UNITED STATES
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FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On September 28, 2022, TCR2 Therapeutics Inc. (the “Company”) issued a press release titled “gavo-cel Continues to Demonstrate Clinical Benefit in Solid Tumors with Additional RECIST Reponses in Ovarian Cancer and Mesothelioma.” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information under this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished herewith 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 liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 8.01 | Other Events. |
Phase 1 Topline Results
On September 28, 2022, the Company announced positive topline results from the Phase 1 portion of the Company’s gavo-cel Phase 1/2 clinical trial for mesothelin-expressing solid tumors, with some patients still being monitored for clinical response or stable disease.
As of the September 9, 2022 data cutoff, 32 patients (including 23 mesothelioma, eight ovarian cancer and one cholangiocarcinoma) had received a single gavo-cel infusion in the Phase 1 portion of the clinical trial. The patients were heavily pretreated with a median of five prior lines of therapy, including immune checkpoint inhibitors in 66% of patients and mesothelin-directed therapies in 19% of patients. Following identification of a dose-limiting toxicity (DLT) at dose level (DL) 5 (5x108 cells/m2 following lymphodepletion) in September 2021, the study proceeded to a dose de-escalation portion, first at DL3.5 (3x108 cells/m2 following lymphodepletion) using a split-dosing approach, and subsequently at DL3 (1x108 cells/m2 following lymphodepletion) which was declared the recommended Phase 2 dose (RP2D). No new DLTs were observed.
gavo-cel demonstrated a disease control rate (DCR) of 77%, which is defined in the Phase 1 portion of the trial as a response or sustained stable disease for at least 3 months post infusion. As measured by blinded independent central review (BICR), 28 of the 30 (93%) patients evaluable for efficacy experienced tumor regression of their target lesions, ranging in magnitude from 4% to 80%. Eight patients experienced target lesion regression greater than 30%, six of whom (four with mesothelioma and two with ovarian cancer) achieved a partial response (PR) according to RECIST 1.1 criteria, including one patient who also achieved a complete metabolic response. One patient with cholangiocarcinoma was also considered to have achieved a PR by investigator assessment, demonstrating that gavo-cel has induced responses in every tumor type tested to date. The overall response rate (ORR) among patients who received gavo-cel following lymphodepletion chemotherapy was 22% by BICR and 26% by investigator assessment. By BICR, the ORR was 21% among patients with malignant pleural/peritoneal mesothelioma (MPM) and 29% among those with ovarian cancer. The median overall survival (OS) for patients with MPM was 11.2 months, whereas the median progression-free survival (PFS) for patients with MPM was 5.6 months.
The primary objectives of the Phase 1 portion of the trial are to evaluate the safety profile of gavo-cel in patients whose tumors overexpress mesothelin and to determine the RP2D. Secondary objectives include ORR and DCR. Exploratory objectives include the assessment of expansion, tumor infiltration and persistence of gavo-cel.
Summary of trial conduct, baseline characteristics and gavo-cel dose:
| • | Screening: Forty-eight percent of patients met the mesothelin expression cutoff as defined per protocol. |
| • | Patient Characteristics: Thirty-two patients received gavo-cel including 23 with mesothelioma, eight with ovarian cancer and one with cholangiocarcinoma, with a median age of 63 years (range, 28-84 years). The median number of prior therapies was five (range 1-13), including immune checkpoint inhibitor therapy in 66% of patients and mesothelin directed therapy in 19% of patients. |
| • | gavo-cel Dose: The 32 patients disclosed to date have received gavo-cel at the following DL: |
| • | DL 0: 5x107 cells/m2 without lymphodepletion – one mesothelioma |
| • | DL 1: 5x107 cells/m2 following lymphodepletion – seven mesothelioma and one ovarian cancer |
| • | DL 2: 1x108 cells/m2 without lymphodepletion – one mesothelioma |
| • | DL 3: 1x108 cells/m2 following lymphodepletion – six mesothelioma, one cholangiocarcinoma and six ovarian cancer |
| • | DL 3.5: 3x108 cells/m2 following lymphodepletion – four mesothelioma and one ovarian cancer |
| • | DL 4: 5x108 cells/m2 without lymphodepletion – one mesothelioma |
| • | DL 5: 5x108 cells/m2 following lymphodepletion – three mesothelioma |
Key topline clinical findings from patients treated with gavo-cel:
| • | Safety Data: gavo-cel was generally well tolerated with a manageable adverse event profile up to DL5. Over the course of the Phase 1 clinical trial, two DLTs were observed: one case of Grade 3 pneumonitis at DL1 that resolved with anti-cytokine therapy, and one case of Grade 5 bronchioalveolar hemorrhage at DL5. All three patients treated at DL5 experienced severe cytokine release syndrome (CRS) which resulted in the Safety Review Team recommending de-escalation. The most frequent Grade 3 or higher non-hematological toxicity among patients treated at the RP2D was CRS, which was reported in 15% of patients. |
| • | Clinical Activity: Thirty patients were evaluable for response. DCR was 77%. Tumor regression was observed in 28 (93%) patients. Eight patients experienced target lesion regression greater than 30%, including six patients who achieved a PR by RECIST criteria (four with MPM and two with ovarian cancer). The ORR by RECIST criteria among patients infused with gavo-cel following lymphodepletion chemotherapy was 22% by BICR, which includes one patient who achieved a complete metabolic response, and 26% by investigator assessment, which includes an additional PR reported in a patient with metastatic cholangiocarcinoma. |
| • | Survival: Among patients with mesothelioma, median OS and PFS were 11.2 months and 5.6 months, respectively, which compare favorably with the published outcomes of patients with relapsed refractory MPM treated in the second-line setting with standard therapy. Among patients with ovarian cancer, median OS and PFS were 8.1 months and 5.8 months, respectively. |
Translational Data: Peak gavo-cel expansion (Cmax) occurred between days 7 and 23. Cmax markedly increased when gavo-cel was administered following lymphodepletion. Cytokine induction post gavo-cel infusion was observed in all evaluable patients, which is indicative of mesothelin target engagement. Post infusion, expression of PD-1 was observed to be upregulated on circulating gavo-cel T cells. Detection of gavo-cel in tumors and malignant effusions showed higher expansion and longer persistence in these tissues as compared to peripheral blood.
Corporate Presentation
The Company from time to time presents and/or distributes to the investment community slide presentations to provide updates and summaries of its business. On September 28, 2022, the Company hosted a conference call and webcast to discuss topline results from the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for mesothelin-expressing solid tumors. A copy of its “Gavo-cel Phase 1 Presentation” slide presentation is being filed herewith as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
Statements contained under this Item 8.01, including Exhibit 99.2, regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to: including express or implied statements regarding the Company’s expectations for the Phase 2 clinical trial of gavo-cel and the Phase 1/2 clinical trial of TC-510, including expected progress and timing of updates; the Company’s expectations for the safety and efficacy of, and enhancements to, gavo-cel, TC-510 and the Company’s other product candidates including compared to other T-cell therapy approaches; the Company’s expectations regarding the estimated patient populations and related market opportunities in gavo-cel’s, TC-510’s and the Company’s other product candidates’ targeted indications; the Company’s expectations regarding manufacturing of gavo-cel, TC-510 and the Company’s other product candidates, the Company’s expectations regarding its development programs and IND-enabling studies; the Company’s expectations regarding expansion opportunities for its TRuC platform; and the Company’s expectations regarding its financial position.
Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of a trial; the possibility that positive results from preclinical studies and correlative studies may not necessarily be predictive of the results of the Company’s planned clinical trials, including the Phase 2 clinical trial of gavo-cel and Phase 1/2 clinical trial of TC-510; the risk that the results from the Phase 2 clinical trial of gavo-cel and Phase 1/2 clinical trial of TC-510 will not support further development and marketing approval; the risk that the Company may be unable to gain approval of gavo-cel, TC-510 and the Company’s other product candidates on a timely basis, if at all; the risk that the Company has over-estimated the potential patient population for its product candidates, if approved; the risk that the current COVID-19 pandemic will impact the Company’s clinical trials and other operations; and other risks set forth under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. All forward-looking statements contained in this presentation speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release issued by TCR2 Therapeutics Inc. on September 28, 2022. | |
| 99.2 | Copy of TCR2 Therapeutics Inc. slide presentation dated September 28, 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.
| TCR2 THERAPEUTICS INC. | ||
| By: | /s/ Eric Sullivan | |
| Name: | Eric Sullivan | |
| Title: | Chief Financial Officer | |
Date: September 28, 2022
Exhibit 99.1
gavo-cel Continues to Demonstrate Clinical Benefit in Solid Tumors with
Additional RECIST Reponses in Ovarian Cancer and Mesothelioma
- Completed Phase 1 clinical trial establishes gavo-cel monotherapy as the first anti-mesothelin cell therapy to demonstrate tolerability and clinical benefit
- Second RECIST partial response in ovarian cancer supports broad potential of gavo-cel
- Consistent tumor regression in 28 of 30 (93%) evaluable patients with disease control rate of 77%
- Progression-free survival of 5.6 months and overall survival of 11.2 months suggest durability of benefit in mesothelioma
- Phase 2 portion of trial underway implementing multiple approaches to further improve clinical outcomes
- TCR2 to host a conference call on Wednesday, September 28, 2022 at 8:00a.m. ET
CAMBRIDGE, Mass., September 28, 2022 – TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from solid tumors, today announced positive topline results from the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for mesothelin-expressing solid tumors, with some patients still being monitored for clinical response or stable disease.
As of the September 9, 2022 data cutoff, 32 patients (including 23 mesothelioma, eight ovarian cancer and one cholangiocarcinoma) had received a single gavo-cel infusion in the Phase 1 portion of the clinical trial. The patients were heavily pretreated with a median of five prior lines of therapy, including immune checkpoint inhibitors in 66% of patients and mesothelin-directed therapies in 19% of patients. Following identification of a dose-limiting toxicity (DLT) at dose level (DL) 5 (5x108 cells/m2 following lymphodepletion) in September 2021, the study proceeded to a dose de-escalation portion, first at DL3.5 (3x108 cells/m2 following lymphodepletion) using a split-dosing approach, and subsequently at DL3 (1x108 cells/m2 following lymphodepletion) which was declared the recommended Phase 2 dose (RP2D). No new DLTs were observed.
gavo-cel demonstrated a disease control rate (DCR) of 77%, which is defined in the Phase 1 portion of the trial as a response or sustained stable disease for at least 3 months post infusion. As measured by blinded independent central review (BICR), 28 of the 30 (93%) patients evaluable for efficacy experienced tumor regression of their target lesions, ranging in magnitude from 4% to 80%. Eight patients experienced target lesion regression greater than 30%, six of whom (four with mesothelioma and two with ovarian cancer) achieved a partial response (PR) according to RECIST 1.1 criteria, including one patient who also achieved a complete metabolic response. One patient with cholangiocarcinoma was also considered to have achieved a PR by investigator assessment, demonstrating that gavo-cel has induced responses in every tumor type tested to date. The overall response rate (ORR) among patients who received gavo-cel following lymphodepletion chemotherapy was 22% by BICR and 26% by investigator assessment. By BICR, the ORR was 21% among patients with malignant pleural/peritoneal mesothelioma (MPM) and 29% among those with ovarian cancer. The median overall survival (OS) for patients with MPM was 11.2 months, whereas the median progression-free survival (PFS) for patients with MPM was 5.6 months.
“We believe our Phase 1 clinical data already position gavo-cel as a first- and best-in-class anti-mesothelin monotherapy with a near-term opportunity during Phase 2 to further improve the depth and durability of clinical benefit by using it in combination with immune checkpoint inhibitors and redosing strategies. These are remarkable data in the context of solid tumors where there have been significant challenges with current CAR-T therapies. I am particularly excited by this second RECIST response in ovarian cancer as it supports the meaningful clinical activity of gavo-cel in a large patient population. Additionally, we continue to observe consistent tumor regression for heavily pre-treated patients with mesothelioma for whom limited options are available,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “As a result, we have narrowed our focus in the short-term to our three core programs, gavo-cel, TC-510 and TC-520, so that we can maximize the number of patients with access to our investigational therapies.”
“The results of the Phase 1 trial underscore the potential clinical value of gavo-cel in a very heavily pretreated patient population that are receiving our engineered T cells as their sixth line of therapy on average,” said Alfonso Quintás-Cardama, M.D., Chief Medical Officer of TCR2 Therapeutics. “gavo-cel has demonstrated a manageable safety profile at the RP2D, induced RECIST responses in every indication studied to date, and has provided a promising survival signal among patients with mesothelioma as well as encouraging preliminary efficacy data in ovarian cancer. These results clearly support the further development of gavo-cel in the Phase 2 portion of the study where we believe that the combination with checkpoint inhibitors and the ability to retreat patients with additional doses of gavo-cel will allow us to increase patients’ exposure to gavo-cel, potentially translating into even higher response rates and improved durability of benefit.”
“We have already dosed a number of patients in combination with checkpoint inhibitors, including patients with ovarian cancer, in the randomized Phase 2 portion of the trial and look forward to providing ongoing progress updates on the various arms of the study as well as following the remaining patients still on the Phase 1 portion. We are clearly delighted that patients with various cancers continue to derive meaningful benefit from gavo-cel,” added Dr. Menzel.
The primary objectives of the Phase 1 portion of the trial are to evaluate the safety profile of gavo-cel in patients whose tumors overexpress mesothelin and to determine the RP2D. Secondary objectives include ORR and DCR. Exploratory objectives include the assessment of expansion, tumor infiltration and persistence of gavo-cel.
Summary of trial conduct, baseline characteristics and gavo-cel dose:
| • | Screening: Forty-eight percent of patients met the mesothelin expression cutoff as defined per protocol. |
| • | Patient Characteristics: Thirty-two patients received gavo-cel including 23 with mesothelioma, eight with ovarian cancer and one with cholangiocarcinoma, with a median age of 63 years (range, 28-84 years). The median number of prior therapies was five (range 1-13), including immune checkpoint inhibitor therapy in 66% of patients and mesothelin directed therapy in 19% of patients. |
| • | gavo-cel Dose: The 32 patients disclosed to date have received gavo-cel at the following DL: |
| • | DL 0: 5x107 cells/m2 without lymphodepletion – one mesothelioma |
| • | DL 1: 5x107 cells/m2 following lymphodepletion – seven mesothelioma and one ovarian cancer |
| • | DL 2: 1x108 cells/m2 without lymphodepletion – one mesothelioma |
| • | DL 3: 1x108 cells/m2 following lymphodepletion – six mesothelioma, one cholangiocarcinoma and six ovarian cancer |
| • | DL 3.5: 3x108 cells/m2 following lymphodepletion - four mesothelioma and one ovarian cancer |
| • | DL 4: 5x108 cells/m2 without lymphodepletion – one mesothelioma |
| • | DL 5: 5x108 cells/m2 following lymphodepletion – three mesothelioma |
Key topline clinical findings from patients treated with gavo-cel:
| • | Safety Data: gavo-cel was generally well tolerated with a manageable adverse event profile up to DL5. Over the course of the Phase 1 clinical trial, two DLTs were observed: one case of Grade 3 pneumonitis at DL1 that resolved with anti-cytokine therapy, and one case of Grade 5 bronchioalveolar hemorrhage at DL5. All three patients treated at DL5 experienced severe cytokine release syndrome (CRS) which resulted in the Safety Review Team recommending de-escalation. The most frequent Grade 3 or higher non-hematological toxicity among patients treated at the RP2D was CRS, which was reported in 15% of patients. |
| • | Clinical Activity: Thirty patients were evaluable for response. DCR was 77%. Tumor regression was observed in 28 (93%) patients. Eight patients experienced target lesion regression greater than 30%, including six patients who achieved a PR by RECIST criteria (four with MPM and two with ovarian cancer). The ORR by RECIST criteria among patients infused with gavo-cel following lymphodepletion chemotherapy was 22% by BICR, which includes one patient who achieved a complete metabolic response, and 26% by investigator assessment, which includes an additional PR reported in a patient with metastatic cholangiocarcinoma. |
| • | Survival: Among patients with mesothelioma, median OS and PFS were 11.2 months and 5.6 months, respectively, which compare favorably with the published outcomes of patients with relapsed refractory MPM treated in the second-line setting with standard therapy. Among patients with ovarian cancer, median OS and PFS were 8.1 months and 5.8 months, respectively. |
| • | Translational Data: Peak gavo-cel expansion (Cmax) occurred between days 7 and 23. Cmax markedly increased when gavo-cel was administered following lymphodepletion. Cytokine induction post gavo-cel infusion was observed in all evaluable patients, which is indicative of mesothelin target engagement. Post infusion, expression of PD-1 was observed to be upregulated on circulating gavo-cel T cells. Detection of gavo-cel in tumors and malignant effusions showed higher expansion and longer persistence in these tissues as compared to peripheral blood. |
About the Phase 1/2 Clinical Trial in Advanced Mesothelin-Expressing Solid Tumors
The Phase 1/2 clinical trial (NCT03907852) is evaluating the safety and efficacy of gavocabtagene autoleucel (“gavo-cel”; previously known as TC-210), TCR2’s T cell receptor fusion construct directed against mesothelin. The trial is enrolling patients with either mesothelin expressing non-small cell lung cancer (NSCLC), ovarian cancer, cholangiocarcinoma, or malignant pleural/peritoneal mesothelioma (MPM). The Phase 1 dose escalation portion of the clinical trial utilized a modified 3+3 design with four increasing gavo-cel doses. At each dose, gavo-cel was tested in two separate dose levels: first without lymphodepletion and then following lymphodepleting chemotherapy.
In the Phase 2 portion of the clinical trial, patients will receive gavo-cel at the recommended Phase 2 dose (1x108 cells/m2 following lymphodepletion). A total of 75 patients will be treated in the MPM cohort and a total of 20 patients will be treated in each one of the following indications: ovarian, NSCLC and cholangiocarcinoma. In the MPM cohort, patients will be randomized to receive either single agent gavo-cel, gavo-cel in combination with OPDIVO® (nivolumab), or gavo-cel in combination with OPDIVO and YERVOY® (ipilimumab). Patients enrolled in the ovarian cancer, NSCLC or cholangiocarcinoma cohorts will all receive gavo-cel in combination with OPDIVO.
About Mesothelin-Expressing Solid Tumors
Mesothelin is a cell-surface glycoprotein highly expressed in a wide range of solid tumors, including malignant pleural/peritoneal mesothelioma, ovarian cancer, cholangiocarcinoma, breast cancer, pancreatic cancer and others. Overexpression of mesothelin is associated with poorer prognosis in some cancers due to its active role in both malignant transformation and tumor aggressiveness by promoting cancer cell proliferation, invasion, and metastasis. Of the wide range of solid tumors expressing mesothelin, non-small cell lung cancer, ovarian cancer, mesothelioma and cholangiocarcinoma represent a patient population up to 81,000 annually in the United States alone.
TCR2 Therapeutics Conference Call and Webcast
TCR2 Therapeutics will host a conference call and webcast on Wednesday, September 28, 2022 at 8:00am E.T. In order to participate in the conference call, please register at https://bit.ly/3BTJ9Z7. Participants can register via this link up to ten minutes prior to start time. The webcast and presentation will be made available on the TCR2 Therapeutics website in the Investors section under Events at investors.tcr2.com/events. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.
About TCR2 Therapeutics
TCR2 Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for patients suffering from solid tumors. The Company is focused on the discovery and development of product candidates against novel and complex targets utilizing its proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells). The TRuC platform is designed to specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). For more information about TCR2, please visit www.tcr2.com.
Forward-looking Statements
This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding the therapeutic potential of gavo-cel, TC-510 and TCR2’s other product candidates, including
potential improvements in efficacy, safety and durability in the Phase 2 portion of the gavo-cel trial, expectations regarding future growth and prospects, future clinical development plans and anticipated timing of data updates, the development of the Company’s TRuC-T cells, their potential characteristics, applications and clinical utility, and the potential therapeutic applications of the Company’s TRuC-T cell platform.
The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim and topline results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR2’s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, including TCR2’s ability to secure additional manufacturing facilities; TCR2’s ability to enroll patients in its clinical trials; whether TCR2’s cash resources will be sufficient to fund TCR2’s foreseeable and unforeseeable operating expenses and capital expenditure requirements, the impact of the COVID-19 pandemic on TCR2’s ongoing operations; and other risks set forth under the caption “Risk Factors” in TCR2’s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR2 believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.
Moreover, except as required by law, neither TCR2 nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Investor and Media Contact:
Carl Mauch
Senior Director, Investor Relations and Corporate
Communications (617) 949-5667
carl.mauch@tcr2.com
# # #
Phase 1 Dataset September 2022 Exhibit 99.2
Forward Looking Statements This presentation has been prepared by TCR2 Therapeutics Inc. (“we,” “us,” or “our”) and contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development plans, our clinical results and other future conditions. All statements, other than statements of historical facts, contained in this presentation, including express or implied statements regarding our expectations for the Phase 2 clinical trial of gavo-cel and the Phase 1/2 clinical trial of TC-510, including expected progress and timing of updates; our expectations for the safety and efficacy of, and enhancements to, gavo-cel, TC-510 and our other product candidates including compared to other T-cell therapy approaches; our expectations regarding the estimated patient populations and related market opportunities in gavo-cel’s, TC-510’s and our other product candidates’ targeted indications; our expectations regarding manufacturing of gavo-cel, TC-510 and our other product candidates, our expectations regarding our development programs and IND-enabling studies; our expectations regarding expansion opportunities for our TRuC platform; and our expectations regarding our financial position are forward-looking statements. These statements are based on management’s current expectations and beliefs and are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of a trial; the possibility that positive results from preclinical studies and correlative studies may not necessarily be predictive of the results of our planned clinical trials, including the Phase 2 clinical trial of gavo-cel and Phase 1/2 clinical trial of TC-510; the risk that the results from the Phase 2 clinical trial of gavo-cel and Phase 1/2 clinical trial of TC-510 will not support further development and marketing approval; the risk that we may be unable to gain approval of gavo-cel, TC-510 and our other product candidates on a timely basis, if at all; the risk that we have over-estimated the potential patient population for our product candidates, if approved; the risk that the current COVID-19 pandemic will impact our clinical trials and other operations; and the other risks set forth under the caption “Risk Factors” in our most recent Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on March 22, 2022, as updated in our most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as filed with the SEC on August 8, 2022, and in our future filings with the SEC available at the SEC’s website at www.sec.gov. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. You should not place undue reliance on any forward‐looking statements, which speak only as of the date they are made. While we may elect to update these forward-looking statements at some point in the future, we assume no obligation to update or revise any forward-looking statements except to the extent required by applicable law. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Agenda Phase 1 Key Takeaways | Garry Menzel, PhD Gavo-cel Phase 1 Data | Alfonso Quintás-Cardama, MD KOL: Gavo-cel Experience in the Clinic | Raffit Hassan, MD KOL: Standard of Care in Mesothelioma | Patrick Forde, MD Gavo-cel Phase 2 Trial Design | Garry Menzel, PhD Q&A
Phase 1 Key Takeaways Baseline Established Additional strategies in the Phase 2 clinical trial are designed to improve preliminary profile Combination with checkpoint inhibitors Redosing Earlier lines of therapy RP2D: manageable safety profile and reversible adverse events Most frequent Grade ≥ 3 AE: CRS in 15% of patients Safety Data Ovarian Cancer: earlier focus due to encouraging early activity MPM: potential frontline setting if CPI combo improves durability of benefit NSCLC: expansion opportunity with new MSLN threshold Path Forward DCR, Disease Control Rate; ORR, Overall Response Rate; PFS, Progression Free Survival; OS, Overall Survival; RP2D, Recommended Phase 2 Dose; AE, Adverse Event; CRS, Cytokine Release Syndrome; MPM, Malignant Pleural/Peritoneal Mesothelioma; CPI, Checkpoint Inhibitor; NSCLC, Non-Small Cell Lung Cancer; MSLN, Mesothelin 93% - Heavily pretreated patients that experienced tumor regression 77% - Disease Control Rate (DCR) New RECIST Responses in ovarian cancer (29% ORR), MPM (21% ORR) MPM: 5.6 PFS, 11.2 OS Efficacy Data
TRuCs Represent Advancement Upon Existing T Cell Therapies Antibody binder Costimulatory domain ζ ζ ζ CAR-T Cell (Chimeric Antigen Receptor) Modified TCRα and β TCR-T Cell (T Cell Receptor) ε δ α ζ β γ ε ζ ε δ α ζ β γ ε ζ TRuC-T Cell (T Cell Receptor Fusion Construct) Utilizes Full TCR Complex Signaling HLA Independent
Preclinically, TRuCs Show Superiority Over CARs Superior Intratumoral Infiltration Superior Tumor Control vs. CAR-Ts Optimal Metabolic Profile for Enhanced Fitness Higher Gene Expression Associated with T Cell Activation and Migration Glucose uptake Mitochondrial load
Clinically, gavo-cel Has Shown Activity Where Others Have Failed Patients treated with anti-mesothelin CAR-T monotherapy 74 Total RECIST Responses reported 1 Patients evaluable treated with gavo-cel (TRuC-T cell) monotherapy 30 Total RECIST Responses reported 6 1Maus et al., 2013, Cancer Immunol. Res.; 2Beatty et al., 2014, Cancer Immunol. Res.; 3Hass et al., 2019, Mol. Therapy.; 4www.med.upenn.edu/cellicon2021/assets/user-content/documents/tanyi.pdf; 5Adusumilli et al., 2021, Cancer Discovery; 6Wang et al., 2021, Cell Mol. Immunol. First Anti-Mesothelin Cell Therapy to Demonstrate Tolerability and Clinical Benefit
gavo-cel Achieved Consistent Tumor Regression in 93% of Evaluable Patients 21/22 MPM 6/7 Ovarian 1/1 CHO Data Cutoff – September 9, 2022 MPM, Malignant Pleural/Peritoneal Mesothelioma; CHO, Cholangiocarcinoma ** CHO PR by Investigator Assessment * Tumor volume decrease based on best response assessed
Promising Signal in Platinum Refractory Ovarian Cancer Ovarian Highlights 6/7 patients experienced tumor regression 2/7 patients experienced RECIST partial responses Most recent RECIST response (Patient 33) is ongoing at month 4; experiencing continuous monthly improvement of radiological response Efficacy Data ORR: 29% (gavo-cel + LD) PFS: 5.8 months OS: 8.1 months Data Cutoff – September 9, 2022 -49 Month 1 Month 2 Month 3 ORR, Overall Response Rate; PFS, Progression Free Survival; OS, Overall Survival; LD, Lymphodepletion * Tumor volume decrease based on best response assessed
Patient 33 – Platinum Refractory Ovarian Cancer Partial Response (RECIST v1.1), Tumor Regression Deepened Over 3 Months (49%) 66-year-old female, High grade, Stage IV serous ovarian cancer TP53 mutated Total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy Carboplatin/paclitaxel Bevacizumab/Paclitaxel Bevacizumab maintenance Weekly Paclitaxel Enrolled in gavo-cel Clinical Trial Lymphodepletion with Flu/Cy gavo-cel at 1x108/m2 (RP2D) Week 4 16mm, 5cm3 Target Lesion 1 Lymph Node Week 8 13mm, 2.7cm3 Week 12 12mm, 2.1cm3 Target Lesion 2 Lymph Node Baseline 28mm, 18.5cm3 Week 4 20mm, 8.5cm3 Week 8 15mm, 4.3cm3 Week 12 13mm, 2.3cm3 Baseline 21mm, 14.9cm3 Days from gavo-cel infusion Change from baseline Diameters Volumes
Phase 1 Data Support a Path Forward as Mesothelioma Leader MPM Highlights 21/22 patients experienced tumor regression 5/22 patient partial responses by target lesion assessment; 4/22 experienced RECIST partial responses 1 patient experienced complete metabolic response Efficacy Data ORR: 21% (gavo-cel + LD) PFS: 5.6 months OS: 11.2 months ORR, Overall Response Rate; PFS, Progression Free Survival; OS, Overall Survival; LD, Lymphodepletion * Tumor volume decrease based on best response assessed Data Cutoff – September 9, 2022
Significant Potential Opportunity in Mesothelin-Expressing Solid Tumors Refs: Inaguma 2017, SEER Statistics, Morello 2016, Tozbikian 2014 ~215,000 Patients Across Multiple Target Indications NSCLC, Non-Small Cell Lung Cancer; ORR, Overall Response Rate 76% Mesothelioma Population: 1,800 Orphan Drug Designation 4 RECIST Partial Responses 21/22 Tumor Regression ORR 21% 31% NSCLC Population: 62,600 50% Cholangiocarcinoma Population: 4,000 Orphan Drug Designation 1 Partial Response (by Investigator Assessment) 1/1 Tumor Regression 58% Ovarian Cancer Population: 12,400 2 RECIST Partial Responses 6/7 Tumor Regression ORR 29% 30% 36% 66% 40% 20% 55% Esophageal Cancer Population: 5,000 Triple Negative Breast Cancer Population: 15,000 Pancreatic Cancer Population: 38,000 Gastric Cancer Population: 11,000 Endometrial Cancer Population: 13,000 Colorectal Cancer Population: 81,000 Percent of Patients with Mesothelin Surface Expression
Phase 2 Modifications Aim to Further Improve Outcomes and Patient Access 01 02 03 Better Clinical Responses and Persistence CPI Combination Increasing Depth and Duration of Response Redosing Improved Immune Health Limit Prior Lines of Therapy Ovarian Cancer + Mesothelioma 04 Increased Patient Eligibility New Mesothelin Threshold NSCLC + Cholangiocarcinoma NSCLC, Non-Small Cell Lung Cancer
Phase 1 Data
gavo-cel Phase 1 Trial in MSLN+ Solid Tumors LD, Lymphodepletion; RP2D, Recommended Phase 2 Dose; MPM, Malignant Pleural/Peritoneal Mesothelioma; NSCLC, Non-Small Cell Lung Cancer RP2D Phase 1: Dose Finding (‒ LD) Cohorts = 1 patient (+ LD) Cohorts = 3 patients Dose Level 1 (+ LD) Dose Level 0 (- LD) 1 Dose Level 3 (+ LD) Dose Level 2 (- LD) 2 Dose Level 5 (+ LD) Dose Level 4 (- LD) 3 Dose Level 7 (+ LD) Dose Level 6 (- LD) 4 (5x107 cells/m2) (1x108 cells/m2) (5x108 cells/m2) (1x109 cells/m2) Lymphodepletion (LD) Fludarabine: 30 mg/m2 x4d Cyclophosphamide: 600 mg/m2 x3d Mesothelin Expression IHC assay Central lab (Roche/Ventana) Cut-off: ≥50% 2+/3+ Indications MPM Ovarian cancer NSCLC Cholangiocarcinoma Phase 1 Objective: Determine RP2D
Patient Tumor Characteristics Dose Level (gavo-cel dose) No. Patients DL 0 (no LD) 5x107/m2 n=1 DL 1 5x107/m2 n=8 DL 2 (no LD) 1x108/m2 n=1 DL 3 1x108/m2 n=13 DL 3.5 3x108/m2 n=5 DL 4 (no LD) 5x108/m2 n=1 DL 5 5x108/m2 n=3 Overall n=32 (%) Age, Median (Range) 61 70 (36-84) 46 59 (28-70) 63 (43-69) 67 52 (37-66) 63 (28-84) Diagnosis 1 MPM 7 MPM 1 Ovarian 1 MPM 6 MPM, 6 Ovarian 1 Cholangio 4 MPM, 1 Ovarian 1 MPM 3 MPM 23 MPM 8 Ovarian 1 Cholangio MSLN 2+/3+ 90 72 (55-100) 90 70 (50-95) 75 (50-92) 60 65 (65-73) 70 (50-100) Median No. Prior Rx 8 5 9 5 7 7 4 5 (1-13) Prior ICI, n (%) 1 (100) 6 (75) 1 (100) 6 (46) 4 (80) 1 (100) 2 (66) 21 (66) Prior Anti-MSLN Therapy, n (%) 1 (100) 1 (13) 1 (100) 1 (8) 2 (40) 0 1 (33) 6 (19) Bridging Therapy, n (%) 0 6 (75) 0 12 (92) 5 (100) 1 (100) 1 (33) 25 (78) Data Cutoff – September 9, 2022 RP2D DL, Dose Level; RP2D, Recommended Phase 2 Dose; MSLN, Mesothelin; ICI, Immune Checkpoint Inhibitors; MPM, MPM, Malignant Pleural/Peritoneal Mesothelioma; Cholangio, Cholangiocarcinoma
Grade ≥3 Treatment Emergent Adverse Events Adverse Event DL 0 (no LD) 5x107/m2 n=1 (%) DL 1 5x107/m2 n=8 (%) DL 2 (no LD) 1x108/m2 n=1 (%) DL 3 1x108/m2 n=13 (%) DL 3.5 3x108/m2 n=5 DL 4 (no LD) 5x108/m2 n=1 (%) DL 5 5x108/m2 n=3 (%) Overall n=32 (%) Hematologic Lymphopenia 0 8 (100) 0 13 (100) 5 (100) 0 3 (100) 29 (91) Neutropenia 1 (100) 8 (100) 0 13 (100) 5 (100) 1 (100) 3 (100) 31 (97) Thrombocytopenia 0 2 (25) 0 2 (15) 1 (20) 0 2 (67) 7 (22) On Target / On Tumor CRS 0 2 (25) 0 2 (15) 1 (20) 0 3 (100) 8 (25) HLH/ MAS 0 0 0 0 0 0 0 0 Neurotoxicity 0 0 0 0 0 0 0 0 On Target / Off Tumor Pericarditis / Pericardial effusion 0 0 0 0 1 (20) 0 0 1 (3) Pleuritis / Pleural effusion 0 0 0 1 (8) 1 (20) 0 0 2 (6) Peritonitis / Ascites 0 0 0 1 (8) 0 0 0 1 (3) Other Pneumonitis 0 1 (13)* *0 0 3 (60) 0 1 (33) 5 (16) Sepsis 0 1 (13) 0 0 0 0 0 1 (3) Hemorrhage 0 0 0 0 0 0 1 (33)* 1 (3) RP2D Data Cutoff – September 9, 2022 *Dose Limiting Toxicity DL, Dose Level; LD, Lymphodepletion; RP2D, Recommended Phase 2 Dose; HLH, Hemophagocytic Lymphohistiocytosis; MAS, Macrophage Activation Syndrome
Consistent Tumor Regression in Patients with gavo-cel Tumor Regression in 93% of Patients, Disease Control Rate 77% Blinded Independent Central Review All gavo-cel + LD ORR 20% 22% MPM ORR 18% 21% Ovarian ORR 29% 29% * DCR = PR or SD lasting at least 3 months * DL0 (5x107/m2) DL1 (5x107/m2, + LD) DL2 (1x108/m2) DL3 (1x108/m2, + LD) DL3.5 (3x108/m2,+ LD) DL4 (5x108/m2) DL5 (5x108/m2, + LD) Data Cutoff – September 9, 2022 MPM OVA MPM OVA MPM MPM MPM MPM MPM MPM OVA MPM MPM MPM MPM MPM MPM MPM OVA OVA MPM MPM MPM OVA OVA CHO MPM MPM MPM MPM DL, Dose Level; LD, Lymphodepletion; DCR, Disease Control Rate; ORR, Overall Response Rate; PR, Partial Response; SD, Stable Disease * Tumor volume decrease based on best response assessed
Patient Response and Follow-up as of September 9th, 2022 Months Patients alive at 6 months * 70% Patients alive at 1 year * 31% Patients alive as of cutoff 12 Data Cutoff – September 9, 2022 *Kaplan-Meier survival estimates ** CHO PR by Investigator Assessment CHO, Cholangiocarcinoma; SD, Stable Disease; PR, Partial Response; CR, Complete Response; PD, Progressive Disease; FU, Follow-Up
Survival in Mesothelioma ORR 21%, PFS 5.6 Months, OS 11.2 Months Benchmarks in Second Line Post Platinum-Based Therapy Fennell et al Phase 2 VIM Study. ASCO 2021 Popat et al Phase 3 PROMISE-meso Study. Ann Oncol 2020 Fennell et al Phase 3 CONFIRM Study. Lancet Oncol 2021 Study n ORR (%) PFS (mo) OS (mo) Vinorelbine vs Supportive Care1 98 3.1 4.2 9.3 56 1.8 2.8 9.1 Pembrolizumab vs Vinorelbine or Gemcitabine2 73 22 2.5 10.7 71 6 3.4 12.4 Nivolumab vs Placebo3 221 11 3 10.2 111 1 1.8 6.9 Data Cutoff – September 9, 2022 Overall Survival Median 11.2 months Progression Free Survival Median 5.6 months ORR, Overall Response Rate; PFS, Progression Free Survival; OS, Overall Survival
Survival in Ovarian Cancer after gavo-cel Infusion ORR 29%, PFS 5.8 Months, OS 8.1 Months Median 8.1 months Median 5.8 months Progression Free Survival Overall Survival -49 DL1 (5x107/m2, + LD) DL3 (1x108/m2, + LD) ORR, Overall Response Rate; PFS, Progression Free Survival; OS, Overall Survival; DL, Dose Level; LD, Lymphodepletion * Tumor volume decrease based on best response assessed Data Cutoff – September 9, 2022
Patient 5 – Platinum Refractory Ovarian Cancer Partial Response (RECIST v1.1), Tumor Regression (61%) 70-year-old female High grade, Stage IV serous ovarian cancer TP53R248Q, CCNE1 amplified, wild type BRCA1/2 Failed 6 prior lines of chemotherapy Enrolled in gavo-cel Clinical Trial Lymphodepletion with Flu/Cy gavo-cel at 5x107/m2 (Dose Level 1) Week 4 14mm, 4cm3 Target Lesion 1 Lymph Node Week 12 10mm, 2.3cm3 Week 24 9mm, 1.3cm3 Target Lesion 2 Lymph Node Baseline 19mm, 7.6cm3 Week 4 14mm, 3.3cm3 Week 12 9mm, 2.9cm3 Week 24 10mm, 1.7cm3 Baseline 27mm, 24cm3 Week 24 19mm New Lesion Lymph Node Days from gavo-cel infusion Change from baseline Diameters Volumes
gavo-cel Displayed Dose-Dependent Expansion and Cytokine Release Peak Expansion Peak IFN-�� Peak IL-6 Data Cutoff – September 9, 2022
Intratumor Infiltration and Persistence Greater Than in Blood TRuC-T Cell Migration and Infiltration Evident from Serous Effusions Diagnosis MPM CHO MPM MPM Ovarian MPM Response SD PR* PR SD SD PR MPM: Malignant Pleural/Peritoneal Mesothelioma; CHO: Cholangiocarcinoma; PR: Partial Response; SD: Stable Disease day 10 day 10 day 16 day 21 day 64 day 57 day 76 day 43 day 58 day 56 day 70 day 86 - Undetectable day 35 day 27 - Undetectable serosal effusion peripheral blood peritoneal nodule * PR by Investigator Assessment Analysis performed in a subset of patients (n=6); all analyzable samples showed detectable levels of gavo-cel, but not all showed increased expansion at disease sites Data Cutoff – September 9, 2022
gavo-cel: SMRP and MPF Data vs. Best Target Lesion Response Patients with baseline levels of SMRP in normal range were excluded *CHO PR by Investigator Assessment SMRP -24.5 -23.3 -20.8 -3.8 -19.4 -15.5 -5.3 -3.7 -9.1 -17.9 -10.9 -9.6 -39.4 -49.0 -10.4 -3.8 -5.0 -67.4 -65.7 -79.5 -11.8 48.4 Best target lesion response 26.2 -63.6 MPF -25.0 -23.3 -20.8 -5.0 -19.4 -15.5 -49.0 -10.9 -9.1 -17.9 -3.7 -9.6 -39.4 -63.6 -10.4 -3.8 -3.8 -67.4 -65.7 -79.5 -11.8 48.4 -12.7 -53.6 -60.9 -24.5 Best target lesion response 26.2 -5.3 * SMRP, Soluble Mesothelin-Related Peptides; MPF, Megakaryocyte Potentiating Factor; PR, Partial Response; SD, Stable Disease; PD, Progressive Disease; CHO, Cholangiocarcinoma Data Cutoff – September 9, 2022
Phase 2 Trial Trial Modifications & Design
Clinical Activity At or Below gavo-cel RP2D Manageable safety profile Clinical activity at ≤RP2D in 3/3 tumor indications 5 RECIST PRs Multiple patients near 30% tumor regression DL0 (5x107/m2) DL1 (5x107/m2, + LD) DL2 (1x108/m2) DL3 (1x108/m2, + LD) DL, Dose Level; LD, Lymphodepletion; RP2D, Recommended Phase 2 Dose; PR, Partial Response * Tumor volume decrease based on best response assessed Data Cutoff – September 9, 2022
Phase 2 Incorporates Four Changes Aiming to Boost Patient Outcomes Durability and Persistence Checkpoint Inhibitor Combinations 3 Limit Prior Lines of Therapy ≤5 4 Broadening Patient Access Increased Patient Eligibility with New MSLN Threshold for NSCLC and Cholangiocarcinoma 1 Redosing (LD + gavo-cel) 2 MSLN, Mesothelin, NSCLC, Non-Small Cell Lung Cancer; LD, Lymphodepletion
LD, Lymphodepletion; CPI, Checkpoint Inhibitor; RP2D, Recommended Phase 2 dose; MPM, Malignant Pleural/Peritoneal Mesothelioma; NSCLC, Non-Small Cell Lung Cancer; Cholangio, Cholangiocarcinoma Phase 2 Expansion Cohorts in MSLN+ Solid Tumors RP2D 1x108 cells/m2 PATIENT POPULATION: ≤5 PRIOR LINES OF THERAPY n=20 NSCLC gavo-cel + nivolumab Mesothelin Expression MPM, Ovarian: ≥50%, 2+/3+ NSCLC, Cholangio: ≥50%, 1+/2+/3+ Key Objectives Primary: ORR (RECIST v1.1), DCR (ORR+SD) Secondary: PFS, OS Retreatment Patient with a confirmed response (i.e. PR or CR) and then exhibits symptoms or signs of PD Patients with SD for at least 8 weeks In Collaboration with n=20 Cholangio gavo-cel + nivolumab Futility analysis near midpoint in each MPM arm n=15 MPM gavo-cel n=10 n=15 MPM gavo-cel + nivolumab n=10 n=15 MPM gavo-cel + nivolumab + ipilumumab n=10 Randomization (1:1:1) n=20 Ovarian Cancer gavo-cel + nivolumab
Increase in Patient Eligibility with New MSLN Threshold Data based on internal analysis in September 2022 MSLN Threshold Comparison Non-Small Cell Lung Cancer patients eligible for therapy based on Phase 2 threshold 29% Cholangiocarcinoma patients eligible for therapy based on Phase 2 threshold 16% New Threshold: ≥50% tumor cells irrespective of MSLN intensity (1+/2+/3+) MSLN, Mesothelin
Source: CRISPR public materials, Trial: NCT04035434 (CARBON) Redosing Allowed from 12 Weeks, Could Deepen Patient Responses CRISPR Highlights: Evaluated safety and efficacy of CTX110 with the option of as second consolidation dose in aggressive 2L+ LBCL; n=29 Option for 2nd CTX110 infusion with LD following disease progression 5 out of 8 patients receiving a second dose saw an improved response Based on gavo-cel Phase 1 manufacturing experience: Patients had 2 doses from one manufacturing run 100% Patients had 3 doses from one manufacturing run 97% Patients eligible for a redosing based on Phase 2 protocols 46% LD, Lymphodepletion
CPIs Expected to Improve Activity of TRuC-T Cells Immunoinhibitory Mechanisms May Play A Role in Resistance Multiparameter immunofluorescence assay performed using MultiOmxyTM (Neogenomics) Patient #3 – MPM 64% Target Lesion Regression Patient #21 – MPM 10% Target Lesion Regression PanCK = tumor marker; CD3 = T cell marker; CD68 = TAM marker; CD155 = TIGIT ligand; PD-L1 = PD-1 ligand Baseline Post-tx (wk8) PanCK CD3 CD155 PanCK CD3 CD155 PanCK CD68 PD-L1 PanCK CD68 PD-L1 MPM, Malignant Pleural/Peritoneal Mesothelioma; CPI, Checkpoint Inhibitor
Refocused Pipeline to Deliver Near-Term Clinical Data MSLN, Mesothelin; MPM, Malignant Pleural/Peritoneal Mesothelioma; NSCLC, Non-Small Cell Lung Cancer; TNBC, Triple Negative Breast Cancer; RCC, Renal Cell Carcinoma; AML, Acute Myeloid Leukemia
Q&A