On May 26, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the publication of two abstracts on neratinib to be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Puma Biotechnology, MAY 26, 2022, View Source [SID1234615136]). The ASCO (Free ASCO Whitepaper) Annual Meeting will be held in person at McCormick Place in Chicago, Illinois, and online from June 3 – 7, 2022. The corresponding abstracts of the two posters that Puma will be presenting are now live on the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting website. The full posters will be available on the Puma website following the presentations.

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Full abstracts of the following posters are available online at: ASCO (Free ASCO Whitepaper).org/abstracts.

Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Abstract 4079: Targeting HER2 mutation-positive advanced biliary tract cancers with neratinib: final results from the phase 2 SUMMIT ‘basket’ trial
JJ Harding, S Piha-Paul, RH Shah, JM Cleary, D Quinn, I Braña, V Moreno, M Borad, S Loi, I Spanggaard, J Ford, D DiPrimeo, MF Berger, LD Eli, F Meric-Bernstam, DB Solit, GK Abou-Alfa
Presenter: James J. Harding, MD | Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College
Date/Time: June 4, 2022, at 9:00 am ET
Poster Session: Breast Cancer—Metastatic

Abstract 1028: Neratinib plus fulvestrant plus trastuzumab (N+F+T) for hormone receptor-positive (HR+), HER2-negative, HER2-mutant metastatic breast cancer (MBC): Outcomes and biomarker analysis from the SUMMIT trial
K Jhaveri, JW Goldman, SA Hurvitz, A Guerrero-Zotano, N Unni, A Brufsky, H Park, J Waisman, ES Yang, I Spanggaard, S Reid, M Burkard, A Prat, S Loi, J Crown, A Hanker, C Ma, R Bose, LD Eli, H Wildiers
Presenter: Komal L. Jhaveri, FACP, MD | Memorial Sloan Kettering Cancer Center
Date/Time: June 6, 2022, at 9:00 am ET

On May 26, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that the company and its collaborators will present a total of 26 abstracts at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held virtually and in person in Chicago from June 3-7, 2022 (Press release, Foundation Medicine, MAY 26, 2022, View Source [SID1234615135]).

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Presentations focus on the power of genomic research to provide physicians and researchers with the latest insights on innovative treatment strategies for patients, including those with early-stage cancers, and cancers with rare or complex alterations. Highlights of this data include:

Research demonstrating the value of FoundationOneLiquid CDx blood-based comprehensive genomic profiling (CGP) to support physicians in finding the answers they need to make informed treatment decisions for their patients, such as detecting resistance alterations, and to provide researchers with genomic insights to aid in the discovery and utilization of new biomarkers
Several studies from Foundation Medicine researchers and collaborators at prominent cancer institutions highlighting the broad utility of real-world genomic data from the Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) and the FoundationCore Genomic Database. These studies explore:
Opportunities to use these databases to achieve more equity in cancer care, such as using real-world data to reveal ancestry-associated differences in genomic alterations in non-small cell lung cancer (NSCLC)
Areas to bring CGP into earlier stages of disease to assist in curative intent treatment planning or selection
The potential value of the predictive complex biomarkers tumor mutational burden (TMB) and microsatellite instability (MSI) to aid in consideration of first line immunotherapy in metastatic endometrial cancer
The ability of diverse MET alterations to support treatment planning in NSCLC
"At Foundation Medicine, we provide doctors and researchers with tools to help them find answers and take action on treatment options for patients across cancer types and stages. At this year’s ASCO (Free ASCO Whitepaper), we will demonstrate the expanded capacity of our tests to detect actionable complex biomarkers and alterations in earlier stages of cancer to support care decisions for patients," said Priti Hegde, PhD, chief scientific officer at Foundation Medicine. "We are proud of our many collaborations on this research with partners across the oncology community. These collaborations reinforce Foundation Medicine’s role as an essential partner with the scientific expertise and real-world data to support efficient progress for equitable patient care."

The Value of Liquid Biopsy in Identifying Actionable Alterations

LCMC LEADER neoadjuvant screening trial: LCMC4 evaluation of actionable drivers in early stage lung cancers. Abstract #TPS8596.

In collaboration with the Lung Cancer Research Foundation, the Lung Cancer Mutation Consortium, and Memorial Sloan Kettering Cancer Center, this Trial in Progress abstract details the umbrella trial design of the LCMC4 Evaluation of Actionable Drivers in EaRly-Stage Lung Cancer (LEADER) clinical trial. Foundation Medicine’s tissue-based CGP test, FoundationOneCDx, and its blood-based CGP test, FoundationOneLiquidCDx, will both be used in the LEADER trial to screen for 10 actionable driver mutations in 1,000 patients with high-risk, resectable NSCLC who are candidates for neoadjuvant therapy. Results will enable selection of neoadjuvant therapy and enrollment onto independent therapeutic trials with genomically matched neoadjuvant treatment, standard therapies, or other trials if no driver is detected.

CtDNA shed as a tool to select immune checkpoint inhibitors (ICPI) with or without chemotherapy for patients (pts) with advanced non-small cell lung cancer (aNSCLC). Abstract #9045.

Using the CGDB, this study with Gustave Roussy Cancer Center investigated circulating tumor DNA (ctDNA) shed as an indicator to support treatment selection for patients with advanced NSCLC. Researchers found that elevated plasma tumor fraction (TF) can identify patients at risk of early progression on immune checkpoint inhibitors (ICPI) who may benefit from chemotherapy in addition to an ICPI. In patients with low/intermediate TF, the study found that outcomes on ICPIs alone are similar to those receiving both chemotherapy and ICPI treatment, suggesting TF’s ability as a non-invasive tool to identify patients for single-agent ICPI.

Genomic landscape of acquired resistance to targeted therapies in patients with solid tumors: a study from the National Center for Precision Medicine (PRISM). Abstract #3016.

Researchers from Gustave Roussy Cancer Center and Institut Bergonié set up a study using FoundationOneLiquid CDx to detect ctDNA in an effort to characterize the landscape of secondary resistance mechanisms in patients with solid tumors. While many targeted therapies are approved for treatment in solid tumors, acquired resistance to these therapies remains as a barrier limiting the ultimate effectiveness of these treatments. Researchers reported that polyclonal secondary genomic alterations represent a frequent clinical resistance mechanism that may explain the low rate of sustained complete remission for patients treated with targeted therapies.

The Power of Real-World Genomic Data to Shape the Future of Cancer Care

A real-world (rw) evidence study quantifying the clinical value of multi-gene testing in early-stage lung adenocarcinoma (LUAD). Abstract #8525.

In collaboration with Cleveland Clinic Cancer Center and Flatiron Health, this study used the CGDB to assess the potential value of CGP in early-stage lung adenocarcinoma (LUAD). Researchers found that CGP of early-stage LUAD can identify EGFR, ALK, ROS1, RET and other drivers and enable appropriate selection of targeted therapies and timely use of effective first line therapy at recurrence. By avoiding the use of ICPIs in patients unlikely to respond, CGP could represent a way to avoid ineffective treatment and risk of tyrosine kinase inhibitor (TKI)-associated toxicity.

Biomarker associations of immune checkpoint inhibitor versus chemotherapy effectiveness in first-line metastatic endometrial carcinomas: A real-world study. Abstract #5596.

Using real world data from the CGDB, this study in partnership with the Yale School of Medicine evaluated TMB greater than 10 mutations per megabase and MSI-high as predictive biomarkers for ICPI benefit in comparison to standard of care chemotherapy in first line metastatic endometrial cancer (mEC). More favorable time to next treatment and overall survival were observed on ICPI versus chemotherapy in first line treatment among those with high TMB and/or MSI-high, but not those without. The results of this study suggest that a randomized controlled trial in this setting using these biomarkers has a favorable chance of success to develop a chemotherapy-sparing first line option for patients with mEC.

Clinical and genomic characteristics of pts with durable benefit from immune checkpoint inhibitors (ICPI) in advanced non-small cell lung cancer (aNSCLC). Abstract #9048.

In collaboration with Dana-Farber Cancer Institute, this study queried the CGDB to better understand patients with advanced NSCLC who had a durable response to ICPIs. The two-year mark has increasingly become a milestone in progression-free patients with advanced NSCLC, with a subset experiencing ongoing disease control even after discontinuing active treatment. In a cohort of 4,030 advanced NSCLC patients, 4.6% were free of progression or treatment failure at 24 months, with a median overall survival of almost 5 years. 41% of those patients stopped immunotherapy usage before the two-year mark. Researchers also found that elevated TMB was associated with durable benefit on ICPIs, as well as prolonged progression-free survival after the 2-year mark and deserves further investigation as a biomarker for prolonged benefit from ICPIs in advanced NSCLC.

Ancestry-based differences in gene alterations in non-small cell lung cancer: Real-world data using genetic ancestry analysis. Abstract #9125.

In this study, researchers investigated alteration prevalence in a large real-world NSCLC cohort, stratified by genetic ancestry. Together with Juntendo University Graduate School of Medicine and others, the study looked at FoundationCore, Foundation Medicine’s robust real-world dataset, to reveal ancestry-associated differences in genomic alterations in NSCLC. Age and sex were also associated with differences in prevalence of gene alterations and immunotherapy-associated biomarkers, such as high TMB status.

Real-world (rw) analysis of quantitative MET copy number (CN) as a biomarker in advanced NSCLC (aNSCLC). Abstract #9123.

Researchers used real-world data from the CGDB to explore the genomic landscape of MET amplification in NSCLC and its association with outcomes to MET TKIs. In partnership with the University of Colorado, CGP results from 64,521 tissue and 5,177 blood-based NSCLC samples were queried for MET amplification, which was detected in 3.3% of tissue samples and 3.2% of high TF blood samples. MET amplification was found to be associated with response to MET TKIs. In TKI-naïve patients, MET copy number was negatively correlated with the presence of a concurrent NSCLC driver, suggesting that further studies evaluating MET copy number as a predicative biomarker for MET TKIs, and as an indicator of MET dependence to aid therapy section, are warranted.

Activating MET kinase domain mutations define a novel molecular subtype of non-small cell lung cancer that is clinically targetable with the MET inhibitor elzovantinib (TPX-0022). Abstract #9124.

In this study conducted in partnership with Dana-Farber Cancer Institute and Turning Point Therapeutics, researchers investigated a novel, actionable subtype of NSCLC characterized by activating MET tyrosine kinase domain (MET-TKD) mutations in the absence of METex14 mutations. Looking at a multi-institutional dataset of cancers that underwent genomic profiling, including FoundationCore, researchers found that potentially actionable MET-TKD mutations represent a novel genomic subtype in 0.6-0.9% of NSCLC and occur in the absence of other known drivers in a subset of cases.

The following is a list of select abstracts that will be presented at the meeting. To access all abstracts being presented by Foundation Medicine and its collaborators, please visit: meetinglibrary.asco.org.

On May 26, 2022 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported a Trials in Progress poster that is being presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Aulos Bioscience, MAY 26, 2022, View Source [SID1234615134]). The poster showcases the study design for the company’s first-in-human Phase 1/2 trial of AU-007 that is currently enrolling patients in Australia. AU-007 is a human monoclonal antibody computationally designed by Biolojic Design, with a highly differentiated approach to harnessing the power of interleukin-2 (IL-2) to eradicate solid tumors.

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"AU-007 stands apart with a mechanism of action that is entirely different from every other IL-2 therapeutic in development," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "This Phase 1/2 study is the first time that a computationally designed human monoclonal antibody has been tested in humans. By addressing the IL-2 negative feedback loop, we believe AU-007 could potentially subdue immune suppression and prevent the toxic side effects of IL-2, leading to a novel treatment for solid tumor cancers."

The Trials in Progress poster describes how AU-007 can bind human IL-2 with picomolar affinity and precisely block IL-2’s binding to CD25, without hindering IL-2’s binding to CD132/CD122. Through this unique mechanism of action, AU-007 can transform the IL-2 negative feedback loop into a positive one, tipping the balance toward immune activation and away from immune suppression. Recently released preclinical data of murine models demonstrate that redirected IL-2 signaling by AU-007 can lead to significant tumor growth inhibition, and complete MC38 colorectal tumor elimination when AU-007 is dosed in combination with checkpoint inhibitors.

The company’s Phase 1/2 trial (NCT05267626) is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Phase 1 consists of three dose escalation arms evaluating AU-007 either as a monotherapy, in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin administered once every two weeks. The Phase 2 portion of the trial evaluates a dosing regimen selected from dose escalation for expansion in specified tumor types to further define the safety and initial efficacy of AU-007. Dosing of patients commenced in May, and preliminary data from the Phase 1 portion of the clinical trial is expected by late 2022.

The Trials in Progress poster is available to meeting registrants as an e-poster on the ASCO (Free ASCO Whitepaper) Annual Meeting website and will be presented live in the Trials in Progress poster session "Developmental Therapeutics—Immunotherapy" on Sunday, June 5, 2022, 8:00 a.m. to 11:00 a.m. CDT.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

On May 26, 2022 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and biologic cancer therapeutics, reported new data from the ongoing Phase 1b clinical trial studying RGX-202-01 in combination with FOLFIRI and bevacizumab (FOLFIRI/BEV) in second-line advanced colorectal cancer (CRC) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3-7 in Chicago, Illinois (Press release, Inspirna, MAY 26, 2022, View Source [SID1234615133]).

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"These exciting new data show the potential of RGX-202-01 to drive meaningful responses in patients with advanced or metastatic colorectal cancer, especially in the KRAS mutant setting where there is a clear opportunity to improve on the standard of care," said Andrew Hendifar, M.D., Assistant Professor at Cedars-Sinai Medical Center and principal investigator on the study. "RGX-202-01 employs a novel mechanism by inhibiting SLC6a8, part of a pathway that becomes activated by colorectal cancer cells in order for these cells to survive, proliferate, and metastasize. Importantly, along with its preliminary signal of efficacy, these results also demonstrate that RGX-202-01 is very well-tolerated, enabling it to be combined with FOLFIRI/BEV and provide further optionality in this difficult-to-treat indication."

RGX-202-01 is an oral, potential first-in-class small molecule inhibitor of SLC6a8, a creatine transporter that drives colorectal cancer and certain other cancers’ progression. It is currently being evaluated in a Phase 1b dose escalation and expansion study in combination with FOLFIRI/BEV in second-line, advanced or metastatic CRC. The primary endpoint of the study is to determine maximum tolerated dose (MTD), overall response rate (ORR), and treatment-emergent adverse events (TEAEs). In the dose escalation stage of the study, two dose levels of RGX-202-01 with FOLFIRI/BEV have been evaluated in patients with advanced or metastatic CRC who have progressed on available oxaliplatin based first line therapy. In the ongoing expansion stage, additional patients with CRC are being treated at the dose of 3000mg PO BID to provide further characterization of the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the treatment.

Key findings to be presented at ASCO (Free ASCO Whitepaper) 2022:

The data cutoff for the presentation is April 28, 2022. As of data cutoff, 19 patients were enrolled in the study, including eight total patients in the dose escalation stage treated with either 2400mg twice daily (BID) of RGX-202-01 plus FOLFIRI/BEV (n = 4) or 3000mg BID RGX-202-01 plus FOLFIRI/BEV (n = 4), and 11 patients treated in the expansion stage with 3000mg BID RGX-202-01 plus FOLFIRI/BEV.
The dose escalation stage did not reach an MTD.
No dose limiting toxicities (DLT) were observed at either 2400mg BID or 3000mg BID doses.
There were only two Grade 4 TEAEs, and one of those was considered unrelated to treatment with RGX-202-01, and no Grade 5 TEAEs were observed.
17 patients were evaluable for response per RECIST v1.1 at data cutoff, of which 10 patients had KRAS mutant tumors and seven patients had KRAS wild-type tumors.
In the KRAS mutant population, five patients (50%) had confirmed partial responses (PR) and five patients (50%) had stable disease (SD).
In the KRAS wild-type population, one patient (14%) had an unconfirmed PR, five patients (71%) had SD, and one patient (14%) had progressive disease (PD).
Preliminary median progression-free survival (mPFS) was 11.8 months in the enrolled patients with KRAS mutant tumors.
Tumor regression was observed to deepen over time in patients with KRAS mutant tumors, with first radiographic achievement of PR appearing as late as 40 weeks post-treatment induction.
Overall, results show ORR and mPFS exceed expected benefit with standard-of-care alone in second-line CRC.
"We are very encouraged by the data reported today showing a strong signal of activity and meaningful responses, especially in patients harboring KRAS mutant tumors," said Masoud Tavazoie, M.D., Ph.D., Chief Executive Officer of Inspirna. "The results not only support our efforts to continue advancing RGX-202-01 in CRC, but also validate the ability of our RNA-DRIVEr platform to discover and develop new drug candidates with the potential to address cancers of high unmet medical need. We look forward to sharing these results at ASCO (Free ASCO Whitepaper) and further advancing RGX-202-01 drug development."

The abstract is available for viewing on the ASCO (Free ASCO Whitepaper) website, and the poster will be available at View Source following the session.

Poster Presentation Details

Title: Phase 1b study of RGX-202-01, a first-in-class oral inhibitor of the SLC6A8/CKB pathway, in combination with FOLFIRI and bevacizumab (BEV) in second-line advanced colorectal cancer (CRC)

Date and time: Saturday, June 4, 2022, 8:00 a.m. CDT

Session: Gastrointestinal Cancer—Colorectal and Anal

Abstract ID: 3579

On May 6, 2022 Pionyr Immunotherapeutics, Inc., a company developing first-in-class Myeloid TuningTM antibody therapeutics that enhance the body’s antitumor immunity by altering, or "tuning," immune cells within the tumor microenvironment, reported that PY314, a monoclonal antibody targeting TREM2 (triggering receptor expressed on macrophages 2), was safe and well-tolerated in a Phase 1a dose-escalation study as a single agent and in combination with pembrolizumab at its label-approved dose (Press release, Pionyr Immunotherapeutics, MAY 26, 2022, View Source [SID1234615132]). A maximum tolerated dose (MTD) was not observed over the range of PY314 doses tested and a dose for study expansion was recommended based on an analysis of clinical data (including PK exposure) in the context of supportive preclinical data models. The study will be featured in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 3-7 virtually and in Chicago.

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"Pionyr developed PY314 to precisely bind human TREM2 and retune the tumor microenvironment by driving the selective depletion of TREM2 positive tumor-associated macrophages. Removing these macrophages shifts the balance of myeloid cells towards more pro-inflammatory populations and is expected to increase and promote anti-tumor immune responses," said Leonard Reyno, EVP and Chief Medical Officer of Pionyr Immunotherapeutics. "We have applied what we have learned from the Phase 1a study to identify a recommended dose for Phase 1b expansion studies. We have already begun enrolling patients in these studies and expect to have new data this year and into 2023."

Safety and Tolerability as a Monotherapy and in Combination with Pembrolizumab Support Additional Clinical Studies

The Phase 1a dose-escalation study of PY314 was a non-randomized, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PY314 as a single agent and in combination with checkpoint inhibitor pembrolizumab in 28 subjects with advanced solid tumors. Dosing was intravenous and administered once every three weeks. Four predefined dose levels of PY314 were delivered both as a single agent and in combination with pembrolizumab. No dose-limiting toxicities, drug-related serious adverse reactions, or high-grade treatment-related adverse events (TRAEs) that resulted in treatment discontinuance were seen. Twelve patients experienced at least one TRAE, and these were low-grade in all but one subject who experienced a treatment-related immune system disorder. Eight patients experienced serious adverse events, all unrelated to treatment.

Linear Dose-Response Observed and Recommended Dose for Expansion Studies Determined

PY314 pharmacokinetics were linear and dose-proportional, with a half-life of five to nine days and no evidence of interference by pembrolizumab. The best radiographic response was stable disease, observed in eleven subjects (39.3%), which ranged in duration from nine to 42 weeks. Ten mg/kg PY314 was determined to be the recommended dose for expansion. Five expansion cohorts in patients with metastatic refractory solid tumors (triple-negative or HR-positive HER2 negative metastatic breast cancer, non-small cell lung cancer, renal cell carcinoma, colorectal cancer, ovarian cancer) are enrolling. Information about the ongoing Phase 1b expansion study is available at www.clinicaltrials.gov.

Poster Presentation at ASCO (Free ASCO Whitepaper) 2022

The poster titled, "A Phase 1a Dose Escalation Study of PY314, a TREM2 (Triggering Receptor Expressed on Myeloid Cells 2)-Targeting Monoclonal Antibody," will be featured in a poster session at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting on Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT. The abstract is currently available on the ASCO (Free ASCO Whitepaper) 2022 website here, and the poster will be available on the Pionyr company website here after the completion of the ASCO (Free ASCO Whitepaper) poster session.

About Myeloid TuningTM

Pionyr has developed a therapeutic platform called Myeloid Tuning, a process that rebalances the tumor microenvironment (TME) to promote anti-tumor immunity. Myeloid cells are a type of immune cell and are part of a family of cell types that play an important role in both the activation and suppression of the immune response to cancer.

One such critical type of myeloid cell, tumor-associated macrophages (TAM), are a key component of the TME. TAMs are generally categorized into two functionally contrasting subtypes called M1-like and M2-like macrophages: M1-like typically exerts anti-tumor functions, including directly mediating antibody-dependent cell-mediated cytotoxicity (ADCC) to kill tumor cells; M2-like macrophages can promote the occurrence and metastasis of tumor cells, inhibit T cell-mediated anti-tumor immune response, promote tumor angiogenesis and lead to tumor progression.

Myeloid Tuning TM effectively describes the mechanism of introducing agents that shift the balance of inhibitory myeloid cells – including M2-like TAMs – towards more inflammatory M1-like TAMs to promote anti-tumor immune responses in the TME and destroy solid tumors.

About PY314

PY314 is a humanized IgG1 afucosylated monoclonal antibody, delivered by intravenous infusion, that binds Triggering Receptor Expressed on Myeloid Cells 2 (TREM2) on the surface of immunosuppressive, pro-tumorigenic myeloid cells. It is designed to deplete TREM2-expressing TAMs, leading to productive anti-tumor immunity. Preclinical data generated by Pionyr suggest that when TAMs are depleted from tumors, pro-inflammatory, anti-tumorigenic immune cells such as CD8 T-cells, natural killer (NK), and M1-like macrophages become activated and penetrate tumors leading to tumor destruction. PY314 is currently being evaluated in a Phase 1b dose-expansion study as a single agent and in combination with pembrolizumab (Keytruda) as a treatment for refractory solid tumors and gynecologic cancer, colorectal cancer, lung adenocarcinoma, renal cell carcinoma, triple-negative breast cancer, hormone receptor/growth factor receptor-negative breast cancer, and ovarian cancer.