On July 19, 2021 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) reported that it has entered into an exclusive, worldwide licensing agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to in-license the late stage monoclonal antibody candidate, suvratoxumab (Press release, Aridis Pharmaceuticals, JUL 19, 2021, View Source [SID1234584941]).
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The highlights of the agreement are:
Phase 3-ready candidate. Suvratoxumab monoclonal antibody (mAb) for prevention of pneumonia has been licensed from AstraZeneca. Suvratoxumab extends Aridis’ pneumonia franchise by complementing the existing AR-301 Phase 3 pneumonia treatment program.
Lancet ID publication. Phase 2 data involving n=196 patients recently published in The Lancet Infectious Diseases journal showed safety and a statistically significant (47%) relative reduction of pneumonia in S. aureus colonized, mechanically ventilated patients less than 65 years old, with corresponding reduction in the number of days needed in the ICU and hospital.i
Up to €25 million Euros funding (approximately $30 million). EU Commission’s Innovative Medicines Initiatives (IMI) funding for suvratoxumab Phase 3 clinical trial
AstraZeneca’s equity stake in Aridis. AstraZeneca becomes a shareholder of Aridis through the issuance of common stock and has right of first negotiation for future licensing of suvratoxumab.
Monoclonal
Antibody
Targeting
Disease
Development
Status
Next
Milestone
suvratoxumab or
‘AR-320’
Staphylococcus
aureus alpha
toxin
S. aureus colonized
patients at high risk
of developing
pneumonia
Phase 2
completed
Phase 3
launch
4Q-2021
Deal Highlights
Aridis acquires global exclusive rights for development and commercialization of
suvratoxumab for all indications
AstraZeneca retains rights of first negotiation for future licensing
Aridis will make an upfront payment to AstraZeneca of $11m in cash and Aridis common
stock. AstraZeneca will also receive up to a further $115m on achievement of certain
development and sales-related milestones, in addition to tiered royalties on net sales
Up to €25 million Euros (approximately $30m) from EU Commission’s Innovative Medicines
Initiative (IMI) COMBACTE clinical trial consortium for the Phase 3 trial for suvratoxumab
Development Overview: Suvratoxumab Phase 3 Clinical Study
Suvratoxumab and AR-301 are complementary products. Suvratoxumab’s focus on preventive treatment of S. aureus pneumonia complements Aridis’ AR-301 Phase 3 mAb program which is being developed as a therapeutic treatment of S. aureus pneumonia.
A multinational, randomized, double blinded, placebo controlled Phase 2 study (n=196 patients) showed that mechanically ventilated ICU patients colonized with S. aureus who are treated with suvratoxumab saw a relative risk reduction of pneumonia by 32% in the overall intend to treat (ITT) study population, and by 47% in the under 65 year old population, which is the target population in the planned Phase 3 study. The relative risk reduction in the target population reached statistical significance, and was also associated with a substantial reduction in the duration of care needed in the ICU and hospital.i [see https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30995-6/fulltext]
Aridis believes that suvratoxumab (product code name ‘AR-320’) will be first-line treatment, first to market, first-in-class pre-emptive treatment of S. aureus colonized patients. The same first-line, first to market and first-in-class strategy applies to the acute treatment with the monoclonal antibody AR-301 which the Company believes makes Aridis a globally dominant leader in this space.
Aridis comments
"We are pleased to have been selected as AstraZeneca’s licensee. The strong data from the Phase 2 trial gives us an advantage to define the patient population, primary endpoint, and the Phase 3 clinical study design to support a clear path to the Phase 3 confirmatory trial," said Vu Truong, Ph.D., Aridis’ Chief Executive Officer.
"We intend to efficiently leverage our collaboration with the globally renowned HAP/VAP experts in the EU Commission’s Innovative Medicines Initiative (IMI) COMBACTE consortium and our global network of existing clinical sites to launch the Phase 3 study for AR-320 in the 4th quarter this year," said Hasan Jafri, M.D., Aridis’ Chief Medical Officer. "We are delighted that this Phase 3-ready candidate is supported by IMI through the COMBACTE consortium and are excited to demonstrate the potential for suvratoxumab to fulfill an unmet medical need in a highly vulnerable and high-risk population, while also offering substantial pharmacoeconomic benefits," said Dr. Jafri.
AstraZeneca comments
Mark Esser, Vice President, Microbial Sciences, BioPharmaceuticals R&D, AstraZeneca said: "Suvratoxumab has the potential to transform pulmonary infection management in ventilated patients. We are pleased to complete this licensing deal with Aridis who we believe are well placed to take suvratoxumab forward."
IMI’s COMBACTE consortium comments
"On behalf of IMI’s COMBACTE consortium, I would like to express our continued support and strong enthusiasm for suvratoxumab," said Dr. Marc JM Bonten, MD/PhD, Managing Entity and Scientific and Academic coordinator of COMBACTE (University Medical Center, Utrecht). "We plan to leverage the consortium’s vast network of clinical sites and principal investigators across Europe to facilitate the execution of this important Phase 3 study to its timely completion," said Dr. Bonten.
Dr. Bruno Francois, a world renowned VAP expert and the Academic COMBACTE Lead for the Phase 3 study (University Hospital of Limoges) further added, "After the very promising SAATELLITE phase 2 trial, starting this phase 3 is very exciting as it could bring a new class of molecules to treat severe bacterial infections, to patients. The COVID pandemic has highlighted the importance of having therapeutic options to address emerging infectious threats and antimicrobial resistance (AMR) remains a serious threat. In this context, the AR-320 study is very timely. Lastly, the public-private partnership approach which made the phase 2 study successful, will undoubtedly be one of the major strengths of the coming phase 3 study."
About suvratoxumab (‘AR-320’)
Suvratoxumab (also referred to as MEDI4893) is a fully human, half-life extended IgG1 monoclonal antibody targeting S. aureus alpha toxin. Alpha-toxin is a key virulence factor that is secreted by both methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA). It is believed that AR-320 protects against alpha-toxin mediated destruction of host cells, preserving the human immune cells. AR-320’s mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA and MSSA.
About IMI’s COMBACTE Consortium
The European Commission’s Innovative Medicines Initiative (IMI) is the world’s biggest public-private partnership in the life sciences, whose goal is to develop next generation vaccines, medicines and treatments, such as new antibiotics [see View Source The IMI-funded COMBACTE project aims to give antibiotic drug development a much-needed boost by pioneering new ways of designing and implementing efficient clinical trials for novel antibiotics. COMBACTE forms part of the New Drugs for Bad Bugs (ND4BB) initiative, IMI’s wider program to tackle AMR. The COMBACTE consortium comprises a large network of over 1,000 hospitals in Europe that are potential clinical sites for clinical trial conduction [see View Source