On November 17, 2022 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported financial results for the quarter ended September 30, 2022 (Press release, Immatics, NOV 17, 2022, View Source [SID1234624198]).
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"The initial results from our Phase 1a and Phase 1b cohort A showed a highly encouraging confirmed objective response rate of 50% for patients treated at or above target dose. Early data from cohort A alone have shown a confirmed objective response rate of 80%. With these encouraging results, we have built momentum for our multi-cohort strategy designed to leverage the full clinical potential of targeting PRAME," commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "We look forward to sharing the next data readouts from all three Phase 1b expansion cohorts in 2023, as well as initiating the Phase 1/2 clinical trial of our TCR Bispecific candidate, TCER IMA402, targeting PRAME. With the recent addition of new capital, we have the resources to deliver on our corporate objectives for 2023 and to fund operations into 2025."
Third Quarter 2022 and Subsequent Company Progress
Adoptive Cell Therapy Programs
ACTengine IMA203 (PRAME) – In October, Immatics provided an interim update from the ongoing IMA203 TCR-T monotherapy. The update covered data from 27 patients in the completed Phase 1a dose escalation and first 5 patients in the Phase 1b dose expansion (cohort A) treated with IMA203 monotherapy.
Treatment with IMA203 continues to show manageable tolerability.
Confirmed objective response rate (cORR): 50% (6/12) at target dose or above with at least 1 billion infused TCR-T cells across Phase 1a and 1b; thereof 80% cORR (4/5) in Phase 1b patients alone with all responses ongoing at data cut-off.
Confirmed responses observed across different solid tumor types: cutaneous melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma.
Immatics has introduced improvements that may influence clinical outcomes, including higher cell doses, optimizing the cell product through manufacturing enhancements and working with disease area experts to gradually reduce the patient fraction that are very heavily pre-treated with extreme tumor burden. Immatics continues to implement such improvements to the IMA203 trial.
ACTengine IMA203 is currently being evaluated in three ongoing Phase 1b dose expansion cohorts:
Cohort A – IMA203 monotherapy interim analysis demonstrated cORR in 4 of 5 patients (80%) with early signs of prolonged durability at 12 weeks of follow-up. All responses were ongoing at data cut-off. Patients are treated at provisional recommended phase 2 dose (RP2D) and dose level (DL) 5.
Cohort B – The first patient in the Phase 1b expansion cohort B was treated with IMA203 in combination with the PD-1 immune checkpoint inhibitor nivolumab in May 2022. Patients will be treated at RP2D.
Cohort C – The first patient was treated in August 2022 with IMA203CD8, Immatics’ 2nd -generation monotherapy product candidate in which IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor that engages functional CD4 and CD8 T cells directed against PRAME. As IMA203CD8 is a novel product candidate under a new IND2 amendment, a staggered enrollment is being implemented with the first three patients being treated at DL3. Following the initial DL3, patients will be treated at DL4 and DL5.
Further data read-outs on all three individual cohorts are planned throughout 2023.
2) IND = Investigational New Drug
ACTengine IMA204 (COL6A3 exon 6) – Immatics and the University of Pennsylvania co-authored a research paper published in the peer-reviewed journal, Science Translational Medicine, that highlighted Immatics’ differentiated approach to develop TCR-based therapies through its proprietary discovery platforms, XPRESIDENT and XCEPTOR. With this approach, Immatics identified a novel proprietary HLA-A*02:01-presented target generated by a tumor-specific alternative splicing event in the abundantly expressed protein collagen type VI alpha-3 (COL6A3). This target is expressed at high target density across multiple solid cancer indications and specific to the tumor stroma. Targeting tumor stroma provides an innovative therapeutic opportunity to disrupt the tumor microenvironment. Immatics has engineered target-specific, affinity-enhanced proprietary TCRs, one of them being CD8-independent and thus facilitating targeting of COL6A3 exon 6 positive cells by both CD4 and CD8 T cells. The TCR-T candidate, IMA204 was able to eliminate tumor cells at physiological target levels in in vitro studies and in vivo mouse models. Due to Immatics focusing its clinical resources on the three IMA203 Phase 1b cohorts as well as accelerating the clinical development for the PRAME TCER IMA402, the company has delayed the IND submission for an ACTengine candidate directed against COL6A3 exon 6.
TCR Bispecifics Programs
TCER IMA401 (MAGEA4/8) – IMA401 is being developed in collaboration with Bristol Myers Squibb; 9 centers in Germany have been activated and are enrolling patients.
TCER IMA402 (PRAME) – In preclinical data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2022, TCER IMA402 showed potent and selective activity against PRAME-positive tumor cell lines in vitro. In vivo studies in mice demonstrated dose-dependent anti-tumor activity confirming that sufficiently high drug doses are key to achieving the desired anti-tumor effects over a prolonged time period. Pharmacokinetic characteristics of the half-life extended IMA402 suggest the potential for a favorable dosing regimen in patients with prolonged drug exposure at therapeutic levels. Immatics has completed the manufacturing process development for IMA402, and manufacturing of the clinical batch is on track for 2H 2022 with a planned start of the Phase 1/2 trial in 2023. The submission of the CTA/IND3 application is planned for 2Q 2023.
3) Clinical Trial Application (CTA) is the equivalent of an Investigational New Drug (IND) application in Europe
TCER Platform – In November, Immatics presented preclinical data of its next-generation, half-life extended TCR Bispecific format which showed higher potency in vitro than multiple other established formats, at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The proprietary TCER format consists of three distinct elements designed for optimal efficacy and minimal toxicity risk in patients: 1) high affinity TCR domains targeting tumor-specific peptide HLA molecules 2) low affinity T cell recruiter against CD3/TCR, and 3) a human IgG Fc region (silenced) for half-life extension, favorable stability and manufacturability. The poster can be accessed on Immatics’ website here.
PRAME Target (IMA203, IMA402) – In November, Immatics presented comprehensive target characterization and validation data at the SITC (Free SITC Whitepaper) Annual Meeting. The data support PRAME as a highly relevant target for Immatics’ TCR-based therapies, ACTengine IMA203 and TCER IMA402. These therapies have the potential to address a wide variety of cancer indications such as cutaneous melanoma, ovarian cancer, uterine cancer, non-small cell lung cancer, triple-negative breast cancer, head and neck cancer and uveal melanoma, among others. The poster can be accessed on Immatics’ website here.
Corporate Developments
In October 2022, Immatics successfully completed the underwritten public offering of 10,905,000 ordinary shares at a price of $10.09 per ordinary share, raising approximately $110 million before deducting underwriting discount and offering expenses. The offering included participation from investors including Armistice Capital Master Fund Ltd., Dellora Investments, EcoR1 Capital, Nantahala Capital, Perceptive Advisors, Rock Springs Capital, RTW Investments, LP, Samsara BioCapital, SilverArc Capital, Sofinnova Investments, Wellington Management, 683 Capital and other specialist biotech investors.
On October 24, 2022, GSK provided Immatics with notice of its decision to terminate their collaboration. Initially announced on February 20, 2020, the terms of the agreement included a €45 Million (~$50 Million) upfront payment to Immatics and the potential for additional milestone and royalty payments in return for access to two of Immatics’ TCR-T programs. As communicated to Immatics, GSK’s decision was made unrelated to the programs and the progress achieved in the collaboration to date. The termination will be effective on December 26, 2022.
Third Quarter 2022 Financial Results
Cash Position: Cash and cash equivalents as well as other financial assets total €309.3 million ($301.5 million1) as of September 30, 2022 compared to €324.4 million ($316.2 million1) as of June 30, 2022. The decrease is mainly due to our ongoing research and development activities. This does not include $110 million gross proceeds from our public offering in October 2022. Adding those proceeds, the Company projects a cash runway into 2025.
Revenue: Total revenue, consisting of revenue from collaboration agreements, was €15.1 million ($14.7 million1) for the three months ended September 30, 2022, compared to €6.4 million ($6.2 million1) for the three months ended September 30, 2021. The increase is mainly related to the increased recognition of revenue for the multiple ongoing collaboration agreements.
Research and Development Expenses: R&D expenses were €28.6 million ($27.9 million1) for the three months ended September 30, 2022, compared to €21.2 million ($20.7 million1) for the three months ended September 30, 2021. The increase is mainly related to increased expenses for clinical trials.
General and Administrative Expenses: G&A expenses were €8.4 million ($8.2 million1) for the three months ended September 30, 2022, compared to €8.3 million ($8.1 million1) for the three months ended September 30, 2021.
Net Income/Loss: Net loss was €20.9 million ($20.4 million1) for the three months ended September 30, 2022, compared to a net loss of €27.2 million ($26.5 million1) for the three months ended September 30, 2021. The decrease was primarily the result of the increased revenue from multiple collaboration agreements.
Full financial statements can be found in the current report on Form 6-K filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.
1 All amounts translated using the exchange rate published by the European Central Bank in effect as of September 30, 2022 (1 EUR = 0.9748 USD).
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