2023-03-27 11:07:01 ET
Summary
- Immatics is a leading developer of cell therapies.
- It has a number of big pharma deals.
- If the molecule can show durability of response, this will be a very big news in the field.
Immatics ( IMTX ) is a German biotech developing targeted TCR-based immunotherapies focusing on solid tumors. The company was once known for working in cancer vaccines, but in the last decade, it became a TCR therapeutics powerhouse. The technology here consists of Adoptive Cell Therapies ((ACT)) and antibody-like TCR Bispecifics. The ACT part has both autologous and allogeneic versions. Some of these assets are running through phase 1b trials. These are the latest stage trials so far for this company.
The pipeline looks like this:
Lead candidate is ACTengine® IMA203 (PRAME), which has three phase 1b trial cohorts, as monotherapy, in combination with checkpoint inhibitors, and with a 2nd-generation asset called IMA203CD8. The company will provide an update on all three cohorts by the second half of 2023, and decide which cohort to move ahead with at that time. The second asset, TCER® IMA401 (MAGEA4/8), is running through a phase 1.
The company is developing a 100,000 sq. ft. state of the art manufacturing facility near Houston. It has an expedited manufacturing process with a short turnaround time for its autologous products. The company has both autologous products and allogeneic ones. The autologous products are manufactured through a platform called ACTengine, while the allogeneic ones are TCR Bispecifics manufactured through TCER.
Trials for the lead asset is ongoing, but the company has released some initial data. In the phase 1a dose escalation monotherapy basket trial, 27 patients were treated. The molecule was well-tolerated with no SAEs. Treatment-emergent adverse events (TEAEs) were acceptable and manageable. 48% ORR was observed in the trial. This was across multiple solid cancers across all doses.
In the phase 1b dose expansion cohort A, the following data was observed :
• 80% (4/5) initial ORR in patients with 4 different solid tumors
• 80% (4/5) confirmed ORR : Confirmation of all objective responses after ~3 months; all responses ongoing
Thus, the therapy is well-tolerated, and there is drug activity - these are the key takeaways from these early data. About safety, the company provides more granularity. There was some expected cytopenia of grades 1 to 4 because of the lymphodepletion required for patients. There was a lot of cytokine release syndrome, with 31 of 32 patients experiencing some grade of CRS. Fortunately, though, 29 of these patients had only grade 1 or 2 CRS, with just 2 having grade 3. All CRS were resolved quickly. There were low to moderate ICANS or Immune effector cell-associated neurotoxicity syndrome; however, neither the CRS nor the ICANS was dose dependent, and there were no other dose limiting toxicities.
In its recent earnings update , the company announced making a number of small but significant changes to its pipeline. These include switching from Bristol Myers Squibb's Opdivo in a front line setting to IMA203CD8 TCR-T therapy in a last-line setting. These changes, the company reiterated, was not an effect of the GSK termination. GSK, which had a major 2020 deal with Immatics for two T-CR therapeutics, terminated the deal along with a number of other cell therapy deals.
Immatics has major big pharma collaborations. The company was originally backed by Amgen, who helped it raise funds in the pre-IPO years. BMS had a 2019 deal, which it later expanded to pay $60mn in upfront fees and $20mn more for expanding the 2019 deal. Celgene had a deal worth $75mn in upfront fees. As Celgene was acquired by BMS, BMS revised and expanded this deal thrice, and it is now worth $4.2bn on paper.
Financials
IMTX has a market cap of $516mn and a cash balance of $386mn, which includes proceeds from a $110mn secondary offering the company launched after announcing strong data last year. R&D expenses were €106.8 million ($113.9 million) for the year ended December 31, 2022, while G&A expenses were €36.1 million ($38.5 million). At that rate, the company's cash will last well into 2025.
Bottomline
Immatics is something of a microcap R&D behemoth which attracts a lot of big pharma collabs. They have produced some strong early data in difficult to treat cancers, and they have a good deal of cash. What they don't have yet, and desperately need, is durability. If the treatment duration of response is as good as the actual response itself, this stock will be going places. I will watch this one closely.
For further details see:
Immatics: German Small-Cap Developer Of TCR Therapies