Alligator Bioscience: ATOR-1017 pre-clinical data support a best-in-class 4-1BB antibody profile

On May 3, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that it will present pre-clinical data for the drug candidate ATOR-1017 at the Protein Engineering Summit (PEGS) 14th Annual Meeting in Boston, US (Press release, Alligator Bioscience, MAY 3, 2018, View Source [SID1234538678]). ATOR-1017 is a monoclonal antibody that activates the costimulatory receptor 4-1BB expressed on T cells in the tumor area and is being developed for the treatment of metastasizing cancer.

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The data support a best-in-class profile for ATOR-1017, with a strong potential for high efficacy and tumor-directed immune activation.

ATOR-1017 is dependent on cross-linking with Fc-gamma receptors. This means that it has to bind both 4-1BB and Fc receptors for full activity. Both 4-1BB and Fc-gamma receptors are highly expressed in certain tumors and these receptors could be used as predictive efficacy biomarkers. Patients that overexpress these receptors should demonstrate a higher efficacy response to ATOR-1017, resulting in an increased immune activation in the tumors compared to the rest of the body. This supports that ATOR-1017 has the potential for a superior benefit/risk profile.

"I am very encouraged by these pre-clinical data. ATOR-1017 has the ideal profile to become a best-in-class 4-1BB antibody, with strong efficacy and minimal side-effects. This is perfectly in line with Alligator’s strategy to build a pipeline of tumor-directed immunotherapies" said Christina Furebring, SVP Research at Alligator Bioscience.

Today at 4:20 p.m. local EDT (10:20 pm CEST) Dr Peter Ellmark, VP Discovery at Alligator, will give an oral presentation with the title: "Tumor-directed targeting of Effector T cells and Regulatory T cells". Dr Ellmark is chairing the session on "Agonist Immunotherapy Targets" at PEGS.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 3:00 p.m. CEST on 3 May 2018.

About ATOR-1017
ATOR-1017 is an immunostimulatory antibody (IgG4) that binds to the costimulatory receptor 4-1BB (also known as CD137) expressed on tumor-specific T cells and NK cells. 4-1BB has the capacity to support the immune cells involved in tumor control, making 4-1BB a particularly attractive target for cancer immunotherapy.

ATOR-1017 is differentiated from other 4-1BB antibodies, partly because of its unique binding profile, but also because its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells. The aim is to achieve effective tumor-targeted immune stimulation with minimum side effects.

COHERUS BIOSCIENCES RE-SUBMITS BIOLOGICS LICENSE APPLICATION FOR CHS-1701 (PEGFILGRASTIM BIOSIMILAR CANDIDATE)

On May 3, 2018 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported the re-submission of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, to the U.S. FDA under the 351(k) pathway (Press release, Coherus Biosciences, MAY 3, 2018, View Source [SID1234531702]).

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The BLA is supported by similarity data from analytical, pharmacokinetic, pharmacodynamics, and immunogenicity studies comparing CHS-1701 and Neulasta and integrates new immunogenicity data obtained from using a more revised immunogenicity assay.

"The CHS-1701 BLA re-submission marks a significant milestone in our ongoing transition to a commercial company as we tightly focus on execution of our strategic plan," said Denny Lanfear, President and CEO of Coherus BioSciences. "Pegfilgrastim is the largest selling oncology product in the U.S., and CHS-1701 is the cornerstone of our oncology franchise. We believe we have a strong competitive position with this product, exemplified by our comprehensive clinical immunogenicity data as well as our excellent analytical biosimilarity data."

10-Q – Quarterly report [Sections 13 or 15(d)]

G1 Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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10-Q – Quarterly report [Sections 13 or 15(d)]

Lpath has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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10-Q – Quarterly report [Sections 13 or 15(d)]

Vical has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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