On November 10, 2022 Phio Pharmaceuticals (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology makes immune cells more effective in killing tumor cells, reported the results of several studies of its INTASYL compounds (Press release, Phio Pharmaceuticals, NOV 10, 2022, View Source [SID1234623674]).

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INTASYL compounds are chemically modified siRNA’s that provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity targeting a broad range of cell types and tissues.

INTASYL drugs precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy (ACT) applications.

INTASYL is the only self-delivering RNA interference (RNAi) technology focused on immuno-oncology therapeutics. Phio is developing several INTASYL compounds, one of which is in an on-going Phase 1b clinical trial for the treatment of advanced melanoma.

The posters will be presented on November 10th and 11th at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which is being held in Boston, MA from November 8 – 12, 2022.

About the Posters

Abstract #788 titled: A Phase 1b study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of neoadjuvant use of PH-762 administered intratumorally in subjects with advanced melanoma

About PH-762: PH-762 is an INTASYL compound that reduces the expression of PD-1, a protein that inhibits T cells’ ability to kill cancer cells. By suppressing PD-1, the T cells are re-activated to kill cancer cells. PH-762 is being developed as a standalone drug therapy (Direct-to-Tumor) and also in combination with ACT.

About the poster: This trial in progress poster reports on the clinical trial design and updates on the continuing enrollment in its Phase 1b study of PH-762 for the treatment of patients with advanced melanoma. The study is being conducted at the Gustave Roussy Institute, one of the largest cancer centers in Europe. Topline safety data from the first group of subjects is expected to be announced during the first quarter of 2023. [Review the poster]

Abstract # 1402 titled: PH-894, an INTASYL self-delivering siRNA targeting BRD4, has dual functions to sensitize tumor cell killing and activate CD8 T cells

About PH-894: PH-894 is an INTASYL compound that silences BRD4, a protein that controls gene expression in both T cells and tumor cells, thereby effecting the immune system as well as the tumor. What sets this compound apart is its dual mechanism: INTASYL PH-894 suppression of BRD4 in T cells results in T cell activation; additionally, suppression of BRD4 in tumor cells results in tumors becoming more sensitive to T-cell killing.

About the poster: This poster presentation includes data further exploring the antitumor mechanism of PH-894, a self-delivering RNAi compound that specifically silences the BRD4 gene. In this study, Phio showed that using PH-894 can activate T cells to improve their cancer cell killing ability and to target tumor cells to make them more sensitive to killing. [Review the poster]

Abstract #1431 titled: Intratumoral PH-109 INTASYL; self-delivering RNAi targeting connective tissue growth factor (CTGF) provides efficacy in vivo in a mouse model of metastatic breast cancer

About PH-109: PH-109 is an INTASYL compound that suppresses the Connective Tissue Growth Factor (CTGF) protein, a protein associated with poor prognosis in breast cancer.

About the poster: The poster presentation announces proof-of-concept in vivo data showing efficacy of intratumorally administered PH-109, in an orthotopic 4T1 model of metastatic mammary cancer. These results show that PH-109 reduced tumor growth and reduced metastatic lung lesions compared to the control arms. Mice were also treated with the chemotherapy drug, doxorubicin. In contrast to doxorubicin, PH-109 showed no evidence of toxicity. [Review the poster]

Abstract #537 titled: Local immunotherapy with INTASYL self-delivering RNAi targeting CTLA-4 provides robust tumor control in vivo

About CTLA-4: CTLA-4 is a protein that inhibits the ability of T cells to kill tumor cells. The CTLA-4 targeting INTASYL compound demonstrated dose-associated anti-tumor activity in two tumor models in vivo. Local delivery may avoid/minimize the severe systemic adverse events associated with current CTLA-4 therapeutics.

About the poster: The poster presentation demonstrates proof-of-concept in vivo data showing intratumoral efficacy of a novel INTASYL targeting murine CTLA-4 in two syngeneic mouse tumor models. These study results showed a dose-dependent anti-tumor effect that was comparable to that seen with antibodies. The Company expects treating intratumorally with an INTASYL compound targeting CTLA-4 may have less toxicity than with current antibody treatment, while maintaining similar efficacy. This shows that INTASYL can be used against multiple clinically proven checkpoint inhibitors – CTLA-4 and PD-1. [Review the poster]

Abstract #493 titled: PH-804, an INTASYL self-delivering RNAi compound that targets TIGIT enhances NK cell cytotoxicity to tumor cells

About PH-804: PH-804 is an INTASYL compound that targets TIGIT, a protein that inhibits the activity of Natural Killer (NK) cells.

About the poster: The poster presentation discusses results from a pre-clinical study demonstrating that NK cells, when treated with PH-804, increased activation and enhanced the ability of NK cells to kill cancer cells. [Review the poster]

Abstract #409 titled: Manufacturing of a clinical scale CD8 TIL product, AGX148, with and without gene silencing of PD-1 using self-delivering RNAi INTASYL PH-762

About the poster: This poster presentation by AgonOx, Inc., in collaboration with Phio and the Providence Cancer Institute’s Cell Processing Facility, shows that it has completed three full scale IND-enabling manufacturing runs of its ACT product, AGX148, CD8 tumor infiltrating lymphocytes (TIL) that are highly enriched for tumor-reactivity (DP TIL), with and without Phio’s PH-762, an INTASYL compound that knocks down PD-1 protein expression on cells. These manufacturing runs demonstrate the ability to scale up clinical grade DP TIL and that DP TIL treated with PH-762 demonstrated durable silencing of PD-1 in vivo. PD-1 knockdown also enhanced the activity of DP TIL in in vitro tumor co-culture assays. This step forward in manufacturing is an important part of AgonOx’s movement towards the clinic and will support an IND application with the FDA. AgonOx expects to start a clinical trial evaluating the safety, tolerability, and efficacy of AGX148 combined with PH-762 in subjects with advanced solid malignancies.

On November 10, 2022 IconOVir Bio, Inc. (IconOVir), a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, reported new preclinical data demonstrating proof-of-concept for its lead program ICVB-1042 (Press release, IconOVir Bio, NOV 10, 2022, View Source [SID1234623673]). ICVB-1042 is an oncolytic adenovirus (Ad), rationally designed with genomic modifications to confer tumor selective replication and enhanced tumor cell killing, as well as allow for either intravenous (IV) or intratumoral (IT) delivery. The data will be presented in three posters at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2022), which is being held in Boston, MA and virtually from November 8-12, 2022.

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"The new data presented at SITC (Free SITC Whitepaper) reaffirm the power of our differentiated approach to OV development, which allows us to create and combine proprietary mutations to optimize OVs, and to translate this engineering into potentially best-in-class product candidates," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir. "Based on preclinical testing across a range of tumor types and preclinical model systems, we believe ICVB-1042 offers superior tumor selectivity, broader tropism and more effective anti-cancer activity compared to earlier-generation OVs, which could transform the care and treatment of people living with a range of solid tumors. We look forward to advancing ICVB-1042 into Phase 1 studies next year, as we work toward our mission of curing cancer and restoring life to every patient, everywhere."

Preclinical Data Demonstrate ICVB-1042’s Selective Replication, Broad Tumor Tropism, Safety and Anti-Tumor Activity

IconOVir presented two abstracts describing the results of in vitro and in vivo studies. These data demonstrate that ICVB-1042 selectively replicates in tumor cells compared to normal cells, while also benefiting from enhanced tropism, anti-tumor activity and tolerability.

In a poster presentation titled, "Nonclinical characterization of ICVB-1042, a novel E2F-tumor selective oncolytic virus with the potential to treat solid tumors," IconOVir describes key therapeutic properties of IV-administered ICVB-1042, including its high tumor selectivity and ability to replicate effectively in tumor tissue. The data show:

ICVB-1042 is well-tolerated and induces tumor-selective replication and cell killing across a broad range of human tumor cell lines, including breast, prostate, bladder, lung and glioblastoma;
ICVB-1042 is 100-fold more cytotoxic in tumor cells compared to normal cells; and
ICVB-1042 virus particles increase in both tumors and plasma over time, in a manner correlative with efficacy.
In a poster presentation titled, "Evaluation of the anti-tumor activity of ICVB-1042, a novel E2F-tumor selective oncolytic virus, selectively targeting tumor cells in an established human glioblastoma mouse model," IconOVir presents new preclinical data from studies comparing the anti-tumor activity and selectivity of ICVB-1042 with that of ICVB-940, a comparator virus engineered by IconOVir that is based on an adenovirus type-5 (Ad5) clinical-stage OV under evaluation for treatment of glioblastoma. The data show that:

ICVB-1042 demonstrates enhanced tumor cell killing over ICVB-940 in 11 of 13 human glioma tumor cell lines;
ICVB-1042 induces significant decreases in tumor volume and increases in time to progression over ICVB-940; and
ICVB-1042 is well-tolerated, resulting in no deaths or group mean body weight loss in the treatment window.
Preclinical Proof-of-Concept Data for Proprietary Mutations Designed to Improve Tropism

IconOVir presented an abstract demonstrating proof-of-concept for a proprietary mutation made to Ads to enhance tropism to malignant cells. This mutation, the replacement of wild-type fiber with a chimeric Ad5/Ad34 fiber, is incorporated into ICVB-1042.

Viral entry into target cells through interactions with surface receptor proteins is a key determinant of viral tropism. Ads contain a trimeric fiber protein with a central shaft and globular knob that help tether it to the cell surface receptor. Ad5, which was used in first-generation OV therapies, utilizes the coxsackie Ad receptor (CAR) for cell entry, however CAR downregulation during cancer progression limits the therapeutic effect of OVs that rely on this surface protein. Group B Ads instead use CD46, a receptor frequently overexpressed in cancer, for cell entry, creating an opportunity to equip OVs with chimeric fibers to enhance tropism to malignant cells. IconOVir engineered ICVB-1042 to include an Ad5/34 chimeric fiber, which enables viral entry via CD46 instead of CAR proteins, with the goal of addressing limitations of first-generation Ad5-based OVs.

In a poster presentation titled, "The chimeric Ad5/Ad34 fiber of ICVB-1042 oncolytic virus requires the CD46 cell surface receptor for efficient tumor entry," IconOVir describes the cell entry requirements for ICVB-1042 compared to ICVB-421 (wtAd5 + YPET). The data showed:

The Ad5/34 fiber of ICVB-1042 effectively binds CD46 and not CAR;
CD46 expression is required for efficient infection by ICVB-1042;
CD46 deficiency induces resistance to ICVB-1042-induced cytotoxicity; and
The expression of human CD46 on mouse cells allows viral entry, but not replication of ICVB-1042.
Based in part on these results, IconOVir is developing ICVB-1042 for delivery both IV and IT. IconOVir plans to advance into a Phase 1 clinical study evaluating ICVB-1042 delivered IV in patients with advanced solid tumors in the first half of 2023.

On November 10, 2022 Seagen Inc. (Nasdaq: SGEN) reported that data from the company’s diverse pipeline of targeted cancer therapy candidates will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting being held November 8-12 in Boston (Press release, Seagen, NOV 10, 2022, View Source [SID1234623672]). The presentations highlight data from multiple ongoing clinical and preclinical research studies that employ Seagen’s proprietary antibody-drug conjugate (ADC) technology, as well as other novel cancer targeting approaches.

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"Seagen has a deep heritage in pioneering first-in-class antibody-drug conjugates. We are encouraged by initial results from a clinical study of SGN-B6A, a wholly owned investigational antibody-drug conjugate that demonstrated antitumor activity with an acceptable safety profile in previously treated patients with non-small cell lung cancer, head and neck cancer, and esophageal cancer," said Megan O’Meara, M.D., Senior Vice President of Early-Stage Development at Seagen. "We are also sharing new data demonstrating enhanced preclinical activity of enfortumab vetodin in combination with immune checkpoint inhibitors, as well as preclinical data that support the initiation of a first-in-human study of a bispecific molecule called SGN-BB228."

Highlights From SGN-B6A Program Presented at SITC (Free SITC Whitepaper)

Data from an ongoing Phase 1 study of SGN-B6A, an ADC directed to integrin beta-6, which is overexpressed in multiple solid tumors, showed early efficacy signals in at least three cancer types, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and esophageal squamous cell carcinoma (ESCC).

Dose escalation cohorts enrolled 79 participants with metastatic or unresectable solid tumors, whose disease had relapsed or was refractory to standard of care therapies and had not previously received an MMAE-containing agent or agent targeting integrin beta-6. Participants had received a median of 3 lines of therapy for metastatic disease prior to enrollment in the study. SGN-B6A demonstrated a manageable and tolerable safety profile at the explored dose levels and schedules. Intermittent dosing schedules (2Q3W, 2Q4W) are being evaluated further. The initial anti-tumor activity observed in heavily pre-treated patients is encouraging and has triggered expansion cohorts in NSCLC, HNSCC, and ESCC, which are currently ongoing. SGN-B6A is an investigational agent, and its safety and efficacy have not been established.

Additional Details of Seagen Presentations at SITC (Free SITC Whitepaper) Annual Meeting 2022

All posters will be available at the beginning of the session, both in-person and virtually.

On November 10, 2022 4D pharma plc (AIM: DDDD) (in administration), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that new biomarker data from two ongoing clinical trials of its lead immuno-oncology single strain Live Biotherapeutic, MRx0518, at the at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting (SITC 2022), held from November 8-12, 2022 (Press release, 4d Pharma, NOV 10, 2022, View Source [SID1234623671]). The two e-posters are available via the 4D pharma website at View Source

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"The two posters presented at the prestigious SITC (Free SITC Whitepaper) 2022 event demonstrate 4D pharma’s commitment and leadership in understanding the mechanisms of action of its Live Biotherapeutic Products," said Dr. Alex Stevenson, Chief Scientific Officer at 4D pharma. "Building on previously published clinical and biomarker results, with this new data we show how MRx0518 is able to drive meaningful clinical benefit for patients by acting on both the human immune system to overcome immunosuppression for better outcomes with immune checkpoint inhibitor therapy, and the microbiome"

One poster presentation highlights the suppressed immune state of patients who have acquired resistance to prior anti-PD-1/PD-L1 immune checkpoint inhibitors, at baseline compared to controls. Following treatment with the combination of MRx0518 and KEYTRUDA (pembrolizumab), there is an increased expression of the activation markers HLA-DR and CD86, and a trend in reduction of myeloid cells expressing the immune checkpoint PD-L1, in responders but not non-responders. The results also identify a significant increase in circulating CD8+ T cells after treatment with the combination, in responders but not in non-responders, an immune population well known to correlate with better outcomes for immune checkpoint inhibitor treatment.

A second poster presents the first clinical microbiome and metabolome modulation data for MRx0518, building on previously reported immunomodulatory data from the same study. Following neoadjuvant treatment with MRx0518 monotherapy, there is a significant increase in the presence of MRx0518 in stool samples which then returns to baseline levels. This data supports 4D pharma’s thesis regarding the viability and pharmacokinetics of safe and effective transient colonization of its orally administered Live Biotherapeutics in the human gastrointestinal tract. In addition, the results demonstrate treatment with the single strain LBP MRx0518 is associated with significant shifts in gut microbiome composition and significant increases in short-chain fatty acid metabolites that may contribute to the anti-tumorigenic efficacy demonstrated by MRx0518

Poster presentation details are as follows:

Presentation Title: Combination of MRx0518 and anti-PD-1 overcomes checkpoint inhibitor resistance via myeloid modulation

Presenting Author: Dr. June Li, Research Scientist, Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center

Abstract Number: 838

Presentation Title: Oral administration of MRx0518 in treatment-naïve cancer patients is associated with compositional taxonomic and metabolomic changes indicative of anti-tumorigenic efficacy

Presenting Author: Dr. Mark P. Lythgoe, Academic Clinical Fellow in Medical Oncology and Pharmacist, Imperial College London

Abstract Number: 627

On 24 June 2022, David Pike and James Clark of Interpath Advisory were appointed as administrators of 4D pharma plc. The administrators have had no oversight of or involvement in the preparation of the SITC (Free SITC Whitepaper) 2022 poster presentations nor in any materials which will be circulated in advance of or during SITC (Free SITC Whitepaper) 2022. Therefore, the administrators make no statement or representation in respect of the materials shared or discussed in advance of or during SITC (Free SITC Whitepaper) 2022.

About MRx0518

MRx0518 is single strain Live Biotherapeutic product in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumors. It is currently being evaluated in three clinical trials in cancer patients. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumors and is being conducted at Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA (pembrolizumab) in patients who have previously progressed on anti PD-1 therapies. The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer. A fourth clinical trial is planned, in collaboration with Merck KGaA and Pfizer Inc., of BAVENCIO (avelumab) in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

On November 10, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported updated overall survival (OS) results from its Phase 1/2 study evaluating GRANITE, an individualized vaccine-based immunotherapy, for the treatment of advanced solid tumors (Press release, Gritstone Oncology, NOV 10, 2022, View Source [SID1234623670]). These results, along with results from a clinicopathologic analysis of metastatic MSS-CRC patients with and without a molecular response, will be presented via a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting.

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"The follow-up data from our Phase 1/2 study in patients with MSS-CRC who have received at least two prior lines of therapy continue to demonstrate an association between molecular response and overall survival," said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. "The median overall survival (MOS) in patients with MSS-CRC that had a molecular response has still not been reached and will now exceed 22 months; an additional four months since our last update in May 2022. This is a notable difference compared to the 6–7-month MOS typically observed in third-line MSS-CRC and the 7.8 month MOS in patients without a molecular response within our study. The clinicopathologic analysis shows MSS-CRC patients who achieve a molecular response do not have high tumor mutation burden, PD-L1 expression or high expression of IFNg-related genes. We are also observing molecular responses in patients with liver metastases, a subset that typically receives little benefit from immunotherapy. The recent publication of GRANITE Phase 1/2 results in Nature Medicine detail the program’s novel approach, and the data to date demonstrate its promise in hard-to-treat, late-line settings. The randomized Phase 2/3 GRANITE study in first-line CRC, where patients generally have more time to mount an immune response, is ongoing and preliminary data are expected in 4Q2023."

The Phase 1/2 study is evaluating the safety, immunogenicity, and clinical activity of GRANITE in combination with PD-1 checkpoint inhibitor, nivolumab and subcutaneous anti-CTLA-4 antibody ipilimumab in advanced solid tumors. This study enrolled and treated 29 patients with previously treated, metastatic solid tumors including patients with colorectal cancer, gastroesophageal adenocarcinoma, and non-small cell lung cancer. Of 13 patients with MSS-CRC, 6 experienced a molecular response defined as ≥30% reduction in circulating tumor DNA (ctDNA) and continue to have an overall survival advantage compared to those patients without a molecular response.

Updated OS data from GRANITE Phase 1/2:

6 of 13 treated patients with MSS-CRC had a molecular response and the observed median overall survival in this group will now exceed 22 months (median OS not yet reached versus 7.8 months in those without a molecular response). This compares to a median overall survival not yet reached and exceeding 18 months as reported in May 2022.
Clinicopathologic characteristics from GRANITE Phase 1/2:

4 of 6 patients with molecular response had liver metastasis.
All patients had PD-L1 expression <1% and low levels of IFNg-related gene expression.
Median tumor mutational burden was 2.9 and 3.6 mutations/MB in those with and without molecular response, respectively.
SITC presentation details are as follows:
Abstract 660: Clinicopathologic Characteristics of Patients with Metastatic Colorectal Cancer with Molecular Responses Following Treatment with an Individualized Neoantigen Vaccine Regimen
Date/Time: Friday, Nov. 11, 2022: 9:00am – 8:30pm EST
Session: Clinical Trials In Progress
Location: Boston Convention & Exhibition Center: Hall C

About GRANITE
Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens (TSNA). Gritstone identifies these TSNA using its proprietary artificial intelligence platform, EDGE. GRANITE is an individualized neoantigen-based immunotherapy program that uses adenoviral ("prime") and self-amplifying mRNA ("boost") vectors to deliver personalized immunotherapy containing the relevant neoantigens. GRANITE was granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS-CRC.