Kiromic Biopharma Inc Stock Price, News & Analysis

Kiromic Biopharma, Inc. (Nasdaq: KRBP) has submitted a novel Investigational New Drug (IND) application to the FDA for a Phase 1 clinical trial of KB-ISM, a universal CAR-T therapy targeting solid tumors expressing Iso-mesothelin. The trial, titled ALEXIS-ISO-1, will evaluate the safety and efficacy of allogeneic Gamma Delta T-cells expressing a CAR against Isoform 2 of Mesothelin. The trial is set to enroll 30 patients and will last 18 months, with initial data expected by Q4 2021. FDA feedback on the IND submission is anticipated within 30 days.

Kiromic Biopharma (Nasdaq: KRBP) has announced the identification of new targets for solid tumor treatment using its AI-driven platforms, CancerDiff and Diamond AI. The targets include novel epitopes of NY-ESO-1 and a splice variant of Mesothelin, showing promise for CAR Gamma Delta T-cell therapy. Preclinical results were shared at the AACR meeting, highlighting the efficacy of these targets. Kiromic's AI distinguishes it in the immunotherapy field by significantly reducing the time and cost of biomarker identification, enhancing their drug discovery process.

Kiromic Biopharma (Nasdaq: KRBP) has submitted a novel IND to the FDA for a Phase 1 clinical trial of KB-PD1, a T-Cell therapy targeting PD-L1 in solid tumors. This therapy aims for improved efficacy and safety while lowering manufacturing costs. The ALEXIS-PRO-1 trial will include 30 patients with PD-L1 positive solid malignancies, with dosing expected by Q3 2021, pending FDA approval. Preliminary results showed rapid tumor elimination without toxicity, signifying potential advancements in cancer treatment.

Kiromic BioPharma (NASDAQ: KRBP) reported its quarterly results for the period ending March 31, 2021, achieving significant scientific milestones. The company plans to submit two IND applications to the FDA by May 2021 for its ALEXIS-PRO-1 and ALEXIS-ISO-1 therapies. Financial highlights include a cash position of $7.3 million, a net loss of $3.9 million, and an increase in R&D expenses by 83.41%. General and administrative expenses surged by 151.15% due to higher headcount and professional services.

Kiromic BioPharma (Nasdaq: KRBP) showcased its innovative technologies at the AACR 2021 meeting, highlighting their use of AI in developing CAR-T therapies for solid tumors. The company presented six posters on their proprietary platforms, including CancerDiff and CancerSplice, which harmonize large data sets for biomarker identification. Kiromic's AI-driven approach is believed to significantly lower development timelines compared to industry standards. The firm aims to lead in allogenic CAR-T therapies, expecting to realize this vision with planned human trials in Q3 2021.

Kiromic BioPharma (NASDAQ: KRBP) reported its financial results for 2020, highlighting significant milestones in drug development and corporate growth. The company enhanced its cash position to over $10 million following a successful IPO that raised $15 million. R&D expenses surged to $5 million, with a net loss of $19 million, up from $3.7 million in 2019. Kiromic plans to resubmit two IND applications for clinical trials focused on innovative CAR-T therapies. The company emphasizes its strategy using the DIAMOND AI platform to advance treatment efficacy in cancer.

Kiromic BioPharma (Nasdaq: KRBP) announced an interview with CEO Dr. Maurizio Chiriva-Internati, scheduled to air on The RedChip Money Report on Bloomberg Television on Saturday, March 27 at 7 p.m. local time. The interview will cover key topics including IND filing timelines, expanded indications, and GMP manufacturing updates. This segment reaches approximately 73 million homes, providing a platform for discussing Kiromic's immuno-oncology advancements and the proprietary Diamond AI platform that aids in oncology therapeutic development.

Kiromic Biopharma, Inc. (Nasdaq: KRBP) announced a planned resubmission of two investigational new drug (IND) applications to the FDA for its Allogenic Gamma-Delta T cell therapy targeting various solid tumors. Retaining 80% of the original protocols, the revised INDs aim for open enrollment, allowing broader eligibility across multiple cancers, enhancing potential market reach. Key changes include exclusively intravenous administration, streamlining procedures. The company expects IND resubmissions in 2Q 2021, with first-in-human dosing anticipated in 3Q 2021 and safety data by 4Q 2021.

Kiromic BioPharma, Inc. (Nasdaq: KRBP) has completed a licensing agreement for chPD1 with Longwood University, marking a significant milestone in CAR-T development. This innovative receptor not only inhibits the PD-1 pathway but also activates T-cell responses, potentially enhancing effectiveness against solid tumors. Kiromic's chimeric PD1 CAR-T aims to tackle challenges posed by the tumor micro-environment, positioning the company favorably for future clinical trials. Experts believe this advancement could distinguish Kiromic's offerings in the competitive CAR-T landscape.