On November 3, 2023 Ankyra Therapeutics, an emerging clinical stage biotechnology company pioneering anchored immunotherapies to treat cancer, reported data from a preclinical study using ANK-101, an IL-12 anchored therapeutic, in combination with cytotoxic chemotherapy and immune checkpoint blockade, to treat head and neck squamous cell carcinoma, modeled by murine oral carcinoma (MOC1) (Press release, Ankyra Therapeutics, NOV 3, 2023, View Source [SID1234636931]). The study was conducted jointly by Ankyra Therapeutics and the Center for Immuno-Oncology, part of the National Institute of Health’s National Cancer Institute Center for Cancer Research. The findings are being presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting November 1-5, 2023 in San Diego, CA.

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Following treatment with combinations of murine ANK-101, cisplatin (cis-platinum), and anti-PD-1 alone or together, tumor size and mouse survival were recorded. Data presented showed that a single dose of mANK-101 was associated with a significant delay in tumor growth in the MOC1 model, while anti-PD-1 and cisplatin alone, or in combination, had minimal impact on tumor growth. When mANK-101 was combined with either cisplatin or anti-PD-1, no further delay in tumor growth compared to monotherapy mANK-101 was observed; however, triple therapy (ANK-101, cisplatin, anti-PD-1) further delayed tumor growth and increased survival when compared to mANK-101 monotherapy.

"These are promising preclinical results for ANK-101, not only as a monotherapy but also in combination with chemotherapy and checkpoint inhibitors," said Howard L. Kaufman, M.D., President and CEO of Ankyra Therapeutics. "These data suggest that anchored IL-12 could improve the current standard of care in head and neck carcinoma while adding limited additional toxicity."

Ankyra Therapeutics is pioneering a new class of tumor-directed, anchored immuno-oncology agents, and its lead asset comprises IL-12 linked to aluminum hydroxide. The IL-12 complex is designed for local retention of functional IL-12 within the tumor microenvironment. Previous pre-clinical data demonstrated retention of IL-12 for up to 4 weeks without evidence of systemic toxicity, maximizing therapeutic potency while minimizing systemic exposure and on-target/off-tumor side effects. The U.S. Food and Drug Administration (FDA) and Health Canada have recently approved the company’s Investigational New Drug (IND) application for ANK-101: in early 2024, Ankyra plans to initiate a first-in-human Phase I clinical trial of ANK-101 as a single agent anchored immunotherapy in patients with advanced solid tumors who have failed standard of care treatments.

"As we prepare to enter the clinic, we are very encouraged by these results," said Leisha A. Emens, M.D., Ph.D., Senior Vice President of Translational Research of Ankyra Therapeutics. "In our preclinical studies, ANK-101 increases immune activity within the tumor microenvironment, priming the tumor for greater clinical benefit from the combination of chemotherapy and PD-1 blockade."

About ANK-101

ANK-101 is an anchored drug complex composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks but does not diffuse into the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with recruitment and retention of tumor-specific CD8+ T cells, NK cells and M1 macrophages activating innate and adaptive anti-tumor immunity. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents.

On November 3, 2023 Scholar Rock (NASDAQ: SRRK), a Phase 3, clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported new data from its Phase 1 DRAGON proof-of-concept trial of SRK-181, a selective inhibitor of latent TGFβ1 activation being developed with the aim of overcoming resistance to checkpoint inhibitor therapy in patients with advanced cancer (Press release, Scholar Rock, NOV 3, 2023, View Source [SID1234636930]). These data will be presented in two poster presentations during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting & Pre-Conference being held November 1 – 5th in San Diego.

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The first poster focuses on the safety, efficacy, and preliminary biomarker data in patients with anti-PD-1 resistant clear cell renal cell carcinoma (ccRCC) in Part A2 (dose escalation) and Part B (dose expansion) of the Phase 1 DRAGON trial. The ccRCC cohort was the focus for that poster, as it was the fastest cohort to achieve enrollment goals. The second poster focuses on preliminary biomarker data from part B of the trial in patients with multiple tumor types.

Data presented continues to support proof of concept for SRK-181 in 28 heavily pretreated patients with ccRCC resistant to anti-PD-1. SRK-181 was generally well tolerated and showed promising anti-tumor activity in this patient population. Of 28 evaluable patients in the ccRCC cohort, six patients treated with SRK-181 in combination with pembrolizumab had confirmed partial responses (PRs) and achieved a best tumor reduction of 33% to 93%, with an objective response rate (ORR) of 21.4%. In the biomarker analysis for ccRCC, levels of circulating granulocytic myeloid-derived suppressor cells (gMDSC) correlated with clinical activity in ccRCC patients treated with SRK-181 in combination with pembrolizumab. The data cutoff for all analyses was August 29, 2023.

"The DRAGON trial has successfully delivered on its objective of demonstrating proof of concept for SRK-181 by showing promising anti-tumor activity. These data, along with biomarker results that support proof of mechanism, highlight the immunosuppressive role of TGFβ as a mechanism of anti-PD-1 resistance in patients," said Jay Backstrom, M.D., M.P.H., President and Chief Executive Officer of Scholar Rock. "We are particularly encouraged by the responses observed in patients with ccRCC who had been treated with multiple lines of therapy before receiving SRK-181."

Safety data from ccRCC cohort continue to show SRK-181 is generally well tolerated

Safety data from the ccRCC cohort (n=30 patients; part A2: 1 patient on 800mg q3w and 1 patient on 1600mg q3w and Part B: 28 patients on 1500 mg q3w) continue to show SRK-181 has been generally well tolerated when used in combination with pembrolizumab. No dose-limiting toxicities were observed at any dose level, including at 1500 mg q3w in combination with pembrolizumab, the recommended dose selected for Part B.

One Grade 4 treatment-related adverse event (AE) was observed, dermatitis exfoliative generalized. No Grade 5 treatment-related AEs occurred. Treatment-related serious adverse events were dermatitis exfoliative generalized (1 patient), pemphigoid and rash (both in 1 patient), immune-related hepatitis (1 patient), and diarrhea, nausea, and vomiting (all three in 1 patient).

Preliminary results of SRK-181 in ccRCC patients show promising anti-tumor activity

The response was assessed by principal investigators based on RECIST 1.1. Out of the 28 ccRCC patients with evaluable responses (defined as all enrolled patients except those who are still on study, but pending post-treatment radiographic evaluation):

Six patients had confirmed PRs (defined as at least a 30% tumor reduction), with best tumor reduction of 33% to 93%, and remained on study for 2.8+ to 16.3+ months (5 of the 6 patients remained on for over 6.5 months).
Ten patients had stable disease (SD) (defined as tumors with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). Five of these patients continued in the study.
The objective response rate (ORR), defined as the percentage of patients with a partial or complete response to therapy, was 21.4% and the disease control rate (DCR), defined as the percentage of patients whose disease shrinks or remains stable over a certain time period, was 57%. In this difficult to treat population, anti-PD-1 retreatment is generally associated with single-digit ORR or no response.1
Biomarker data support proof of mechanism in multiple tumor types

The biomarker strategy includes measuring effects of SRK-181 on both circulating and tumor immune cells, such as tumor infiltration by CD8+ T cells and reductions in myeloid-derived suppressor cell (MDSC) populations. The analysis included patients from Part B with ccRCC, melanoma, non-small cell lung cancer (NSCLC), or urothelial carcinoma (UC).

Following treatment with SRK-181 and pembrolizumab, circulating MDSC levels decreased below baseline in all patients with PRs (n=7), which included those in the ccRCC, melanoma, and UC cohorts. CD8+ T cells were measured in tumor types for which paired biopsy samples (i.e., samples before and after treatment for individual patients) of sufficient quality were available: UC, melanoma, and NSCLC. In those patients (n=8), SRK-181 treatment was associated with an increase in CD8+ T cell infiltration into tumors. These findings were consistent with preclinical data showing that treatment with SRK-181 and anti-PD-(L)1 therapy decreased circulating MDSC levels and increased CD8+ T cell infiltration into tumors, which correlated with tumor response and survival benefit.

The results will be presented at the SITC (Free SITC Whitepaper) 38th Annual Meeting in two poster presentations, details of which can be found below. The posters will be made available in the Publications & Posters section of Scholar Rock’s website following the conference.

Title: Establishing Proof of Mechanism in Patients: Preliminary Biomarker Data of SRK-181 (a latent TGFβ1 inhibitor) from DRAGON Study
Presentation Type: Poster 726
Presenter: Susan Henry, PhD, Senior Director, Translational Sciences, Scholar Rock, Inc.
Location: Exhibit Halls A and B1, San Diego Convention Center
Date/Time: November 4, 11:55 AM – 1:25 PM PST and 7 – 8:30 PM PST

Title: Safety, Efficacy, and Biomarker Results of SRK-181, a Latent TGFβ1 Inhibitor, in Anti-PD-1 Resistant Metastatic ccRCC Patients
Presentation Type: Poster 666
Presenter: Timothy Yap, MBBS, PhD, FRCP, Medical Oncologist and Physician-Scientist; and Associate Professor, Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center
Location: Exhibit Halls A and B1, San Diego Convention Center
Date/Time: November 4, 11:55 AM – 1:25 PM PST and 7 – 8:30 PM PST

For conference information, visit View Source

(1) Pal, et al. The Lancet. 2023; 15;402(10397):185-195.

About SRK-181

SRK-181 is a selective inhibitor of TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies, in advanced cancer. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest that TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity. (2) SRK-181 specifically targets the latent TGFβ1 isoform in a context-independent manner, designed to enable complete inhibition of TGFβ1 in all compartments within the tumor microenvironment. Scholar Rock believes that SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing. The trial is currently enrolling and dosing patients in multiple proof of concept cohorts conducted in parallel, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and clear cell renal cell carcinoma (ccRCC). SRK-181 is an investigational product candidate and its efficacy and safety have not been established. SRK-181 has not been approved for any use by the FDA or any other regulatory agency.

On November 3, 2023 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, reported data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting in San Diego, CA (Press release, Fulgent Genetics, NOV 3, 2023, View Source [SID1234636929]).

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"These data support our mission to build a holistic platform to provide comprehensive solutions and services across the cancer care continuum, including early detection, diagnostics, and monitoring, as well as drug discovery and development," said Ming Hsieh, Chairman and CEO of Fulgent Genetics and co-founder of Fulgent Therapeutics. "We see strong momentum in our precision diagnostics business as a driver of core revenue, and we are encouraged by the steady progress of our therapeutic development for FID-007 in oncology indications."

The poster titled, "Critical clinical evaluation of plasma to tumor tissue concordance by cancer type using Illumina’s cell-free ctTSO500 commercial liquid biopsy assay," explores the critical role of comparing ctDNA variants detected in plasma with those found in tissue, shedding light on the practical implementation of liquid biopsy technology. The research presents a meticulous analysis of plasma-to-tissue concordance across various cancer types, offering valuable insights into the considerations for validation, using Illumina’s cutting-edge ctTSO500 commercial liquid biopsy assay. The clinical research findings, based on a comprehensive examination of 124 cases across different cancers, reveal significant concordance variations, often linked to the cancer stage and the timing of biopsy and blood sample collection. In uterine cancers, the researchers detected 65.9% of the SNV/indel variants in plasma that were also in FFPE, 47% in colon cancer, 67% in gastric cancer, 56% in bladder cancer, 51% in larynx cancer, and 41% in prostate. The study calls for the involvement of certified labs, highlighting the need for stringent quality management and regulatory alignment. The research ultimately underscores the reproducibility, sensitivity, and practical importance of Illumina’s ctTSO500 liquid biopsy, particularly for patients who either cannot or prefer not to undergo traditional solid biopsies for cancer screening.

The poster titled, "FID-007: Nanoencapsulated Paclitaxel Derived from a Novel Nano-Drug Delivery Platform," highlights progress for Fulgent Pharma’s lead therapeutic oncology candidate, FID-007, in various cancers. Similar to data presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in June, of 40 evaluable patients with weekly dose levels from 15 mg/m2 to 160 mg/m2, 7 (18%) had a partial response (PR) by RECIST 1.1 (pancreatic, biliary tract, and HNSCC) and 14 (35%) had stable disease. Three out of 4 HNSCC patients with PR had previously been treated with taxane. The duration of follow-up (months), median (range) is 12.0 (0.4 – 38.9). No high-grade neuropathy has been noted to date. Preliminary clinical data suggests FID-007 may have anti-tumor activity in heavily pre-treated patients across various tumor types. Based on the lack of adverse events, pharmacokinetics, and early indications of treatment effect, 125 mg/m2 has been chosen as the recommended Phase 2 dose. In addition, subgroup analysis based on 7 patients for Head and Neck cancer and 4 patients for Ampullary/Pancreatic cancer showed 57% and 50% objective response rate, respectively.

The posters will be available on the Investor Relations section of the company’s website at View Source

About FID-007

FID-007 consists of paclitaxel encapsulated in a polyethyloxazoline (PEOX) polymer excipient designed to enhance PK, biodistribution, and tolerability. In addition to allowing the drug to remain in solution until it can enter a cancer cell, the PEOX nanoparticle is designed to preferentially deliver paclitaxel to the tumor through the leaky hyperpermeable vasculature.

On November 3, 2023 SQZ Biotechnologies Company (OTC: SQZB), focused on unlocking the full potential of cell therapies, reported clinical data for three programs focused on the treatment of Human Papillomavirus 16 positive (HB16+) driven cancers at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2023 (Press release, SQZ Biotech, NOV 3, 2023, View Source [SID1234636928]).

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"Our programs have shown a favorable safety profile and the ability to effect clinical benefit for patients," said Howard Bernstein, M.D., Ph.D., Interim Chief Executive Officer and Member of the Board of Directors. "While these results are early, the management team and the board of directors are encouraged by the potential of Cell Squeeze based therapeutics and are committed to exploring strategic alternatives for the company and its proprietary technology."

Key findings:

SQZ Activating Antigen Carriers ("AAC") Platform in Oncology
Poster# 693: SQZ-AAC-HPV-101: Initial data from a phase I dose escalation/expansion study of SQZ-AAC-HPV, a red blood cell-based therapeutic cancer vaccine for HPV16+ solid tumors

Of the five patients treated, one patient experienced a confirmed complete response and two patients experienced stable disease
SQZ-AAC-HPV monotherapy is considered generally safe and well-tolerated at all dose levels
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology
Poster# 692: COMMANDER-001: Safety data from a phase I/II dose escalation/expansion study of SQZ-eAPC-HPV, a cell-based mRNA therapeutic cancer vaccine for HPV16+ solid tumors

Completed enrollment for highest-dose cohort of monotherapy dose escalation trial
Observed BOR of Stable Disease in 40 Percent (8 of 20) of Treated Patients
SQZ-eAPC-HPV monotherapy is considered generally safe and well-tolerated at all dose levels
SQZ Antigen Presenting Cell ("APC") Platform in Oncology:
Poster# 594: SQZ-PBMC-HPV-101: Increased overall survival in a subset of patients with recurrent, locally advanced, or metastatic HPV16+ tumors treated with cell-based vaccine, SQZ-PBMC-HPV

A subset of patients with paired biopsies (6 of 18) showed increased CD8 T cell infiltration when compared to baseline
These patients with increased CD8 T cell infiltration demonstrated an improved overall survival ("OS") when compared to patients with decreased CD8 T cell infiltration
Median OS [95% CI) for Increase in CD8: 606.5 days [314.0, 713.0] compared to median OS [95% CI) for Decrease in CD8: 170.0 days [54.0, 220.0]
SQZ-PBMC-HPV monotherapy is considered generally safe and well-tolerated at all dose levels
About Human Papillomavirus Positive Cancers

Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years, often leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer, HPV+ tumors account for 4.5% of all cancers worldwide resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

On November 3, 2023 Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, reported molecular real-world data (RWD) demonstrating that high PPARG expression in patients with MIUC is associated with an immunosuppressive tumor microenvironment (TME) and shorter real-world progression-free survival to anti-PD1 treatment (Press release, Flare Therapeutics, NOV 3, 2023, View Source [SID1234636927]). The translational data were shared at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (SITC) (Free SITC Whitepaper) 2023 taking place November 1-5, 2023 in San Diego, California.

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"While immunotherapy approvals have changed the treatment landscape for MIUC, approximately 70% of patients will still succumb to refractory or acquired resistance," said Michaela Bowden, Ph.D., Chief Development Officer at Flare Therapeutics. "These results offer a unique opportunity to further investigate an immune-mediated mechanism of action for FX-909 with potential to combine with an anti-PD1 agent."

In the poster presentation titled, "PPARG amplification is associated with lack of response to anti-PD1 in Muscle-Invasive Urothelial Cancer," molecular RWD, comprising 1,393 genomic and/or transcriptomic profiles from MIUC patients were utilized to evaluate baseline PPARG expression and amplification associated with anti-PD1 response in MIUC patients. Additional key takeaways are as follows:

Higher PPARG expression and PPARG amplification are negatively correlated with PD-L1 expression in MIUC.
Tumors with elevated PPARG levels and PPARG amplification exhibited a suppressive immune phenotype, typified by an inverse association with CD8+ T cell infiltration.
PPARG amplification is significantly associated with shorter real-world Progression Free Survival to anti-PD1.
FX-909, a first-in-class covalent PPARG inhibitor, entered the clinic this year and is currently being evaluated in a Phase 1 study. The data presented today suggest that FX-909 in combination with ICI agents could potentially provide a new therapeutic strategy that helps MIUC patients with high PPARG expression overcome resistance to immunotherapy.

About FX-909
Flare Therapeutics’ lead investigational compound, FX-909, is a first-in-class novel, highly potent and selective small molecule that inhibits the transcription factor peroxisome proliferator-activated receptor gamma (PPARG) to treat patients with the luminal subtype of advanced urothelial carcinoma (UC) and potentially other solid tumors. Preclinical data for FX-909 has demonstrated robust anti-tumor activity, excellent PK/PD correlation, durable efficacy, and a favorable safety profile in mouse models of UC (PPARG-amp and RXRA-mut) at very low oral doses.

About the FX-909 Phase 1 Study
The ongoing phase 1 study is a first-in-human, dose-escalation and -expansion study of FX-909 in patients with advanced solid malignancies, including advanced urothelial carcinoma. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of FX-909. FX-909 will be given initially in a dose-escalation phase (Part A) to determine the recommended phase 2 dose. FX-909 will be given initially orally once daily in 28-day cycles. Part B will be a monotherapy expansion phase to further evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of FX-909 in patients with locally advanced (unresectable) or metastatic urothelial carcinoma. Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05929235).

About Advanced Urothelial Carcinoma (UC)
In 2020, there were an estimated 725,549 people living with bladder cancer in the United States alone, making it the sixth most common cancer overall, and fourth most common among men (SEER – 2020). Each year, there are more than 83,000 new cases diagnosed among men and women, and about 25% of those cases are classified as muscle-invasive UC (DRG 2020). Advanced UC has high rates of recurrence, where treatment outcomes have remained poor with typical five-year survival rates of 8% in advanced metastatic disease (SEER – 2020). The transcription factor peroxisome proliferator-activated receptor gamma (PPARG) is associated with the luminal lineage subtype reflecting approximately 65% of all advanced UC cases (Robertson, Cell 2017). Recurrent genetic alterations in PPARG are characteristic of this molecular subtype.