BioPharma
Revolutionizing CAR T-Cell Therapy
March 2024
OTCQB: KRBP Kiromic.com
Forward Looking Statements
This presentation 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 December 31, 2022, and as detailed from time to time in our SEC filings. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward- looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Such forward-looking statements relate only to events as of the date of this press release. We undertake no obligation to update any forward-looking statements except to the extent required by law.
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Contents
The Kiromic Difference and Market Opportunity
Diamond AITM (Artificial Intelligence)
Gamma Delta T-cell (GDT) Therapy:
Mechanism of Action (MOA), Product Pipeline, cGMP Manufacturing
Current Status and Path Forward
The Kiromic Difference
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Kiromic BioPharma
is an allogeneic Gamma
Delta T-cell therapy
company featuring unique, proprietary, end-to-end bioinformatic, AI targeting, and manufacturing technologies to address solid tumors
1 | 2 | 2 | 3 | ||
Diamond AITM | Gamma Delta | Allogeneic, | |||
Neural | CAR-T Cell | Off-the-shelf | |||
Network | Therapy | Cellular Therapy | |||
Platform | not ill cancer patients, | ||||
Cells from healthy donors, | |||||
4 | for maximum efficacy | ||||
4 | 5 | ||||
Solid | |||||
Malignancies | In-House | ||||
cGMP | |||||
(~90% of all | |||||
Manufacturing | |||||
cancers1) |
1American Cancer Society, Cancer Facts & Figures,
2022..https://www.cancer.org/research/cancer-facts-statistics.html.
Strategic Competitive Landscape
8 Known Companies in the Gamma Delta T Cell Therapy space. No Known Competitors with AI-drivenTechnology Combined with a Gamma Delta CAR-TDelivery Platform.
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AI-DRIVEN
CAR-GDT
Solid Malignancy Market Opportunity
Global CAR T-Cell | |
Therapy Market | 90% |
by 20271 (USD) | |
$33+ | |
Billion | of Cancers Are |
Solid Malignancies2 | |
- Global CAR T-Cell Therapy Market, By Product Type, By Tumor Type, By Indication, By Treatment Type, By Targeted Antigen, By End User, By Region, Competition, Forecast and Opportunities, 2017-2027 (ReportLinker)
- American Cancer Society, Cancer Facts & Figures, 2022..https://www.cancer.org/research/cancer-facts- statistics.html
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Competitive Difference
Allogeneic Gamma Delta Based T-Cell Therapies
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Superior
specificity for multiple solid tumors
Superior
Efficacy from
γδT cells
- Potential broad treatment for solid malignancies that express Kiromic-developedbiomarkers such as Iso- mesothelin.
- Solid tumors represent approx. 90% of new cancer diagnoses but finding specific targets to treat them has been challenging.
- Kiromic tackles the issue by identifying new cancer specific targets.
- Strong efficacy in pre-Clinical animal models.
- In solid tumors, the benefit of infiltrating conventional T cells may vary.
- In contrast, GDT cells are the infiltrating immune cells most likely to be associated with positive outcomes, as shown in an analysis of 18,000 tumors from 39 indications1
Vertical
Integration
Lower Costs/
Greater Access2
- In-house cGMP manufacturing
- In-houseQC/EM lab
- In-house product and process development (R&D and MSAT)
1.Outpatient treatment means reduced hospitalization and other treatment related costs.
2. Lower projected cost
increases patient and health care professional access to these therapies, and potentially provides important quality-of-life benefits for patients as well.
- Gentles AJ, Newman AM, Liu CL, et al. The prognostic landscape of genes and infiltrating immune cells across human cancers. Nat Med. 2015 Aug;21(8):938-945.
- Maziarz RT. CAR T-cell therapy total cost can exceed $1.5M per treatment. Cell Therapy Next; May 29, 2019.
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Contents
The Kiromic Difference and Market Opportunity
Diamond AITM (Artificial Intelligence)
Gamma Delta T-cell (GDT) Therapy:
Mechanism of Action (MOA), Product Pipeline, cGMP Manufacturing
Current Status and Path Forward
Artificial Intelligence and Bioinformatic Analytic Discovery & Development Platform
Algorithms and Large-Scale Genomics Analysis for Target Prediction
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Discovery | Development | Manufacturing | Clinical Trials |
A.I. integrated with each stage of the Kiromic therapy production lifecycle Discovering New Multi-tumor Targets
Identifying Optimal Donors and Patients to Maximize the Therapy Success
The Kiromic Difference - Diamond AITM Target Discovery Platform
Diamond AITM target discovery platform powers innovation and significantly reduces development time and cost.
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- Diamond AI drives discovery by sifting through billions of data points to identify cancer specific immunotherapy targets, donors with the best GDT cell yields, and patients who will most likely benefit from our therapies.
Large Cancer Genomics | Diamond AITM |
Studies | Data Mining Tools |
2 Diamond AI prediction and
validation platform reduce | |
development costs by seeking | 3 Laboratory studies are then |
to eliminate targets, donors, | |
and patients that will | performed to confirm the validity |
ultimately fail laboratory | of the AI selections. |
analysis. |
• | Cancer / Normal | |
Differences | ||
Large Normal Tissue | • | Cell Surface Proteins |
Genomics Studies | • | Unique Targetable |
Peptides | ||
• | Optimal Donor and | |
Patient Selection |
Protein Structures, Gene
Models, Gene Metadata
Target | Target | Therapy Candidates |
Donor & | Validation | |
Patient | (Algorithm and | |
Selection | wet lab Validation) | |
- Diamond Donor AI uses demographics, cytometry, and sequence data to identify the best GDT cell donors -
reducing manufacturing cost and potentially improving potency. Diamond data mining can guide selecting patients likely to benefit from Kiromic's therapies.
Clinical Trials
(Phase I)
*
Diamond Clinical AI models can continually improve the AI model to maximize efficacy.
- In Development
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Kiromic Biopharma Inc. published this content on 06 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 March 2024 18:03:06 UTC.