On August 25, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it will give status updates and details on the recent clinical development plans for the clinical drug candidates mitazalimab, ATOR-1015 and ATOR-1017 on a virtual R&D Day on August 27 (Press release, Alligator Bioscience, AUG 25, 2020, View Source [SID1234563992]).

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"These clinical plans provide an excellent opportunity for Alligator to have two or even three competitive cancer therapeutics in clinical efficacy studies by the end of 2021", commented Per Norlén, CEO of Alligator Bioscience.

Mitazalimab is Alligator’s most advanced immunotherapy candidate intended for the treatment of different types of cancer. It activates CD40, a receptor on the dendritic cells which allows the immune system to selectively attack the cancer.

Next step in the development of mitazalimab is the submission of a Phase II clinical trial application (CTA) which is planned for December 2020. The study (OPTIMIZE-1) is an open-label, multi-center trial assessing the clinical efficacy of mitazalimab in combination with chemotherapy (mFolfirinox) in patients with metastatic pancreatic cancer. The OPTIMIZE study will be performed at several clinics in Europe, with inclusion of the first patient H1 2021.

Clinical data previously communicated from mitazalimab’s Phase I development program demonstrated that mitazalimab is safe and tolerated at clinically relevant dose levels, with early signs of clinical activity identified, including a partial response in a patient with renal cell cancer and prolonged stable disease ≥6 months in 10 patients. There is still one patient in the Phase I study, now treated with mitazalimab for more than 30 months.

ATOR-1015, wholly owned by Alligator, is a tumor-localizing, bispecific CTLA-4 and OX40 antibody developed for treatment of metastatic cancer. The first indication will be skin cancer (malignant melanoma) where the target molecule CTLA-4 has been proven effective but associated with significant toxicity.

Promising data from the ongoing ATOR-1015 Phase I clinical trial was presented in June 2020 and dose escalation has continued at high doses. The positive tolerability profile of ATOR-1015 has led to the frontloading of a Phase Ib study for demonstration of single-agent activity. This allows for an efficacy readout as early as H2 2021 in malignant melanoma. This could significantly increase the value of the concept and will be followed by a Phase II combination study with anti-PD-1.

The interim data include doses up to 600 mg (about 10 mg/kg) and show that ATOR-1015 is well tolerated, thus supporting for the concept. Dose-escalation is currently at 750 mg (12.5 mg/kg). The drug related adverse events in the study have generally been mild and transient. No dose-limiting toxicity or severe immune-related adverse events have been reported.

ATOR-1017 is Alligator’s wholly owned 4-1BB antibody in clinical Phase I development for the treatment of metastatic cancer. ATOR-1017 activates 4-1BB receptors on T cells which increases the ability of the immune system to detect and kill tumor cells. ATOR-1017 has a unique profile which creates an opportunity for a strong and tumor-directed immune activation that can increase efficacy and reduce side effects for the patient.

The ongoing Phase I study is a dose escalation study in patients with advanced cancer. The study is conducted at three different clinics in Sweden and is planned to include up to 50 patients. The objectives of the study are to assess the safety and tolerability of ATOR-1017, to determine the recommended dose for the subsequent Phase II studies, but also to assess initial signs of efficacy.

A more detailed invitation to the R&D Day on August 27 will be distributed shortly.

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 11:00 a.m. CEST on August 25, 2020.

On August 24, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a poster presentation featuring Neo-STAT, the Company’s next generation Immuno-STAT (Selective Targeting and Alteration of T cells) scaffold, at the 16th Annual PEGS Boston Essential Protein Engineering & Cell Therapy Summit (Press release, Cue Biopharma, AUG 24, 2020, View Source [SID1234608298]). Neo-STAT biologics are designed for targeted modulation of tumor-specific T cells with enhanced antigen modularity.

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Presentation Details
Title: Neo-STAT: A new biologics platform for selective targeting of tumor-specific T cells with enhanced antigen modularity
Presenter: Ahmet S. Vakkasoglu, Ph.D., senior scientist
Date: August 31-September 4, 2020

The poster highlights the engineering of the Neo-STAT platform, a scaffold with pocket-stabilized, peptide-free HLA molecules that enables enhanced antigen modularity through exogenous peptide loading. Compared to first generation scaffolds, the design of Neo-STAT improves the productivity and efficiency of scaffold production. Additionally, Neo-STAT biologics can incorporate diverse T cell epitopes, including peptides bearing post-translational modifications, peptide mixtures and peptides derived from tumor neo-antigens, thereby broadening the flexibility and therapeutic impact of the Immuno-STAT platform to target a wider spectrum of disease-associated epitopes.

"We are pleased to be presenting the Neo-STAT platform, which was developed to allow for the generation of therapeutic molecules incorporating diverse T cell epitopes," said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. "The Neo-STAT platform enables us to access a wider range of therapeutically relevant epitopes, including near-term applications in cancer immunotherapy with shared as well as personalized tumor antigens. In addition to cancer immunotherapy, we are also assessing the potential applications of Neo-STAT in infectious diseases, particularly against novel pathogens where immediate T cell responses could provide protective immunity before other prophylactic vaccination approaches are developed."

About Immuno-STAT
Immuno-STAT biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

On August 24, 2020 Tentarix reported that it was launched with a $50 Million Series A Financing and will leverage the ITS HuTARG core protein engineering platform to create multispecific binding molecules based on fully human antibody variable domains (Vds) (Press release, Tentarix Biotherapeutics, AUG 24, 2020, View Source [SID1234570452]). Tentarix’s mission is to develop first-in-class multispecific therapies. The Company is focused on modalities that have tissue specific function and is building a team that aims to transform biologics.

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On August 24, 2020 Enlivex Therapeutics Ltd., a clinical-stage immunotherapy company, reported that the U.S. Patent and Trademark Office issued a notice of allowance for a new patent application covering ALLOCETRATM, the company’s immunotherapy product candidate (Press release, Enlivex Therapeutics, AUG 24, 2020, View Source [SID1234569021]). Upon issuance, the new patent will provide added intellectual property protection, including methods, uses and pharmaceutical compositions. The company expects that this new patent will be issued in the United States during the fourth quarter of 2020.

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ALLOCETRATM has been designed to provide a novel immunotherapy mechanism of action that targets life-threatening clinical indications that are defined as "unmet medical needs", including organ dysfunction and acute multiple organ failure associated with Sepsis and COVID-19, as well as treating solid tumors by modulating such tumors’ microenvironment.

On August 24, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported the Food and Drug Administration (FDA) granted a third Fast-Track designation to its lead drug candidate, repotrectinib (Press release, Turning Point Therapeutics, AUG 24, 2020, View Source [SID1234564367]).

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The designation was granted for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK tyrosine kinase inhibitors (TKIs) and have no satisfactory alternative treatments. Repotrectinib was previously granted two Fast Track designations for the treatment of ROS1-positive advanced non-small cell lung cancer patients, first for patients with one prior line of platinum-based chemotherapy and one prior ROS1 TKI, and second for patients without prior ROS1 TKI treatment. There are no approved targeted therapies for patients previously treated with another ROS1 or TRK TKI.

"We believe repotrectinib has the potential to make a meaningful difference in the lives of cancer patients with ROS1- or NTRK-driven tumors and are pleased to receive our third Fast-Track designation that may help expedite its development," said Athena Countouriotis, M.D., president and chief executive officer. "NTRK-driven cancers are estimated to occur in up to 50,000 patients annually, however there are currently no approved therapies for those patients previously treated with another TRK TKI."

Turning Point recently reported early interim data from its registrational Phase 2 TRIDENT-1 study of repotrectinib, showing a confirmed objective response rate of 50 percent (3/6) in the cohort of NTRK-positive TKI-pretreated advanced solid tumor patients. A total of 40 patients are planned for enrollment in this cohort, and the FDA recently provided guidance that 6 months of follow up from the last response in this cohort may be sufficient to support potential approval. Previous guidance was 12 months. This recent guidance and Fast-Track designation may provide a faster path to potential approval.

About Fast Track Designation
Fast Track is an FDA program intended to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need.

A drug candidate that receives Fast Track designation may be eligible for:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication with FDA;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met;
Rolling submission of a New Drug Application (NDA) for review by FDA.