NORTH CHICAGO, Ill. and SEATTLE, Jan. 4, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV), and Umoja Biopharma (Umoja), an early clinical-stage biotechnology company, today announced two exclusive option and license agreements to develop multiple in-situ generated CAR-T cell therapy candidates in oncology using Umoja's proprietary VivoVec^TM platform. The first agreement provides AbbVie an exclusive option to license Umoja's CD19 directed in-situ generated CAR-T cell therapy candidates. This includes UB-VV111, Umoja's lead clinical program for hematologic malignancies currently at the IND-enabling phase. Under the terms of the second agreement, AbbVie and Umoja will develop up to four additional in-situ generated CAR-T cell therapy candidates for discovery targets selected by AbbVie.

"As we continue to strengthen our oncology portfolio, we believe that in-situ CAR-T cell therapy represents a paradigm shift utilizing genetic medicine concepts," said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research at AbbVie. "We look forward to working with Umoja's team to advance next-generation in-situ CAR-T therapies, and potentially expand the patient populations and indications benefitting from conventional CAR-T approaches."

Umoja's VivoVec^TM gene delivery platform combines third generation lentiviral vector gene delivery with a novel T-cell targeting and activation surface complex. This enables T cells in the body to manufacture their own cancer-fighting CAR-T cells in vivo. This has the potential to eliminate a number of challenges associated with traditional CAR-T approaches including reliance on gathering a patient's own or donor cells which are modified externally before being delivered back to the patient, the associated time lag and manufacturing challenges of ex vivo cell modification, and the need for patient's lymphodepletion.

"AbbVie is an ideal partner for Umoja given their broad expertise in development and commercialization of novel therapeutics in hematology, oncology, and beyond," said David Fontana, Ph.D., chief operating and business officer at Umoja.

"By bringing together AbbVie's like-minded pursuit of addressing patient unmet needs with our investments in vector biology and fully-owned commercial-scale manufacturing, we look forward to progressing multiple VivoVec™ drug candidates into the clinic in the coming years," added Andrew Scharenberg, M.D., co-founder and chief executive officer at Umoja.

Under the terms of the two agreements, Umoja received upfront payments and an equity investment from AbbVie. Additionally, for the two agreements combined, Umoja may be eligible to receive up to $1.44B in aggregate for option exercise fees, development and regulatory milestones, with the potential for Umoja to earn additional sales-based milestones and tiered royalties on worldwide net sales.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

About Umoja Biopharma

Umoja Biopharma, Inc. is a clinical-stage biotechnology company aiming to develop off-the-shelf therapeutics that improve the reach, effectiveness, and access of CAR T cell therapies in both oncology and autoimmunity. Umoja's VivoVec^TM in vivo gene delivery technology empowers a patient's own immune system to fight disease. Enabling its core technology is the Company's state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. Umoja believes its approach can provide broader access and improved effectiveness of the most advanced immunotherapies, enabling more patients to live better, fuller lives. To learn more, connect with Umoja on LinkedIn and visit http://umoja-biopharma.com/.

AbbVie Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Umoja Forward-Looking Statements:

This press release contains forward-looking statements about Umoja Biopharma, Inc. (the "Company," "we," "us," or "our"). The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company's current and future research and development programs, preclinical and clinical trials, as well as any economic, market and social disruptions. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

SOURCE:- AbbVie