Audio webcasts of the presentations will be available via the Investors section of the Jazz Pharmaceuticals website at View Source A replay of the webcasts will be archived on the website for 30 days.

AFFIMED RECEIVES FAST TRACK DESIGNATION FOR COMBINATION THERAPY OF AFM24 WITH ATEZOLIZUMAB FOR EGFR WILD-TYPE NON-SMALL CELL LUNG CANCER

On May 29, 2024 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the FDA has granted Fast Track designation to the combination of its innate cell engager (ICE) AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic non-small cell lung cancer (NSCLC) not harboring any activating EGFR mutations (EGFR wild-type) after progression on PD-(L)1 targeted therapy and platinum-based chemotherapy (Press release, Affimed, MAY 29, 2024, View Source [SID1234643804]). Data from the AFM24-102 study in this patient population will be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 1, 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The clinical data of AFM24 in combination with the checkpoint inhibitor atezolizumab is compelling. We’re observing meaningful responses in patients resistant to prior checkpoint inhibitor treatment," said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed. "The Fast Track designation emphasizes the belief in the potential of this combination therapy to address currently unmet needs of patients with this devastating, life threatening disease who have exhausted all standard of care options, including chemotherapy and checkpoint inhibitors."

Fast Track is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The FDA’s decision is based on initial activity observed in the first evaluable patients of the phase 2 part of the AFM24-102 study of AFM24 in combination with atezolizumab in heavily pretreated patients with NSCLC EGFRwt. With the Fast Track designation, the therapeutic development of the combination can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate its development.

About FDA Fast Track Designation

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Its purpose is to get important new drugs to patients earlier. Fast Track addresses a broad range of serious conditions. With Fast Track designation, a new therapy is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
Please refer to Fast Track | FDA for further information.

Conference Call and Webcast Information

Affimed will host a conference call and webcast for the financial community on June 1, 2024, at 6:00 p.m. CDT / 7:00 p.m. EDT. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link:

https://register.vevent.com/register/BIff607338e5d247f99b548240be2ad413, and you will be provided with dial-in details and a pin number.

About AFM24
AFM24 is a tetravalent, bispecific ICE that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.