On March 14, 2023 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, reported that Phase 1 dose escalation data for IO-108, a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) is selected for oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14 – 19, 2023 in Orlando, Florida (Press release, Immune-Onc Therapeutics, MAR 14, 2023, View Source [SID1234628736]). In addition, preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will be presented as a late-breaking poster at AACR (Free AACR Whitepaper) 2023.

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"We are very excited that our interim clinical data of IO-108 is selected for oral presentation at AACR (Free AACR Whitepaper) 2023. This reflects the clinical significance and broad market potential of IO-108 as monotherapy and in combination with an anti-PD-1 for treatment in a variety of solid tumors. Such a distinguished recognition, together with the acceptance of our IO-312 late breaking abstract for poster presentation at the meeting, signifies the strength and breadth of our pioneering myeloid checkpoint inhibitor programs across multiple cancer types," said Charlene Liao, Ph.D., founder, chief executive officer and board chair of Immune-Onc. "Immune-Onc has built a strong oncology pipeline guided by our deep expertise in myeloid biology and drug development, and we are proud that our first-in-class myeloid checkpoint inhibitors are demonstrating clinical benefits in Phase 1 studies for patients with some of the hardest-to-treat cancers."

Details of Immune-Onc’s AACR (Free AACR Whitepaper) 2023 presentations are as follows:

Abstract Number: 9498
Title: A first-in-human phase 1 trial of IO-108, an antagonist antibody targeting LILRB2 (ILT4), as monotherapy and in combination with pembrolizumab in adult patients with advanced relapsed or refractory solid tumors: Dose escalation study
Presenter: Matthew H. Taylor, M.D., assistant member, Developmental Cancer Therapeutics Laboratory and co-medical director, Providence Melanoma Program, Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon.
Session Title: Novel Immunotherapy Combination Clinical Trials
Session Date and Time: Tuesday, April 18, 2:30 p.m. – 4:30 p.m. ET
Presentation Number: CT040

Abstract Number: LB217
Title: A novel bispecific LILRB4/CD3 antibody with potent killing of monocytic acute myeloid leukemia cells
Presenter: Charlene Liao, Ph.D., chief executive officer of Immune-Onc Therapeutics, Inc
Session Title: Late-Breaking Research: Immunology 2
Session Date and Time: Tuesday, April 18, 9:00 a.m. – 12:30 p.m. ET
Location: Poster Section 36, Poster Board #10

Abstracts and full session details can be accessed through the AACR (Free AACR Whitepaper) Online Program Planner

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting and the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.

The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation and is actively enrolling several expansion cohorts, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab). To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab. The company is also actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or tislelizumab).

On March 14, 2023 Incyte (Nasdaq:INCY) reported that multiple abstracts from across its oncology portfolio will be presented during the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, held April 14-19, in Orlando, Florida (Press release, Incyte, MAR 14, 2023, View Source [SID1234628735]).

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As Incyte continues to advance research in areas where we believe we can have the biggest impact for patients, we look forward to sharing new pre-clinical and clinical data from our expansive oncology portfolio at this year’s AACR (Free AACR Whitepaper)," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Notably, a plenary session will feature data on pemigatinib in previously-treated solid tumors with activating FGFR1–3 alterations, and five-year results from the L-MIND study of tafasitamab (Monjuvi) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will be highlighted in a late-breaking oral presentation."

Key abstracts from Incyte-sponsored and partner programs include:

Oral Presentation in a Plenary Session

Pemigatinib

Clinical and Translational Findings of Pemigatinib in Previously Treated Solid Tumors with Activating FGFR1–3 Alterations in the FIGHT-207 Study (Abstract #CT016. Session: Novel Biomarker-Driven Molecularly Targeted Therapy Trials. Tuesday, April 18, 2023, 10:15 a.m. – 10:30 a.m. ET)

Oral Presentation

INCB123667 (CDK2)

Development of a CDK2-Selective Small Molecule Inhibitor INCB123667 for the Treatment of CCNE1hi Breast Cancers (Abstract #1143. Session: Small Molecule Therapeutic Agents. Sunday, April 16, 2023, 3:52 p.m. – 4:07 p.m. ET)

Tafasitamab

Five-Year Safety and Efficacy of Tafasitamab in Patients with Relapsed or Refractory DLBCL: Final Results from the Phase 2 L-MIND Study1 (Abstract #CT022. Session: Novel Clinical Trials for Hematological Malignancies. Sunday, April 16, 2023, 3:20 p.m. – 3:30 p.m. ET)

Poster Presentations

INCA33890 (PD-1×TGFbR2)

INCA33890, a Novel PD-1×TGFbR2 Bispecific Antibody Conditionally Antagonizes TGF Signaling in Primary Immune Cells Co-expressing PD-1 (Abstract #2936. Session: Therapeutic Antibodies 2. Monday, April 17, 2023, 1:30 p.m. – 5:00 p.m. ET)

INCB098377 (PI3Kδ)

Discovery of INCB098377: a Potent Inhibitor of Phosphoinositide 3-Kinase-Gamma (Abstract #5162. Session: Modifiers of the Tumor Microenvironment. Tuesday, April 18, 2023, 1:30 p.m. – 5:00 p.m. ET)

LIMBER (MPN)

A Phase 1 Study of Ruxolitinib in Combination with Abemaciclib for Patients with Primary or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Abstract #CT242. Session: Phase 1 and First-in-Human Clinical Trials in Progress. Tuesday, April 18, 2023, 1:30 p.m. – 5:00 p.m. ET)

Preclinical Characterization of the BET Inhibitor, INCB057643, in Combination with Ruxolitinib for Treatment of Myeloproliferative Neoplasms (MPN) (Abstract #6274. Session: Epigenetics. Wednesday, April 19, 2023, 9:00 a.m. – 12:30 p.m. ET)

Pemigatinib

Drug Combination Screen Identifies Pemigatinib, an FGFR Inhibitor, as a Mechanism to Overcome KRASG12C Inhibitor Resistance in Lung Cancer (Abstract #412. Session: Drug Resistance in Molecular Targeted Therapies 2. Sunday, April 16, 2023, 1:30 p.m. – 5:00 p.m. ET)

Pemigatinib, an FGFR Inhibitor, Overcomes Resistance to KRASG12C Inhibitors in Mesenchymal-Like NSCLC Tumors (Abstract #430. Session: Drug Resistance in Molecular Targeted Therapies 2. Sunday, April 16, 2023, 1:30 p.m. – 5:00 p.m. ET)

P-Selectin Glycoprotein Ligand-1

P-Selectin Glycoprotein Ligand-1 Modulates the Functions of Human T Cells and Macrophages in Vitro (Abstract #6373. Session: Immune Checkpoints. Wednesday, April 19, 2023, 9:00 a.m. – 12:30 p.m. ET)

Tafasitamab

Combination of BTK Inhibitor Orelabrutinib, Anti-CD19 Antibody Tafasitamab, and IMiD Lenalidomide for the Treatment of B Cell Malignancies2 (Abstract #4013. Session: Tyrosine Kinase and Phosphatase Inhibitors 1. Tuesday, April 18, 2023, 9:00 a.m. – 12:30 p.m. ET)

Preclinical Study of CD19 Detection Methods Using Monoclonal Antibodies Post Tafasitamab Treatment1 (Abstract #6329. Session: Anticancer Immunotherapeutics. Wednesday, April 19, 2023, 9:00 a.m. – 12:30 p.m. ET)

Zilurgisertib

Clinical Trial Simulation to Inform Dose Selection of Zilurgisertib, an ALK2 inhibitor, in Patients with Anemia Due to Myelofibrosis (MF) (Abstract #CT243. Session: Phase 1 and First-in-Human Clinical Trials in Progress. Tuesday, April 18, 2023, 1:30 p.m. – 5:00 p.m. ET)

For registered attendees, the virtual meeting platform and all on-demand sessions will be available through July 19, 2023. More information regarding the AACR (Free AACR Whitepaper) Annual Meeting 2023 can be found at View Source

About Pemazyre (pemigatinib)
Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test3. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States, Europe and Japan.

Pemazyre is a trademark of Incyte Corporation.

About Tafasitamab (Monjuvi / Minjuvi)
Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name MONJUVI in the U.S., and marketed by Incyte under the brand name Minjuvi in Europe and Canada.

XmAb is a registered trademark of Xencor, Inc.

About Jakafi (ruxolitinib)
Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older3.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

On March 14, 2023 Strand Therapeutics, the programmable mRNA company developing curative therapies for cancer and other diseases, reported the details of its poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, being held from April 14 – 19, 2023 in Orlando, Florida (Press release, Strand Therapeutics, MAR 14, 2023, View Source [SID1234628734]).

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Strand will present preclinical data from its lead programmable mRNA candidate STX-001, a multi-modal synthetic self-replicating mRNA technology that delivers a prolonged and locally-acting IL-12 cytokine to the tumor microenvironment. STX-001, when delivered directly to the tumor, induces a highly immunogenic tumor cell death while the mRNA-encoded IL-12 payload promotes recruitment of effector T cells and NK cells into the tumor microenvironment.

Details of the presentation are as follows:

Presentation Title: STX-001, a locally administered LNP-formulated self-replicating mRNA that encodes the therapeutic payload IL-12, induces deep systemic immune responses to solid tumors

Session Category: Experimental and Molecular Therapeutics

Session Title: Gene and Vector-based Therapy

Session Date and Time: Monday Apr 17, 1:30 PM – 5:00 PM ET

Location: Orange County Convention Center, Orlando, Florida, Poster Section 16

Poster Board Number: 2

Permanent Abstract Number: 2731

The full text of the abstract will be published to the AACR (Free AACR Whitepaper) Online Program Planner at 4:30 PM ET on Tuesday, March 14. The abstract will also be published in an online-only supplement to the AACR (Free AACR Whitepaper) journal Cancer Research on Friday, March 31. Additional meeting information is available on the AACR (Free AACR Whitepaper) website.

On March 14, 2023 AbCellera (Nasdaq: ABCL) reported two upcoming poster presentations on its T-cell engager platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, to be held at the Orange County Convention Center in Orlando, Florida, from April 14 to 19 (Press release, AbCellera, MAR 14, 2023, View Source [SID1234628733]).

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AbCellera will present the complete characterization of its panel of differentiated CD3-binding antibodies and demonstrate how it enables customized design of T-cell engagers for cancer targets. Additionally, AbCellera will present data on the discovery and characterization of antibodies against MAGE-A4, a validated peptide-MHC (pMHC) target for cancer treatment. Together, these two presentations illustrate how AbCellera’s CD3 panel integrates with its antibody discovery and development engine to streamline T-cell engager development.

Details on AbCellera’s poster presentations at AACR (Free AACR Whitepaper) are as follows:

Title: Identifying T-cell engagers with optimal potency and cytokine-release profiles with a diverse panel of CD3-binding antibodies
Abstract Number: 1886
Date and Time: Monday, April 17 from 9:00 a.m. to 12:30 p.m. ET

Title: Breaking barriers to access intracellular targets with T-cell engagers: Discovery of diverse, developable, and ultra-specific antibodies against a MAGE-A4 pMHC
Abstract Number: 1891
Date and Time: Monday, April 17 from 9:00 a.m. to 12:30 p.m. ET

On March 14, 2023 Orum Therapeutics, Inc. ("Orum"), a private biotechnology company pioneering the development of tumor-directed targeted protein degraders (TPDs), reported that it will present new preclinical data for its ORM-5029, ORM-6151, and PD-1-Cbl-b programs in three separate presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 taking place April 14-19 in Orlando (Press release, Orum Therapeutics, MAR 14, 2023, View Source [SID1234628732]).

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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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ORM-5029 is a potential first-in-class targeted protein degrader therapy currently in a Phase 1 clinical trial for HER2-expressing breast cancer. ORM-6151 is currently in the IND-enabling stage for CD33-positive hematologic malignancies, such as acute myeloid leukemia (AML). Orum’s PD-1-Cbl-b immuno-oncology program utilizes a novel approach designed to deliver proprietary Cbl-b inhibitors specifically to PD-1-expressing exhausted T cells, while blocking PD-1/PD-L1 interaction. This strategy is expected to limit systemic exposure of Cbl-b inhibitors and minimize c-Cbl inhibition that can lead to off-target toxicity.

Presentation Details

Poster Title: Development of RNAscope multiplex-based assay for exploratory pharmacodynamic biomarkers assessment in breast cancer patients from Phase I clinical trial of ORM-5029, a potent GSPT1 degrader
Date and Time: Monday April 17, 9:00 AM – 12:30 PM ET
Session Category: Clinical Research Excluding Trials
Session Title: Biomarkers for Elucidation of Tumor Biology and Metastasis
Session Location: Section 38
Poster Board Number: 21
Abstract number: 2118

Poster Title: ORM-6151: A first-in-class CD33-antibody enabled GSPT1 degrader for AML
Date and Time: Monday, April 17, 1:30PM – 5:00PM ET
Session Category: Experimental and Molecular Therapeutics
Session Title: Drug Delivery Systems
Session Location: Section 15
Poster Board Number: 3
Abstract number: 2700

Poster Title: A novel antibody-enabled dual precision targeted protein stabilization (TPS²) that augments anti-tumor immune response by targeting CBL-B inhibitor to exhausted T cells while blocking checkpoint molecule, PD-1
Date and Time: Tuesday Apr 18, 9:00 AM – 12:30 PM ET
Session Category: Clinical Research Excluding Trials
Session Title: Immunomodulatory Agents and Interventions
Session Location: Section 40
Poster Board Number: 22
Abstract number: 4436

About Orum’s GSPT1 Platform Using the TPD² Approach

Orum’s GSPT1 platform uses the company’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach to build novel targeted protein degraders combined with the precise tumor cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-specific TPDs for the treatment of cancer. Orum has developed new molecular glue degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to cancer cells and degrade the intracellular target protein GSPT1 and cause tumor cell death.

About Orum’s TPS² Approach

Orum’s Dual-precision Targeted Protein Stabilization (TPS²) approach combines novel targeted protein inhibitors with the precise cell delivery mechanism of antibodies to increase the levels of intracellular target proteins in a cell-type-specific manner for oncology and immuno-oncology. The first program applying the TPS² approach is a Cbl-b inhibitor (Cbl-bi) conjugated to anti-PD-1 antibody. By delivering Cbl-bi specifically to exhausted T cells, the conjugate restores effector T cell function where PD-1 checkpoint blockade alone is insufficient, while also enabling T cells to overcome the immunosuppressive mechanisms in a tumor microenvironment.