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AbbVie and Umoja Biopharma Announce Strategic Collaboration to Develop Novel In-Situ CAR-T Cell Therapies

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AbbVie (NYSE: ABBV) and Umoja Biopharma announced two exclusive option and license agreements to develop in-situ generated CAR-T cell therapy candidates in oncology using Umoja's proprietary VivoVecTM platform. The collaboration combines AbbVie's expertise in oncology with Umoja's gene delivery platform to advance next-generation in-situ CAR-T therapies. Umoja received upfront payments and an equity investment from AbbVie, with the potential to earn up to $1.44B in aggregate for option exercise fees, development and regulatory milestones, and additional sales-based milestones and tiered royalties on worldwide net sales.
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The collaboration between AbbVie and Umoja Biopharma signifies a strategic investment into the rapidly evolving field of CAR-T cell therapies. From a financial perspective, the upfront payments and equity investment into Umoja by AbbVie, along with the potential for Umoja to receive up to $1.44 billion in option exercise fees, development, regulatory milestones and additional sales-based milestones and tiered royalties on worldwide net sales, underscore the high economic stakes involved in the development of innovative cancer treatments. This partnership could significantly impact AbbVie's long-term revenue streams and diversify its oncology portfolio.

It is imperative to note that the deal's structure, which includes milestone payments, aligns Umoja's incentives with the successful progression of the clinical programs. This risk-sharing approach is common in the biotech industry, as it mitigates the financial burden on the larger pharmaceutical company while providing the biotech partner with the necessary funding to advance their research. Investors should watch for the progression of Umoja's lead clinical program, UB-VV111, as it moves through the IND-enabling phase, as this could be a pivotal driver for both companies' valuations.

The partnership hinges on the innovative VivoVecTM gene delivery platform, which promises to address some of the limitations of conventional CAR-T cell therapies. The in-situ generation of CAR-T cells could potentially streamline the treatment process by eliminating the need for external cell modification and reducing the time from patient diagnosis to treatment. The implications for patient outcomes could be substantial, as this method may also reduce the need for lymphodepletion—a process with significant side effects. The ability to generate CAR-T cells within the patient's body represents a leap forward in personalized medicine, potentially increasing the efficacy and safety profile of these treatments.

Moreover, the collaboration's focus on developing up to four additional CAR-T cell therapy candidates highlights the commitment to expanding the range of treatable cancers. The success of these therapies in clinical trials could revolutionize the treatment landscape for hematologic malignancies and solid tumors, potentially leading to improved survival rates and quality of life for patients. The medical community will be closely monitoring the clinical data generated from these trials, as they could set new standards for CAR-T cell therapies.

This collaboration represents a strategic alignment within the biotechnology sector, combining AbbVie's extensive experience in oncology drug development and commercialization with Umoja's cutting-edge gene delivery technology. The focus on in-situ generated CAR-T cell therapy candidates could position both companies at the forefront of a new wave of genetic medicine. By leveraging Umoja's proprietary platform, AbbVie may accelerate the development of next-generation therapies and potentially expand the indications for CAR-T treatment beyond what is currently possible with conventional methods.

It is crucial to understand the competitive landscape of the CAR-T space, where several major players are vying for market share. The success of this collaboration could disrupt the current market dynamics, as the VivoVecTM platform may offer a differentiated and potentially superior approach. The biotechnology industry often sees increased investor interest and valuation premiums for companies that bring forth disruptive technologies, especially when partnered with established pharmaceutical firms like AbbVie. As such, this partnership could significantly influence investor sentiment and market trends within the biotech sector.

  • Collaboration to leverage Umoja's VivoVecTM gene delivery platform and AbbVie's expertise in oncology to develop in-situ generated chimeric antigen receptor (CAR)-T cell therapy candidates

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 VivoVecTM 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 VivoVecTM 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, FacebookInstagramX (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 VivoVecTM 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.

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SOURCE AbbVie

FAQ

What collaboration was announced by AbbVie and Umoja Biopharma?

AbbVie and Umoja Biopharma announced two exclusive option and license agreements to develop in-situ generated CAR-T cell therapy candidates in oncology using Umoja's proprietary VivoVecTM platform.

What is Umoja's lead clinical program for hematologic malignancies?

Umoja's lead clinical program for hematologic malignancies is UB-VV111, currently at the IND-enabling phase.

What is the potential financial benefit for Umoja from the collaboration?

Umoja received upfront payments and an equity investment from AbbVie and may be eligible to receive up to $1.44B in aggregate for option exercise fees, development and regulatory milestones, and additional sales-based milestones and tiered royalties on worldwide net sales.

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About ABBV

AbbVie Inc. is a pharmaceutical company headquartered in North Chicago, Illinois. It is ranked 6th on the list of largest biomedical companies by revenue. Their primary product is Humira (adalimumab) ($21 billion in 2022 revenues, 37% of total), administered via injection. It is approved to treat autoimmune diseases including rheumatoid arthritis, Crohns disease, plaque psoriasis, and ulcerative colitis.