On September 16, 2020 Synaffix B.V., a biotechnology company enabling antibody-drug conjugates (ADCs) with best-in-class therapeutic index, based on proprietary GlycoConnect, HydraSpace and toxSYN technology platforms, reported promising findings from its latest in vivo benchmarking study (Press release, Synaffix, SEP 16, 2020, View Source [SID1234565220]).

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In this mouse BT-474 xenograft study, trastuzumab-based ADCs prepared using Synaffix’s proprietary SYNtecan E linker-payload demonstrated an efficacy profile equivalent to deruxtecan-based ADCs. SYNtecan E is an exatecan-based linker-payload that contains the HydraSpace polar spacer technology, a conventional dipeptide cleavable linker and is conjugated, in this study, to the native antibody glycan using GlycoConnect. Deruxtecan is the linker-payload used in Enhertu, the FDA-approved ADC indicated for previously treated, HER-2 positive unresectable or metastatic breast cancer.

Following just a single dose, both HER-2-targeting ADCs, which have the same drug-to-antibody ratio (DAR) and administered at the same dose level, achieved complete tumor regression.

A poster of the data will be presented at the World ADC Digital conference on Thursday, 17 September 2020 at 3:30p-4:00p EDT.

Floris van Delft, CSO of Synaffix said:

"Given the recent clinical and commercial success observed with deruxtecan-based ADCs, we have been very excited with our first data for ADCs with the same mechanism of action."

"Exatecan mesylate has completed Phase 3 studies as a single agent already and comes with a well-understood toxicology profile. That said, its relatively challenging biophysical properties have likely contributed to limited exploration within the ADC context to date, despite its high potency and putative bystander killing potential. We have resolved the ADC aggregation issue by combining exatecan with our highly polar HydraSpace technology, providing highly stable and efficacious ADCs. We look forward to presenting further data on this new linker-payload and introducing it to our collaborators in due course."

Deruxtecan and SYNtecan E both belong to the family of camptothecins and are potent DNA topoisomerase 1 inhibitors that release DXd and exatecan as the active catabolite respectively.

SYNtecan E represents one of multiple options within the toxSYN linker-payload platform, which spans multiple mechanisms of action and can be evaluated in combination with GlycoConnect and HydraSpace technologies. This consolidated ADC platform enables any company with an antibody to rapidly co-discover an ADC with Synaffix and then develop and market the resulting ADC as part of its own pipeline under a license agreement.

On September 16, 2020 Roche reported that it will publish its Sales Results for the 3rd Quarter of 2020 prior to the opening of the Swiss Stock Exchange on Thursday, October 15th, 2020 (Press release, Hoffmann-La Roche, SEP 16, 2020, View Source [SID1234565217]).

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On September 16, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,774,150 which covers compositions of matter directed to Alligator’s bispecific drug candidate ATOR-1015 (Press release, Alligator Bioscience, SEP 16, 2020, View Source [SID1234565215]). The granted patent’s earliest expiry year is 2036.

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"ATOR-1015 constitutes a new concept, a tumor-localizing bispecific CTLA-4 antibody. Our invention addresses one of the key challenges within immuno-oncology, i.e. the narrow therapeutic window of CTLA-4 drugs. This is now protected by a granted US patent", commented Per Norlén, CEO at Alligator Bioscience.

ATOR-1015 is developed for the treatment of metastatic cancer. Promising safety data from the ongoing ATOR-1015 Phase I clinical study was presented at ASCO (Free ASCO Whitepaper) in June 2020. The Phase I dose escalation study is planned to be completed during the fourth quarter 2020 and the subsequent Phase Ib efficacy study in malignant melanoma is due to start in 2021.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CEST on September 16, 2020.

On September 15, 2020 Hangzhou Sumgen Biotech Co., Ltd. (hereinafter "Sumgen") reported the completing of a 220 million RMB series B funding led by Addor Capital, co-led by Cowin Capital and Sinowisdom, and jointly participated by BOCOM International, Haoshuo Investment, and Dynamic Balance Capital (Press release, Sumgen Biotech, SEP 15, 2020, View Source;a=nav&id=240 [SID1234656265]). This round of funding is primarily used for the R&D and industrialization of Sumgen’s innovative drugs. StartPointAdvisors served as the exclusive financial consultant for this funding round.

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On September 15, 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 the peer-reviewed publication of preclinical data focused on the in vivo detection of tumor antigen-specific T cells in a paper published in Nature Methods titled, "In vivo detection of antigen-specific CD8 T cells by immuno-positron emission tomography (Press release, Cue Biopharma, SEP 15, 2020, View Source [SID1234608295])." The study was co-authored by Steven C. Almo, Ph.D., co-founder of Cue Biopharma, professor and chair of biochemistry, professor of physiology & biophysics and the Wollowick Family Foundation chair in multiple sclerosis and immunology at Albert Einstein College of Medicine and Hidde Ploegh, Ph.D., a renowned expert in molecular immunology and a member of the program in cellular and molecular medicine at Boston Children’s Hospital.

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In this work, researchers employed dimeric protein scaffolds to develop a novel immuno-positron emission tomography (immunoPET) imaging approach. These protein scaffolds, known as synTacs, consist of Fc-based covalent peptide-major histocompatibility complex (pMHC) dimers, which form the core structure of Cue Biopharma’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform. By targeting synTacs labelled with positron emitting isotopes against specified tumor antigens, researchers were able to specifically and non-invasively detect tumor antigen-specific T cells in murine solid tumor models. In the same study, similar application of synTacs deploying viral antigens could detect and engage virus-specific T cells in the lung tissue.

"These studies demonstrate the remarkable breadth of applications supported by the Immuno-STAT platform, as it enables clinical applications for highly selective targeted treatments of cancer, autoimmune diseases and infectious diseases, but, also as demonstrated in the Nature Methods paper, the potential to serve as prognostics and diagnostics for mechanism-of-action and treatment efficacy by revealing the in vivo distribution of the biologic and its target T cells in diseased tissue," said Dr. Almo.

"This work highlights the power of the Sortase A coupling technology developed in our lab, as it readily allowed the site-specific, stoichiometric and highly reproducible installation of PET imaging tags (64Cu2+ and 89Zr4+ and 18F) for the in vivo tracking of antigen-specific T cells targeting tumor cells and virally infected cells in the disease tissue. These advances highlight the strength of modular biologic platforms, like the Immuno-STAT platform, that can be deployed for targeting and tracking antigen-specific effector lymphocytes in the patients to gain predictive insights into pharmacodynamic and clinical responses," elaborated Dr. Ploegh.

Specific detection of intratumoral T cells by this newly developed immunoPET approach provides further support that the core component of the Immuno-STAT scaffold can penetrate into the tumors and directly engage tumor-resident T cells. These data highlight the modular nature and the broad applicability of the Immuno-STAT platform to selectively deliver cargoes, such as imaging agents or immunomodulatory signals to tumor-resident T cells.

Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, commented, "We are highly encouraged by these results, as they highlight the inherent advantages of our engineered biologics platforms. Data showing the efficient penetration of the HPV16 E7 targeted synTac into solid tumors are particularly noteworthy, as similar technologies are unable to deliver cargoes past the tumor periphery. Further, this synTac is analogous to our lead asset, CUE-101, which carries a covalently linked IL-2 variant and is currently being evaluated in a Phase 1 trial in HPV16 driven head and neck squamous cell carcinoma."

Albert Einstein College of Medicine and its faculty members acknowledge the following relationships with Cue Biopharma, Inc.: Dr. Almo holds equity in Cue Biopharma, Inc., receives royalties from existing license agreements between Einstein and Cue, and is a member of its Science Advisory Board. Albert Einstein College of Medicine holds equity in Cue and receives royalties from existing licensing agreements.