Leading the FightAgainst Solid Tumors
About Us
Pioneering Novel Approaches
to Deliver on the Promise of TILs
At Turnstone, our mission is to develop new medicines to treat and cure patients with solid tumors.
Solid tumors present a major burden to society, with high mortality and poor outcomes associated with more advanced disease. Approved immunotherapies represent a significant advancement in the treatment of solid tumors, but many patients either do not respond or experience relapsed disease following an initial response. We believe the most significant challenge to creating curative immunotherapies in these patients is the low numbers of T cells that can recognize and attack the tumor, which we refer to as tumor‑reactive T cells.
To address this problem, we are pioneering a differentiated approach to tumor infiltrating lymphocytes, or TILs. We are developing next-generation TIL therapies by selecting the most potent (meaning able to mediate an anti-tumor response) and tumor-reactive T cells, which we refer to as Selected TILs. We are developing next-generation TIL therapies for potential treatment across multiple solid tumors.
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One Turnstone
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One Focus
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One Fight
Leadership
Experienced Team of
Leaders and Innovators
Turnstone has assembled a seasoned management team, an accomplished Board of Directors and a distinguished Scientific Advisory Board whose contributions to science have meaningfully advanced the field and helped inform our understanding of the relationship between cancer and the immune system.
Our passionate team of leaders comprises world-renowned professionals with deep expertise in TILs, cell therapy, tumor immunology, innate and adaptive immunity, oncolytic viruses, and in the discovery and development, manufacturing, and business and commercial development of complex biologics.
Sammy Farah, PhD, MBA
President & Chief Executive Officer
Stewart Abbot, PhD
Chief Scientific Officer
Saryah Azmat
Chief Business Officer
Mike Burgess, MBChB, PhD
Interim Chief Medical Officer
P. Joseph Campisi, Jr., Esq.
Chief Legal Officer
Vijay Chiruvolu, PhD
Interim Chief Technology Officer
Venkat Ramanan, PhD
Chief Financial Officer
David Stojdl, PhD
SVP, Discovery Research
Chad Green, PhD
SVP, Technical Operations
TJ Langer
SVP, Cell Therapy Development and External Innovation
Adina Pelusio
SVP, Clinical Operations
Karen Major
VP, Regulatory
George Smith, MBA, PhD
VP, Cell Therapy Business Operations
James Mulé, IPhD
Associate Center Director of Translational Science
Moffitt Cancer Center
Nicholas Restifo, MD
Advisor, Cancer Data Science Laboratory
National Institutes of Health
Eric Tran, PhD
Adoptive Cell Therapy Laboratory Lead
Providence Cancer Institute
Jerel Davis, PhD
Chairman & Director
Versant Ventures
Mike Burgess, MBChB, PhD
Executive Director
Turnstone Biologics
Sammy Farah, PhD, MBA
Director
Turnstone Biologics
Robert Gould
Director
Fulcrum Therapeutics
Rishi Gupta, JD
Director
OrbiMed
Patrick Machado
Director
Former CFO/CBO Medivation
Kanya Rajangam, MD, PhD
Director
Senti Biosciences
Jeff Courtney
In Memoriam
Our Approach
Tumor infiltrating lymphocytes (TILs) are a type of cell therapy that harness the patient’s own immune cells to target their own tumors. TIL therapy involves the isolation of lymphocytes from the patient’s tumor, expansion of the isolated cells outside the body, and then infusion of the cells back into the patient. TILs have the ability to penetrate, recognize, and kill cancer cells and offer potential to treat or cure solid tumors.
Turnstone’s next-generation Selected TILs have the potential for treatment of multiple solid tumors. Our innovative Selected TIL approach focuses on selecting and expanding the most potent tumor-reactive T cells to overcome the limitations of bulk TILs. This approach is grounded in work conducted in academia that demonstrated improved clinical responses for Selected TILs in solid tumors. We are leveraging this work to establish a standardized manufacturing process for large scale production of our Selected TILs.
Our Selected TIL approach employs the following foundational principles with the goal of yielding the greatest number and proportion of tumor-reactive T cells in our TIL products:
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Unbiased identification of patient-specific tumor antigens.
We seek to identify the most comprehensive set of patient-specific tumor antigens. We use an unbiased identification process that aims to find and capture the greatest diversity of antigens with the potential to drive the most robust T cell response. Our proprietary approach is unlike other TIL products that are biased toward a specific subset or class of antigen(s), which may miss relevant tumor antigens or focus on the wrong targets.
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Selection of greatest breadth of tumor-reactive T cells from patient extracted TILs.
Our goal is to capture and isolate the greatest number and proportion of a patient’s tumor-reactive T cells that have the potential to attack and destroy heterogeneous solid tumors. We aim to select the greatest diversity of T cells by using a function-based screening process that confirms reactivity to the identified patient-specific tumor antigens rather than relying on a bioinformatics-based prediction algorithm that may not be truly predictive.
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Expansion of tumor-reactive T cells and removal of non-tumor-reactive bystander cells.
We expand our selected tumor-reactive TIL population to magnitudes consistent with bulk TIL products and actively remove unnecessary bystander cells. This selective expansion resulted in a substantially higher proportion of tumor-reactive T cells in the final product, which we believe will result in targeted tumor killing.
Our Superior Killing Virus, or SKV Vaccinia, is derived from the Copenhagen strain of vaccinia that exhibits powerful oncolytic activity in human tumors and we have engineered the viral backbone to develop a highly potent viral immunotherapy. The SKV Vaccinia backbone modifications were specifically designed and selected to support:
- Enhanced immune activation through removal of immunosuppressive genes
- Highly selective tumor targeting for increased potency and safety
- Delivery of multiple transgenes to encode for specific functions
- Optimized viral spread and infection in the tumor
- Systemic and intra-tumoral (IT) administration
RIVAL-01, our lead clinical stage viral immunotherapy program, being developed in partnership with Takeda, utilizes the inherent activity of the SKV Vaccinia backbone and includes a rationally selected payload combination designed to further drive oncolytic and immune-mediated killing of the tumor. The three key payloads encoded in RIVAL-01 include:
- Flt3L, a growth factor to support the differentiation and expansion of highly relevant antigen-presenting dendritic cells which are critical for anti-tumor immune response
- IL-12, a pro-inflammatory cytokine to promote T-cell cytotoxicity, activate innate immune cells and minimize immunosuppression
- Anti-CTLA-4, an antibody that inhibits CTLA-4-mediated immunosuppression and downregulation of T-cell activation
We believe that Turnstone is strongly positioned to be a leader in leveraging viral immunotherapy to further increase the activity of our TIL therapies, if approved.
Viral immunotherapy is a therapeutic modality with widespread potential to drive and modulate immune responses to solid tumors. Many viruses have inherent oncolytic activity that can be modulated through genetic engineering. These viruses preferentially infect, replicate within, and kill malignant tumor cells, and can induce broad immune responses. Viral immunotherapies are designed to convert immunologically unresponsive “cold” tumor microenvironments to more reactive “hot” tumor microenvironments and thereby enhance the activity of other immunotherapies.
We are initially evaluating viral immunotherapies in combination with our lead Selected TIL product candidate, TIDAL-01, via two approaches:
- Administration of virus prior to TIL extraction to optimize TIL harvest and broaden applicability to additional tumor types with low immune cell infiltration, and
- Administration of virus following treatment with TIDAL-01 to optimize TIL trafficking and infiltration into solid tumors and to support the anti-tumor functions of infiltrating immune cells.
Scientific Resources
Explore academic selection strategies that have demonstrated clinical proof of concept, relevant to Turnstone’s differentiated approach to TIL therapy:
Learn more about our scientific and clinical research, and the potential of Turnstone’s Selected TIL therapy in a broad range of solid tumors:
Pipeline
Designed to Shift the Paradigm
for the Treatment of Solid Tumors
We are applying our Selected TIL approach for the potential treatment of a wide range of solid tumors. We are developing a broad pipeline aimed at improving outcomes for patients with cancers, as illustrated in the chart below.
| Program | Product Overview | Key Indications | Preclinical | Phase 1 | Phase 2 | Phase 3 | Next Anticipated Milestone | |
|---|---|---|---|---|---|---|---|---|
| Selected TILs | ||||||||
| TIDAL-01 | Tumor-reactive selected TILs |
Breast Cancer, Colorectal Cancer, Uveal Melanoma |
+
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Initial clinical data in mid-2024 | ||||
| Cutaneous Melanomas, Non-cutaneous Melanomas |
+ Moffitt Collaboration*
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| Combination with viral immunotherapy |
Solid Tumors |
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IND submission | |||||
| TIDAL-02 | Selected TILs with next- gen manufacturing and TIL quality enhancements |
Solid Tumors |
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IND submission | ||||
| Selected TILs | |||
| Preclinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|
TIDAL-01Tumor-reactive selected TILs +
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TIDAL-01Tumor-reactive selected TILs 
+
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TIDAL-01Combination with viral immunotherapy |
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TIDAL-02Selected TILs with next-gen manufacturing and TIL quality enhancements |
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Partners
Optimizing Technological Innovations
Through Strategic Partnerships
We are backed by successful top-tier life science and biotech investors committed to Turnstone’s growth, and have forged select collaborations with key academic institutions, major biopharmaceutical companies, elite researchers and prominent international cancer medical centers to support the development of our next-generation Selected TIL and immunotherapy pipeline.
Together with our strategic partners, we are devoted to delivering transformative therapies to the millions of cancer patients underserved by current treatment options.
Key Collaborators
In November 2022, Turnstone announced a Cooperative Research and Development Agreement with the National Cancer Institute (NCI) to study TIL therapy in novel combinations with viral immunotherapy.
In July 2022, Turnstone announced a strategic alliance with Moffitt Cancer Center focused on the development of Turnstone’s pipeline of tumor-reactive selected TILs targeting solid tumors.
In April 2022, Turnstone announced a TIL therapy research collaboration with CRCHUM to develop novel strategies for tumor-reactive T-cell selection in Turnstone’s TIL therapy candidates against solid tumor indications.
Select Investors
News
Careers
Empowering Our People
to Drive Science Forward
Turnstone is committed to true innovation, fearless execution and operational excellence. Our team work with an unrelenting sense of urgency to fulfill our mission. Our decision-making is driven by bold science and our therapeutics are designed with the patient at the forefront of our thoughts.
We continue to build a values-driven organization that embraces diversity, equity, and recognizes that the sum of our parts drives more success than any single individual. Our talented people and deeply ingrained culture are vital elements in maintaining our competitive edge in the vast biotech universe and key to unlocking the full potential of cancer immunotherapy.
If you are passionate about making a difference for patients and are excited by our mission and science, Turnstone might just be for you.
Team Opportunities
Turnstone Biologics (“Turnstone”), a public clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1 trial in solid tumors for the lead TIL therapy candidate, TIDAL-01, and a Phase 1 trial in partnership with the Moffitt Cancer Center.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Job Description:
The Sr. Clinical Trial Manager (CTM) manages the execution of clinical trials, including vendors (e.g., Clinical Research Organization) and study sites related issues, with supervision from the Director, Clinical Operations, of which this position will report into. This position works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all Turnstone functional areas and global office sites is essential.
He/She develops, manages, and coordinates all clinical trial activities for their studies including managing Clinical Research Organizations (CROs), vendors and internal team members. The Sr CTM develops and applies best practices in the development, initiation, planning, execution, control and closing of projects. He/She is a proficient communicator and effective influencer who builds and maintains strong relationships internally and externally. All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures.
Responsibilities:
- Responsibilities include supporting the planning, execution, and interpretation of clinical trials and ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registrations.
- Manage all operational aspects of assigned clinical trial(s)Support the selection of vendors/CROs and provide effective ongoing management to vendors/CROs to ensure compliance and execution of deliverables within the approved budget, study timeline, and study protocol. Independently manages less complex studies
- Monitor and track clinical trial progress and provide status update to stakeholders and at project team meetings to Sr Management as needed.
- Manage or support the Management of study contracting, budget, forecasting, accruals, and payment process for all clinical trial vendors including investigational sites
- Oversee all aspects of data cleaning and facilitate data locks, including oversight of clinical sites, CRO, vendors and collaboration with data management/statistics teams
- Drafts and coordinate review of relevant documents including protocols, informed consents, monitoring plans, with little supervision.
- Must be able to participate in cross-functional strategic initiatives under limited supervision.
- Proactively identify potential issues/risks and recommends/implement solutions. Facilitate and SMT for assigned projects Prepare and/or present written and oral presentations regarding clinical trial progress/results internally and externally.
- Participate in clinical development initiatives such as clinical standard operating procedures, eTMF, etc.
- Coach members of a work team and ensures adherence to established guidelines
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Education and Experience:
- Thorough understanding of FDA, ICH and GCP guidelines
- Proven track record showing clear proficiency in clinical trial management skills
- Proven complex problem-solving skills collaboratively and independently
- Solid vendor management experience, e.g., CRO, laboratory, and clinical supply logistics
- Broad understanding of clinical operations related to pharmaceutical drug development process
- Detailed understanding of all aspects of oncology clinical protocol design and implementation & overall drug development
- Ability to effectively interface with personnel at clinical sites
- Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
- Excellent interpersonal, verbal, and written communication skills
- Ability and willingness to travel internationally and domestically
The ideal candidate should have a BA, BS in biological degree or degree in nursing, pharmacy, medical technology or equivalent mix of education, certifications, and experience. Minimum of 9 years of clinical trial management experience, at least 5 of which are as a Clinical Trial Manager for clinical development studies at a pharmaceutical/biotech organization or a combination of CRO and pharmaceutical/biotech, excluding OTC drugs
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To Apply:
Please click here to apply!
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Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Turnstone Biologics (“Turnstone”), a public clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1 trial in solid tumors for the lead TIL therapy candidate, TIDAL-01, and a Phase 1 trial in partnership with the Moffitt Cancer Center.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
Job Description:
Turnstone Bio is seeking a driven and experienced Senior Manager to support the Manufacturing Operations Team. This successful candidate will oversee Turnstone Bios Manufacturing network by providing technical and operational support of the TIDAL-01 process at our external CDMOs, such as: leading or supporting scheduling end to end patient journey, operational and/or process readiness, and improvements, The successful candidate should be detail oriented and enjoy working in a dynamic high-paced environment to deliver innovative therapies to patients in need.
This is a key position requiring routine interaction with Clinical Operations, External Manufacturing Operations, MSAT, PD, Quality Assurance, and Supply Chain. The role will provide support Turnstone Bio Manufacturing network, including the Ottawa, CAN and San Diego, California (TBio sites), and External MFG partners. As such, flexibility to provide remote support, as necessary, for manufacturing operations is required. In addition, this candidate will support the evaluation of new or future external and internal manufacturing capabilities.
Responsibilities:
• Interact with TBio leadership to influence strategic and technical guidance on ongoing clinical production internally, and at External MFG partners
• Establish and manage business processes to drive process improvements using data-driven results (e.g. scheduling enhancements and optimization, MFG process an operational improvements)
• Coordinate with upstream Clinical Operations and downstream Clinical Manufacturing teams, ensuring clear flow of communication across the manufacturing lifecycle
• Collaborate with Process Development teams on implementation of process optimizations, and new technology, critical reagents, and materials
• Provide on-site/remote Subject Matter Expert (SME) support for GMP MFG operations.
• Leads CMO/CDMO evaluations to support ramp up
• Acts as MFG Ops Person-in-Plant (PiP) to oversee all aspects of operations at CMOs/CDMOs and works with CMOs/CDMOs to implement improvements and necessary corrections to ensure compliant CGMP operations in line with any regulatory filings and product specifications.
• Tracks and maintains budget related to activities at the CMO/CDMO and is responsible for ensuring activities complete per project timelines.
• Manage Materials Management relationship, ensures material kitting process is defined for TIDAL-01, and supports inventory consolidation (consumption reports in SAP vs. actual usage)
• Champions business and process improvements for material ingress in the MFG suites
• Leads and supports operations (technical, quality, supply chain, manufacturing, QC, packaging and logistics) activities associated with the manufacture of products at CMOs/CDMOs and partners.
• Partners with CMO/CDMO to ensure successful manufacture of products required for clinical supply, process validation, and/or commercial supply.
• Provides guidance for equipment and support process validation activities with MSAT at the contract manufacturing facility. Provides technical/operational input/feedback to MSA and, Process Development for defining the critical parameters of new and existing processes.
• Collaborates with manufacturing quality partner and internal quality teams to develop processes and systems that enable compliant, successful technology transfers, operation, and lifecycle management of CGMP clinical and commercial manufacturing processes, ensuring all product delivery schedules are met.
• Drives timely decisions and facilitates active communication and information flow between contract manufacturer and Turnstone Biologics team members.
• Authors technical documents for regulatory agency submission in support of manufacturing processes and serves as process subject matter expert in health authority interactions.
• Identifies and drives process and operational optimization initiatives and addresses opportunities for efficiency, capacity improvements, and cost reduction.
• Partners with MSAT, Process Development, and Quality teams to identify and drive process optimization initiatives and address opportunities for efficiency and capacity improvements.
• Owns and drives change controls to make necessary changes to CGMP processes.
Education and Experience:
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- • Bachelor’s degree, in life sciences, engineering or related field and 8 or more years of industry experience; Masters degree with 8+ or more years of experience; PhD and 3-5 years of experience
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- • Enjoy working in a fast-paced environment
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- • Experience in cell or gene therapies preferred
The anticipated salary range for this role is $140,000 – $170,000.
To Apply:
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Contact
General Inquiries
info@turnstonebio.com
Partner
with Us
bd@turnstonebio.com
Talent Acquisition
hr@turnstonebio.com
Investors & Media
ir@turnstonebio.com
Clinical Trial Inquiries
ct@turnstonebio.com
California
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USA
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CANADA
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