On March 10, 2021 Genmab A/S (Nasdaq: GMAB) reported that two posters evaluating investigational medicines created using Genmab’s DuoBody technology will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, taking place virtually April 10-15 and May 17-21 (Press release, Genmab, MAR 10, 2021, View Source [SID1234576409]). The posters summarize data from a preclinical evaluation of the investigational medicine, epcoritamab (DuoBody-CD3xCD20) in combination with standard of care therapies for the treatment of B-cell lymphomas, and a preclinical mechanism of action evaluation of GEN1042 (DuoBody-CD40x4-1BB). The abstracts have been published on the AACR (Free AACR Whitepaper) website and may be accessed via the Online Meeting Planner. All e-poster presentations will be made available on the on-demand Virtual Congress platform on www.aacr.org. Epcoritamab is being co-developed by Genmab and AbbVie. GEN1042 is being co-developed by Genmab and BioNTech.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to present data showcasing the progress we are making with key investigational medicines in our product pipeline utilizing the innovative DuoBody bispecific antibody platform," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Together with our partners, we continue to employ the DuoBody technology platform to effectively create opportunities for innovative antibody drug design and development with the goal of transforming cancer treatment."

Epcoritamab (DuoBody-CD3xCD20):
Preclinical evaluation of epcoritamab combined with standard of care therapies for the treatment of B-cell lymphomas

GEN1042 (DuoBody-CD40x4-1BB):
DuoBody-CD40x4-1BB (GEN1042) induces dendritic-cell maturation and enhances T-cell activation and effector functions in vitro by conditional CD40 and 4-1BB agonist activity

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.1 CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.2,3 Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

About GEN1042 (DuoBody-CD40x4-1BB)
GEN1042 (DuoBody-CD40x4-1BB) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. It is being co-developed under an agreement in which the companies share all costs and future profits for the product on a 50:50 basis. CD40 and 4-1BB were selected as targets to enhance both dendritic cells (DC) and antigen-dependent T-cell activation, using an inert DuoBody format.

On March 10, 2021 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported that it has obtained a term loan facility from Hercules Capital (NYSE: HTGC), a leader in customizing debt financing for companies in the life sciences market (Press release, Humanigen, MAR 10, 2021, View Source [SID1234576425]). Under the terms of the facility, Hercules will provide Humanigen up to $80 million of secured debt financing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The term loan facility provides working capital to support the production of lenzilumab, strengthens our balance sheet and increases our financial flexibility as we prepare for the potential Emergency Use Authorization and commercial launch of lenzilumab in 2021," said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen.

The facility consists of a $25 million initial term loan, with up to an additional $55.0 million available for future draws subject to achievement of future milestones and satisfaction of other conditions. The facility provides for an interest-only period and the four-year term is extendable under certain conditions. Loans under the facility are secured by the company’s assets.

"Hercules is excited to be partnering with Humanigen as it advances lenzilumab for COVID-19 and other indications. This structured financing represents a significant commitment from Hercules, which is consistent with our goal of supporting innovative life sciences companies," said Himani Bhalla, Principal at the Life Sciences group at Hercules. "This is an example of the breadth of our platform and our ability to finance life sciences companies through all stages of development."

On March 10, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the planned presentation of two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, taking place April 10-15, 2021 (Press release, Alpine Immune Sciences, MAR 10, 2021, View Source [SID1234576394]). Dr. Mark Voskoboynik of Nucleus Network and The Alfred Hospital in Melbourne, Australia, will be presenting a poster in the Phase 1 Clinical Trials in Progress session on NEON-1, a Phase I study of ALPN-202 in advanced malignancies. Separately, Alpine researchers will present a preclinical poster describing the application of Alpine’s directed evolution platform to the development of fusion proteins capable of tumor antigen-dependent CD28 costimulation, as a distinctive immuno-oncology approach.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the presentations are as follows:

Presentation Title: NEON-1: A first-in-human phase I open-label study of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies

Session Category: Phase I Clinical Trials in Progress
Session Title: Phase I Clinical Trials in Progress
Date Poster Available: Saturday, April 10th
Session Type: E-Poster Session
Poster Number: CT213
Presentation Title: Engineered variant domain fusion proteins provide checkpoint inhibition and tumor antigen dependent CD28 costimulation resulting in potent anti-tumor immunity

Session Category: Immunology
Session Title: Immunomodulatory Agents and Interventions
Date Poster Available: Saturday, April 10th
Session Type: E-Poster Session
Poster Number: 1740
Titles and/or full abstracts are available on the AACR (Free AACR Whitepaper) Virtual Annual Meeting website. Posters for both presentations will be available on the Scientific Publications page of Alpine’s website on April 10th.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor designed to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling.

On March 10, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported its decision to continue enrollment in the REDIRECT trial, which is evaluating AFM13 as a monotherapy for the treatment of patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (Press release, Affimed, MAR 10, 2021, View Source [SID1234576410]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The decision to continue the trial followed a preplanned interim futility analysis. The interim analysis was triggered following enrollment of 20 patients in both Cohort A (³10% CD30) and Cohort B (>1% to <10% CD30). The futility boundary was derived from response rates for previous therapies that have received accelerated approval in relapsed or refractory (R/R) PTCL. The futility analysis demonstrated that the response rate in Cohort A achieved the predefined threshold for continuation of the study. The response rate in Cohort B was sufficiently comparable to allow merging of both cohorts into a single cohort for all patients with CD30 >1%, per the study protocol. Evidence of anti-tumor response was observed in both cohorts with complete and partial responses. The safety analysis was consistent with previously reported data from Affimed’s Phase 1 trials of AFM13, with infusion related reactions (IRRs) representing the main side effect. Following the introduction of mandatory premedication, IRRs were markedly reduced, resulting in fewer dose reductions and a trend towards better activity.

"We are very encouraged by the observed activity of AFM13 in this heavily pretreated patient population, where more than half of the patients had three or more lines of previous therapy. These data reinforce our strategy to broadly develop AFM13 across CD30-positive lymphomas both as monotherapy and in combination with other therapies," said Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. "Having successfully met the criteria for continuation, the trial will move forward by merging the CD30 high- and low-expressing PTCL cohorts for evaluation of the safety and efficacy of AFM13."

"We are excited by this progress and by AFM13’s potential as monotherapy for patients with PTCL," said Dr. Won Seog Kim, Principal Investigator of REDIRECT and Professor of Hematology and Oncology at the Samsung Medical Center, Sungkyunkwan University, Seoul, Korea. "PTCL is an aggressive and challenging cancer to treat in patients who relapse or do not respond favorably to current therapies, which often have high toxicity profiles, and new therapeutic approaches are needed."

AFM13 is also being evaluated in combination with cord-blood derived natural killer cells in CD30-positive lymphomas at MD Anderson Cancer Center (MDACC). Initial data from this investigator sponsored study will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021.

Investor Conference Call and Webcast Details Affimed will host an investor conference call and webcast today, Wednesday, March 10, at 8:30 a.m. EST, to review the REDIRECT study interim analysis. To access the call, please dial +1-646-741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference conference ID 6065008 approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section of the company’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

About AFM13-202 and the REDIRECT Trial Design

REDIRECT (also known as AFM13-202, NCT04101331) is a registration-directed phase 2 open-label, multicenter, global study investigating the efficacy and safety of AFM13 monotherapy in patients with R/R CD30-positive PTCL and Transformed Mycosis Fungoides (TMF).

The study enrolls patients who suffer from CD30 expressing PTCL or TMF and who have relapsed after an earlier standard of care treatment or have refractory disease. Dependent on their disease type and the magnitude of CD30 expression on their tumor cells, study participants are assigned to one of three study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The three cohorts are comprised of Cohort A, which includes PTCL patients with ³10% CD30 expression on tumor cells; Cohort B, which includes PTCL patients with >1% to< 10% CD30 expression on tumor cells; and, Cohort C, currently on hold, which includes TMF patients with ³1% CD30 expression on tumor cells.

The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of objective responses. Further goals of the study are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood.

The study began recruitment in October 2019 at sites in the United States, Australia, South Korea and seven European countries. The TMF arm of the study (Cohort C), which is exploratory only and not relevant to the potential consideration for accelerated approval, will remain paused, due to COVID-19 and the high number of assessments and site visits necessary for this group of patients. To date, no TMF patients have been recruited into the study.

On March 10, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the planned presentation of two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, taking place April 10-15, 2021 (Press release, Alpine Immune Sciences, MAR 10, 2021, View Source [SID1234576426]). Dr. Mark Voskoboynik of Nucleus Network and The Alfred Hospital in Melbourne, Australia, will be presenting a poster in the Phase 1 Clinical Trials in Progress session on NEON-1, a Phase I study of ALPN-202 in advanced malignancies. Separately, Alpine researchers will present a preclinical poster describing the application of Alpine’s directed evolution platform to the development of fusion proteins capable of tumor antigen-dependent CD28 costimulation, as a distinctive immuno-oncology approach.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the presentations are as follows:

Presentation Title: NEON-1: A first-in-human phase I open-label study of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies

Session Category: Phase I Clinical Trials in Progress
Session Title: Phase I Clinical Trials in Progress
Date Poster Available: Saturday, April 10th
Session Type: E-Poster Session
Poster Number: CT213
Presentation Title: Engineered variant domain fusion proteins provide checkpoint inhibition and tumor antigen dependent CD28 costimulation resulting in potent anti-tumor immunity

Session Category: Immunology
Session Title: Immunomodulatory Agents and Interventions
Date Poster Available: Saturday, April 10th
Session Type: E-Poster Session
Poster Number: 1740
Titles and/or full abstracts are available on the AACR (Free AACR Whitepaper) Virtual Annual Meeting website. Posters for both presentations will be available on the Scientific Publications page of Alpine’s website on April 10th.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor designed to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling.