Telix Pharmaceuticals Announces Licensing Agreement with Lilly for Olaratumab

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Melbourne, Australia and INDIANAPOLIS, April 10, 2022 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, “Telix”, the “Company”) today announces that it has entered into a licensing agreement with Eli Lilly and Company (“Lilly”) pursuant to which Telix is granted exclusive worldwide rights to develop and commercialize radiolabeled forms of Lilly’s olaratumab antibody for the diagnosis and treatment of human cancers. Telix’s initial development will focus on a rare type of cancer known as soft tissue sarcoma (STS).

Olaratumab was originally developed by Lilly as a monoclonal (non-radiolabelled) antibody targeting platelet-derived growth factor receptor alpha (PDGFRα). PDGFRα is expressed in several tumor types, including STS. STS is generally a radiation-sensitive cancer that may be inherently amenable to systemic radionuclide therapy, and olaratumab’s ability to target PDGFRα makes it a very novel and potentially exciting candidate for use as a drug-targeting agent. radionuclides. The exclusive worldwide license will allow Telix to reuse olaratumab as a targeting agent for radiopharmaceutical imaging and cancer therapy. Olaratumab has an established safety profile that supports its potential use as a radionuclide targeting agent.

Material terms of the agreement
Under the terms of the agreement, Telix will pay Lilly an upfront payment of 5 million US dollars (~AU$6.7M) for the grant of an exclusive license to Lilly’s intellectual property related to the development of a radiolabeled olaratumab, as well as access to materials for use by Telix in early preclinical and phase clinical studies early in application to potential uses for the diagnosis and treatment of human cancers.

Lilly may be eligible up to 225 million US dollars (~A$301m) in payments based on the achievement of pre-defined development, regulatory and commercial milestones. Lilly would also be eligible to receive industry standard royalties on net sales. The agreement also includes an option for Lilly to obtain an exclusive license to a radiolabeled companion diagnostic to be developed by Telix. In case of exercise, Lilly will pay Telix 5 million US dollars (~ AU$6.7M) and up to 30 million US dollars (~A$40.1 million) in potential development milestones, plus industry-standard royalties.

The agreement has typical termination rights for breaches and related business issues. Telix retains termination rights typical of license agreements of this nature to allow the Company to exit the agreement on a development or commercial basis.

Rely on Telix’s experience in the acquisition and marketing of assets
CEO and Managing Director of Telix Group, Dr. Christian Behrenbruch said, “This in-licensing transaction with Lilly is a valuable – and rare – opportunity to acquire an asset that has demonstrated clinical safety. In our diligence and pre-transaction research, we identified that a radiolabeled version of olaratumab could be effective in patients with STS, especially since it is a highly radiation-sensitive cancer. The safety data generated by Lilly in connection with the initial development program significantly reduces the risks of the program for Telix. We anticipate that early clinical translation with a radiolabeled olaratumab as an imaging agent may also provide valuable clinical insights into whether this asset has potential therapeutic efficacy, demonstrating the benefit of Telix’s “theranostic” approach.

“This acquisition reflects the approach Telix has taken in building its existing pipeline by licensing or acquiring assets that have already been shown to be safe for use in humans and can be exploited as new This partnership also demonstrates the value that Telix can bring as a competent partner with its expertise in the development and manufacture of radiopharmaceuticals, to help redirect or expand the use of promising candidates to better target, detect and treat cancer.

On Soft tissue sarcoma (STS)
Soft tissue sarcoma is a complex disease that encompasses a diverse group of relatively rare cancers, with more than 50 histological subtypes. In United Statesan estimated 13,040 new cases and 5,150 deaths were caused by STS in 2019, representing 0.75% of overall cancer incidence and 0.84% ​​of overall cancer mortality.1 In Europenearly 23,600 new cases of STS increased each year, and the crude incidence rate was 4.7 per 100,000.2 Approximately 39,900 new cases of STS occurred nationwide in China in 2019, representing 1.05% of the overall cancer incidence.3 The crude incidence rate was 2.91/100,000 and generally increased with age. Standard treatment for soft tissue sarcoma includes surgery, radiation therapy, and/or chemotherapy. For patients with advanced, unresectable, or metastatic disease, treatment usually involves chemotherapy with single agents (eg, doxorubicin) or anthracycline-based combination regimens. However, the prognosis for these patients remains poor, with treated patients with metastatic disease having a median overall survival of approximately 12 to 18 months.

About olaratumab
Olaratumab (previously sold under the brand name Lartruvo®) was originally developed as a monoclonal antibody targeting PDGFRα. Olaratumab was granted “accelerated approval” in the US and “conditional approval” in the EU based on Phase 2 trial data that showed a 1-year survival benefit in patients with of STS, when given in combination with standard chemotherapy. Olaratumab was voluntarily withdrawn from the market by Lilly following the failure of the Phase 3 ANNOUNCE clinical trial, in which olaratumab did not improve patient survival.

On Telix Pharmaceuticals Limited
Telix is ​​a biopharmaceutical company specializing in the development and marketing of diagnostic and therapeutic products using targeted molecular radiation (MTR). Telix is ​​headquartered in Melbourne, Australia with international operations in Belgium, Japan, Swissand United States. Telix is ​​developing a portfolio of clinical-stage products that address significant unmet medical needs in oncology and rare diseases. Telix is ​​listed on the Australian Securities Exchange (ASX: TLX). For more information, visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix flagship product, Illuccix® (gallium-68 preparation kit (68Ga) gozetotide (also called 68Ga PSMA-11) injection) for prostate cancer imaging, has been approved by the United States Food and Drug Administration (FDA),4 and by the Australian Therapeutic Goods Administration (TGA).5 Telix is ​​also pursuing marketing authorization applications for this experimental candidate in Europe6 and Canada.7

This announcement has been authorized for publication by Dr. Christian BehrenbruchManaging Director and Group Chief Executive.

Legal Notice

This announcement may include forward-looking statements relating to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “outlook”, “forecast” and “guidance”, or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed. or implied by these forward-looking statements. research statements. Forward-looking statements are based on the Company’s good faith assumptions about existing financial, market, regulatory and other considerations that affect the Company’s business and operations in the future, and there can be no assurance that the any of the assumptions will turn out to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements regarding: the initiation, timing, progress and results of Telix’s preclinical and clinical studies, and Telix’s research and development of Telix; Telix’s ability to advance product candidates, enroll in and complete clinical studies, including multinational clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialization of Telix’s product candidates, if or when they have been approved; estimates of Telix’s expenses, future revenues and capital requirements; the financial performance of Telix; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. The actual results, performance or achievements of Telix may differ materially from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

To the fullest extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions.

The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its subsidiaries (all rights reserved).

1 American cancer society 2020.
2 RARECAR project 2013.
3 Yang et al. Cancer Biol Med. 2019.
4 ASX disclosure December 20, 2021.
5 ASX disclosure November 2, 2021.
6 ASX disclosure December 10, 2021.
7 ASX Disclosure December 16, 2020.

SOURCE Telix Pharmaceuticals Limited

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