Kiromic BioPharma Pipeline to Prioritize a New Gamma Delta T-cell Product Candidate
Kiromic BioPharma (NASDAQ: KRBP) is set to submit its first IND application for Deltacel/KB-GDT™ in the second half of 2022, aiming for clinical trial activation by year-end. This marks a strategic pivot towards allogeneic, non-engineered therapies. The company plans to expand its pipeline with three additional IND filings in 2023, totaling five GDT clinical trials. The shift follows a recent research agreement to enhance preclinical data generation for these therapies, potentially addressing the growing cancer cell therapy market projected to exceed $33 billion by 2027.
- Submission of the IND application for Deltacel/KB-GDT™ by the end of 2022.
- Expansion of the product pipeline to five allogeneic GDT clinical trials.
- Recent sponsored research agreement to support IND applications and enhance data generation.
- None.
IND for Non-Engineered Deltacel/KB-GDT™ to be Submitted in the Second Half of 2022 with Beginning of Clinical Trial Activation Expected by Year-End
Three Additional IND Filings Will Expand the Company’s Pipeline to Five Allogeneic Gamma Delta T-cell Clinical Trials and Three Product Candidates
Kiromic expects to submit its first new investigational new drug (IND) application to the
These three additional IND filings will expand the Company’s pipeline to five allogeneic GDT clinical trials and three product candidates.
This reprioritization and expansion of Kiromic’s pipeline follows a recently announced sponsored research agreement to generate in vivo preclinical data. The Company believes that, through this agreement, we will be able to efficiently generate data for our GDT allogeneic therapies and other pre-clinical assets to support our anticipated IND filings.
“We are well positioned to prioritize Deltacel/KB-GDT™ in combination with a standard antitumor modality as our first IND, which we intend to submit to the FDA during the second half of this year with the expected beginning of trial activation by year-end. We believe that this shift both de-risks and accelerates our immediate path forward, enabling us to advance our non-viral, non-engineered product candidate while also reducing costs and mitigating current supply chain headwinds associated with a virus-based approach,” stated
“Against the backdrop of a global cancer cell therapy market that’s expected to exceed
These three IND applications will expand Kiromic’s therapeutic pipeline to five allogeneic GDT clinical trials (see accompanying graphic), including:
- New IND #1: Deltacel™ in combination with a standard antitumor modality, with clinical activation expected to begin by the end of the fourth quarter of 2022
- New IND #2: Procel™ in combination with a standard antitumor modality, with clinical activation expected to begin by the end of the second quarter of 2023
- ALEXIS – PRO-1 Procel™ as a monotherapy, with clinical activation expected to begin by the end of second quarter 2023
- New IND #3: Isocel™ in combination with a standard antitumor modality, targeting clinical activation to begin by the end of the fourth quarter of 2023
- ALEXIS – ISO-1 Isocel™ as a monotherapy, targeting clinical activation to begin by the end of the fourth quarter of 2023
Clinical Trial Candidate |
Target |
Phase I |
New IND #1 DeltacelTM ln combination with standard antitumor modality Allogeneic, Non-Viral, Non-engineered off-the-shelf GDT therapy |
Universal Non-Engineered |
Q4 2022
Expected Beginning of
|
New IND #2 Procel™ in combination with standard antitumor modality Allogeneic, off-the-shelf, GDT CAR-T therapy |
PD-L1 |
Q2 2023
Expected Beginning of
|
ALEXIS – PRO-1 Procel™ Allogeneic, off-the-shelf, GDT CAR-T therapy |
PD-L1 |
Q2 2023
Expected Beginning of
|
New IND #3 Isocel™ in combination with standard antitumor modality Allogeneic, off-the-shelf, GDT CAR-T therapy |
Isoform of Mesothelin |
Q4 2023
Expected Beginning of
|
ALEXIS – ISO-1 Isocel™ Allogeneic, off-the-shelf, GDT CAR-T therapy |
Isoform of Mesothelin |
Q4 2023
Expected Beginning of
|
About
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Kiromic makes such forward-looking statements pursuant to the safe harbor provisions of the United States Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as: “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding: Kiromic’s current and anticipated IND applications including statements regarding the scope of and timing for submission of an IND application; the Deltacel™ product platform; the sponsored research agreement and the data that will be generated as a result of such collaboration; the timing for submitting and activating Kiromic’s IND applications; the benefits of utilizing non-genetically engineered Gamma Delta T cells as our first in-human study; Kiromic’s ability to achieve its objectives; and the timing for the initiation and successful completion of Kiromic’s clinical trials of its product candidates. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in our Annual Report on Form 10-K for the year ended
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Global Head, Corporate Communications
281-468-7683
ldyson@kiromic.com
LHA Investor Relations
212-201-6614
tpatel@lhai.com
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