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
HOUSTON, TX, USA I Juen 21, 2022 I Kiromic BioPharma, Inc. (NASDAQ: KRBP), a clinical-stage biotherapeutics company using its proprietary DIAMOND AI® (artificial intelligence) and data mining platform to discover and develop cell therapies with a focus on immuno-oncology, announces a strategic pipeline shift to prioritize its allogeneic, non-engineered off-the-shelf product candidate, Deltacel/KB-GDT™.
Kiromic expects to submit its first new investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in the second half of 2022. The IND will seek to evaluate Deltacel in combination with a standard antitumor modality, with the expected beginning of trial activation by year-end. Deltacel consists of Gamma Delta T-cells (GDT) that are expanded, enriched, and activated through a proprietary method. Kiromic will also pursue INDs for its Procel™ and Isocel™ product candidates in combination with a standard antitumor modality in 2023.
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 Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.
“Against the backdrop of a global cancer cell therapy market that’s expected to exceed $33 billion by 2027, Kiromic’s product pipeline now encompasses three additional Gamma Delta T-cell therapeutic candidates, Deltacel™, Procel™, and Isocel™. Each is being developed to target solid tumors – which represent 90% of all cancers – and each is ideally positioned to address unmet medical needs. We look forward to advancing these candidates into the clinic with the goal of providing new treatment options to patients with cancer,” added Mr. Bersani.
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
Activation Process for New
IND #1 Clinical Trial
|
|
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
Activation Process for New
IND #2 Clinical Trial
|
|
ALEXIS – PRO-1
Procel™
Allogeneic, off-the-shelf, GDT CAR-T therapy
|
PD-L1
|
Q2 2023
Expected Beginning of
Activation Process for
ALEXIS-PRO-1 Clinical Trial
|
|
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
Activation Process for New
IND #3 Clinical Trial
|
|
ALEXIS – ISO-1
Isocel™
Allogeneic, off-the-shelf, GDT CAR-T therapy
|
Isoform of
Mesothelin
|
Q4 2023
Expected Beginning of
Activation Process for
ALEXIS-ISO-1 Clinical Trial
|
About Kiromic BioPharma
Kiromic BioPharma is a clinical stage biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases. Kiromic is in the process of developing a multi-indication gamma delta allogeneic T cell therapy treatment platform that exploits the natural potency of gamma delta T cells to target solid cancers. Kiromic is focused on discovering, developing, and commercializing novel immuno-oncology therapies through its robust product pipeline, leveraged by DIAMOND® AI, a proprietary target discovery engine where data science meets target identification to dramatically compress the timeline and cost of drug development. The Company maintains offices in Houston, Texas. To learn more, visit www.kiromic.com and connect with us on Twitter and LinkedIn.
SOURCE: Kiromic BioPharma
Post Views: 306
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
HOUSTON, TX, USA I Juen 21, 2022 I Kiromic BioPharma, Inc. (NASDAQ: KRBP), a clinical-stage biotherapeutics company using its proprietary DIAMOND AI® (artificial intelligence) and data mining platform to discover and develop cell therapies with a focus on immuno-oncology, announces a strategic pipeline shift to prioritize its allogeneic, non-engineered off-the-shelf product candidate, Deltacel/KB-GDT™.
Kiromic expects to submit its first new investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in the second half of 2022. The IND will seek to evaluate Deltacel in combination with a standard antitumor modality, with the expected beginning of trial activation by year-end. Deltacel consists of Gamma Delta T-cells (GDT) that are expanded, enriched, and activated through a proprietary method. Kiromic will also pursue INDs for its Procel™ and Isocel™ product candidates in combination with a standard antitumor modality in 2023.
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 Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.
“Against the backdrop of a global cancer cell therapy market that’s expected to exceed $33 billion by 2027, Kiromic’s product pipeline now encompasses three additional Gamma Delta T-cell therapeutic candidates, Deltacel™, Procel™, and Isocel™. Each is being developed to target solid tumors – which represent 90% of all cancers – and each is ideally positioned to address unmet medical needs. We look forward to advancing these candidates into the clinic with the goal of providing new treatment options to patients with cancer,” added Mr. Bersani.
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
Activation Process for New
IND #1 Clinical Trial
|
|
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
Activation Process for New
IND #2 Clinical Trial
|
|
ALEXIS – PRO-1
Procel™
Allogeneic, off-the-shelf, GDT CAR-T therapy
|
PD-L1
|
Q2 2023
Expected Beginning of
Activation Process for
ALEXIS-PRO-1 Clinical Trial
|
|
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
Activation Process for New
IND #3 Clinical Trial
|
|
ALEXIS – ISO-1
Isocel™
Allogeneic, off-the-shelf, GDT CAR-T therapy
|
Isoform of
Mesothelin
|
Q4 2023
Expected Beginning of
Activation Process for
ALEXIS-ISO-1 Clinical Trial
|
About Kiromic BioPharma
Kiromic BioPharma is a clinical stage biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases. Kiromic is in the process of developing a multi-indication gamma delta allogeneic T cell therapy treatment platform that exploits the natural potency of gamma delta T cells to target solid cancers. Kiromic is focused on discovering, developing, and commercializing novel immuno-oncology therapies through its robust product pipeline, leveraged by DIAMOND® AI, a proprietary target discovery engine where data science meets target identification to dramatically compress the timeline and cost of drug development. The Company maintains offices in Houston, Texas. To learn more, visit www.kiromic.com and connect with us on Twitter and LinkedIn.
SOURCE: Kiromic BioPharma
Post Views: 306
