On October 3, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the receipt of a ‘Study May Proceed’ letter from the U.S. Food and Drug Administration (FDA), 30 days after submitting its Investigational New Drug (IND) application for a Phase 1/2 dose escalation study of ONCT-808, an autologous chimeric antigen receptor (CAR) T therapy targeting ROR1, in patients with aggressive B cell non-Hodgkin’s lymphoma (B NHL), including those who have failed previous CD19 CAR T treatment (Press release, Oncternal Therapeutics, OCT 3, 2022, View Source [SID1234621628]).

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"We are very pleased with the clearance of our IND application for our lead autologous CAR T product candidate, ONCT-808," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "This will be our second clinical program focusing on the important ROR1 cancer target, following the initiation of our phase 3 study for our ROR1 antibody zilovertamab, announced last week. ROR1 is an exciting and promising target that is highly expressed in a wide range of cancers and is an ideal candidate for cell therapy applications due to its highly specific tumor expression, and association with tumor survival mechanisms. Our initial dose finding study will enroll patients with aggressive B NHL, including those that have failed prior CD19 therapy, which represent a significant unmet need in the market today. We expect to initiate the study in the coming months and to present interim results at a scientific conference in 2023."

On October 3, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that management will participate in upcoming investor conferences (Press release, Zymeworks, OCT 3, 2022, View Source [SID1234621627]):

Stifel 2022 Healthcare Conference. Zymeworks’ management will participate in one-on-one meetings and present on November 15th – 16th in New York, NY.

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Jefferies London Healthcare Conference. Zymeworks’ management will participate in one-on-one meetings and present on November 15th – 17th in London, United Kingdom.

In addition, Zymeworks will present an update on its preclinical research programs at an Early R&D day on October 20th, 2022, in New York, NY. At this event, led by Paul Moore, PhD, Zymeworks’ Chief Scientific Officer, we plan to present data from multiple preclinical product candidates built upon our industry-leading multispecific and next-generation TOPO1i based ADC platforms as well as an update to our future scientific vision.

All presentations and webcasts will be available on Zymeworks’ website at View Source

On October 3, 2022 Cardiff Oncology, Inc. (the "Company") Presented its corporate presentation (Presentation, Cardiff Oncology, OCT 3, 2022, View Source [SID1234621626]).

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On October 3, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported clinical data on the Company’s product candidate OMBLASTYS (131I-omburtamab) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, OCT 3, 2022, View Source [SID1234621625]). Data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center ("MSK") at the International Society of Pediatric Oncology ("SIOP") Annual Congress held September 28 through October 1, 2022, in Barcelona, Spain.

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In an oral presentation, Dr. Kramer presented interim results for 32 patients enrolled in the Company’s ongoing pivotal 101 multicenter study of omburtamab radiolabeled with Iodine-131. The results showed a twelve-month overall survival ("OS") of 73.5%, with a median follow-up of 25 months. Further, the interim results showed an objective response rate ("ORR") of 31.3% in the patients with measurable disease after central review based on Response Assessment in Neuro-Oncology ("RANO") criteria and European Association of Neuro-Oncology ("EANO")/European Society for Medical Oncology ("ESMO") criteria, and that a total of 75.0% of the patient with measurable disease achieved disease control. Serious Adverse Events ("SAE") was found in 40.6% of the patients and were mostly related to myelosuppression.

"We are excited to report these data that together with Study 03-133 is the basis of our BLA," said Thomas Gad, President, and Interim Chief Executive Officer. "The disease burden these patient and their families are facing represent a significant unmet medical need, which we hope to be able to address with OMBLASTYS after our PDUFA date on November 30, 2022.

Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

On October 3, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported the 1st Symposium on IRAK4 in Cancer taking place virtually on October 7, 9:00am-1:00pm ET (Press release, Curis, OCT 3, 2022, View Source [SID1234621624]).

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Hosted by Drs. Guillermo Garcia-Manero, Hagop Kantarjian, and Amit Verma, this symposium will focus on IRAK4, an essential protein in innate immune response and promising target in the treatment of hematologic malignancies and other cancers. Experts across academia and industry will discuss IRAK4 biology, the present understanding of IRAK4 function, and the future of anti-cancer therapeutic development focused on this target.

"Following the success of the VISTA Symposium over the past two years, Curis is proud to be sponsoring the first symposium on IRAK4 in cancer," said James Dentzer, President, and Chief Executive Officer of Curis. "IRAK4 shows great promise as a potential immunotherapy target for the treatment of hematologic cancers, as well as solid tumors, and we look forward to advancing the conversation on how this promise is being translated into meaningful results for patients."

Symposium hosts:

Guillermo Garcia-Manero, M.D. – Symposium Co-Chair – Professor, Department of Leukemia; Chief, Section of Myelodysplastic Syndromes and Deputy Chair, Translational Research, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Hagop Kantarjian, M.D. – Symposium Co-Chair – Professor, Department Chair, and Samsung Distinguished University Chair in Cancer Medicine, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center; Associate Vice President for Global Academic Programs, MD Anderson Cancer Center
Amit Verma, M.B.B.S. – Symposium Co-Chair – Professor, Department of Oncology (Medical Oncology), Department of Medicine (Oncology & Hematology), and Department of Developmental & Molecular Biology, Albert Einstein College of Medicine; Director, Division of Hemato-Oncology, Montefiore Department of Oncology; Associate Director, Translational Science, Montefiore Einstein Cancer Center; Co-Director, Montefiore Einstein Blood Cancer Institute.
Joining our hosts will be the following speakers and participants:

Omar Abdel-Wahab, M.D. – Edward P. Evans Chair in MDS, Director, Memorial Sloan Kettering Cancer Center (MSK) for Hematologic Malignancies; Member, Human Oncology and Pathogenesis Program & Leukemia Service
Kian-Huat Lim, M.D., Ph.D. – Associate Professor, Division of Oncology, Department of Medicine, Washington University School of Medicine in St. Louis
Alan List, M.D. – Chief Medical Officer, Precision BioSciences
Robert Martell, M.D., Ph.D. – Head of Research and Development, Curis
Dr. Grzegorz Nowakowski, M.D., Professor of Oncology and Medicine, Division of Hematology, Mayo Clinic, Rochester, Minnesota, and Deputy Director, Clinical Research, Mayo Clinic Comprehensive Cancer Center
Marc Raaijmakers, M.D., Ph.D. – Professor of Hematology, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands
Daniel Starczynowski, Ph.D. – Katherine Stewart Waters Endowed Chair of Hematologic Malignancies; Co-Leader, Hematologic Malignancies Program; Co-Chief Scientific Officer, Innovation Ventures; Associate Director for Basic Sciences, UC Cancer Center; Professor, Division of Experimental Hematology and Cancer Biology, Cincinnati Children’s Hospital Medical Center
Ulrich Steidl, M.D., Ph.D. – Professor, Department of Cell Biology, Department of Oncology, and Department of Medicine (Oncology & Hematology), Albert Einstein College of Medicine; Deputy Director, and Associate Director for Basic Science, Montefiore Einstein Cancer Center; Co-Director, Montefiore Einstein Blood Cancer Institute; Interim Director, Ruth L. and David S. Gottesman Institute for Stem Cell Research and Regenerative Medicine
The virtual event will address topics including:

IRAK4 Biology
Biology Overview – Amit Verma, M.B.B.S
Spliceosomes – Daniel Starczynowski, Ph.D.
IL1RAP as a common upstream mechanism of IRAK4 activation – Ulrich Steidl, M.D., Ph.D.
Role of IRAK4 in Innate Immunity
Myddosome signaling and the inflammasome – Alan List, M.D.
Inflammatory signaling and dysregulation & hematopoietic recovery- Marc Raaijmakers, M.D., Ph.D.
IRAK4 in Hematologic Cancers
Myelodysplastic Syndrome and Acute Myeloid Leukemia – Guillermo Garcia-Manero
B cell malignancies – Grzegorz Nowakowski, M.D.
Dissecting the Mechanism of Action – Omar Abdel-Wahab, M.D.
IRAK4 in Solid Tumors
Pancreatic cancer & biliary, colorectal and gastric cancers – Kian-Huat Lim, M.D., Ph.D.
Industry Panel: IRAK4 Therapeutic Strategies
IRAK4’s Role in Therapy Resistance – Daniel Starczynowski
IRAK4 Kinase Inhibitor – Robert Martell, M.D., Ph.D.