On June 21, 2022 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, reported a strategic pipeline shift to prioritize its allogeneic, non-engineered off-the-shelf product candidate, Deltacel/KB-GDT (Press release, Kiromic, JUN 21, 2022, View Source [SID1234616135]).
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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