HUTCHMED Announces that Inmagene Exercises Option to License Two Drug Candidates as Part of Strategic Partnership
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The licensing of drug candidates IMG-007 and IMG-004 by Inmagene represents a strategic milestone for HUTCHMED that could potentially enhance its financial position. The agreement structure includes milestone payments of up to US$92.5 million for development and US$135 million for commercialization, in addition to royalties upon commercialization. These figures are substantial and could provide significant revenue streams over time if the candidates progress successfully through clinical development and onto the market.
Investors should note that such deals are common in the biopharmaceutical industry and serve as a risk-sharing mechanism. They allow the innovator company to benefit from the expertise and resources of a partner while retaining a stake in the future success of the product. The receipt of approximately 7.5% of shares in Inmagene by HUTCHMED not only represents an immediate equity interest but also aligns the interests of both companies towards the successful development of the drugs.
However, the inherent risk of drug development, particularly in the volatile field of immunological diseases, should be considered. While the potential for high returns is significant, the timeline for such returns is typically long-term and subject to the successful navigation of clinical trials and regulatory approvals.
The advancement of IMG-007 and IMG-004 into clinical development underscores the importance of novel treatments in the field of immunological diseases. IMG-007, an OX40 antagonistic monoclonal antibody (mAb) and IMG-004, a reversible, non-covalent, highly selective oral BTK inhibitor, represent innovative approaches to treating conditions like atopic dermatitis and alopecia areata.
OX40 is a costimulatory molecule that plays a role in the activation and survival of T cells, which are implicated in various autoimmune and inflammatory diseases. By antagonizing OX40, IMG-007 may reduce the pathological immune response. On the other hand, BTK inhibitors like IMG-004 are designed to interrupt signaling pathways that are crucial for the proliferation and survival of certain immune cells, potentially reducing inflammation and autoimmunity.
The initiation of global Phase IIa clinical trials for IMG-007 and the completion of a Phase I study for IMG-004 indicate progress but also highlight the early stage of these assets. The path from Phase IIa to commercialization is fraught with challenges, including demonstrating safety and efficacy in a larger patient population, which is critical for regulatory approval and market acceptance.
The licensing agreement between HUTCHMED and Inmagene could have broader implications for the market landscape of immunological disease treatments. As the prevalence of diseases like atopic dermatitis and alopecia areata increases globally, the demand for more effective and targeted therapies grows correspondingly.
Entering into strategic partnerships and licensing agreements is a key trend among biopharmaceutical companies aiming to expand their pipelines and leverage external R&D capabilities. The success of such collaborations can influence investment trends and competitive dynamics within the industry. For stakeholders, the potential commercialization of IMG-007 and IMG-004 could mean the introduction of new treatment options that may improve patient outcomes and capture market share from existing treatments.
It is also important to consider the competitive landscape. The presence of other monoclonal antibodies and BTK inhibitors in the market or in development can impact the potential success of IMG-007 and IMG-004. The ability of these drugs to differentiate themselves in terms of efficacy, safety and cost will be crucial for their market performance.
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announced that, Inmagene Biopharmaceuticals (“Inmagene”) has exercised options to license two drug candidates discovered by HUTCHMED, IMG-007 and IMG-004 (the “Options”) pursuant to the terms of the strategic partnership announced on January 11, 2021. Following the exercise of the Options and subject to receipt by HUTCHMED of ordinary shares representing approximately
As part of the partnership, HUTCHMED granted Inmagene exclusive options to multiple drug candidates solely for the treatment of immunological diseases. Since the execution of the Option agreement, Inmagene has funded and led two of these candidates, IMG-004 and IMG-007, to clinical development. For each of the drug candidates, IMG-004 and IMG-007, HUTCHMED is entitled to receive potential payments subject to the achievement of development milestones of up to US
In 2023, Inmagene initiated two global Phase IIa clinical trials in adults with moderate-to-severe atopic dermatitis and in adults with alopecia areata, with the investigational OX40 antagonistic monoclonal antibody (mAb) IMG-007. It also completed a Phase I single ascending dose (SAD) study of IMG-004, a reversible, non-covalent, highly selective oral BTK inhibitor designed to target immunological diseases.
Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: “This is an important step for the progress of these two drug candidates in immunological diseases and demonstrates the potential of the candidates discovered by HUTCHMED. The success of this strategic partnership provides further validation of HUTCHMED’s in-house R&D engine and our collaborative approach to developing some of our innovative drug candidates. We look forward to continuing our partnership with Inmagene and seeing the impact these drug candidates could have for patients with immunological diseases.”
About Inmagene
Inmagene is a global clinical-stage biotechnology company developing novel therapeutics for immunological and inflammatory diseases. The company’s highly differentiated clinical-stage pipeline has multiple candidates with best-in-class potential. The lead asset IMG-007, a non-depleting anti-OX40 mAb, is in two global Phase IIa clinical trials in atopic dermatitis and alopecia areata. IMG-004, a non-covalent reversible BTK inhibitor is in a Phase I multiple ascending dose (MAD) study. IMG-008, an in-house developed long-acting anti-IL-36R mAb is entering global Phase I clinical development.
For more information, please visit www.inmagenebio.com.
About IMG-007
IMG-007 is a humanized anti-OX40 IgG1 mAb, with an elongated half-life and silenced antibody-dependent cell-mediated cytotoxicity (ADCC) function. OX40-OX40L axis is important in T cell activation, expansion, and survival, thereby having an important role in the pathogenesis of a spectrum of immunological and inflammatory diseases. In nonclinical studies, IMG-007 demonstrated the ability to selectively and potently block the signaling between OX40 and OX40L. Phase I SAD data suggests a 31-day half-life at anticipated therapeutic dose levels, enabling the potential for once every 12 weeks (Q12W) dosing, and a favorable safety profile without any pyrexia and chills, differentiating from similar molecules in development. It is being evaluated for the treatment of moderate-to-severe atopic dermatitis and alopecia areata in two Phase IIa studies.
About IMG-004
Designed specifically for inflammatory and autoimmune diseases that usually require long-term treatment, IMG-004 is a reversible, non-covalent, potent, highly selective and brain permeable oral agent. Phase I SAD study results suggest a long half-life and durable pharmacodynamics (PD) effect, enabling the potential for once-daily (QD) dosing. Following the ongoing Phase I MAD study, IMG-004 will be evaluated in chronic spontaneous urticaria (CSU) and rheumatoid arthritis (RA).
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of IMG-004 and IMG-007, the further clinical development for IMG-004 and IMG-007, its expectations as to whether any studies on IMG-004 and IMG-007 would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support approval of IMG-004 and IMG-007 for the treatment of patients with atopic dermatitis or other indications in jurisdictions such as China, the U.S., the E.U. or Japan, the efficacy and safety profile of IMG-004 and IMG-007;Inmagene’s ability to fund, implement and complete its further clinical development and commercialization plans for IMG-004 and IMG-007; the timing of these events; Inmagene’s ability to satisfy the terms and conditions under the license agreement, assumptions regarding changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of IMG-004 and IMG-007, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of IMG-004 and IMG-007 for a targeted indication; the sufficiency of funding; Inmagene’s ability to successfully develop, manufacture and commercialize IMG-004 and IMG-007, and the impact of COVID-19 or other infectious diseases on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
CONTACTS
| Investor Enquiries | +852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com |
| Media Enquiries | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
FAQ
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