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Special Report: AdAlta is strengthening the leadership teams of its AdCella and AdSolis subsidiaries with the appointments of two well credentialled chief medical officers to meet the expected increase in clinical activity.
AdAlta (ASX:1AD) has appointed Kevin Lynch as the consultant chief medical officer (CMO) for AdCella while a yet unnamed consultant CMO with more than 30 years’ experience in respiratory and orphan drug development has been appointed to AdSolis.
Earlier this month, the company formed a clinical advisory board and appointed an additional adviser to advance its lead asset AD-214, which is domiciled under AdSolis.
1AD said the collective expertise and global reach of the healthcare professionals on the CAB would be crucial in guiding AD-214’s Phase 2 clinical trial preparations and ensuring its success.
The company also collaborated with venture capital firm SYNthesis BioVentures Fund to establish AdCella during Q4 FY24 to facilitate entry of innovative cellular immunotherapies from Asia into Western regulated markets by leveraging its i-body technology.
1AD said the appointments were the latest important steps towards expanding its clinical pipeline and executing its AdSolis and AdCella strategies.
Dr Lynch has 30 years’ experience across all stages of clinical development, regulatory and reimbursement approvals and post-registration medical activities.
He has contributed to multiple transformational therapies in haematology/oncology at both early- to late-stage therapies, including imatinib, nilotinib, lenalidomide and pomalidomide.
He has also led high level regulatory interactions in Australia (including for cell therapies), China, South Korea, Singapore, Europe, and other markets.
Importantly, Dr Lynch provided senior input into multiple interactions with the US Food & Drug Administration.
1AD said he co-founded PopulusBio, a company focused on accelerating the development of therapies for people with debilitating diseases.
As the consultant CMO of AdCella, he will help support the selection of in-licensed cellular immunotherapies and the design and execution of Phase 1 clinical trials by AdCella.
Meanwhile, the new unnamed consultant CMO of AdSolis will formally start in 2025 and provide strategic oversight for the clinical development of AD-214.
They will also lead execution of its anticipated Phase 2 clinical trials for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
1AD said the new appointment would also bring to the role more than 30 years’ experience as a board certified and practising pulmonary physician including faculty appointments at Stanford University, Johns Hopkins and Washington University School of Medicine.
Their experience included more than 20 years of clinical development, regulatory and medical affairs work, almost exclusively in respiratory and/or orphan diseases.
They also held leadership roles supporting approval, post-approval and indication extension clinical studies and medical affairs for both currently marketed drugs for IPF.
The appointment of Dr Lynch comes on the heels of the company signing a non-binding term sheet with a Chinese company in respect of a CAR-T cell therapy product that has demonstrated safety and potential efficacy in small clinical trials in advanced gastric cancers.
It also has potential application in other gastro-intestinal cancers.
The non-binding term sheet sets out the proposed financial terms under which AdCella would license the product subject to assumptions being tested during a detailed due diligence period and several other conditions being met.
Additional non-binding term sheets are expected to be executed during the current quarter.
Separately, 1AD expects to receive financing inflows of up to $1.07m during the quarter from the Australian R&D Tax Incentive rebate and existing investment facilities net of repayment of the Victorian Government R&D Cash Flow Loan Facility.
This will add to the cash in bank of $1.91m as at the end of September.
This article was developed in collaboration with AdAlta, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.