Immatics Presents Comprehensive Preclinical Data Set for

0
191


  • TCER® IMA402 is a next-generation, half-life prolonged TCR Bispecific concentrating on an HLA-A*02:01-presented peptide derived from PRAME
  • In preclinical research, IMA402 demonstrated enhanced anti-tumor exercise in vivo and decreased T cell engager-associated toxicities as a part of general favorable in vitro security profile
  • Pharmacokinetic traits of half-life prolonged IMA402 counsel potential for a positive dosing routine in sufferers with extended drug publicity at therapeutic ranges
  • IMA402 is a part of Immatics’ technique to leverage the complete scientific potential of concentrating on PRAME, one of the promising targets for TCR-based therapies
  •  Phase 1/2 scientific trial on observe to begin in 2023; submission of the CTA/IND1 software is deliberate for 2Q 2023

 

Tuebingen, Germany and Houston, Texas, September 10, 2022 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical firm lively within the discovery and growth of T cell-redirecting most cancers immunotherapies, at present introduced a complete preclinical information set for its T cell partaking receptor (TCER®) product candidate IMA402 on the European Society for Medical Oncology (ESMO) Congress 2022 held in Paris, France, from September 9 to 13, 2022. IMA402 is the corporate’s second program in its TCR Bispecifics pipeline and is directed towards an HLA-A*02:01-presented peptide derived from PRAME, a most cancers goal broadly expressed in lots of stable tumors. The information can be found as an ePoster on the ESMO platform at 9 AM on Saturday, September 10, and might be offered in the course of the poster session from midday to 1 PM CEST on Monday, September 12.

Immatics TCER® molecules are “off-the-shelf” TCR Bispecifics engineered with two binding areas: a TCR area and a T cell recruiter area.

1) Clinical Trial Application (CTA) is the equal of an Investigational New Drug (IND) software in Europe

Data Highlights:
TCER® format is optimized for efficacy and security

  • The IMA402 TCER® makes use of a high-affinity TCR designed to particularly bind to an HLA-A*02:01-presented peptide derived from PRAME on tumor cells
  • The T cell recruiter area is a proprietary low-affinity T cell recruiter towards the TCR/CD3 complicated that demonstrates superior in vivo tumor management in comparison with analogous TCER® molecules designed with higher-affinity variants of a extensively used antibody recruiter
  • The IMA402 TCER® is optimized to scale back T cell engager-associated toxicities in sufferers, which is demonstrated by decreased recruiter-mediated cytokine launch in vitro

Compelling preclinical information

  • IMA402 confirmed potent and selective exercise towards PRAME-positive tumor cell traces in vitro
  • In vivo research in mice demonstrated dose-dependent anti-tumor exercise of IMA402. Sufficiently excessive drug doses had been key to reaching the specified anti-tumor results over a chronic interval
  • In vitro security evaluation together with toxicity screening towards 20 regular tissue sorts, entire blood cytokine launch evaluation and alloreactivity analysis confirmed favorable security profile for IMA402
  • The half-life prolonged format of IMA402 confers a serum half-life of >1 week in mice suggesting a positive dosing routine and extended drug publicity at therapeutic ranges when in comparison with TCR Bispecifics missing half-life extension methods

 Clinical trial evaluating IMA402 in sufferers with stable tumors to begin in 2023

  • IMA402 is designed to permit excessive dosing not restricted by toxicities with the objective of reaching related therapeutic doses in tumor tissue and obtain a significant scientific profit in sufferers

“Improving drug safety, efficacy and dosing schedule are key considerations in the field of bispecific T cell engaging molecules. The promising preclinical results for our next-generation, half-life extended TCER® IMA402 reflect the potential of our TCR Bispecific approach for patients with solid tumors,” commented Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. “We look forward to initiating the IMA402 Phase 1/2 clinical trial in 2023 as part of our strategy to tackle PRAME with two distinct therapeutic modalities. We believe PRAME is the most promising, clinically validated T cell target for solid cancers to date and with our cell therapy and bispecific approaches, we are well positioned to provide innovative treatment options for a variety of cancer patient populations with different medical needs.”

To allow the beginning of the Phase 1/2 trial in 2023, Immatics has accomplished the manufacturing course of growth for IMA402 and manufacturing of the scientific batch is on observe for 2H 2022. The Phase 1 a part of the trial will begin with a minimal anticipated organic impact stage (MABEL) dose of IMA402 and could have an adaptive design geared toward accelerating dose escalation to find out the really helpful Phase 2 dose (RP2D). HLA-A*02:01-positive sufferers with totally different stable tumors expressing PRAME will initially obtain weekly infusions of IMA402. Pharmacokinetics information might be assessed all through the trial and may present a chance to adapt the remedy interval. The Phase 2a dose enlargement a part of the trial might be designed to comprise a number of cohorts to additional consider IMA402 in particular indications and mixture therapies. Submission of the IND1 software is deliberate for Q2 2023.

The ESMO Congress 2022 poster presentation is accessible on Immatics’ web site utilizing this hyperlink.

About TCER®
Immatics’ half-life prolonged TCER® molecules are next-generation, antibody-like “off-the-shelf” biologics that leverage the physique’s immune system by redirecting and activating T cells in direction of most cancers cells expressing a particular tumor goal. The design of the TCER® molecules permits the activation of any T cell within the physique to assault the tumor, whatever the T cells’ intrinsic specificity. Immatics proprietary biologics are engineered with two binding areas: a TCR area and a T cell recruiter area. The TCER® format is designed to maximise efficacy whereas minimizing toxicities in sufferers. It comprises a high-affinity TCR area that’s designed to bind particularly to the most cancers goal peptide on the cell floor offered by an HLA molecule. The antibody-derived, low-affinity T cell recruiter area is directed towards the TCR/CD3 complicated and recruits a affected person’s T cells to the tumor to assault the most cancers cells. With a low-affinity recruiter aiming for optimized biodistribution and enrichment of the molecule on the tumor web site as an alternative of the periphery, TCER® are engineered to scale back the incidence of immune-related opposed occasions, corresponding to cytokine launch syndrome. In addition, the TCER® format consists of an Fc-part conferring half-life extension, stability, and manufacturability. TCER® are “off-the-shelf” biologics and thus instantly out there for affected person remedy. They could be distributed by way of customary pharmaceutical provide chains and supply the chance to achieve a big affected person inhabitants with out the necessity of specialised medical facilities.

– END –

About Immatics
Immatics combines the invention of true targets for most cancers immunotherapies with the event of the precise T cell receptors with the objective of enabling a strong and particular T cell response towards these targets. This deep know-how is the inspiration for our pipeline of Adoptive Cell Therapies and TCR Bispecifics in addition to our partnerships with world leaders within the pharmaceutical trade. We are dedicated to delivering the facility of T cells and to unlocking new avenues for sufferers of their battle towards most cancers.

For common updates about Immatics, go to www.immatics.com. You may observe us on Instagram, Twitter and LinkedIn.

Forward-Looking Statements:
Certain statements on this press launch could also be thought of forward-looking statements. Forward-looking statements usually relate to future occasions or Immatics’ future monetary or working efficiency. For instance, statements in regards to the timing of product candidates and Immatics’ concentrate on partnerships to advance its technique are forward-looking statements. In some instances, you possibly can determine forward-looking statements by terminology corresponding to “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of those phrases or variations of them or comparable terminology. Such forward-looking statements are topic to dangers, uncertainties, and different components which may trigger precise outcomes to vary materially from these expressed or implied by such ahead wanting statements. These forward-looking statements are based mostly upon estimates and assumptions that, whereas thought of affordable by Immatics and its administration, are inherently unsure. New dangers and uncertainties might emerge every now and then, and it’s not potential to foretell all dangers and uncertainties. Factors which will trigger precise outcomes to vary materially from present expectations embody, however will not be restricted to, numerous components past administration’s management together with common financial circumstances and different dangers, uncertainties and components set forth in filings with the SEC. Nothing on this presentation needs to be considered a illustration by any individual that the forward-looking statements set forth herein might be achieved or that any of the contemplated outcomes of such forward-looking statements might be achieved. You mustn’t place undue reliance on forward-looking statements, which communicate solely as of the date they’re made. Immatics undertakes no obligation to replace these forward-looking statements. All the scientific and scientific information offered inside this press launch are – by definition previous to completion of the scientific trial and a scientific examine report – preliminary in nature and topic to additional high quality checks together with customary supply information verification.

For extra data, please contact:

Media and Investor Relations Contact
Jacob Verghese or Eva Mulder
Trophic Communications
Phone: +49 89 2070 89831 or +31 6 52 33 1579
[email protected]

 



Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here