WATERTOWN, Mass.--(BUSINESS WIRE)--SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today announced that the independent Data and Safety Monitoring Board (DSMB) for the Phase 1/2 clinical trial SQZ-PBMC-HPV-101 has recommended that the trial advance into the combination stage with checkpoint inhibitors. In June, the company presented initial results from the first three monotherapy cohorts at the American Society of Clinical Oncology annual meeting demonstrating that the investigational cell therapy is safe and well-tolerated and can stimulate immune responses in certain patients with advanced or metastatic human papillomavirus positive (HPV16+) tumors. Data from the highest dose monotherapy cohort has been accepted for oral presentation at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress being held December 8-11, 2021.
We are encouraged by our initial SQZ-PBMC-HPV-101 Phase 1/2 trial data and pleased to advance the highest dose of our SQZ APC clinical candidate into the combination stage of the trial, said Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies. Based on our preclinical studies and available clinical trial data, we believe SQZ APCs could work synergistically with checkpoint inhibitors to provide additional clinical benefit to patients. Our clinical team and trial sites are ready to begin this important phase of the study.
The combination stage of the trial is now open for enrollment and will include checkpoint inhibitors targeting the PD-(L)1 and CTLA-4 pathways. In parallel, the company plans to continue to enroll in the highest dose monotherapy cohort.
The DSMB recommendation and initiation of the combination cohorts will trigger a Roche collaboration agreement milestone payment. The companys most recently reported cash runway projections anticipated these proceeds.
New data from the monotherapy portion of the SQZ-PBMC-HPV-101 trial will be part of an oral presentation at ESMO-IO on December 9 in Geneva, Switzerland. Full presentation details can be found below.
ESMO-IO Presentation Details
Abstract Title: SQZ-PBMC-HPV-101: Preliminary results of a first-in-human, dose-escalation study of a cell-based vaccine in HLA-A*02+ patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors
Lead Author: Jong Chul Park, MD, Massachusetts General Hospital; Developmental Therapeutics Member, Dana-Farber/Harvard Cancer Center
ESMO-IO will publish full abstracts on their website on Thursday, December 2 at 12:00 pm CET. SQZ will post its oral presentation on the company website on December 9 at 11:00 am CET.
SQZ-PBMC-HPV-101 Trial Design
SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The studys primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination stages of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and the definition of a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days.
About Human Papillomavirus Positive Cancers
Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer HPV+ tumors account for 4.5% of all cancers worldwide, resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.
About SQZ Biotechnologies
SQZ Biotechnologies Company is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies for patients around the world and has active programs in Oncology, Autoimmune and Infectious Diseases, as well as additional exploratory initiatives to support future pipeline growth. The companys proprietary Cell Squeeze technology offers the unique ability to deliver multiple biological materials into many cell types to engineer what we believe can be a broad range of potential therapeutics. With demonstrated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, our approach could significantly broaden the therapeutic range and accessibility of cell therapies. The companys first therapeutic applications seek to generate target-specific immune responses, both in activation for the treatment of solid tumors and infectious diseases, and in immune tolerance for the treatment of autoimmune diseases. For more information, please visit http://www.sqzbiotech.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements relating to our platform development, manufacturing capabilities, product candidates, preclinical and clinical activities, progress and outcomes, development plans, clinical efficacy, therapeutic impact, strategic partnerships and market opportunities. These forward-looking statements are based on management's current expectations. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, risks and uncertainties related to our limited operating history; our significant losses incurred since inception and expectation to incur significant additional losses for the foreseeable future; the development of our initial product candidates, upon which our business is highly dependent; the impact of the COVID-19 pandemic on our operations and clinical activities; our need for additional funding and our cash runway; the lengthy, expensive, and uncertain process of clinical drug development, including uncertain outcomes of clinical trials and potential delays in regulatory approval; our ability to maintain our relationships with our third party vendors and strategic partners; and protection of our proprietary technology, intellectual property portfolio and the confidentiality of our trade secrets. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission could cause actual results to differ materially from those indicated by the forward-looking statements. Any forward-looking statements represent management's estimates as of this date and SQZ undertakes no duty to update these forward-looking statements, whether as a result of new information, the occurrence of current events, or otherwise, unless required by law.
Certain information contained in this press release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this press release, we have not independently verified, and we make no representation as to the adequacy, fairness, accuracy or completeness of any information obtained from third-party sources.
See the rest here:
SQZ Biotechnologies Announces Independent DSMB Recommendation to Advance Lead Cell Therapy Candidate Into Combination With Checkpoint Inhibitors -...
- Cell Therapy Basics - February 21st, 2024
- FDA Approves Amtagvi, First Cell Therapy for Skin Cancer - BioPharm International - February 21st, 2024
- Cellenkos Approved to Proceed with CK0803 Neurotrophic T regulatory Cell therapy to Treat Second Cohort in ALS Trial - PR Newswire - February 21st, 2024
- Astellas and Kelonia enter CAR-T cell therapy collaboration worth over $800m - PMLiVE - February 21st, 2024
- Bridging Therapy With CAR T-Cell Therapy in LBCL - OncLive - February 21st, 2024
- FDA approves first cell therapy to treat aggressive forms of melanoma - NPR - February 21st, 2024
- Iovance, with approval of 'TIL' cell therapy, readies for complex launch - Yahoo Finance - February 21st, 2024
- Cancer treatment: FDA approves type of cell therapy for patients with late-stage melanoma - FOX 26 Houston - February 21st, 2024
- Pharmalittle: We're reading about weight loss drugs, a cell therapy for melanoma, and more - STAT - February 21st, 2024
- On heels of cancer cell therapy win, Peninsula biotech looks to raise $211M - San Francisco Business Times - The Business Journals - February 21st, 2024
- FDA approves cell therapy to treat melanoma - FOX 26 Houston - February 21st, 2024
- Toddler Beats Childhood Leukemia After Car T-Cell Therapy - City of Hope - February 21st, 2024
- FDA Approves First One-time Cell Therapy for a Solid Tumor - BioSpace - February 21st, 2024
- Iovance wins FDA approval for cell therapy - BioProcess Insider - BioProcess Insider - February 21st, 2024
- FDA Approves Iovance Cancer Treatment, the First Cell Therapy for a Solid Tumor - MedCity News - February 21st, 2024
- Promising target for CAR T-cell therapy leads to potent antitumor responses against cutaneous and rare melanomas - Medical Xpress - February 21st, 2024
- Reinforcing Cell Therapy with Microfluidic Cell Sorting - RegMedNet - February 21st, 2024
- Study finds interleukin-24 enhances CAR-T cell therapy's effectiveness against cancer stem cells - News-Medical.Net - February 21st, 2024
- Understanding CAR T-Cell Therapy: Balancing the Risks and Benefits - Medriva - February 21st, 2024
- Keeping Track: Iovance's Amtaqvi Approval Brings T Cell Therapy To Solid Tumors - Pink Sheet - February 21st, 2024
- Tevogen Bio Holdings Inc., a Cell Therapy Company, Announces Completion of Business Combination and is to be ... - Yahoo Finance - February 21st, 2024
- What is CAR-T cell therapy, used for cancer treatment? Experts explain - India Today - India Today - February 21st, 2024
- UPDATE: 2seventy splits once more, sending cell therapy pipeline to Regeneron in 'dramatic' change - FierceBiotech - January 31st, 2024
- Revolutionary CAR T-cell therapy shows promise in reversing age-related metabolic dysfunction - News-Medical.Net - January 31st, 2024
- BioCardia Pivots to Biomarker Strategy to Prove Heart Failure Cell Therapy Benefits - precisionmedicineonline.com - January 31st, 2024
- Sequencing With CAR T-Cell Therapy for LBCL - OncLive - January 31st, 2024
- Single-cell analysis of refractory anti-SRP necrotizing myopathy treated with anti-BCMA CAR-T cell therapy ... - pnas.org - January 31st, 2024
- Regeneron to acquire 2seventy's cell therapy pipeline - Yahoo Finance - January 31st, 2024
- Trial of cell-based therapy CK08031 finishes dosing 1st patients - ALS News Today - January 31st, 2024
- Exploring Gene and Cell Therapy Integration in Pharmacies - PharmaNewsIntel - January 31st, 2024
- HBS Alumna Fighting Cancer with a Novel Cell Therapy - MBA - hbs.edu - January 31st, 2024
- YUHS partners with KURE.AI Therapeutics for cell therapy development - KBR - January 31st, 2024
- Global CAR-T Cell Therapy Market Report 2024-2034: Accelerated Growth Fueled by Intensive R&D, Growing Medical ... - Yahoo Finance - January 31st, 2024
- Oricell Announces FDA Clearance of IND Application for OriCAR-017, a novel GPRC5D Targeted CAR-T Cell Therapy ... - PR Newswire - January 31st, 2024
- A new chapter in cell therapy: engineered B cells reach the clinic for the first time - Labiotech.eu - January 31st, 2024
- Harnessing the Dark Genome: New Approach Greatly Improves Cancer T-Cell Therapy - SciTechDaily - January 31st, 2024
- Cell therapies | Harvard Stem Cell Institute (HSCI) - November 16th, 2023
- Oncternal Therapeutics Participating in Oppenheimer & Co.’s Virtual Fireside Chat: Discussion of ROR1 CAR T Cell Therapy in Hematological... - April 15th, 2023
- Basal Cell Carcinoma Treatment - The Skin Cancer Foundation - January 4th, 2023
- Adoptive Cell Therapy - Cancer Research Institute (CRI) - December 27th, 2022
- National Medical Commission prohibits use of stem cell therapy to treat patients with autism - Hindustan Times - December 18th, 2022
- Tumor buster - where will the CAR-T cell therapy missile go? - December 18th, 2022
- Gilead lands new cell therapy for Kite in $225M Arcellx deal, providing global scale for future J&J-Legend showdown - FierceBiotech - December 10th, 2022
- Non-Small Cell Lung Cancer Treatment (PDQ)Patient Version - November 24th, 2022
- CAR-T Cell Therapy Program - Frequently asked questions - November 24th, 2022
- EdiGene Announces Completion of Last Patient Dosing in Phase I Clinical Trial of ET-01, its Investigational Gene-editing Hematopoietic Stem Cell... - November 24th, 2022
- Radiation Therapy for Non-Small Cell Lung Cancer - November 6th, 2022
- AvenCell to Present New Data from Lead Universal CAR T Cell Therapy Program at 64th American Society of Hematology Annual Meeting and Exposition -... - November 6th, 2022
- Instil Bio's stock falls 35% after disclosing the cell therapy company paused enrollment in clinical trials - MarketWatch - November 6th, 2022
- Creative Medical Technology Holdings Announces FDA Clearance of Investigational New Drug (IND) Application for AlloStem, a Novel Cell Therapy for the... - November 6th, 2022
- Photodynamic Therapy to Treat Cancer - NCI - October 29th, 2022
- Researchers at University Hospitals create a breakthrough in CAR-T cell therapy for cancer patients - News 5 Cleveland WEWS - October 29th, 2022
- Mustang Bio Announces Phase 1/2 Clinical Trial Data of MB-106, a First-in-Class CD20-targeted, Autologous CAR T Cell Therapy, to be Presented at 11th... - October 29th, 2022
- Gilead, working to improve cancer cell therapy, partners with California startup - BioPharma Dive - October 21st, 2022
- Allogene starts first pivotal trials of an 'off-the-shelf' cell therapy for cancer - BioPharma Dive - October 13th, 2022
- Vita Therapeutics Closes $31 Million Series B Financing to Develop Cell Therapies for Neuromuscular Diseases and Cancers - Business Wire - October 13th, 2022
- CAR T-cell Therapy Market Riding on the Wave of Growth and will Grow at a CAGR of 30.6% to 2031 | TMR Study - GlobeNewswire - October 13th, 2022
- Inceptor Bio and Avectas Announce Collaboration to Improve Manufacturing of CAR-T Cell Therapies for the Treatment of Solid Tumors - PR Newswire - October 13th, 2022
- Cell Therapy Technologies Market Expected to Reach US ~$12.27 Billion and CAGR 14.5% by 2030 Polaris Market Research - Digital Journal - October 13th, 2022
- Early Data on GPRC5D-Directed CAR T-Cell Therapy Open Doors for New Myeloma Treatment Strategies - Precision Oncology News - October 13th, 2022
- BREAKTHROUGH TECHNOLOGY FOR IPS-DERIVED CELL THERAPIES TURNED INTO GMP PLATFORM BY TREEFROG THERAPEUTICS & INVETECH - PR Newswire - October 13th, 2022
- Cabaletta Bio Announces CABA-201, a Newly Designed CD19-Targeting CAR T Cell Therapy Engineered to Address a Broad Range of Autoimmune Diseases -... - October 13th, 2022
- Breast cancer treatment: These targeted therapies are a ray of hope for patients - Health shots - October 13th, 2022
- Two-Year Clinical Data for DiscGenics's Progenitor Cell Therapy for Lumbar Disc Degeneration to Be Presented at NASS 2022 - PR Newswire - October 13th, 2022
- Mayo Clinic Minute: What is CAR-T cell therapy? - Finger Lakes Times - October 13th, 2022
- Gamma Biosciences and Lonza Collaborate to Co-develop Reagents for Clinical Cell Selection in the Cocoon Platform USA - English - USA - English - PR... - October 13th, 2022
- Merck and Moderna Move Forward with Personalized Cancer Vaccine - BioSpace - October 13th, 2022
- First Patient With B-NHL or CLL Treated With MB-106 in Phase 1/2 Study - Targeted Oncology - October 13th, 2022
- MaxCyte to Report Third Quarter 2022 Financial Results on November 9, 2022 - Yahoo Finance - October 13th, 2022
- Iovance Biotherapeutics Announces First Patient Dosed with PD-1 Inactivated Tumor Infiltrating Lymphocyte (TIL) Therapy - GlobeNewswire - October 13th, 2022
- Elicera Therapeutics: PhD thesis describing the iTANK-platform awarded best of the year 2021 in Sweden in the field of gene and cell therapy -... - October 13th, 2022
- Integrating CAR T-Cell Therapy Into Community Oncology Practices - Targeted Oncology - October 4th, 2022
- About CAR-T cell therapy - Mayo Clinic - October 4th, 2022
- Autologous immune-cell therapy, practiced in Japan, now helping Vinmec Hospital, treat cancer patients in Hanoi, Vietnam, after technology transfer by... - October 4th, 2022
- Oncternal Therapeutics Receives IND Clearance for ONCT-808, its autologous CAR T Product Candidate Targeting ROR1 for the Treatment of Aggressive B... - October 4th, 2022
- Regenerative Spine and Pain Institute: Treating Pain with PRP and Stem Cell Therapy - Community News - October 4th, 2022
- City of Hope To Accelerate Immunotherapy Research And Treatment Innovation with $15 Million Gift From Ted Schwartz Family - City of Hope - October 4th, 2022
- Lineage Establishes New R&D Facility in U.S. and Expands Current GMP Manufacturing Facility in Israel - Business Wire - October 4th, 2022
- Century Therapeutics Announces Appointment of Daphne Quimi and Timothy Walbert to its Board of Directors - Yahoo Finance - October 4th, 2022
- SQZ Biotechnologies Publishes Preclinical Research Demonstrating SQZ AAC Platform's Potential as an Effective Red Blood Cell-Derived Immunotherapy -... - October 4th, 2022