UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 17, 2022 (
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| Item 1.01 | Entry into a Material Definitive Agreement. |
On March 15, 2022, Alaunos Therapeutics, Inc. (the “Company”) entered into Amendment #3 (the “Third Amendment”) to a Cooperative Research and Development Agreement, dated January 9, 2017, by and among the National Cancer Institute, the Company and Precigen, Inc., as amended (the “CRADA”). Pursuant to the Third Amendment, the term of the CRADA is extended retroactively for one year, from January 9, 2022 to January 9, 2023. In addition, the Third Amendment makes certain administrative changes, including the Company’s name, principal investigator and address.
The foregoing summary of the Third Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Third Amendment, a copy of which, subject to any applicable confidential treatment, will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
| Item 7.01 | Regulation FD Disclosure. |
On March 17, 2022, the Company’s Chief Executive Officer, Kevin S. Boyle Sr., and Vice President of Research & Development, Drew Deniger, gave a presentation at the Oppenheimer 32nd Annual Healthcare Conference. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 7.01, including Exhibit 99.1, is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Presentation, dated March 2022. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Alaunos Therapeutics, Inc. | ||||||
| Date. March 17, 2022 | By: | /s/ Kevin S. Boyle, Sr. | ||||
| Name: | Kevin S. Boyle, Sr. | |||||
| Title: | Chief Executive Officer | |||||
Exhibit 99.1 Attacking Solid Tumors with Novel TCR-T Cell Therapies Oppenheimer 32nd Annual Healthcare Conference March 2022
Forward Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward- looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” “believes” or other words or terms of similar meaning. These statements include, but are not limited to, statements regarding the Alaunos Therapeutics, Inc.'s (”Alaunos or the Company ) business and strategic plans, the Company's ability to raise capital, and the timing of the Company's research and development programs, including the anticipated dates for enrolling and dosing patients in the Company’s clinical trials. Although the management team of Alaunos believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Alaunos, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, among other things, changes in the Company’s operating plans that may impact its cash expenditures; the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Alaunos’ product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indication; the strength and enforceability of Alaunos’ intellectual property rights; and competition from other pharmaceutical and biotechnology companies as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Alaunos, including those risks and uncertainties listed in the most recent Form 10-Q and Form 10-K filed by Alaunos with the Securities and Exchange Commission. We are providing this information as of the date of this presentation, and Alaunos does not undertake any obligation to update or revise the information contained in this presentation whether as a result of new information, future events, or any other reason. 2
Shareholder Value Creation: A Clinical Stage TCR-T Company Targeting Solid Tumors Vision 2022 – Execution Mindset, Delivering Results Phase 1/2 TCR-T Library Trial Enrolling; FPI anticipated 1H22, interim data expected 1 Weaponizing the 2H22 immune system with powerful TCRs to treat 2 Clinical Library of 10 TCRs (KRAS, TP53, EGFR) Targeting Six Solid Tumor Indications solid tumors Targeting driver mutations Utilize internal cGMP Manufacturing Facility For TCR-T Library Trial 3 using T cells genetically modified with proprietary non- viral Sleeping Beauty platform TM 4 Proprietary TCR Discovery Platform, hunTR , Expanding and Advancing the Pipeline 3
From Ziopharm to Alaunos: Focused and Executing on Advancing our Novel TCR-T Platform February 2021 August 2021 October 2021 December 2021 Library Trial IND Clear to Kevin S. Boyle, Sr. Completed manufacturing Consolidated Proceed & Appointed CEO process qualification in Operations to Houston Departure of Laurence Company’s GMP facility January 2022 Cooper as CEO Trial Open for Enrollment & cGMP facility operational January 2022 Rebranding December 2021 to Alaunos Added four new targets to TCR-T Library & Renegotiated SVB loan November 2021 May 2021 September 2021 CAR-T JV (Eden IL-12 Winddown Strategic Restructuring BioCell) Winddown 4
TCR-T Platform with Multiple Solid Tumor Programs in Pipeline PROGRAM TARGETS INDICATION DISCOVERY PRECLINICAL IND-ENABLING PHASE 1 Lung Colon/rectum Library TCR-T cell Endometrium Therapy KRAS, TP53 & EGFR Hotspot Mutations Pancreas (Company Sponsored at MDACC) Ovary Bile Duct mbIL-15 KRAS & TP53 Solid Tumors TCR-T cell Therapy Hotspot Mutations Undisclosed Targets Cancer-specific Cancers with & Modalities Hotspot Mutations Somatic Mutations TM (hunTR ) 5
TCR-T is Superior to Other Cell Therapy Approaches for Solid Tumors TCR-T CAR-T TIL Target Intracellular & Extracellular Antigens Proven Efficacy in Solid Tumors Defined Target Specificity Targets Somatic Neoantigens Established Transposon-based Gene Transfer 6 Table above not based on head-to-head trials
A Differentiated TCR-T Program Targeting Solid Tumors TM Targeting Hotspot S leeping Beauty hunTR Platform (human neoantigen Mutations Technology T cell Receptor) Hotspot mutations are Non-viral transposition Robust discovery engine ideal targets for technology has favorable enables expansion of defeating cancer safety profile TCR Library Rapid, flexible & cost- effective manufacturing 7
Our TCR-T Cell Platform Targets Solid Tumors in Large Patient Populations with Unmet Clinical Need Cancer Type 2022 Incidence - USA • In the US, 92% of new cancer cases Lung 236,740 are solid tumors Colon and Rectum 151,030 • 4,804 patients are diagnosed every day with cancerous solid tumor 65,950 Endometrial • 1,548 patients die every day from a Pancreas 62,210 solid tumor cancer Ovary 19,880 Bile Duct 8,000 8 8 Source: https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html https://www.cancer.org/cancer/bile-duct-cancer/about/key-statistics.html; CA CANCER J CLIN 2021;71:7–33
KR AS , TP53, EGFR Mutations are Commonly Expressed in Targeted Indications High frequency tumor targets, not expressed in normal tissues Killer TCR-T cells specific for the mutation without off-tumor toxicity Unmet clinical need for patients with solid tumors 9 Source: Catalogue of Somatic Mutations in Cancer (COSMIC) database https://cancer.sanger.ac.uk/cosmic
TCRs Can Give Patients' T Cells a New Ability to Recognize and Kill Tumor Cells with Common Mutations 10
TCR Library Captures High Frequency Mutations and HLA Types • Common HLAs are represented in our TCR library • Certain mutations have more than one HLA restriction • As more TCRs are added to our library, the addressable patient market size will further increase 11
Non-viral S leeping Beauty Platform for Manufacturing TCR-T Cells • Efficient integration without the complexity of gene editing or viral approaches • Rapid, cost-effective manufacturing • Flexible approach to add TCRs; attractive choice for library • Platform can accommodate large transgene size • Process scalable for clinical production 12
TCR-T Cells Recognize KR AS , TP53, EGFR Mutations and Kill Solid Tumor Cells Powerful TCRs: Naturally-occurring, high avidity TCRs recognize low levels of neoantigens No off-target toxicity observed: Specificity for the mutation with negligible recognition of the wild type sequences Tumor killing: Recognition of tumor cells that express mutation and HLA Note: Refers to TP53 mutant reactive TCRs 13
Actively Enrolling First-in-Human TCR-T Clinical Trial with Innovative Library Approach Trial enrolling patients where a TCR matching a neoantigen / HLA pairing is available in Phase I Objectives: our TCR-T library. Define dose limiting toxicity (DLT) and Phase I is a prospective, open-label, dose-escalation study of TCR-T cells in patients the maximum tolerated dose (MTD) or with progressive or recurrent solid tumors who have failed standard therapy utilizing a recommended phase II dose (RP2D). Bayesian optimal interval design (BOIN) with an accelerated dose escalation. Evaluate the feasibility of TCR-T cell Patients will be enrolled in one of three dose cohorts. drug product manufacturing. Expect to dose first patient in 1H 2022 (NCT05194735). Phase II (Dose Expansion) is a prospective, open-label, single-dose portion of the study which is expected to begin once the MTD/RP2D in the Phase I part has been determined. 14
Each Autologous TCR-T Cell Product is Manufactured with a TCR Matched for the Patient’s Mutation and HLA Type Screening 1 6 2 Selection of TCR from Infusion Library for Manufacturing 5 3 TCR Expression & Peripheral Blood Expansion Leukapheresis 4 Sleeping Beauty Transposition of TCR 15
State of the Art, In-House cGMP Manufacturing Facility Operational Provides control Located in over clinical Houston near Texas TCR-transposed T cells targeting manufacturing, including Medical Center neoantigens have been grown: expertise and scheduling with high TCR expression to clinical dose levels Staffed by highly skilled Will be used for with high viability Alaunos personnel early phase clinical manufacturing 16
TM hunTR Program Rapidly Expands TCR Library Targeting Hotspot Mutations Focus on neoantigens, particularly those arising from hotspot mutations Empirical screening of TCRs from CD4+ and CD8+ T cells directly from tumor High-throughput TCR screening 17
mbIL-15 Improves the Persistence and Anti-tumor Activity of TCR-T cells in the Tumor Microenvironment (TME) Pro-survival signaling limits negative signals from the TME Stem-cell memory mbIL-15 TCR-T cells regenerate TCR-T cells Limit effects of HLA loss by supporting TILs and NK cells Potential for TCR-T cell therapy without lymphodepletion 18 CONFIDENTIAL
Experienced Management Team Kevin S. Boyle, Sr. Ellee de Groot, PhD Raffaele Baffa, MD, PhD Chief Executive Officer EVP Operations Chief Medical Officer Melinda Lackey Drew Deniger, PhD Mike Wong SVP Legal VP Research & Development VP Finance Melinda Lackey 19
Shareholder Value Creation: A Clinical Stage TCR-T Company Targeting Solid Tumors Vision 2022 – Execution Mindset, Delivering Results Phase 1/2 TCR-T Library Trial Enrolling; FPI anticipated 1H22, interim data expected 1 Weaponizing the 2H22 immune system with powerful TCRs to treat 2 Clinical Library of 10 TCRs (KRAS, TP53, EGFR) Targeting Six Solid Tumor Indications solid tumors Targeting driver mutations Internal cGMP Manufacturing Facility For TCR-T Library Trial 3 using T cells genetically modified with proprietary non- viral Sleeping Beauty platform TM 4 Proprietary TCR Discovery Platform, hunTR , Expanding and Advancing the Pipeline 20