On June 22, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported the company will receive a $10 million milestone payment from Janssen Biotech, Inc. (Janssen) triggered under the Collaboration and License Agreement between the two companies (Press release, Halozyme, JUN 22, 2020, View Source [SID1234561320]). The milestone payment is associated with the first commercial sale in the European Union of Janssen’s subcutaneous formulation of DARZALEX (daratumumab) utilizing ENHANZE, which was recently granted marketing authorization by the European Commission.

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On June 22, 2020 Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that updated pharmacodynamic and safety data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, occurring June 22 – 24, 2020 (Press release, Exicure, JUN 22, 2020, View Source [SID1234561336]).

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The AACR (Free AACR Whitepaper) poster, titled "Phase 1b/2 Study of an Intratumoral TLR9 Agonist Spherical Nucleic Acid (AST-008) and Pembrolizumab: Evidence of Immune Activation," is presenting new preliminary pharmacodynamic and safety data of cavrotolimod (AST-008), alone and in combination with pembrolizumab, from Exicure’s ongoing Phase 1b/2 clinical trial (ClinicalTrials.gov identifier: NCT03684785). Cavrotolimod (AST-008) is a novel SNA configuration of a toll-like receptor 9 (TLR9) agonist oligonucleotide, designed to trigger anti-tumor immune responses.

Gene expression analysis data from patient tumor biopsies demonstrated increases in leukocytes in injected tumors after intratumoral (IT) cavrotolimod (AST-008) alone and in combination with pembrolizumab versus baseline. Uninjected tumors also showed increased immune cell levels after patients received cavrotolimod (AST-008) and pembrolizumab, suggesting immune cell trafficking.

Dose-dependent activation of key immune cells, including cytotoxic T cells and natural killer cells, as well as increases in cytokine/chemokine levels were observed in patient blood after IT cavrotolimod (AST-008) treatment alone, and cavrotolimod (AST-008) plus pembrolizumab treatment. We expect that activation of these cell types and expression of immune system signaling proteins may help produce anti-tumor effects.

Cavrotolimod (AST-008) was well-tolerated, with a safety profile consisting primarily of injection site reactions and flu-like symptoms, which is believed to reflect local and systemic immune activation. No cavrotolimod (AST-008)-related serious adverse events or dose limiting toxicity have been reported.

Using these data, a recommended Phase 2 dose of 32 mg cavrotolimod (AST-008) has been identified for the Phase 2 portion of the clinical trial now underway, where cavrotolimod (AST-008) will be given in combination with pembrolizumab or cemiplimab for the treatment of locally advanced or metastatic Merkel cell carcinoma or cutaneous squamous cell carcinoma, respectively, in patients with progression despite approved anti-PD-(L)1 therapy.

This poster is being presented during the AACR (Free AACR Whitepaper) Virtual Meeting II in the session Late-Breaking Research: Clinical Research 1 / Endocrinology under abstract number LB-140. The poster will be available for viewing from June 22 – 24.

On June 22, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported preclinical data for its next generation anti-folate receptor alpha (FRα) ADC, IMGN151, which is being investigated in tumors with a broad range of FRα expression (Press release, ImmunoGen, JUN 22, 2020, View Source [SID1234561352]). The findings were shared via poster presentation at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting II.

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"Engineered to include multiple antibody and linker-payload innovations, IMGN151 targets tumors with a broad range of FRα expression," said Eric Westin, MD, Vice President of Clinical Development and Translational Sciences at ImmunoGen. "IMGN151 demonstrated enhanced anti-tumor activity in both in vitro and in vivo preclinical models, with complete regression of human tumor xenograft models induced in those with high, medium, and low levels of FRα expression. Based on these data, we look forward to exploring IMGN151 in the clinic in multiple FRα-positive epithelial malignancies, including ovarian, endometrial, triple negative breast, and non-small cell lung cancer."

IMGN151 PRECLINICAL DATA
Poster Presentation, Abstract 2890

IMGN151 comprises an asymmetric, bivalent, biparatopic antibody targeting two independent epitopes of FRα, linked to a highly potent maytansinoid derivative, DM21, via a cleavable peptide linker with enhanced stability, longer half-life, and increased bystander activity. The average drug per antibody ratio is 3.5. IMGN151 activity was characterized against cell lines and xenograft models with a wide range of FRα expression and compared to mirvetuximab soravtansine (IMGN853). Cell lines and xenograft models originated from ovarian, endometrial, breast, and cervical cancer.

Key findings include:

The protease-cleavable linker deployed in IMGN151 improves stability and ADC exposure; as compared to IMGN853, pharmacokinetic studies in cynomolgus monkeys showed increased ADC half-life by 60 hours and conjugate exposure in vivo by 40%.
The IMGN151 biparatopic format boosted antibody binding events and DM21 payload delivery in tumor cell lines; the increased payload delivery and greater membrane permeability of DM21 enhanced bystander killing activity.
In vitro, IMGN151 was more active against FRα-positive cell lines, with the most pronounced effect in cells with low to medium levels of FRα.
In vivo, IMGN151 demonstrated better activity over IMGN853 against low and medium levels of FRα, and equivalent activity to IMGN853 against FRα high tumors with lower effective dose; all tested doses were well tolerated.
Additional information can be found at www.aacr.org.

ABOUT IMGN151

IMGN151 is a next-generation ADC, designed to address the unmet needs of cancer patients with tumor types expressing lower levels of folate receptor alpha (FRα). IMGN151 comprises an asymmetric, bivalent, biparatopic antibody targeting two independent epitopes of FRα, linked to a highly potent maytansinoid derivative, DM21, via a cleavable peptide linker with enhanced stability, longer half-life, and increased bystander activity.

On June 22, 2020 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule modulators to address unmet medical needs in oncology and autoimmune diseases, reported that preclinical data of dual LSD1 and HDAC6 inhibitor JBI-802, will be presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting II (Press release, Jubilant Therapeutics, JUN 22, 2020, View Source [SID1234561368]). The preclinical data demonstrated that JBI-802 has strong efficacy in multiple in vivo cancer models mediated by LSD1 and HDAC6 inhibition, while demonstrating excellent selectivity against other HDACs and superior in vivo efficacy compared to single agents targeting LSD1 or HDAC6.

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"We are excited to reveal these new data from our study of JBI-802 whose first-in-class dual mechanism of action targets the overexpression of two proteins, while exhibiting a favorable tolerability profile," said Syed Kazmi, President and Chief Executive Officer of Jubilant Therapeutics Inc. "These data support the additional development of this novel dual epigenetic inhibitor as a potential therapeutic agent for genetically-defined cancers."

A link to the e-poster, listed below, is available through the AACR (Free AACR Whitepaper) website.

Title: Novel Dual Small Molecule Inhibitor Targeting LSD1 and HDAC6
Poster Number: 1756
Date and Time: June 22, 2020 at 8:45 a.m. Eastern Daylight Time (EDT)
Session Title: Epigenetic Targets
Presenter: Dhanalakshmi Sivanandhan, et al.

Key highlights from the study which examined anti-proliferative activity of JBI-802 on select acute myeloid leukemia (AML), chronic lymphocytic leukemia, small cell lung cancer, sarcoma and multiple myeloma cell lines as compared to single agents, include the following:

JBI-802 demonstrated strong tumor growth inhibition in erythroleukemia and multiple other hematological tumors as compared to single agents;
Syngeneic models showed single agent activity with unique mechanism of action and that JBI-802 can be combined with checkpoint inhibitors safely in this mouse model; and
The molecule showed a favorable tolerability profile at efficacious doses.
JBI-802 is currently being evaluated in IND-enabling studies for the treatment of AML and other solid tumors and first-in-human clinical studies are expected in 1H 2021. Jubilant Therapeutics Inc. is developing a pipeline of novel, differentiated therapeutic assets; for partnership opportunity inquiries please contact [email protected].

On June 22, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that Ryan Spencer, Chief Executive Officer, will participate in a virtual fireside chat at the H.C. Wainwright Virtual Fireside Chat Series on Thursday, June 25, at 10:50 a.m. E.T (Press release, Dynavax Technologies, JUN 22, 2020, View Source [SID1234561281]).

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The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "investors" section of the Company’s website at View Source