Adaptimmune and Galapagos Sign Clinical Collaboration Agreement with an Option to Exclusively License Adaptimmune's TCR T-cell Therapy Candidate, uza-cel, in Head & Neck Cancer and Potential Future Solid Tumor Indications

Rhea-AI Summary

Adaptimmune and Galapagos have entered a clinical collaboration to evaluate Adaptimmune's TCR T-cell therapy candidate, uza-cel, in head & neck cancer. The trial aims to leverage Galapagos' decentralized manufacturing platform to improve efficacy and durability. Initial trials showed an 80% response rate with partial responses in four out of five patients. Adaptimmune will receive $70M upfront, $30M in R&D funding, and potentially up to $465M in milestone payments, with additional tiered royalties. Galapagos has an option to license uza-cel for global development and commercialization.

Positive

• Adaptimmune will receive an initial payment of $70 million upfront.
• Additional $30 million in R&D funding secured.
• Potential milestone payments up to $465 million.
• Uza-cel showed an 80% response rate in initial trials.
• Partnership leverages Galapagos' decentralized manufacturing for better efficacy.
• Galapagos has the option to license uza-cel for global development.

Negative

• Potential risk if milestones and development targets are not met.
• Dependency on successful trial outcomes for further funding.
• Financial burden on Adaptimmune to conduct clinical proof-of-concept trial.

Financial Analyst

Financial Overview: Adaptimmune's agreement with Galapagos provides a notable $100 million initial payment (including $70 million upfront and $30 million in R&D funding). Such an infusion is significant for Adaptimmune's liquidity and R&D capabilities. Additionally, the deal includes potential milestone payments up to $465 million, which could greatly impact revenue streams if the product advances successfully. Earnings: The milestone structure, including tiered royalties, offers long-term revenue prospects, but investors must consider the risks associated with developmental milestones and regulatory approvals. Valuation: For Galapagos, the deal supports their expansion into oncology, potentially enhancing their valuation by diversifying their product pipeline. Investors should weigh the upfront costs against future revenue potential.

Medical Research Analyst

Clinical Implications: The collaboration focuses on developing uza-cel using Galapagos' decentralized manufacturing platform. Preliminary data from the Phase 1 SURPASS trial shows an 80% response rate in head & neck cancer, which is promising. However, it's essential to consider that these are early-phase results and efficacy in a larger population is yet to be proven. Innovation: The decentralized manufacturing platform aims to reduce vein-to-vein time to seven days, which could be important for timely treatments. This approach may enhance patient outcomes by providing fresher and potentially more effective T-cells. Broader Impact: If successful, this collaboration could pave the way for quicker access to advanced therapies in oncology.

Market Research Analyst

Market Position: Adaptimmune's partnership with Galapagos strategically positions both companies to address unmet needs in oncology, specifically head & neck cancer. Market Potential: Head & neck cancer represents a market with significant unmet needs and the next-generation TCR T-cell therapy targeting MAGE-A4 could capture substantial market share if proven effective. Competitive Landscape: The success of this collaboration could set a precedent in the cell therapy market, enhancing both companies' competitive edges. However, competition from other advanced therapies remains a critical factor to monitor.

• Adaptimmune and Galapagos to conduct clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next-generation MAGE-A4 TCR T-cell therapy) produced on Galapagos' decentralized manufacturing platform in patients with head & neck cancer
• Uza-cel has shown encouraging results in head & neck cancer with partial responses in four out of five patients to date in a Phase 1 trial using Adaptimmune's centralized manufacturing platform
• Initial in vitro testing of uza-cel produced on Galapagos' decentralized manufacturing platform has shown encouraging data that support further clinical development
• Adaptimmune to receive initial payments of $100 million, comprising $70 million upfront and $30 million of R&D funding, option exercise fees of up to $100 million, additional development and sales milestone payments of up to a maximum of $465 million, plus tiered royalties on net sales
• Galapagos has been granted an option to exclusively license uza-cel for global development and commercialization in head & neck cancer, and potential future solid tumor cancer indications

Adaptimmune will hold a conference call tomorrow (May 31^st) at 8 a.m. EDT
(webcast link here and more details below)

Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - May 30, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), and Galapagos NV (NA: GLPG) (NASDAQ: GLPG) announced today that they have entered into a clinical collaboration agreement with an option to exclusively license Adaptimmune's next-generation TCR T-cell therapy (uza-cel) targeting MAGE-A4 for head & neck cancer and potential future solid tumor indications, using Galapagos' decentralized cell manufacturing platform.

Uza-cel is a next-generation clinical-stage engineered TCR T-cell therapy developed by Adaptimmune, targeting the MAGE-A4 cancer antigen expressed in various solid tumors. Uza-cel is engineered to express the CD8α co-receptor alongside the engineered TCR that targets MAGE-A4. Data indicate that co-expression of CD8α may broaden and increase the immune response against solid tumors.¹

The Adaptimmune sponsored Phase 1 SURPASS trial with centrally manufactured uza-cel has shown encouraging results in head & neck cancer with an overall response rate of 80%. Initial in vitro results suggest that uza-cel, produced on Galapagos' decentralized manufacturing platform, yields early phenotype T-cells that could improve efficacy and durability compared to uza-cel centrally manufactured on Adaptimmune's platform.² In addition, Galapagos' decentralized manufacturing platform offers the potential for the delivery of fresh, fit cells with a vein-to-vein time of seven days in a patient population in which rapid access to treatment is vital.

Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: "Data with uza-cel from our Phase 1 SURPASS trial has demonstrated compelling early results in ovarian, bladder, and head & neck cancers. In head & neck cancer, we have seen reductions in target lesions across all five patients treated to date, and there have been four confirmed partial responses. Combining uza-cel with Galapagos' unique decentralized manufacturing platform is a natural synergy and has the potential to deliver an even more effective TCR T-cell therapy for people with critical late-stage cancers."

Dr. Paul Stoffels³, Galapagos' Chief Executive Officer and Chairman: "We are excited to partner with Adaptimmune, a pioneer in TCR T-cell therapy, as this fully aligns with our strategic vision to advance novel cell therapies. This collaboration enables us to expand our oncology cell therapy portfolio to include treatments for solid tumors and next-generation therapies, leveraging our innovative, decentralized cell therapy manufacturing platform. For patients with head & neck cancer, an area with significant unmet medical needs, this collaboration offers the promise for faster access to a potentially transformative treatment."

Under the terms of the agreement, Adaptimmune will receive an upfront exclusivity payment of $70 million, plus $15 million in R&D funding at signing. A further $15 million in R&D funding will follow subject to the start of dosing in the proof-of-concept trial. Adaptimmune will be responsible for the clinical proof-of-concept trial in head & neck cancer and the supply of the vector for the manufacturing of uza-cel. Galapagos will be responsible for the delivery of fresh uza-cel product for the head & neck cancer proof-of-concept trial using its innovative, decentralized cell therapy manufacturing platform.

Adaptimmune will retain the right to develop, manufacture, commercialize, and otherwise exploit uza-cel for platinum-resistant ovarian cancer (currently being developed in the SURPASS-3 trial).

Following completion of the proof-of-concept trial, Galapagos has an exclusive option to license global rights to uza-cel for a maximum of $100 million, depending on the number of indications in relation to which the option is exercised. In addition, Adaptimmune is eligible to receive development, regulatory and sales milestone payments of up $465 million, unless the agreement is terminated, and tiered royalties on net sales in the mid-single to low-double digit range.

Conference call / webcast details - 8 a.m. EDT May 31^st

A live webcast and replay can be accessed at https://www.gowebcasting.com/13364 . Call in information is as follows: 1-844-763-8274 (US or Canada) or +1-647-484-8814. Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

About Galapagos' T-cell manufacturing platform

Galapagos' decentralized, innovative T-cell manufacturing platform has the potential for the administration of fresh, fit cells within a median vein-to-vein time of seven days, greater physician control and improved patient experience. The platform consists of an end-to-end xCellit™ workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza's Cocoon®) and a proprietary quality control testing and release strategy.

About Galapagos

We are a biotechnology company with operations in Europe and the US dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit www.glpg.com or follow us on LinkedIn or X (formerly Twitter).

About Adaptimmune

Adaptimmune is a clinical-stage biopharmaceutical company focused on designing, developing, and delivering cell therapies to transform the lives of people with cancer. The Company's unique engineered T-cell receptor (TCR) platform enables the engineering of T-cells to target and destroy cancers across multiple solid tumor types.

Forward-looking statement

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended 31 December, 2023, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

Adaptimmune Contacts

Investor Relations
Juli P. Miller, Ph.D. - VP, Corporate Affairs and Investor Relations
M : +1 215 460 8920
Juli.Miller@adaptimmune.com

Media Relations
Dana Lynch, Senior Director of Corporate Communications
M: +1 267 990 1217
Dana.Lynch@adaptimmune.com

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¹ Poster presentation ESMO 2021: Safety and efficacy from the SURPASS trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating a CD8α co-receptor and an affinity optimized TCR targeting MAGE-A4, Annals of Oncology, vol. 32, suppl. 5, pp. S604-S605. Poster presentation SITC 2021: Enhancement of TCR-engineered T-cells targeting MAGE-A4 antigen by co-expression of CD8α and inhibition of AKT signaling during ex vivo T-cell expansion. SITC Annual Meeting. Nov. 10-14, 2021. Washington, DC and virtual. Emily Schmidt, PhD, et al.

² Data on file

³ Throughout this press release, 'Dr. Paul Stoffels' should be read as 'Dr. Paul Stoffels, acting via Stoffels IMC BV'

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/211023

FAQ

What companies are involved in the clinical collaboration for uza-cel?

Adaptimmune and Galapagos are collaborating on the clinical trial for uza-cel.

What is the financial arrangement of the Adaptimmune and Galapagos collaboration?

Adaptimmune will receive $70M upfront, $30M in R&D funding, up to $465M in milestone payments, and tiered royalties.

How effective is uza-cel in treating head & neck cancer?

Initial trials show an 80% response rate with partial responses in four out of five patients.

What is the significance of Galapagos' decentralized manufacturing platform?

The decentralized manufacturing platform may improve the efficacy and durability of uza-cel by delivering fresh, fit cells with rapid access to treatment.

What future potential does uza-cel have?

Uza-cel has potential for treating head & neck cancer and other solid tumor indications.

What are the possible financial outcomes for Adaptimmune in this collaboration?

Adaptimmune could earn up to $465M in milestone payments and tiered royalties based on net sales.