zetatauri
2 년 전
Oncternal Therapeutics Announces the Appointment of Jill DeSimone to the Board of Directors
4:05 pm ET January 4, 2023 (Globe Newswire) Print
GlobeNewswireJanuary 04, 2023
SAN DIEGO, Jan. 04, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the appointment of Jill DeSimone to its board of directors.
"We are thrilled to have Jill join the Oncternal board of directors. Jill's accomplishments building a multi-billion dollar oncology business in the U.S. are a great fit for supporting Oncternal's transition into a late-stage oncology company," said James Breitmeyer, M.D., Ph.D., Oncternal's President and CEO. "As we embark into our first global Phase 3 registrational study Zilo-301, we will greatly benefit from her guidance to help us build a compelling patient-centric value proposition for Zilovertamab."
Ms. DeSimone was most recently President of U.S. Oncology at Merck & Co., Inc., where she built the company's oncology division, growing it to over a $9 billion business in just eight years. She led three key product launches and more than 45 indication launches, including Keytruda(R). Prior to joining Merck, she served as senior vice president of Global Women's Health at Teva Pharmaceutical Industries Ltd from 2012 to 2014. Prior to her time at Teva, Ms. DeSimone served in several roles of increasing responsibility at Bristol Myers Squibb from 1980 to 2012, including senior vice president of U.S. Oncology & Commercial from 2010 to 2012 and senior vice president of U.S. Virology/HIV from 2006 to 2010. Ms. DeSimone currently serves as a member of the board of directors of Praxis Precision Medicines, Inc. and Affini-T Therapeutics Inc. She also serves as a board member for the Florida Cancer Specialists Foundation, a nonprofit organization that delivers non-medical aid for individuals undergoing cancer treatment. Ms. DeSimone received a B.S. in pharmacy from Northeastern University and completed a fellowship with the Wharton School of the University of Pennsylvania.
"I am honored to join the board at Oncternal, as it continues to advance its first-in-class late-stage oncology pipeline," said Ms. DeSimone. "I believe Zilovertamab and ROR1 can play a key role in addressing significant unmet needs in hematological malignancies and solid tumors, and I look forward to working with the board at Oncternal to continue to bring important therapeutic innovations to patients."
TechandBio
2 년 전
-- Interim Phase 1/2 results for zilovertamab plus ibrutinib in MCL presented at ASCO 2022, with ORR of 85% compare favorably to historical single agent ibrutinib data and support moving into Phase 3 Study ZILO-301
-- Interim data from p53-mutated CLL patients in the same Phase 1/2 study showed encouraging activity in sub-group analyses, with landmark PFS of 100% at 36 months, compares favorably to historical PFS for ibrutinib monotherapy
-- Established a clinical trial and supply agreement with Pharmacyclics for the donation of ibrutinib for our global registrational Phase 3 study, ZILO-301, of zilovertamab in patients with MCL, which is on track to be initiated in September 2022
-- Advanced development of ONCT-808, the lead candidate for our autologous CAR-T program targeting ROR1-expressing malignancies, with IND submission on track for later this month
-- Executing IND enabling studies for ONCT-534, the lead candidate in our novel dual-action androgen receptor inhibitor (DAARI) program
-- Extended cash runway guidance to fund operations into the first half of 2024 with $78.9 million in cash and cash equivalents and no debt as of June 30, 2022
ONCT pipeline is showing more promising data than VelsoBio & NBE Therapeutics here is the key & the valuation of where ONCT should be. Abbive wants this pipeline & will make a take over offer sooner than later. The team at ONCT is top notch sesoned vets from some of the top biotech companies in the world. Their Pedigree is next level.
If you take a formula of three buyouts in the last year and change 2.8 Billion Merck on Velsobio & Boehringer Buyout of NBE-Therapeutics for 1.5 Billion & Trillium 2.2 Billion bought by Pfizer Onct is worth north of Billion. Their pipeline is more mature and their top line data is superior. Onct market cap of 67 Million has 20 to 30x ROI potential from these levels.
Merck inks $2.8B VelosBio buyout to snag anti-ROR1 ADC
https://www.fiercebiotech.com › biotech › merck-inks-...
Merck has struck a deal to buy VelosBio for $2.75 billion. The takeover will give Merck control of an antibody-drug conjugate (ADC) that caused objective ...
You've visited this page 5 times. Last visit: 8/21/22
Boehringer inks $1.5B NBE buyout, joining Merck in new ...
https://www.fiercebiotech.com › biotech › boehringer-i...
Boehringer Ingelheim has struck a deal to buy NBE-Therapeutics for €1.2 billion ($1.5 billion) to add a ROR1-directed antibody-drug conjugate
Oncternal therapeutics: Zilovertamab Phase 3 study Ror1 ZILO-301 Kills cancer stem cells. HUGE Improvement Partnered with AbbV better approach then trillium which was bought out by Pfizer for 2.2 Billion for Hematological malignancies cancers. Next we had the 2 ROR1 buyouts last year and half. This stock is about to quantum leap. Under the radar hidden gem. Billion dollar plus market cap in the making. Onct is helping Imbruvica (PCYC) which as bought out by ABBV 21 Billion and has 9 Billion plus in sales. Zilovertamab in combo with Imbruvica is 50% more affective then Imbruvica alone with less side effects. Plus 9 indications in the ONCT pipeline including Prostate & Breast cancer Her2 (39 Billion market for Her2 Breast cancer in 2025 Onct market cap at 65 Million is extremely undervalued. The chart is turning around. Ror1 first in class in the making.
https://www.fiercebiotech.com/biotech/merck-inks-2-8b-velosbio-buyout-to-snag-anti-ror1-adc
This is the most undervalued asset, 'explosive' move coming.
081 - Oncternal Therapeutics Drives Complete Responders with First in Class ROR1 Antagonist
ONCT Team Includes Veterans from Fate therapeutics, Merck, Pfizer, Gilead, Amgen, Johnson & Johnson, Roche, Lilly, & Takeda. Plus the legendary Kipps who was the primary lead investigator for PCYC Imbruvica for 18 years. Which was bought out by ABBV for 21 Billion Kipps then moved to ONCT were now headed into a phase 3 with ABBV for their blockbuster drug Imbruvica is 50% more affective then Imbruvica alone with less side effects. Plus 9 indications in the ONCT pipeline i
ONCT ROR1 Expressed on Multiple
Solid and Liquid Tumors
MCL 95%
CLL 95%
Uterus 96%
Lymphoma 90%
Prostate 90%
Skin 89%
Pancreatic 83%
Adrenal 83%
Lung 77%
Breast 75%
Testicular 73%
https://www.fiercebiotech.com/biotech/abbvie-pens-imbruvica-supply-pact-support-pivotal-oncternal-trial
August 2022 ONCT Biz presentation.
https://investor.oncternal.com/static-files/f7628e1c-42c5-4c8a-8247-e910ad5555c4
ONCT Pipeline.
https://www.oncternal.com/pipeline
About 50 million shares outstanding.
% Held by Institutions 31%
% Held by Insiders 11%
Insiders have been buying over the last few months
$ONCT
TechandBio
2 년 전
Phase 3 with ABBV that makes their blockbuster drug Ibrutinib formerly pcyc which was bought out by ABBV for 20 billion this drug does 9 Billion in sales annually 50% more effective with less side effects. With ONCT Zilovertamab
R/R MCL: Tumor Reduction and Progression-Free Survival
Zilovertamab + Ibrutinib Data Update at ASCO 2022
85% ORR and median PFS of 35.9 months
ZILO-301: Phase III study of zilovertamab + ibrutinib vs ibrutinib in R/R MCL
ONCT 67 million dollar market cap today 20x-100x+ ROI potential here.
Chart looks primed for showtime!
Onct Leadership team is star studded.
https://oncternal.com/about/team
Thomas Kipps:
https://profiles.ucsd.edu/thomas.kipps
Thomas Kipps, MD, PhD, is Professor of Medicine, Evelyn and Edwin Tasch Chair in Cancer Research, and Deputy Director of Research Operations at the UC San Diego Moores Cancer Center. He received his Ph.D. in Immunology and M.D. from Harvard University and had his residency and fellowship training in Internal Medicine, Hematology, and Genetics at Stanford University.
Education and Training
Columbia College of Columbia University, New York, NY BS 1974 Biochemistry
Harvard Medical School, Boston, MA Ph.D. 1979 Immunology
Awards and Honors
UC San Diego School of Medicine 2004 Evelyn and Edwin Tasch Chair in Cancer Research
Dr. Kipps has a national and international reputation for his work in cancer research, immunology, and gene therapy. He has been a leader in the field for many years, and has helped to develop standardized treatment protocols. He is the author of more than 300 publications and is the PI on several peer-reviewed grants, including an award from NCI/NIH to fund the Chronic Lymphocytic Leukemia Research Consortium (CRC). The CRC involves collaboration with eight other Cancer Centers around the United States and the UK. Dr. Kipps is also the Director of the Blood Cancer Research Fund at the UC San Diego Moores Cancer Center. The Blood Cancer Research Fund concentrates on developing cures for all types of blood related cancers, specifically Chronic Lymphocytic Leukemia (CLL).
Non-canonical Wnt-Receptor Signaling and Targeted Therapies
NIH R01CA236361Apr 15, 2019 - Mar 31, 2024
Role: Principal Investigator
PCYC Karyotype
Pharmacyclics, Inc. Jun 1, 2018 - Dec 31, 2021
PCYC Clonal Evolution
Pharmacyclics, Inc. Feb 21, 2018 - Feb 20, 2021
Role: Principal Investigator
A Phase 1b/2a Study of the ROR1-Targeting Monoclonal Antibody, Cirmtuzumab, and the Bruton Tyrosine Kinase Inhibitor, Ibrutinib, in B-Cell Cancers
California Institute for Regenerative Medicine (CIRM) CLIN2-10192Oct 1, 2017 - Jun 30, 2022
Role: Principal Investigator
Development of ROR1 CAR-T cells to target cancer stem cells in advanced malignancies
California Institute for Regenerative Medicine (CIRM) TRAN1-10258Oct 1, 2017 - Mar 31, 2020
Role: Co-Investigator
Oncternal Research Agreement
Oncternal Therapeutics, Inc. Sep 1, 2016 - Aug 31, 2021
Role: Principal Investigator
Oncternal Therapeutics, Inc. HRPP #140141Apr 1, 2016 - Sep 26, 2018
Role: Principal Investigator
ROR1 Expression in Human Breast Cancer
Breast Cancer Research Foundation BCRF-18-123Oct 1, 2014 - Sep 30, 2019
Role: Co-Investigator
Protein-Coding and Non-Coding RNA Biomarkers for early detection of CLL
MD Anderson Texas R01CA182905Jun 1, 2014 - May 31, 2019
Role: Sub-Site Principal Investigator
Cancer Center Support Grant (CCSG)
NIH/NCI P30 CA23100-28May 1, 2014 - Apr 30, 2024
Role: Senior Deputy Director, Co-Principal Investigator
Specific Targets for Therapy of Patients with Chronic Lymphocytic Leukemia
The Leukemia & Lymphoma Society 7005-14Oct 1, 2013 - Sep 30, 2018
Role: Principal Investigator
Chronic Lymphocytic Leukemia Research Consortium
NIH/NCI 5P01CA081534-14Sep 24, 2012 - Aug 31, 2018
Role: Principal Investigator
Lenalidomide Treatment and the Chronic Lymphocytic Leukemia Microenvironment
NIH R21CA135681Mar 1, 2009 - Feb 28, 2011
Role: Principal Investigator
Center of Nanotechnology for Treatment, Understanding, *
NIH U54CA119335Sep 30, 2005 - Dec 31, 2011
Role: Co-Investigator
Chronic Lymphocytic Leukemia Research Consortium
NIH P01CA081534May 1, 1999 - Aug 31, 2018
Role: Principal Investigator
CHRONIC LYMPHOCYTIC LEUKEMIA RESEARCH CONSORTIUM
NIH P20CA081534May 1, 1999 - Apr 30, 2000
Role: Principal Investigator
MOLECULAR THERAPEUTICS OF RHEUMATOID ARTHRITIS
NIH/NIAMS P50AR044850Sep 28, 1998 - Aug 31, 2004
Role: Co-Investigator
ERB 2NEU DNA VACCINES FOR BREAST CANCER IMMUNOTHERAPY
NIH R01CA066000Sep 1, 1995 - Jun 30, 2003
Role: Principal Investigator
IMMUNOBIOLOGY OF AIDS LYMPHOMAS
NIH R01CA065408Jul 25, 1994 - Jun 30, 1998
Role: Principal Investigator
NEW MODALITIES FOR ACTIVE IMMUNOTHERAPY OF MALIGNANCIES
NIH R01CA057868Aug 25, 1992 - Jul 31, 1994
Role: Principal Investigator
NOVEL THERAPEUTIC APPROACHES IN HIV-ASSOCIATED LYMPHOMAS
NIH R01CA055513Jul 16, 1991 - Jun 30, 1994
Role: Principal Investigator
MECHANISMS OF AIDS-ASSOCIATED LYMPHOMAGENESIS
NIH R01CA054755Mar 14, 1991 - Feb 28, 1995
Role: Principal Investigator
Antibody V Gene Expression B Cell Lymphocytic Leukemia
NIH R37CA049870May 1, 1989 - Jul 31, 2015
Role: Principal Investigator
ANTIBODY V GENE EXPRESSION IN HUMAN B CELL MALIGNANCIES
NIH R01CA049870May 1, 1989 - Apr 30, 1994
Role: Principal Investigator
MULTIPARAMETER FLUORESCENCE ACTIVATED CELL SORTER
NIH S10RR004051Apr 18, 1988 - Apr 17, 1990
Role: Principal Investigator
MULTIPURPOSE ARTHRITIS CENTER
NIH P60AR033489Feb 1, 1987 - Jun 30, 1990
Role: Co-Investigator
HUMAN ANTIBODY DIVERSITY IN HEALTH &AUTOIMMUNITY
NIH R29AR038475Aug 1, 1986 - Jul 31, 1992
Role: Principal Investigator
IMMUNOLOGIC AGING AND AUTOIMMUNITY
NIH R01AG004100Jul 1, 1983 - Aug 31, 1996
Role: Principal Investigator
IMMUNOLOGIC AGING AND AUTOIMMUNITY
NIH R55AG004100Jul 1, 1983 - Aug 31, 1992
Role: Principal Investigator
Specialized Cancer Center Support Grant
NIH P30CA023100Apr 1, 1978 - Apr 30, 2024
Role: Principal Investigator
GENERAL CLINICAL RESEARCH CENTER
NIH M01RR000833Dec 1, 1977 - Sep 30, 2005
Role: Co-Investigator
General Clinical Research Center
NIH M01RR000827Mar 1, 1974 - Nov 30, 2010
Other Onct team comes from a variety of companies including Lily, Amgen, Roche, Johnson & Johnson, ISIS, Janseen, ABBV, Merck, Giliead and much much more. (Page 5)
https://investor.oncternal.com/static-files/f7628e1c-42c5-4c8a-8247-e910ad5555c4
Follow the breadcrumbs.
https://www.oncternal.com/pipeline
$ONCT
TechandBio
2 년 전
Took a starter here.
$ONCT
ZILOVERTAMAB: MONOCLONAL ANTIBODY TARGETING ROR1
ROR1 TARGETED CELL THERAPY PROGRAM
ONCT-534: DUAL-ACTION ANDROGEN RECEPTOR INHIBITOR (DAARI)
85% ORR and median survival of 35.9 months.
ONCT ROR1 expressed on multiple & liquid tumors.
MCL 95%
CLL 95%
Uterus 96%
Lymphoma 90%
Prostate 90%
Skin 89%
Pancreatic 83%
Adrenal 83%
Lung 77%
Breast 75%
Testicular 73%
2 companies in the last 2 years that targets ROR1 have been Merck bought VelosBio for 2.8 Billion & Boehringer inks $1.5B NBE buyout, joining Merck in new cancer ROR1 race. ONCT Market cap is under 60 Million.
Merck inks $2.8B VelosBio buyout to snag anti-ROR1 ADC.
https://www.fiercebiotech.com/biotech/merck-inks-2-8b-velosbio-buyout-to-snag-anti-ror1-adc
Boehringer inks $1.5B NBE buyout, joining Merck in new cancer race.
https://www.fiercebiotech.com/biotech/boehringer-inks-1-5b-nbe-buyout-joining-merck-ror1-adc-race
Clinical Stage Biotech Focused on Hematological Malignancies and
Prostate Cancer with Multiple Modalities and Deep ROR1 Expertise
Hematological Malignancies Prostate Cancer
Zilovertamab – ROR1 monoclonal antibody
• Demonstrated clinical benefit of
combination with ibrutinib compared to
historical ibrutinib monotherapy, including
in difficult-to-treat p53 mutations
• Expect MCL registrational study initiation
in 3Q 2022
ONCT-808 – ROR1 CAR-T Cell Therapy
• Expect IND submission in August 2022
ONCT-534 – Dual Action AR Inhibitor (DAARI)
• First-in-class MOA interacting with both N-
terminal Domain and Ligand-Binding
Domain of the androgen receptor inducing
AR protein degradation
• Active preclinically in AR amplification, splice
variant and LBD mutation models
Zilovertamab – ROR1 monoclonal antibody
• Ph1b study open for advanced prostate cancer
-----------------------------------------------------------------------------------------------------------------
Corporate Highlights
ZILOVERTAMAB: POTENTIALLY FIRST-IN-CLASS MONOCLONAL ANTIBODY TARGETING ROR1
• Safety and efficacy results for zilovertamab + ibrutinib (ABBIE) (PCYC) in patients with MCL/CLL compare favorably to historical single-
agent ibrutinib
• Encouraging efficacy results in patients with p53 mutated CLL, with PFS of 100% at 24 and 30 months
• Agreement with U.S. FDA on Phase 3 global registrational study design for the treatment of patients with R/R MCL
ONCT-808: AUTOLOGOUS CAR-T CELL THERAPY TARGETING ROR1
• Clinical manufacturing agreement with the Dana-Farber Cancer Institute for first-in-human studies
• Research collaborations for next-gen allogeneic CAR-T and CAR-NK cell therapies with Karolinska Institutet & Celularity
ONCT-534: DUAL-ACTION ANDROGEN RECEPTOR INHIBITOR (DAARI)
• Activity in preclinical prostate cancer models of androgen receptor inhibitor resistance, including AR mutations, AR
overexpression and AR splice variants, such as AR-V7
MULTIPLE CATALYSTS
• Planned initiation of zilovertamab + ibrutinib global registrational Phase 3 Study ZILO-301 in 3Q 2022
• Clinical data updates in MCL and CLL
• ONCT-808 ROR1 CAR-T cell therapy IND submission planned in mid-2022
---------------------------------------------------------
Anticipated Pipeline Milestones
Zilovertamab
• MCL global registrational Phase 3 Study ZILO-301 initiation September 2022
• MCL & CLL clinical data update for ongoing Phase 2 4Q 2022
ONCT-808 ROR1 CAR-T cell therapy
• B-Cell malignancies U.S. IND submission August 2022
ONCT-534
• Prostate cancer FDA pre-IND interaction 4Q 2022
Cash & Cash Investments
Cash Runway well into 1H 2024
$78.9M
Debt $0M
ONCT Team Includes Veterans from Fate therapeutics, Merck, Pfizer, Gilead, Amgen, Johnson & Johnson, Roche, Lilly, & Takeda.
August 2022 ONCT Biz presentation.
https://investor.oncternal.com/static-files/f7628e1c-42c5-4c8a-8247-e910ad5555c4
ONCT Pipeline.
https://www.oncternal.com/pipeline
Will add more on closing after the 50 day moving average which is right there 1.165
& add again after we break the 200 day moving average. $1.81
About 50 million shares outstanding.
% Held by Institutions 31%
% Held by Insiders 11%
Insiders have been buying.
$ONCT
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