Procel (KB-PD1) / Kiromic - LARVOL DELTA

Kiromic BioPharma Announces Settlement of Previously Disclosed SEC Investigation (Businesswire) - "Kiromic BioPharma, Inc...today announced that it has entered into a settlement agreement with the U.S. Securities and Exchange Commission (the 'SEC'), resolving the previously disclosed SEC investigation arising from the non-disclosure by Kiromic’s prior executive management of the clinical holds placed on the investigational new drug ('IND') applications the Company filed with the U.S. Food and Drug Administration (the 'FDA') in May 2021. The IND applications pertained to ALEXIS-PRO-1 (Procel) and ALEXIS-ISO-1 (Isocel). In light of the Company’s self-reporting, prompt remediation and cooperation, the SEC has determined not to impose a civil penalty on the Company and there are no ongoing undertakings in connection with the settlement."

Commercial • Oncology • Solid Tumor

Kiromic BioPharma Pipeline to Prioritize a New Gamma Delta T-cell Product Candidate (Businesswire) - "Kiromic BioPharma, Inc...announces a strategic pipeline shift to prioritize its allogeneic, non-engineered off-the-shelf product candidate, Deltacel/KB-GDT™....These three IND applications will expand Kiromic’s therapeutic pipeline to five allogeneic GDT clinical trials...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."

IND • New trial • Pipeline update • Oncology

Kiromic BioPharma Significantly Expands Gamma Delta T cell Product Pipeline with New Sponsored Research Agreement (Businesswire) - "Kiromic BioPharma, Inc...announces it has entered into a sponsored research agreement (SRA) with Principal Investigator James W. Welsh, M.D. of The University of Texas MD Anderson Cancer Center. Under the two-year SRA, in vivo preclinical data will be generated from Kiromic’s Gamma Delta T cell (GDT) allogeneic therapies. This SRA is intended to evaluate efficacy and patient safety outcomes to support three new investigational drug (IND) applications to the U.S. Food and Drug Administration (FDA)....'The first of these three new IND submissions - the Deltacel™ - is expected to be submitted during the second half of the year', stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. 'Importantly, we expect to begin the activation of the Deltacel clinical trial by the end of this year.' In addition to Deltacel/KB-GDT...the second IND is expected to focus on Procel/KB-PD1...The third IND is expected to focus on Isocel/KB-ISO..."

IND • Licensing / partnership • Oncology

Kiromic BioPharma Announces Company Will Directly Submit Amended IND for Procel to the FDA in Second Half of 2022 (Businesswire) - "Kiromic BioPharma, Inc...today announces the Company will submit an amended Investigational New Drug Application (IND) for its first oncology cell therapy candidate Procel™ directly to the FDA in the second half of 2022....Based on the unanimous advice from independent regulatory experts, the Company has determined that it is not necessary to proceed with the previously contemplated Type A meeting with the FDA to further address the CMC issues and instead will move forward with a submission of an amended IND for Procel™ directly to the FDA during the second half of this year. The Company also announces ongoing progress toward the implementation of a current good manufacturing practice (cGMP) mammalian master cell bank (mMCB), which will provide a GMP-grade retroviral vector for gamma delta T (GDT) cell engineering..."

Commercial • IND • Lung Cancer • Mesothelioma • Oncology • Solid Tumor • Thoracic Cancer

Kiromic BioPharma Reports Second Quarter 2021 Financial Results and Operating Highlights (Businesswire) - "The company's plans to submit the prepared response..[to FDA]...by the first half of September 2021. The commencement of the dosing of its first in human clinical trial is expected to be delivered in the first quarter of 2022."

FDA event • New trial • Oncology

Kiromic BioPharma Provides Update on IND Filings on its Off-the-Shelf, Allogeneic CAR-T for Solid Tumors (PRNewswire) - "Two INDs were submitted to the FDA in May 2021 for the first-in-human off-the-shelf allogeneic CAR-T for Solid Tumors. FDA returned with comments on the Company’s allogeneic CAR-T products with respect to: (i) Tracing of all reagents used in manufacturing; (ii) Flow chart of manufacturing processes; (iii) Certificate of Analysis (COA) for the Company’s CAR-T products (allogeneic CAR-T)...The company's timeline for commencement of the dosing of its first in human clinical trial is expected to be tighter but we still plan on delivering in 3Q 2021."

IND • Trial status • Oncology • Solid Tumor

Kiromic BioPharma, Inc. Announces Closing of Public Offering (Businesswire) - "Kiromic BioPharma, Inc...announced the closing of its previously announced underwritten public offering of 8,000,000 shares of its common stock at a public offering price of $5.00 per share, resulting in gross proceeds to the Company of $40 million...The Company intends to use the net proceeds from the offering primarily for clinical trials for its ALEXIS-ISO-1 and ALEXIS-PRO-1 product candidates, GMP facility expansion, intellectual property protection and reinforcement, IND applications and IND enabling trials and working capital and the remainder for general corporate purposes."

Commercial • Oncology