On October 20, 2022 Alligator Bioscience AB (Nasdaq Stockholm: ATORX) (Press release, Alligator Bioscience, OCT 20, 2022, View Source [SID1234622208])

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Alligator Continues Progress in Key Clinical Programs

"The Alligator team has worked with dedication through the last months to continue to deliver on our commitment to develop meaningful therapies for patients with hard-to-treat cancer, while creating value for our stakeholders and shareholders. We have announced promising clinical results and achieved clear progress across our development programs. Our OPTIMIZE-1 Phase 2 study with our lead asset mitazalimab has seen a significant acceleration in patient recruitment allowing us to bring the top-line read-out forward by nine months. We announced the successful conclusion of the Phase 1 study in our second candidate ATOR-1017, confirming previously announced signs of clinical benefit. We are now looking for a partner to embark on the next phase of its development. Moreover, we are moving towards a new Phase 1 study in the US having received IND approval by the FDA for ALG.APV-527, which we are co-developing with Aptevo Therapeutics. This positive momentum puts us in a strong position to achieve our next milestones in the months ahead."
Søren Bregenholt, CEO Alligator Bioscience AB

BUSINESS UPDATE

Clinical Pipeline:
Mitazalimab

On September 14, Alligator announced the presentation of additional data from the Phase 1b dose escalation of the OPTIMIZE-1 study, which confirmed the pharmacological activity of mitazalimab in combination with mFOLFIRINOX and was found to be safe and well tolerated.
Patient enrolment for Phase 2 is ongoing at sites in Europe and has experienced a significant acceleration. Top-line data is now due in Q1 2024, nine months sooner than originally anticipated with the primary endpoint to show efficacy in patients with pancreatic cancer as per Response Evaluation Criteria in Solid Tumors (RECIST)-defined overall response rate (ORR).
Interim efficacy read-out expected in Q4 2022, which will be used to optimize the design of the upcoming OPTIMIZE-2 clinical trial.
ATOR-1017

On September 30, Alligator announced positive safety data from the 900 mg dose cohort in the ATOR-1017 Phase 1 dose escalation study in patients with advanced solid malignancies. Stable disease as best tumor response reconfirms previously reported signs of clinical benefit. This Phase 1 study is fully enrolled and has successfully fulfilled its purpose. Alligator will now seek a partner to support the continued clinical development of ATOR-1017.
ALG.APV-527

On September 19, Alligator and Aptevo Therapeutics announced that the US Food and Drug Administration (FDA) had issued a "may proceed" notification for the ALG.APV-527 investigational new drug application (IND), and the companies are now moving towards initiating a multi-center Phase 1 trial in the US.

Corporate:

As a testament to Alligator’s CD40 expertise, senior staff from the company were invited to present at various prestige medical and scientific conferences, including the World Bispecific Summit in Boston and Immuno UK in London.
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a conference call today at 3:00 p.m. CET for investors, analysts and media, where CEO Søren Bregenholt and CFO Marie Svensson will present and comment on the Q3 interim report, which will be followed by a Q&A session. The call will be held in English. All necessary information to listen-in is available on the following link: View Source

The information was submitted for publication, through the agency of the contact person set out below, at 08:00 a.m. CET on October 20, 2022.