15 Nov2021

Robert Bosch Venture Capital joins Variantyx’s US $26 million Series C funding round

Written by 2020HCP.com. Posted in News

STUTTGART, Germany, Nov. 15, 2021 /PRNewswire/ — Robert Bosch Venture Capital GmbH, the corporate venture capital company of the Bosch Group, has completed an investment in Variantyx Inc. Variantyx and Robert-Bosch Hospital join forces to improve personalized oncology treatment with plans to incorporate the Variantyx solution into the oncology treatment process. Variantyx provides clinicians with advanced diagnostics and personalized treatment recommendations for oncology patients’ based on their unique genetic makeup.

“For several years the Robert-Bosch Hospital, the Robert Bosch Stiftung, and the Bosch Group have been joining forces to fight cancer,” says Dr. Ingo Ramesohl, Managing Director of Robert Bosch Venture Capital. “Variantyx’s solution is outstanding. Together, Variantyx and Bosch are eying to bring new research, diagnostics, and precision medicine to oncology patients and clinicians.” 

Disrupting the genetic testing industry
The Variantyx proprietary platform and comprehensive data analysis enable a better understanding of each patient’s unique genetic composition, providing industry leading diagnoses and personalized treatment recommendations. Variantyx’s tests delve deep into the genetics of an individual, providing insights and analytics that no other diagnostic laboratory can deliver today. Variantyx’s oncology solutions identify the unique genetic alterations in a patient’s tumor. Profiling these alterations helps predict the patient’s response to various therapies, enabling clinicians to provide the most effective personalized care for their patients. 

According to a recent Markets And Markets report, the global genomic diagnostics market size was valued at USD 22.7 bn in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 19% between 2021 and 2025.

“Partnering with RBK enables an entirely new approach to cancer treatment by analyzing the specifics of each individual patient and personalizing care to optimize their healthcare treatment,” says Haim Neerman, co-Founder & Chief Executive Officer at Variantyx. “This opens the door for other areas of medical intervention to take a more innovative and individualized approach to treatment.” 

The Robert Bosch Center for Tumor Diseases (RBCT) is part of the Robert Bosch Medical Research (RBMF) and focuses on improving the treatment of cancer patients. Patients at the Robert-Bosch Hospital are advised and treated in line with the latest research results. “Variantyx’s solution can very well complement the existing and established activities in tumor-research to bring new research quickly to the patient. We are pleased to partner with Variantyx, utilizing their unique proprietary software to analyze data more precisely to create a more insightful approach to cancer therapy,” says Helia Schönthaler, COO of Robert Bosch Medical Research.

12 Nov2021

SQZ Biotechnologies Presents New AAC, eAPC Platform Research and First Enhanced Tumor Infiltrating Lymphocyte Preclinical Data at Society for Immunotherapy of Cancer Annual Meeting

Written by 2020HCP.com. Posted in News

WATERTOWN, Mass.–(BUSINESS WIRE)– SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, today presented new SQZ™ AAC and eAPC preclinical research describing the robust potential of these platforms to treat cancer, including data demonstrating synergistic activity when combined with chemotherapy. The company also presented new research on the development of enhanced tumor infiltrating lymphocytes (TILs) that show increased potency in the absence of exogenous cytokine (IL-2) support. The data was presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held November 10-14, 2021, in Washington, D.C. and virtually.

“Our presentations at SITC provide compelling new preclinical data on the multiple biologically diverse, directed immunity approaches that we are pursuing for cancer therapies,” said Howard Bernstein, M.D., Ph.D., Chief Scientific Officer at SQZ Biotechnologies. “Our AAC and eAPC platform work provides translational insights that are relevant to clinical development, including combination chemotherapy and potential expansion to broader patient populations and tumor types.”

“We are also excited to present initial preclinical results on enhanced tumor infiltrating lymphocytes, highlighting a potential future therapeutic avenue,” said Jonathan Gilbert, Ph.D., Vice President and Head of Exploratory Research, SQZ Biotechnologies. “Working with tumor reactive TILs provided by AgonOx, Inc., we developed mRNA engineered TILs that can proliferate and kill matched patient tumor cells in the absence of exogenous IL-2 cytokine support. Engineered TILs may enable the removal of toxic preconditioning and systemic IL-2 use with TIL therapies, making them more broadly applicable to patients.”

Major Findings from Preclinical Research

Poster #156: RBC-Derived, Activating Antigen Carriers (SQZ™ AACs) Prime Potent T Cell Responses and Drive Tumor Regression In Vivo

  • SQZ™ Activating Antigen Carriers (AAC) were derived from red blood cells (RBCs) and engineered to direct tumor-specific antigens and adjuvant to endogenous professional APCs, which subsequently activated T cell responses in vivo
  • In TC-1 tumor bearing mice, a model of HPV16+ cancers, AACs demonstrated a synergistic therapeutic effect in combination with cisplatin, a common chemotherapy used in many clinical settings
  • Median survival of mice increased in all combination treatment cohorts compared to single agent cisplatin or ACC treatment

Poster #211: SQZ™ eAPCs Generated from PBMCs by Delivery of Multiple mRNAs Encoding for Antigens, Costimulatory Proteins, and Engineered Cytokines

  • SQZ™ Enhanced Antigen Presenting Cells (eAPC) derived from peripheral blood mononuclear cells (PBMCs) and engineered with various mRNA encoding for multiple target antigens and immuno-stimulation signals, including CD86 and membrane bound IL-2 and IL-12, generated robust T cell responses in human in-vitro models
  • HPV16-encoding mRNA delivery to PBMCs stimulated CD8+ T cells across a range of HLA haplotypes, supporting future eAPC clinical development in broad HPV16+ patient populations
  • eAPC data highlights the potential to expand the therapeutic impact across tumor types by changing the antigen-encoding mRNA

Poster #165: Generating Enhanced Tumor Infiltrating Lymphocytes through Microfluidic Cell Squeezing

  • Cell Squeeze® delivery of mRNA encoding membrane bound IL-2 (mbIL2) and IL-12 (mbIL12) into expanded tumor reactive CD8 human tumor infiltrating lymphocytes (TILs) from AgonOx* (AGX-148) demonstrated high levels of membrane-bound cytokine expression in vitro
  • Enhanced TILs proliferated independent of exogenous IL-2 and demonstrated improved granzyme B levels, illustrating the potential to eliminate systemic IL-2 administration in the clinical setting.
  • In an in vitro co-culture model with matched human melanoma cells, enhanced TILs demonstrated increased tumor killing as compared to un-modified TILs

* AgonOx, Inc. is a biotechnology company with a close alignment with the Earle A. Chiles Research Institute at the Providence Cancer Institute in Portland, OR.

26 Oct2021

SQZ Biotechnologies Announces Independent DSMB Recommendation to Advance Lead Cell Therapy Candidate Into Combination With Checkpoint Inhibitors

Written by 2020HCP.com. Posted in News

High Dose Monotherapy Cohort Clinical Data from the SQZ-PBMC-HPV-101 Trial Accepted for Oral Presentation at ESMO IO in December

Cohorts in Combination with anti-PD-(L)1 and anti-CTLA-4 Open for Enrollment

Combination Stage Initiation Triggers Milestone Payment from Roche

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 company’s 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

  • Oral Presentation: Thursday, December 9 at 12:10 pm CET
  • Presentation Number: 48MO

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 study’s 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.

13 Sep2021

SQZ Biotechnologies Announces First Autoimmune Disease Indication for Tolerizing Antigen Carrier (TAC) Platform

Written by 2020HCP.com. Posted in News

IND filing for Celiac Disease Anticipated in Third Quarter 2022

Clinical Translation Supported by Existing Red Blood Cell-Based Manufacturing Capabilities and Preclinical Models Demonstrating Treg Mediated Tolerance

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 first clinical translation of the company’s Tolerizing Antigen Carrier (TAC) platform in autoimmune diseases will be for celiac disease, a chronic autoimmune disorder that afflicts millions of patients and has no approved drug treatment. The company anticipates an IND filing in the third quarter of 2022. In preclinical models, SQZ™ TACs have demonstrated the ability to induce multi-mechanism antigen-specific tolerance relevant to many immune mediated disorders. The company’s celiac disease program may support expansion into additional autoimmune diseases.

07 Sep2021

Verseau Therapeutics Appoints Karen Tubridy as Chief Development Officer

Written by 2020HCP.com. Posted in News

BEDFORD Mass. – September 7, 2021 – Verseau Therapeutics, Inc. today announced the appointment of
Karen Tubridy, Pharm.D. as Chief Development Officer. Karen brings over 25 years of drug development
experience within the biopharmaceutical industry. As CDO, Karen will play a leadership role in
advancing Verseau’s pipeline of first-in-class monoclonal antibodies that are directed at repolarizing
macrophages to enable the immune system to mount a potent attack on cancer.

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