On March 10, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Merus will present preclinical data from our zenocutuzumab and MCLA-129 programs in three poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting being held virtually for two weeks, April 10-15, 2021 and May 17-21, 2021 (Press release, Merus, MAR 10, 2021, View Source [SID1234576518]).

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E-Poster Presentation:

Title: The HER2×HER3 bi-specific antibody zenocutuzumab is effective at blocking growth of tumors driven by NRG1 gene fusions
Abstract #: 956
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents

Title: Zenocutuzumab: An antibody that can overcome HER3 mediated HRG signaling in tumor cells by docking on HER2
Abstract Number: 957
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents

Title: The bispecific antibody MCLA-129 impairs NSCLC tumor growth by targeting EGFR and c-MET, inhibiting ligand-induced signaling and promoting ADCC and ADCP
Abstract Number: 952
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents

Abstracts are available on the AACR (Free AACR Whitepaper) annual meeting website.

The AACR (Free AACR Whitepaper) e-poster website will be launched on Saturday April 10, 2021. All e-posters will be available on this website from Saturday, April 10 to Monday, June 21, 2021. The posters will also be available on the Merus website as of Saturday, April 10, 2021.

About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancers. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.

Learn more about Zeno Dock & Block at View Source

About MCLA-129
MCLA-129 is an ADCC-enhanced Biclonics that is designed to inhibit the EGFR and c-MET signaling pathways in solid tumors. Preclinical data has shown that MCLA-129 reverses resistance to tyrosine kinase resistant non-small cell lung cancer (NSCLC) cell lines resulting in tumor growth inhibition in xenograft models of NSCLC. MCLA-129 is designed to have two complementary mechanisms of action: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.

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

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]).

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"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.

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.

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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.

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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.