On October 1, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported that it will be presenting three abstracts at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, which is being held from Nov. 10-14, both virtually and in person in Washington, D.C (Press release, Bolt Biotherapeutics, OCT 1, 2021, View Source [SID1234618694]).

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The three poster presentations highlight assets in Bolt’s preclinical pipeline, including two Boltbody immune stimulating antibody conjugate (ISAC) candidates and an agonist antibody. BDC-2034 is a Boltbody ISAC targeting CEA, and the other Boltbody ISAC program targets PD-L1. The company’s proprietary agonist antibody targets Dectin-2 (also known as TAM1). Information about these presentations can be found below and on the 2021 SITC (Free SITC Whitepaper) Annual Meeting website.

Title: BDC-2034: Discovery of a CEA-targeting Immune-Stimulating Antibody Conjugate (ISAC) for Solid Tumors
Presenter: William G. Mallet, Ph.D.
Poster Number: 784
Details: Saturday, Nov. 13, 2021, 7:00 a.m. – 8:30 p.m. EST, Poster Hall

Title: Dectin-2, a novel target for tumor macrophage reprogramming in cancer immunotherapy
Presenter: Justin A. Kenkel, Ph.D.
Poster Number: 862
Details: Saturday, Nov. 13, 2021, 7:00 a.m. – 8:30 p.m. EST, Poster Hall

Title: PD-L1-targeted ISAC combines myeloid cell activation, immune-checkpoint inhibition and ADCP to improve anti-tumor efficacy over anti-PD-L1 antibodies in preclinical models
Presenter: Marcin Kowanetz, Ph.D.
Poster Number: 782
Details: Saturday, Nov. 13, 2021, 7:00 a.m. – 8:30 p.m. EST, Poster Hall

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform

ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

On October 1, 2021 RS Oncology, LLC, (RSO) a biotechnical company focused on the treatment of patients with pleural effusion and mesothelioma, reported that acceptance of their novel drug, RSO-021, for use in a Phase 1/2 clinical trial by the Medicines and Healthcare Regulatory Agency in the UK (Press release, RS Oncology, OCT 1, 2021, View Source [SID1234597696]).

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RSO-021 therapy has proven to significantly reduce pre-clinically tumor burden in malignant mesothelioma and other cancer types by inhibiting three key enzymes in the antioxidant signaling network within the mitochondria. Covalent adduction of the active site of a key mitochondrial enzyme by RSO-021 inactivates the peroxidase activity of the enzymes leading to accumulation of hydrogen peroxide to levels incompatible with tumor cell survival, while preserving healthy normal cells. RSO-021 is being developed for the treatment of malignant pleural effusion (MPE) via intrapleural (IP) installation in patients suffering from mesothelioma, breast cancer and other indications causing MPE.

"We’re excited about RSO-021 as a novel metabolic therapy. This clinical trial is an important step in improving treatment for people living with this aggressive cancer," said RS Oncology CEO and General Counsel, Jarrett Duncan. "RSO-021, the result of a collaboration between RSO, the University of Vermont Cancer Center and Wake Forest University School of Medicine, shows tremendous promise. The treatment has shown pre-clinical efficacy in nearly a dozen different indications, signifying broad applicability and therapeutic potential for cancer therapy." "Most notably, treatments using this unique mechanism of action can be guided by a companion diagnostic, identifying patients with sufficiently dysregulated metabolic pathways prone to respond to this novel therapeutic approach." added COO and Head of business development, George Naumov, Ph.D.

RS Oncology, LLC is a preclinical stage biotechnology company based in Cambridge, Massachusetts and London, UK with a mission to eradicate mesothelioma worldwide through new science and an innovative business model. The lead program is currently focused on development of novel therapies that modulate mitochondrial pathways that drive diseases of oxidative stress for treatment of malignant pleural effusion and malignant mesothelioma.

On October 1, 2021 Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases, reported that new preliminary safety, pharmacokinetic, pharmacodynamic, and clinical activity data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating AVB-500 in combination with cabozantinib in patients with clear cell renal cell carcinoma (ccRCC) will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, Aravive, OCT 1, 2021, View Source [SID1234594065]). The meeting is being held November 10-14, 2021 in Washington, D.C.

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Poster Presentation Details:

Title: A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment
Presenter: Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of Aravive
Date: November 13, 2021
Time: 7:00 AM – 8:30 PM ET
Location: Hall E
For additional information, please visit the SITC (Free SITC Whitepaper) 36th Annual Meeting website: View Source

About the AVB-500 Phase 1b/2 ccRCC Trial
Aravive initiated the Phase 1b portion of the Phase 1b/2 trial of AVB-500 in ccRCC in March 2021. The Phase 1b portion of the clinical trial, a dose escalation study, is expected to enroll approximately 18 patients in three dosing arms (15 mg/kg, 20 mg/kg and 25 mg/kg) to evaluate tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of AVB-500 in combination with cabozantinib. The controlled, randomized, open-label Phase 2 portion of the clinical trial is expected to enroll approximately 45 patients and investigate the recommended AVB-500 dose identified during the Phase 1b portion of the clinical trial in combination with cabozantinib versus cabozantinib alone. The primary endpoint is progression-free survival. The trial is enrolling patients with advanced ccRCC who have progressed on front-line treatment. The Phase 1b/2 trial is listed on clinicaltrials.gov NCT04300140.

About AVB-500
AVB-500 is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, AVB-500 selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian, renal and pancreatic cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. AVB-500 is currently being evaluated in multiple clinical trials and has been granted Fast Track Designation by the U.S. Food and Drug Administration in platinum resistant recurrent ovarian cancer. Analysis of all safety data to date showed that AVB-500 has been generally well tolerated with no dose-limiting toxicities or unexpected safety signals.

On October 1, 2021 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company"), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that four abstracts have been accepted for presentation at the SITC (Free SITC Whitepaper) 36th Annual Meeting in Washington D.C. from November 10 –14, 2021 (Press release, ALX Oncology, OCT 1, 2021, View Source [SID1234591866]). The abstracts, which will be presented in a poster session, include new clinical data from ASPEN-01, the ongoing Phase 1b study of evorpacept (also known as ALX148) in patients with head and neck squamous cell carcinoma and with gastric/gastroesophageal cancer, and clinical trial in progress presentations on ASPEN-03 and ASPEN-04, our Phase 2 head and neck cancer studies in collaboration with Merck. In addition, preclinical data will be presented on ALTA-002, a first-in-class SIRPα-directed TLR9 agonist antibody conjugate, which is being developed in collaboration with Tallac Therapeutics.

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Poster Presentation Details

Title: Evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with head and neck squamous cell carcinoma (HNSCC) and with gastric/gastroesophageal cancer (GC); ASPEN-01 (Abstract 498)

Presentation Time: November 12 – 14, 2021, 7:00am – 5:00pm ET

Location: Poster Hall

Title: A phase 2 study of evorpacept (ALX148) in combination with pembrolizumab in patients with advanced head and neck squamous cell carcinoma (HNSCC); ASPEN-03 (Abstract 439)

Presentation Time: November 12 – 14, 2021, 7:00am – 5:00pm ET

Location: Poster Hall

Title: A phase 2 study of evorpacept (ALX148) in combination with pembrolizumab and chemotherapy in patients with advanced head and neck squamous cell carcinoma (HNSCC); ASPEN-04 (Abstract 433)

Presentation Time: November 12 – 14, 2021, 7:00am – 5:00pm ET

Location: Poster Hall

Title: ALTA-002, a SIRPα-directed TLR9 agonist antibody conjugate activates myeloid cells and promotes anti-tumor immunity (Abstract 780)

Presentation Time: November 12 – 14, 2021, 7:00am – 5:00pm ET

Location: Poster Hall

On October 1, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported it will present four posters at SITC (Free SITC Whitepaper)’s 36th Annual Meeting being held Wednesday, November 10, 2021 to Sunday, November 14, 2021 (Press release, Shattuck Labs, OCT 1, 2021, View Source [SID1234591769]).

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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

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Presentation Details

Abstract Title: Phase 1 Dose Escalation Study of the Agonist Redirected Checkpoint SL-172154 (SIRPα-Fc-CD40L) in Subjects with Platinum-resistant Ovarian Cancer
Abstract Number: 429
Presenter: Nehal J. Lakhani, MD, PhD, START Midwest
Date: November 12th – 14th
Virtual Poster Viewing Session: 7:00 a.m. to 5:00 p.m. ET

Abstract Title: Phase 1 Dose Escalation and Dose Expansion Study of an Agonist Redirected Checkpoint (ARC) Fusion Protein, SL-279252 (PD1-Fc-OX40L), in Subjects with Advanced Solid Tumors or Lymphomas
Abstract Number: 494
Presenter: Melissa Johnson, MD, Sarah Cannon Research Institute
Date: November 12th – 14th
Virtual Poster Viewing Session: 7:00 a.m. to 5:00 p.m. ET

Abstract Title: Development of an Integrated Method to Quantify Receptor Occupancy for Agonist Immunotherapeutics That Stimulate Target Cells to Migrate from the Peripheral Blood
Abstract Number: 3
Presenter: Louis Gonzalez, PhD, Shattuck’s Director of Translational Research
Date: November 12th – 14th
Virtual Poster Viewing Session: 7:00 a.m. to 5:00 p.m. ET

Abstract Title: LIGHT (TNFSF14) Co-stimulation Enhances Myeloid Cell Activation and Anti-tumor Immunity in the Setting of PD-1 and TIGIT Checkpoint Blockade
Abstract Number: 585
Presenter: George Fromm, PhD, Shattuck’s Vice President of Research & Development
Date: November 12th – 14th
Virtual Poster Viewing Session: 7:00 a.m. to 5:00 p.m. ET

Further information about the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting can be found at:
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