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Applied BioMath, LLC Announces Collaboration with Ichnos Sciences for Systems Pharmacology Modeling for a Bispecific Antibody in Oncology

On June 29, 2021 Applied BioMath (www.appliedbiomath.com), an industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Ichnos Sciences for the development of a systems pharmacology model for a bispecific antibody in oncology (Press release, Applied BioMath, JUN 29, 2021, View Source [SID1234584488]). Applied BioMath will develop this model to help predict human pharmacokinetics (PK), efficacious dose ranges, first-in-human dose selection, and risk mitigation strategies for cytokine release with immune cell engagers in Oncology.

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"We look forward to collaborating with Applied BioMath and using our preclinical data to develop models which will support us in predicting model-derived PK parameters and optimum dosing regimens in the clinic," said Girish Gudi, Vice President, Global Head of Drug Metabolism and Clinical Pharmacology at Ichnos Sciences.

Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about the mode of action of therapeutics with an understanding of human disease mechanisms. This approach employs proprietary algorithms and software designed specifically for systems pharmacology model development, simulation, and analysis. "One of the advantages of our modeling approach is the accuracy with which it translates from in vitro data and models to in vivo," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "By incorporating the mechanism of action into our model and leveraging the data available from all phases of R&D, we are able to translate and predict the human dose regimen and PK with far better accuracy than existing methods."

Lilly Declares Third-Quarter 2021 Dividend

On June 29, 2021 The board of directors of Eli Lilly and Company (NYSE: LLY) (the "Board") reported that it has declared a dividend for the third quarter of 2021 of $0.85 per share on outstanding common stock (Press release, Eli Lilly, JUN 29, 2021, View Source [SID1234584486]).

The dividend is payable on September 10, 2021 to shareholders of record at the close of business on August 13, 2021.

Kiromic BioPharma, Inc. Announces Pricing of Public Offering

On June 29, 2021 Kiromic BioPharma, Inc. (Nasdaq: KRBP) (the "Company"), an immuno-oncology target discovery and gene-editing company with a proprietary artificial intelligence neural network platform (Diamond AI) that is used to develop novel oncology therapeutics, reported the pricing of its underwritten public offering of 8,000,000 shares of its common stock at a public offering price of $5.00 per share, for gross proceeds of $40 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company (Press release, Kiromic, JUN 29, 2021, View Source [SID1234584485]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,200,000 shares of common stock, solely to cover over-allotments. All of the shares of common stock are being offered by the Company.

The offering is expected to close on or about July 2, 2021, subject to customary closing conditions.

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.

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.

A registration statement relating to the shares of common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on June 29, 2021. The offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained, when available, on the SEC’s website, www.sec.gov, or by contacting ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Selexis and KBI Biopharma Enter into Agreements with Immatics for Integrated Approach to Advance Immatics TCR Bispecific Program Towards IND

On June 29, 2021 Selexis SA and KBI Biopharma (KBI), both JSR Life Sciences companies, reported that they have signed service agreements with Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies (Press release, Selexis
, JUN 29, 2021, View Source [SID1234584484]). The agreements focus on using integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, called TCER (T Cell Engaging Receptors), that simultaneously recruit, activate and stimulate the patient’s own T cells to detect, target and attack tumor cells. Under the agreements, Selexis will utilize its SUREtechnology Platform and KBI will leverage its advanced analytics, process, formulation and cGMP manufacturing for Immatics’ IMA402 program.

"Immatics is pushing beyond the limitations of traditional antibody-based therapies by investigating targets beyond the cell surface to treat solid tumors," said Dirk Lange, chief executive officer at Selexis and president and chief executive officer at KBI Biopharma. "The integrated workflow between Selexis’ SUREtechnology Platform and KBI’s development approach and cGMP Manufacturing is designed to rapidly advance complex, novel product candidates towards investigational new drug submissions, while also providing a strong foundation for subsequent late-stage development and commercialization. Working together to support Immatics provides us a significant opportunity to demonstrate the power of our integrated expertise. We’re excited to work with Immatics as the company advances its TCR Bispecific candidate IMA402 towards the clinic."

Immatics is developing targeted T cell receptor (TCR)-based immunotherapies with an emphasis on solid tumors through two distinct therapeutic modalities: Adoptive Cell Therapies (ACTengine) and antibody-like TCR Bispecifics (TCER). Due to their different modes of action, these modalities are designed to expand the therapeutic value for patients across a broad range of tumor types and stages and to provide a meaningful impact on the lives of cancer patients.

"Having delivered preclinical proof-of-concept for our TCR Bispecifics program IMA402 and having moved this program into GMP process development is a major achievement of Immatics," said Sven Berger, CMC Project Leader at Immatics.

"We have chosen Selexis and KBI because of their expertise in the development and manufacturing of bispecific antibodies. We are looking forward to working with them on our path towards IND for IMA402," commented Michael Mølhøj, Head of CMC Biologics at Immatics.

Selexis’ modular SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein and provides seamless integration of the biologics development continuum, spanning discovery to commercialization. KBI Biopharma will use the enriched pool and the high-performance research cell banks generated by Selexis for process, analytical, and formulation development, and manufacturing of pre-clinical and clinical supplies of Immatics’ TCR Bispecifics.

Cancer Targeted Technology Receives Milestone Payment for Development of Diagnostic PET Imaging Agent for Prostate Cancer

On June 29, 2021 Cancer Targeted Technology (CTT), a privately held Seattle-based biotechnology company, reported that it received a milestone payment from Advanced Accelerator Applications International S.A. (AAA), a Novartis company, triggered by the upcoming clinical trials of investigational 18F-CTT1057, a diagnostic PET imaging agent for prostate cancer (Press release, Cancer Targeted Technology, JUN 29, 2021, View Source [SID1234584483]). CTT1057 targets the biomarker, Prostate Specific Membrane Antigen (PSMA), which is over-expressed on most prostate cancer cells. Prior to licensing, CTT completed prostate cancer clinical trials of CTT1057 in adult males at University of California, San Francisco (UCSF), with encouraging safety and imaging results. Based on this clinical data, binding characteristics of the molecule, and solid patent protection, CTT1057 was licensed to AAA to undergo further development in the upcoming GuidePath and GuideView clinical studies.

"This licensing deal with AAA is an important collaboration for CTT and we are very excited to see CTT1057 moving forward as a potential new imaging agent for prostate cancer," stated Dr. Beatrice Langton-Webster, CTT’s Chief Executive Officer. The milestone payments, along with an NIH SBIR Phase IIB grant, are the key assets that CTT is using to advance its new radiolabeled small molecule drug CTT1403, a companion radiotherapeutic to CTT1057. Features that make the phosphoramidate PSMA-binding scaffold unique include irreversible binding to PSMA and excellent uptake by PSMA-expressing tumor cells. CTT1057 and CTT1403 are a theranostic pair that can both diagnose and treat solid tumors that express PSMA and are being studied together in the current CTT1403 therapeutic clinical trial (NCT03822871) that CTT is conducting with lead investigator Dr. Rahul Aggarwal at UCSF. The unique chemical structures of CTT’s drugs were conceived by Dr. Cliff Berkman, Professor of Chemistry at Washington State University (WSU).