On March 8, 2022 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported several poster presentations at upcoming scientific conferences that support the ongoing investigation of its clinical and preclinical pipeline (Press release, Arcus Biosciences, MAR 8, 2022, View Source [SID1234609708]).

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"Scientific exchange fosters progress in research, and we value the opportunity to contribute to the advancement of cancer research by presenting early data that support the clinical approach to investigating our molecules," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. "The AB521 data presented at the ESMO (Free ESMO Whitepaper) TAT Congress confirm its potential to have an improved clinical profile compared to that of the approved HIF-2a inhibitor; we plan to advance this molecule into a Phase 1/1b study in patients with clear-cell renal cell carcinoma in mid-2022. Etrumadenant, quemliclustat and zimberelimab are already being investigated in randomized and late-stage studies across common cancers like colon, lung, pancreas and prostate."

ESMO Targeted Anticancer Therapies Congress, March 7-8, 2022

Title: AB521, a Clinical-Stage, Potent, and Selective Hypoxia-Inducible Factor (HIF)-2α Inhibitor, for the Treatment of Renal Cell Carcinoma
Abstract number: 252

American Society for Clinical Pharmacology & Therapeutics (ASCPT), March 16-18, 2022

Title: A Mechanistic Pharmacokinetic-Pharmacodynamic (PK-PD) Model of Quemliclustat (AB680), a Small-Molecule Inhibitor of CD73, in Healthy Volunteers and Patients with Gastrointestinal Malignancies
Abstract number: P-102

Title: Population Pharmacokinetics and Pharmacodynamics of Etrumadenant (AB928) in Healthy Volunteers and Cancer Patients
Abstract number: P-196

Title: Population Pharmacokinetics of Zimberelimab (AB122) and Dose Justification by Model Informed Drug Development (MIDD) Approach
Abstract number: P-032

American Association for Cancer Research, April 8-13, 2022

Title: Inhibition of CD39 Results in Elevated ATP and Activation of Myeloid Cells to Promote Anti-Tumor Immunity
Abstract number: 4151

Title: Dual A2aR/A2bR Antagonism with Etrumadenant (AB928) Eliminates the Suppressive Effects of Adenosine on Immune and Cancer Cells in the Tumor Microenvironment
Abstract number: 2728

Title: HPK1 Inhibition Enhances T Cell Activation and Relieves the Immunosuppressive Phenotype of Inhibitory Signals Found in the Tumor Microenvironment
Abstract number: 5762

Arcus Clinical Study Overview

Trial
Name

Arms

Setting

Status

NCT No.

Lung Cancer

ARC-7

zim vs. zim + dom vs. zim +
dom + etruma

1L NSCLC (PD-L1 ≥ 50%)

Ongoing
Randomized
Phase 2

NCT04262856

PACIFIC-8

durva ± dom

Curative-Intent Stage 3 NSCLC

Ongoing
Registrational
Phase 3

NCT05211895

ARC-10

chemo vs. zim vs. zim + dom

1L NSCLC (PD-L1 ≥ 50%)

Ongoing
Registrational
Phase 3

NCT04736173

Colon Cancer

ARC-9

etruma + zim + mFOLFOX vs.
SOC

2L/3L/3L+ CRC

Ongoing
Randomized
Phase 2

NCT04660812

Pancreatic Cancer

ARC-8

quemli + zim + gem/nab-pac
vs. quemli + gem/nab-pac

1L, 2L PDAC

Ongoing
Randomized
Phase 1/1b

NCT04104672

Prostate Cancer

ARC-6

etruma + zim + SOC vs. SOC

2L/3L CRPC

Ongoing
Randomized
Phase 2

NCT04381832

Various

ARC-12

AB308 + zim

Advanced Malignancies

Ongoing
Phase 1/1b

NCT04772989

ARC-14

AB521

Healthy Volunteer

Ongoing
Phase 1

NCT05117554

Carbo/pem: carboplatin/pemetrexed; dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; quemli: quemliclustat; R/R: relapsed/refractory; SOC: standard of care; zim: zimberelimab CRC: colorectal cancer; CRPC: castrate-resistant prostate cancer; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma

On March 8, 2022 Scorpion Therapeutics, Inc. ("Scorpion Therapeutics"), a pioneering oncology company redefining the frontier of precision medicine through its Precision Oncology 2.0 strategy, reported that it will share preclinical proof-of-concept data for STX-H1047-PI3Kα, its lead program targeting the H1047X-mutant form of phosphoinositide 3-kinase alpha ("PI3Kα"), in a late-breaking poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2022 in New Orleans, Louisiana, taking place April 8 – 13, 2022 (Press release, Scorpion Therapeutics, MAR 8, 2022, View Source [SID1234609707]).

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"We are excited to present preclinical data demonstrating the potentially best-in-class profile of our lead program, STX-H1047-PI3Kα. PI3Kα is an established cancer target and one of the most highly mutated targets in cancer. However, approved therapeutic options are limited by significant metabolic side effects and an inability to treat tumors that have progressed into the central nervous system," said Axel Hoos, M.D., Ph.D., CEO of Scorpion Therapeutics. "Consistent with our Precision Oncology 2.0 strategy, we designed STX-H1047-PI3Kα to specifically address these limitations, in hopes of delivering safer and more effective medicines to patients living with certain solid tumors. We look forward to informing the oncology community of our progress during AACR (Free AACR Whitepaper), as we work towards submitting an investigational new drug application for STX-H1047-PI3Kα in 2023."

Details of the poster presentation are as follows:

Presentation Title: Discovery and Characterization of a Mutant Selective PI3KαH1047X Inhibitor with a Best-In-Class Profile
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Abstract Number: LB194
Poster Board Number: 7
Date & Time: Wednesday, Apr 13, 2022 at 9:00 a.m. – 12:30 p.m. CT (10:00 a.m. – 1:30 p.m. ET)
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 16

The abstract and poster presentation will be published online at 12:00 p.m. CT (1:00 p.m. ET) on April 8, 2022 on the AACR (Free AACR Whitepaper) website at www.aacr.org.

On March 8, 2022 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that two abstracts highlighting data from two oncology drug candidates in its pipeline will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 to be held April 8 – 13, 2022 (Press release, MEI Pharma, MAR 8, 2022, View Source [SID1234609706]).

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Details of the poster presentations:

Title: Efficacy and immune profiling of the PI3K delta inhibitor zandelisib (ME-401) in a preclinical model of chronic lymphocytic leukemia (CLL)
Authors: Dr. Maharaj, et. al.
Date: Friday, April 8, 2022, 8:30 AM ET
Abstract ID: 5496

Summary of results: data from preclinical studies with zandelisib ex vivo in normal human T cells and in vivo in a murine CLL model suggest that zandelisib has immunomodulatory properties on human T cells including decreased activation and expression of suppressive markers such as PD-1 and CTLA-4 on inducible regulatory (Tregs) and CD4+ T cells. In the murine CLL model, a reduction in Treg numbers, markers of terminal memory differentiation and T-cell exhaustion on CD4+ and CD8+ T cells, as well as improvement in overall survival was observed.

Title: ME-344, a novel isoflavone mitochondrial inhibitor, in combination with venetoclax constitutes a new metabolism-targeted approach to overcome resistance to Bcl-2 inhibition and standard of care treatment in AML
Authors: Katie Hurrish, et. al.
Date: Wednesday, April 13, 2022, 10:00 AM – 1:30 PM ET
Abstract ID: 3785

Summary of results: data from in vitro and in vivo preclinical studies evaluating the combination of ME-344 with venetoclax in standard-of-care-resistant acute myeloid leukemia (AML) cell lines and relapsed or refractory (R/R) AML patient samples suggest that ME-344, both alone and in combination with venetoclax, inhibits purine biosynthesis, suppresses oxidative phosphorylation, induces apoptosis and decreases Mcl-1, which together target metabolic vulnerabilities of AML cells.

On March 8, 2022 Gennao Bio, a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, reported that an abstract reporting preclinical results of its proprietary, non-viral gene monoclonal antibody (GMAB) platform technology has been selected for an oral presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting, taking place April 8 – 13, 2022 in New Orleans, LA (Press release, Gennao Bio, MAR 8, 2022, View Source [SID1234609705]). Gennao’s GMAB platform utilizes a novel, cell-penetrating antibody to non-covalently form complexes with and systemically target and deliver effective levels of nucleic acids, including immune-stimulating synthetic RNA, to solid tumors.

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The details of the oral presentation are as follows:

Title: Systemic targeting of therapeutic RNA to cancer via a novel, cell-penetrating and nucleic acid binding, monoclonal antibody
Abstract Control Number: 6710
Session Title: Immune Checkpoint and Immune Modulatory Therapy
Session Type: Minisymposium
Session Date and Time: Sunday, April 10, 2022; 3:00 p.m. – 5:00 p.m. Central Daylight Time
Presenter: Elias Quijano, Yale School of Medicine

On March 8, 2022 Sengenics reported the commercial launch of the i-Ome Protein Array Kit (Press release, Sengenics, MAR 8, 2022, View Source [SID1234609704]). The i-Ome Protein Array Kit contains slide-based, high density protein microarrays, comprised of 1600+ immobilized, full-length, correctly folded human proteins. The new product brings the KREX technology within reach to deliver a best-in-class autoantibody discovery tool and to enable researchers focused on autoantibody biomarker identification in the autoimmune disease, immuno-oncology and neuroinflammation fields.

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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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"The Sengenics i-Ome Protein Array Kit offers greater access to exceptional autoantibody discovery power and operating efficiency, unlocking highly multiplexed applications," said Dr. Arif Anwar, Sengenics CEO. "Bearing in mind our customers’ needs, Sengenics reimagined the kit with innovative solutions that extend the unmatched accuracy and reproducibility of KREX technology to fuel more in-depth research across the autoimmune, immuno-oncology and neurology fields."