On November 16, 2021 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported its financial results for the quarter ended September 30, 2021, and provided a business update on its progress over the reporting period (Press release, Immatics, NOV 16, 2021, View Source [SID1234595702]).
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"The unprecedented objective response rate we have observed during early dose escalation in the ACTengine IMA203 trial, encourages us to double down on our development strategy of our programs targeting PRAME," said Harpreet Singh, Ph.D., CEO at Immatics. "Following determination of target dose, we will start a concerted effort in early 2022 with multiple levers to pull to deliver durability of response. This will include deploying ACTengine IMA203 (1) as monotherapy at target dose, (2) in combination with a checkpoint inhibitor, (3) as an efficacy-enhanced next-gen TCR-T approach IMA203CD8 and (4) also now being able to offer IMA203 to patients with fewer lines of pre-treatments or less disease burden. We look forward to providing updates on these clinical outcomes throughout 2022."
Third Quarter 2021 and Subsequent Company Progress
Adoptive Cell Therapy Programs
ACTengine IMA203 – On November 13, Dr. Martin Wermke, coordinating investigator of the Phase 1 trial with IMA203 targeting PRAME, presented updated clinical data as a late-breaking oral presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The dose escalation phase of the trial for IMA203 is ongoing with dose level 3 completed at doses below 1 billion transduced cells in a heavily pre-treated patient population. In 15 out of 16 evaluable patients (94%), treatment with IMA203 achieved disease control and tumor shrinkage was observed in 14 out of 16 patients (88%). Objective responses (partial responses according to RECIST 1.1) were observed in 8 out of 16 patients (50%) across multiple solid cancer indications. 8 out of 13 patients (62%) treated at dose levels 2 and 3 had objective partial responses. Adverse events remained transient and manageable with no high-grade cytokine release syndrome or neurological toxicities observed. No dose limiting toxicities (DLTs) were observed since the previous data release on March 17, 2021. The data also revealed high T cell engraftment and persistence along with clinical responses which were associated with tumor infiltration.
Patient recruitment to the 4th and highest dose level (up to approximately 2.5 billion total transduced cells) for the ACTengine IMA203 trial is ongoing. Immatics plans to expand the IMA203 study to three Phase 1b (dose expansion) study cohorts including IMA203 as a monotherapy, IMA203 in combination with an immune checkpoint inhibitor and IMA203 cells co-transduced with a CD8 co-receptor, called IMA203CD8.
ACTengine IMA203CD8 – Immatics entered into an exclusive license agreement with Baylor College of Medicine (BCM) in Houston, Texas, for the development of next-generation adoptive cell therapies (ACT). BCM conducted foundational research for the use of CD8 co-receptor expression in an ACT setting. Through this agreement with BCM, Immatics gains access to pioneering work in the field of CD8αβ co-receptor expression to develop its next-generation ACT approaches. The agreement underscores Immatics’ long-term strategy to access innovative science and technologies to enhance the tolerability, potency, and ease of use of its TCR-T product candidates.
Immatics presented preclinical proof-of-concept data on its next-generation ACTengine IMA203CD8 program in a poster presentation at the 2021 SITC (Free SITC Whitepaper) Annual Meeting on November 12. The data demonstrated that equipping IMA203-T cells with CD8αβ, a T cell co-receptor, enhances anti-tumor activity of the engineered T cells. Immatics’ IMA203CD8 candidate showed functional superiority among 20 tested CD8 constructs including CD8α. IND submission for IMA203CD8 as part of the Phase 1b study expansion cohort is expected in the first half of 2022.
ACTengine IMA201 and IMA202 – The dose escalation Phase 1a study of the clinical ACTengine programs, IMA201 and IMA202, continues to advance with IMA202 at target dose level 3 and IMA201 at dose level 2. 12 heavily pre-treated patients have been treated with product candidates IMA201 and IMA202. 8 out of 12 patients showed disease control, and tumor shrinkage was observed in 4 patients. All adverse events for IMA201 and IMA202 continue to be transient and manageable with no DLTs observed. The next step in the IMA201 and IMA202 trials is to complete dose escalation including target dose (DL3).
ACTengine IMA204 – The fourth program of the different ACTengine IMA200 TCR-T programs, IMA204, is directed at the novel tumor stroma target COL6A3 exon 6 expressed in a large variety of solid cancers. IMA204 is utilizing a next-generation CD8-independent T cell receptor. IND-enabling studies with IMA204 are being completed. Submission of the IND application for IMA204 is expected in 2022.
TCR Bispecifics Program
TCER IMA401 – IMA401 is an antibody-like, "off-the-shelf" biologic directed against a high-density peptide target derived from MAGEA4/8. Submission of a Clinical Trial Application (CTA) is planned in the fourth quarter of 2021 and patient recruitment will be initiated in the first half 2022.
TCER IMA402 – Immatics presented preclinical proof-of-concept data from its TCER program, IMA402, directed against PRAME, at the PEGS Boston Protein Engineering and Cell Therapy Summit in May. In additional pre-clinical studies, TCER IMA402 designed with a low-affinity T cell recruiter demonstrated superior tumor control than analogous TCER molecules with higher-affinity T cell recruiter domains. Production of GMP material for a Phase 1 clinical study is planned in 2022.
Third Quarter 2021 Financial Results
Cash Position: Cash and cash equivalents as well as other financial assets total €173.2 million ($200.6 million1) as of September 30, 2021, compared to €192.8 million ($223.2 million1) as of June 30, 2021.
Revenue: Total revenue, consisting of revenue from collaboration agreements, was €6.4 million ($7.4 million1) for the three months ended September 30, 2021, compared to €7.9 million ($9.1 million1) for the three months ended September 30, 2020.
Research and Development Expenses: R&D expenses were €21.2 million ($24.5 million1) for the three months ended September 30, 2021, compared to €17.5 million ($20.3 million1) for the three months ended September 30, 2020. The increase is mainly due to expanded clinical activities for the ACTengine IMA200 series, as well as GMP manufacturing for the TCER compound, IMA401.
General and Administrative Expenses: G&A expenses were €8.3 million ($9.6 million1) for the three months ended September 30, 2021, compared to €9.2 million ($10.7 million1) for the three months ended September 30, 2020. The decrease is mainly due to one-time expenses in connection with the listing of the Company in 2020.
Net Loss: Net loss was €27.2 million ($31.5 million1) for the three months ended September 30, 2021, compared to €164.0 million ($189.9 million1) for the three months ended September 30, 2020. The decrease is mainly due to a one-time share listing expense of €152.8 million ($176.9 million) in connection with the listing of the Company in 2020.
Upcoming Investor Conferences
Jefferies Global Healthcare Conference – November 16-18, 2021
Piper Sandler 33rd Annual Healthcare Conference – November 30 – December 2, 2021
11th Annual SVB Leerink Global Healthcare Conference – February 14 – 18, 2022
To see the full list of events and presentations, visit View Source
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, 2021 (1 EUR = 1.1579 USD).
About Immatics’ PRAME Programs
Immatics’ PRAME programs are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers – such as uterine carcinoma, synovial sarcoma, melanoma, ovarian carcinoma, uveal melanoma, squamous NSCLC, breast carcinoma and HNSCC – thereby supporting the programs’ potential to address a broad cancer patient population. PRAME demonstrates a high target peptide density per tumor cell and is homogenously expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT. Through its proprietary TCR discovery and engineering platform XCEPTOR, the Company has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine IMA203, and its TCR Bispecifics pipeline, TCER IMA402. Both therapeutic modalities have distinct attributes and mechanisms of actions suitable for cancer patients at different disease stages and tumor types.
About ACTengine IMA200 programs
Each of the product candidates of the IMA200 programs is based on Immatics’ proprietary ACTengine approach in which the patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine programs IMA201, IMA202 and IMA203 are currently in clinical development for the treatment of solid tumor indications, both in the US and in Germany. All ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.
The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth and the associated programs are co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).
About TCER
Immatics’ TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. To do so, the proprietary biologics are engineered to have two binding regions. The first region contains an affinity- and stability-improved TCR that binds specifically to the cancer target on the cell surface presented by a human leukocyte antigen (HLA) molecule. The second region is derived from an antibody domain that recruits endogenous T cells to the tumor to become activated. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. In addition, the TCER molecule has a Fc-part conferring stability, half-life extension and enhanced manufacturability.