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Agenus to Present New Clinical Data on AGEN1181 at AACR 2021

On March 10, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that two abstracts on AGEN1181, Agenus’ Fc-enhanced next-generation anti-CTLA-4 antibody, were accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 10 – 15, 2021 (Press release, Agenus, MAR 10, 2021, View Source [SID1234576517]).

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In a Phase 1/2 clinical study, AGEN1181 has shown responses in tumors previously unresponsive to immune therapies, including ovarian cancer and MSS endometrial and colorectal cancers. The AACR (Free AACR Whitepaper) presentation will cover the most up to date data. AGEN1181 is active even in patients with the low affinity FcγRIIIA allele, a genetic polymorphism which makes them generally unresponsive to first generation anti-CTLA-4. Further, AGEN1181 has demonstrated the ability to deplete intratumoral Tregs. Tregs are immunosuppressive T cells, and their depletion can allow for an improved antitumor immune response. Importantly, AGEN1181 is active without the neuroendocrine toxicities or hypophysitis observed with first generation agents.

The data to be presented at AACR (Free AACR Whitepaper) will showcase the optimal performance of AGEN1181 in preclinical models and in clinical trials. Preclinical data show that AGEN1181’s Fc enhancement allows it to engage the immune system even in cases of patients with the low affinity FcyRIIIA allele, which first-generation molecules do not do. These data also show that across all observed populations, AGEN1181 has increased efficacy over first-generation antibodies, and that combinations with multiple agents including checkpoint inhibitors such as anti-PD-1 and anti-TIGIT, iNKT-activating therapy, and adoptive T cell therapy, could further increase that efficacy.

In addition, clinical data to date provide evidence that these observations are being borne out in patients. Responses have been observed in patients with in the low-affinity FcyRIIIA allele. Further, AGEN1181 is the first anti-CTLA-4 to show intratumoral Treg depletion in the clinic.

AGEN1181 is currently advancing in a Phase 2 trial in colorectal cancer alone and in combination with balstilimab, Agenus’ anti-PD-1 antibody. As of February 9, Agenus has reported 6 confirmed objective clinical responses in its AGEN1181 Phase 1/2 trial and no complement-mediated toxicities.

Presentation Details:

Abstract title: Fc-enhanced anti-CTLA-4 antibody, AGEN1181: New mechanistic insights for potent antitumor immunity and combination potential in treatment-resistant solid tumors
Presenting author: Antoine Tanne, PhD

Abstract title: Characterization of the pharmacodynamic activity of AGEN1181, an Fc-enhanced CTLA-4 antibody, alone and in combination with the PD-1 antibody balstilimab
Presenting author: Irina Shapiro, PhD

Ocuphire Announces Financial Results for the Full Year 2020 and Provides Corporate Update

On March 10, 2021 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, reported financial results for the full year 2020 and provided a corporate update (Press release, Rexahn, MAR 10, 2021, View Source [SID1234576483]).

"2020 was a transformative year for Ocuphire, with significant achievements on clinical, corporate and financial fronts. We became a Nasdaq-listed company through our reverse merger with Rexahn Pharmaceuticals and raised just over $21 million concurrent with the merger," said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. "Despite the challenges of the COVID-19 pandemic, we consistently hit our planned milestones throughout the year, including initiating multiple Phase 3 and Phase 2 clinical trials and completing enrollment on one Phase 3 trial, and publishing results of two prior Phase 2 trials. We look forward to building on this progress in 2021 as we move forward with our promising Nyxol and APX3330 programs."

Key Anticipated Future Milestones

Phase 3 MIRA-2 trial investigating Nyxol for Reversal of Mydriasis with top line data expected in March 2021
Phase 2 VEGA-1 trial investigating a kit combination of Nyxol and low-dose pilocarpine for treatment of Presbyopia with top line data expected end of Q2 2021
Phase 3 LYNX-1 trial investigating Nyxol for Night Vision Disturbances with top line data expected end of Q3 2021
Phase 2 ZETA-1 trial investigating APX3330 for Diabetic Retinopathy and Diabetic Macular Edema: enrollment initiation expected in Q1 2021 with top line data expected early 2022
Recent Business Highlights

Clinical

Phase 3 MIRA-2 trial investigating Nyxol for Reversal of Mydriasis enrollment initiated and completed
Phase 3 LYNX-1 trial investigating Nyxol in Night Vision Disturbances initiated
Phase 2 trial VEGA-1 to evaluate a combination kit of Nyxol and low-dose pilocarpine in presbyopia initiated
Publications / Grants

Results from ORION-1 Phase 2b trial evaluating the safety and efficacy of Nyxol in glaucoma and presbyopia published in Clinical Ophthalmology
Results from MIRA-1 Phase 2b trial evaluating the safety and efficacy of Nyxol in the reversal of mydriasis (dilation of pupil for eye exams) published in Optometry and Visual Science
Data on the benefits of Ref-1 inhibition via APX3330 demonstrating its potential to treat multiple inflammatory and angiogenic disease processes published in Drug Discovery Today and Inflammatory Bowel Disease
Corporate

Completed reverse merger with Rexahn Pharmaceuticals and are a publicly traded company listed on the Nasdaq Capital Market as OCUP as of November 6, 2020
Raised $21.15 million in a private placement led by institutional healthcare and accredited investors
Participating in multiple Presbyopia events in early 2021 – Discussion on New Advances for Presbyopia, OIS Presbyopia Innovation Forum, and Eyeing Key Events and Programs in the Ophthalmology Space in 2021
2020 Financial Highlights

At December 31, 2020, the company had cash and cash equivalents of approximately $16.4 million.

General and administrative expenses for the year ended December 31, 2020 were $2.8 million compared to $1.8 million for the year ended December 31, 2019. The $1.0 increase was primarily attributable to an increase in stock-based compensation, professional services, insurance, and legal costs associated with the reverse merger in the current period.

Research and development expenses for the year ended December 31, 2020 were $6.6 million compared to $2.4 million for the year ended December 31, 2019. The $4.3 million increase was primarily attributable to clinical trials and manufacturing activities to support clinical advancement of Nyxol as well as regulatory and business development efforts.

Net loss attributable to common stockholders for the year ended December 31, 2020 was $24.6 million compared to $6.2 million for the year ended December 31, 2019.

MannKind Corporation to Participate in Oppenheimer’s 31st Annual Healthcare Conference

On March 10, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the Oppenheimer 31st Annual Healthcare Conference on Wednesday, March 17, 2021 at 1:50 pm (ET) (Press release, Mannkind, MAR 10, 2021, View Source [SID1234576452]). Interested parties can access a link to the webcast from the Events & Presentations section of the Company’s website at View Source The webcast replay will remain available for 14 days following the live presentation.

Arvinas to Participate in Upcoming Virtual Investor Conferences

On March 10, 2021 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that it will participate in two upcoming virtual investor conferences (Press release, Arvinas, MAR 10, 2021, View Source [SID1234576451]). John Houston, Ph.D., President and Chief Executive Officer, will participate in panel discussions at both conferences.

Guggenheim Targeted Protein Degradation Day panel discussion on Tuesday, March 16, 2021 at 10:30 a.m. ET
33rd Annual Roth Conference panel discussion on Wednesday, March 17, 2021 at 5:00 p.m. ET
A live audio webcast of each panel will be available on Arvinas’ website at www.arvinas.com. A replay of each webcast will be archived on Arvinas’ website for 30 days following the presentation.

Jounce Therapeutics to Present Preclinical Data from JTX-8064 Program at the 2021 American Association for Cancer Research Virtual (AACR) Annual Meeting

On March 10, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that preclinical data informing indication selection for the clinical development of its lead macrophage program, JTX-8064, will be presented in a poster session at the upcoming 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting being held April 10- 15, 2021 (Press release, Jounce Therapeutics, MAR 10, 2021, View Source [SID1234576450]).

Poster Title: Tumor associated macrophages and resistance to immune checkpoint blockade: Consideration of cancer indications for the clinical development of JTX-8064, an anti-LILRB2/ILT4 monoclonal antibody
Authors: Lara McGrath, Amy Mueller, Tanzila Rahman, Jeffrey Smith, Mark Yore, Edward Stack, Kristin O’Malley, Andrew Dunn, Kristen Legendre, Reva Shenwai, Margaret Willer, Allison Naumovski, Johan Baeck, and Ben Umiker (Jounce Therapeutics, Inc.)

Session Title: Immunomodulatory Agents and Interventions
Abstract Number: 1727
Date and Time: Saturday, April 10, 2021; 8:00am ET

About JTX-8064

JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) and block interactions with its ligands. JTX-8064 is the first tumor-associated macrophage candidate developed from Jounce’s Translational Science Platform. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting and the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1 clinical trial named INNATE (NCT04669899), for JTX-8064 as a monotherapy and in combination with either JTX-4014, or pembrolizumab, is currently enrolling patients with advanced solid tumors.