Welcome to our dedicated page for Kiromic Biopharma news (Ticker: KRBP), a resource for investors and traders seeking the latest updates and insights on Kiromic Biopharma stock.
Kiromic BioPharma, Inc. (OTCQB: KRBP) is a clinical-stage biotherapeutics company focused on immuno-oncology, and the KRBP news page highlights company announcements, clinical updates and regulatory milestones. Kiromic is developing a multi-indication allogeneic cell therapy platform that uses gamma delta T-cells to target solid tumors, with its lead investigational product Deltacel™ (KB-GDT-01) in a Phase 1 trial for stage 4 non-small cell lung cancer (NSCLC) that has failed standard therapies.
News items for KRBP frequently cover progress in the Deltacel-01 clinical trial, including safety observations, tumor volume changes, partial responses, stable disease assessments and progression-free survival data in individual patients. The company also reports on decisions from the Deltacel-01 Safety Monitoring Committee, transitions from initial cohorts into expansion phases, and the activation of additional clinical trial sites such as the Beverly Hills Cancer Center, Texas Oncology in Tyler, Virginia Oncology Associates and the University of Arizona Cancer Center.
Regulatory and corporate developments appear in this feed as well, including Kiromic’s announcement that the U.S. Food and Drug Administration granted Fast Track designation to Deltacel in combination with low-dose radiation for certain metastatic NSCLC patients, and the company’s disclosure of a settlement agreement with the U.S. Securities and Exchange Commission related to prior non-disclosure of FDA clinical holds.
Investors and observers can use the KRBP news page to follow Kiromic’s ongoing clinical results, site expansions, regulatory designations and corporate updates related to its gamma delta T-cell platform and DIAMOND® AI 2.0 target discovery engine. Regular review of this page can help track how the Deltacel-01 program and Kiromic’s broader immuno-oncology strategy evolve over time.
Kiromic BioPharma, Inc. (NASDAQ: KRBP) announced promising results from a Phase 1 clinical trial of KiroVax/BSK01, a cell therapy cancer vaccine candidate, combined with chemotherapy for metastatic pancreatic cancer. The trial showed a significant progression-free survival (PFS) of 7 months compared to 3.9 months with standard chemotherapy. These findings highlight the potential of KiroVax/BSK01 in addressing advanced solid tumors and may enhance Kiromic's cellular therapy pipeline, including CAR-T therapies.
Kiromic BioPharma (NASDAQ: KRBP) has announced a strategic collaboration with Gemelli Teaching Hospital IRCCS to expedite the analysis of its first allogeneic CAR-T clinical trial candidate, Alexis ISO-1, engineered to address solid tumors. This marks Kiromic's initial AI-identified Gamma Delta T Cell candidate. The company anticipates a Type A meeting with the FDA in H1 2022 to discuss its clinical development pathway. This collaboration leverages Gemelli's extensive cancer research capabilities to enhance the candidate's analysis and development.
Kiromic BioPharma, Inc. (NASDAQ: KRBP) has appointed Daniel Clark as interim Chief Financial Officer, effective September 30, 2021. Mr. Clark previously served as the Company’s Vice President of Finance Operations and Corporate Controller. His appointment follows the resignation of Tony Tontat on September 29, 2021. Clark has extensive financial experience, having worked at The Siegfried Group and KPMG. Kiromic is focused on AI-driven immune-oncology therapies, leveraging its DIAMOND platform for drug discovery and development.
Kiromic BioPharma reported significant operational updates and clinical progress in its Q2 2021 results. The company re-submitted two IND applications for ALEXIS product candidates, anticipating first in-human dosing in Q1 2022. With a new Chief Operating and Manufacturing Officer appointed and a successful public offering generating $37.1 million, Kiromic aims to strengthen its financial position. The company noted a cash decrease to $3.1 million and a 109% increase in R&D expenses, while G&A expenses dropped significantly. Net loss narrowed to $8.9 million, demonstrating improved cost management.
Kiromic Biopharma, Inc. (Nasdaq: KRBP) has successfully completed the acquisition of InSilico Solutions, enhancing its capabilities in bioinformatics and artificial intelligence. This strategic move aims to strengthen Kiromic's lead in developing CAR-T cell therapies by employing advanced techniques to identify optimal biomarkers. The acquisition involves a stock-swap operation, retaining InSilico's entire team and assets. This integration is expected to accelerate the development and manufacturing of Kiromic's off-the-shelf allogeneic CAR-T therapies.
Kiromic BioPharma, Inc. (Nasdaq: KRBP) submitted two INDs to the FDA in May 2021 for its off-the-shelf allogeneic CAR-T for solid tumors. The FDA provided feedback regarding reagent tracing, manufacturing flow charts, and Certificates of Analysis (COA). The company has established a taskforce of industry veterans to address these comments. Kiromic plans to tighten the timeline for commencing human clinical trials, targeting delivery in Q3 2021. The company utilizes an AI platform called DIAMOND for target discovery and gene-editing in cancer treatment.
Kiromic BioPharma, Inc. (Nasdaq: KRBP) has successfully closed its public offering of 8,000,000 shares at $5.00 per share, generating gross proceeds of $40 million. The underwriters have an option for an additional 1,200,000 shares for over-allotments. The funds will primarily support clinical trials for ALEXIS-ISO-1 and ALEXIS-PRO-1, GMP facility expansion, and general corporate purposes. ThinkEquity managed the offering, and the registration statement was effective as of June 29, 2021.
Kiromic BioPharma, Inc. (Nasdaq: KRBP) announced a public offering of 8,000,000 shares of common stock priced at $5.00 per share, aiming for gross proceeds of $40 million. The offering includes a 45-day option for underwriters to purchase an additional 1,200,000 shares for over-allotments. The proceeds will primarily fund clinical trials for ALEXIS-ISO-1 and ALEXIS-PRO-1, facility expansion, intellectual property protection, IND applications, and general corporate purposes. The offering is expected to close around July 2, 2021.
Kiromic Biopharma (Nasdaq: KRBP) is recognized as an innovator in immuno-oncology, showcasing its AI-driven cancer targets at the 4th Annual Next-Gen Immuno Oncology Congress. The presentation focuses on artificial intelligence-selected targets, claiming enhanced safety and efficacy over conventional methods. The company plans to advance Mesothelin isoform 2 in human trials for solid tumors by Q3 2021, utilizing a CAR-T therapy with chPD1. Leadership highlights the potential of AI to significantly improve target specificity and affinity, aiming to reduce side effects and elevate treatment effectiveness.
Kiromic has made significant strides in Gamma Delta T (GDT) cell therapy manufacturing, earning recognition as a pioneer in the field. The company will present its allogeneic CAR-T technology at the Gamma Delta T Cell Summit in July 2021, following a successful showcase of its GDT cells at AACR 2021. Kiromic projects the first in-human dosing for solid tumors in Q3 2021, showcasing promising early clinical data. Notable executives have expressed confidence in their innovative technologies and operational readiness as they prepare for Phase 1 clinical trials.