On March 10, 2021 Complix, a biopharmaceutical company developing a pipeline of transformative Alphabody therapeutics reported that it has signed a significant drug discovery deal with I-Mab (Nasdaq: IMAB), an innovation-driven clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel and highly differentiated biologics in the immuno-oncology therapeutic area (Press release, Complix, MAR 10, 2021, View Source;utm_medium=rss&utm_campaign=complix-signs-global-drug-discovery-and-development-agreement-with-i-mab-to-develop-cell-penetrating-alphabodies-against-two-intracellular-immuno-oncology-targets [SID1234576369]).

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!

Under the terms of the agreement, Complix will use its proprietary Alphabody platform to deliver Cell Penetrating Alphabodies (CPABs) against two immuno-oncology intracellular targets. The resulting CPABs will undergo clinical development that will be jointly managed by both companies.

I-Mab will have an exclusive license to commercialize the CPABs in Greater China, with the rest of the world commercialization rights being equally owned by both companies. In return, Complix is entitled to receive an upfront payment and potential development milestones fees, as well as tiered royalties.

CPABs are a revolutionary class of small proteins engineered to bind to a variety of antigens. Data available show that CPABs have the potential to address a wide range of disease targets, particularly intracellular targets that are difficult for current therapies to reach.

In addition to crossing cellular membranes, Alphabodies have the potential to cross the blood brain barrier to address CNS diseases and to be delivered orally given their ability to cross the gut wall.

On March 10, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that an abstract presenting the interim analysis of a Phase 1b proof-of-concept study of GMI-1359, the Company’s dual antagonist of E-selectin and CXCR4, has been accepted for presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, to be held virtually on April 10-15 and May 17-21 (Press release, GlycoMimetics, MAR 10, 2021, View Source [SID1234576393]). Preclinical studies indicate that targeting both E-selectin and CXCR4, a chemokine receptor, with a single compound could improve efficacy in the treatment of cancers that affect the bone and bone marrow, such as breast and prostate cancer. A second abstract also accepted for presentation highlights, for the first time, preclinical data in pancreatic cancer for the Company’s novel dual antagonist of galectin-3 and E-selectin, GMI-1757. The latter is featured as a late-breaking abstract on the compound’s impact on fibrosis, mononuclear cell infiltration, and anti-PD-L1 therapeutic activity in a pancreatic adenocarcinoma model.

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!

GlycoMimetics Chief Executive Officer Rachel King said, "We look forward to sharing results from two programs in our advancing portfolio at the upcoming AACR (Free AACR Whitepaper) meeting, including the interim analysis of Phase 1b clinical data supporting further advancement of the GMI-1359 program. We are extremely proud to be collaborating with the Duke Cancer Institute on this important work, which we believe holds great promise in delivering a novel approach to treating cancers with bone involvement."

Details on GlycoMimetics e-presentations at the AACR (Free AACR Whitepaper) Meeting are as follows:

Title: "Development of GMI-1359, a Novel Agent Targeting Tumor-microenvironment Cross-talk in Bone Metastatic Breast Cancer"
Presenter: Dorothy Sipkins, M.D., Ph.D., Duke Cancer Institute
Session: e-Presentation
Date and Time: Saturday, April 10, 2021 (available online through Monday, June 21)

Title: A novel glycomimetic compound (GMI-1757) with dual functional antagonism to E-selectin and galectin-3 attenuates fibrosis, facilitates mononuclear cell infiltration and optimizes anti-PD-L1 therapeutic activity in a pancreatic adenocarcinoma model
Presenter: William E. Fogler, M.D., GlycoMimetics
Session: e-Presentation
Date and Time: Saturday, April 10, 2021 (available online through Monday, June 21)

About GMI-1757

An innovative dual antagonist of E-selectin and galectin-3, GMI-1757 was described in a poster presented at the 2018 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). The poster showcased the anti-thrombotic activity of the dual antagonist and suggested the compound may be able to play a role in the treatment of a variety of cancers and fibrotic conditions.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow, such as AML and multiple myeloma, or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor affecting about 900 adolescents a year in the United States. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. A Phase 1b clinical study is underway in breast cancer patients and is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity. GMI-1359 has received Orphan Drug designation and Rare Pediatric Disease designation from the FDA for the treatment of osteosarcoma.

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.