On October 1, 2021 Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported that they will present additional preclinical data on their novel dual mechanism-of-action oncolytic vaccinia virus BT-001 at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC2021) in November 2021 (Press release, Transgene, OCT 1, 2021, View Source [SID1234590662]).

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!

SITC2021 will take place on November 10–14, 2021, at the Walter E. Washington Convention Center in Washington, D.C. and virtually. The poster will be presented on November 13, with the title "Vectorized Treg-depleting aCTLA-4 elicits antigen cross-presentation and CD8+ T cell immunity to reject "cold" tumors". Authors: Monika Semmrich, Jean-Baptiste Marchand, Matilda Rehn, Laetitia Fend, Christelle Remy, Petra Holmkvist, Nathalie Silvestre, Carolin Svensson, Patricia Kleinpeter, Jules Deforges, Fred Junghus, Linda Mårtensson, Johann Foloppe, Ingrid Teige, Eric Quéméneur and Björn Frendéus.

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody is expected to be greatly improved.

BT-001 is being co-developed as part of a 50/50 collaboration between BioInvent and Transgene.

Recruitment in the ongoing Phase I/IIa clinical study of BT-001 (NCT04725331) in Europe and the U.S. is progressing well. The trial evaluates BT-001 as a single agent and in combination with pembrolizumab for the treatment of solid tumors.

Initial Phase I data are expected in the first half of 2022.

On October 1, 2021 -Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported that it will present two abstracts at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting (SITC 2021), being held in Washington D.C. and virtually, November 10-14, 2021 (Press release, Asher Biotherapeutics, OCT 1, 2021, View Source [SID1234590661]).

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!

Collectively, the presentations demonstrate preclinical proof-of-concept for Asher Bio’s cis-targeting approach and lead program AB248. AB248 is an engineered interleukin-2 (IL-2) immunotherapy, designed specifically to target CD8+ effector T cells. Asher expects to file an investigational new drug application for AB248 in the third quarter of 2022.

Details of the presentations are as follows:

Oral Presentation:
Title: CD8-targeted IL-2 drives potent anti-tumor efficacy and promotes action of tumor specific vaccines
Authors: Hussein Sultan, PhD, Kelly Moynihan, PhD, Yuang Song, Ton Schumacher, PhD, Andy Yeung, PhD, Ivana Djuretic, PhD, and Robert D. Schreiber, PhD
Abstract Number: 578
Session: Cellular Therapies, Saturday 11/13/2021, 3:40 pm – 4:55 pm ET

Poster Presentation:
Title: Selective activation of CD8+ T cells by a CD8-targeted IL-2 results in enhanced anti-tumor efficacy and safety
Authors: Kelly Moynihan, PhD, Danielle Pappas, Terrence Park, Wei Chen PhD, Irene Ni, Paul Bessette PhD, Mike Chin, Ton Schumacher, PhD, Andy Yeung, PhD, and Ivana Djuretic, PhD
Abstract Number: 717
Session: Poster Hall E, Friday 11/12/2021, 7:00 am – 8:30 pm ET

Both abstracts will become available online on the SITC (Free SITC Whitepaper) conference website beginning at 8:00 a.m. ET on Tuesday, November 9, 2021.

On October 1, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported five poster presentations at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held in Washington, D.C., and virtually November 10-14, 2021 (Press release, Xencor, OCT 1, 2021, View Source [SID1234590660]).

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 presentations will include updated clinical results from expansion cohorts in the Phase 1 study of vudalimab (XmAb717), a selective PD-1 x CTLA-4 bispecific antibody, in patients with prostate cancer, renal cell carcinoma and other cancers without approved checkpoint therapies. New data from four preclinical-stage programs, including Xencor’s IL-12-Fc cytokine program, PD-L1 x CD28 bispecific antibody program, TGFβR2 bispecific antibody platform, and bispecific NK cell engager platform, will also be presented.

Presentation Details

Abstract 523, "Preliminary clinical experience with XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors"
Abstract 707, "IL12 Fc-fusions engineered for reduced potency and extended half-life exhibit strong anti-tumor activity and improved therapeutic index compared to wild-type IL12 agents"
Abstract 698, "PD-L1 targeted CD28 costimulatory bispecific antibodies enhance T cell activation in solid tumors"
Abstract 872, "PD1 x TGFbR2 and CD5 x TGFbR2 bispecifics selectively block TGFbR2 on target-positive T cells, promote T cell activation, and elicit an anti-tumor response in solid tumors"
Abstract 787, "Natural Killer cell engagers activate innate and adaptive immunity and show synergy with proinflammatory cytokines"
Posters will be available in the poster hall and virtually to registrants of the SITC (Free SITC Whitepaper) Annual Meeting, beginning at 7:00 a.m. ET on Friday, November 12. In the poster hall, odd numbered posters will be displayed on Friday, November 12, and even numbered posters will be displayed on Saturday, November 13. Posters will be archived under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com.

About Vudalimab (XmAb717)

Vudalimab (XmAb717) is an XmAb bispecific antibody that simultaneously targets immune checkpoint receptors PD-1 and CTLA-4 and is designed to promote tumor-selective T-cell activation. Xencor’s approach to dual checkpoint/co-stimulation reduces the need for the multiple antibodies and allows for more selective targeting of T cells with high checkpoint expression, which may potentially improve the therapeutic index of combination immunotherapies. In preclinical studies, dual blockade of PD-1 and CTLA-4 with vudalimab significantly enhanced T cell proliferation and activation, and anti-tumor activity in vivo. Xencor has initiated a Phase 2 clinical study of vudalimab in patients with metastatic castration resistant prostate cancer (mCRPC), as a monotherapy or in combination depending on subtype, and a Phase 2 clinical study in patients with advanced gynecologic and genitourinary malignancies, as well as high-risk mCRPC.

On October 1, 2021 Compass Therapeutics, Inc. (OTC:CMPX), a clinical-stage, oncology focused biotechnology company developing proprietary immuno-modulatory and anti-angiogenic antibody therapeutics, and ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, reported that the Phase 1 monotherapy dose escalation and expansion study data for CTX-009 (ABL001/ES104), a bispecific dual angiogenesis inhibitor targeting DLL4 and VEGF-A, has been selected for an oral plenary presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held virtually on October 7-10, 2021 (Press release, Compass Therapeutics, OCT 1, 2021, View Source [SID1234590659]). The oral presentation will include single agent safety, tolerability, exploratory DLL4 expression analysis, and clinical activity data for CTX-009 in heavily pre-treated patients with metastatic, anti-VEGF-resistant solid tumors, mainly of colorectal and gastric origin.

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!

Oral Presentation Details:

Title: Phase Ia/Ib Dose-Escalation Study of ABL001 (CTX-009, Bispecific Antibody Targeting DLL4 and VEGF-A) as a Single Agent in Patients with Advanced Solid Tumors

Abstract Number: 4749

Session Title: Plenary Session 2: New Drugs on the Horizon I

Presenter: Jeeyun Lee, MD, Samsung Medical Center, Seoul, Korea

Date: October 8, 2021 at 10:45 a.m. EDT

About CTX-009

CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Pre-clinical and early clinical data of CTX-009 suggests that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. CTX-009 has completed a Phase 1 monotherapy dose escalation and expansion study. Phase 1b and Phase 2 combination studies are ongoing.

On October 1, 2021 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported the acceptance of four abstracts to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36TH Annual Meeting (SITC 2021) taking place November 10-14, 2021, at the Walter E. Washington Convention Center in Washington, D.C (Press release, Neoleukin Therapeutics, OCT 1, 2021, View Source [SID1234590657]).

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!

"Presentations by our scientists and collaborators at SITC (Free SITC Whitepaper) 2021 will highlight promising preclinical data with NL-201, a fully de novo IL-2/IL-15 agonist, currently in phase 1 clinical development," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "We look forward to sharing data on the ability of NL-201 to activate the tumor microenvironment, to demonstrate antitumor activity via intratumoral administration, and to be combined with novel therapeutic candidates."

Details of the poster presentations are as follows:

Title: NL-201 Induces Inflammation in a ‘Cold’ Tumor Microenvironment through Upregulation of MHC-I, Expansion of the TCR Repertoire, and Potent Antitumor Activity when Combined with PD-1 Inhibition

Poster/Abstract Number: 716
Date/Time: Saturday, November 13, 5 a.m. to 8:30 p.m., ET

Title: Intratumoral Administration of NL-201, an Alpha-Independent IL-2/15 Receptor Agonist, Inhibits the Growth of Both Injected and Uninjected Tumors in Preclinical Models

Poster/Abstract Number: 898
Date/Time: Saturday, November 13, 5 a.m. to 8:30 p.m., ET

Title: A First-in-Human Phase 1 Study of NL-201 in Patients with Relapsed or Refractory Cancer (Trials in Progress)

Poster/Abstract: 509
Date/Time: Friday, November 12, 5 a.m. to 8:30 p.m. ET

Title: ICT01, an Anti-BTN3A Monoclonal Antibody, and NL-201, an Alpha-Independent IL-2/IL-15 Agonist, Combine to Elicit a Potent Anti-Tumor Response by Synergistically Stimulating g9d2 T Cell Activation and Proliferation

Poster/Abstract Number: 563
Date/Time: Friday, November 12, 5 a.m. to 8:30 p.m. ET

Poster presentations will be accessible in person and virtually. Onsite posters will be displayed in the SITC (Free SITC Whitepaper) Poster Hall located in Hall E of the convention center. ePosters will be available for SITC (Free SITC Whitepaper) attendees on Nov. 12 at 7 am ET and can be accessed on the SITC (Free SITC Whitepaper) virtual meeting site. All attendees will receive information on how to access the site after they have registered.

About NL-201
NL-201 is a de novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models.