On May 27, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported the publication of three abstracts related to its OncoMimcs pipeline, including EO2401, its first-in-class off-the-shelf OncoMimics cancer immunotherapy, ahead of poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 in Chicago and virtually (Press release, Enterome, MAY 27, 2022, View Source [SID1234615217]).

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Enterome will present clinical proof-of-concept data from its most advanced OncoMimics drug candidate, EO2401, a therapeutic cancer vaccine candidate currently in clinical development for the treatment of patients with first progression/recurrence of glioblastoma (ROSALIE trial, EOGBM1-18) and for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma (SPENCER trial, EOADR1-19).

A third poster describing the Phase 1/2 trial (SIDNEY, EONHL1-20) with Enterome’s second OncoMimics vaccine, EO2463, in non-Hodgkin lymphoma will also be presented at ASCO (Free ASCO Whitepaper).

Details of the poster presentations and session are as follows:

ROSALIE Trial (EOGBM1-18)

Title: EO2401, a novel microbiome-derived therapeutic vaccine for patients with recurrent glioblastoma
Track: Central Nervous System Tumors
Abstract number: #2034
Date and Time: Sunday, June 5, 8:00 AM-11:00 AM CDT
Presenter: Professor Wolfgang Wick, Universitätsklinikum Heidelberg and German Cancer Research Center, Heidelberg, Germany
Authors: Wick, W. et al
SPENCER Trial (EOADR1-19)

Title: EO2401, a novel microbiome-derived therapeutic vaccine for patients with adrenocortical carcinoma (ACC)
Track: Genitourinary Cancer—Kidney and Bladder
Abstract number: #4596
Date and Time: Saturday, June 4, 1:15 PM-4:15 PM CDT
Presenter: Professor Vivek Subbiah, The University of Texas MD Anderson Cancer Center (MDACC), Houston, TX
Authors: Baudin, E. et al
SIDNEY Trial (EONHL1-20)

Title: A novel microbial-derived peptide therapeutic vaccine (EO2463) as monotherapy and in combination with lenalidomide and rituximab, for treatment of patients with indolent non-Hodgkin lymphoma
Poster session: Hematologic Malignancies/Lymphoma and Chronic Lymphocytic Leukemia
Poster number: #TPS7586
Date and Time: Saturday, June 4, 8:00 -11:00 AM CDT
Authors: Zinzani, P.L et al
More information on the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting and related poster presentations can be found at www.asco.org

About OncoMimics Peptides

OncoMimics peptides are gut microbiome-derived peptides that closely mimic antigens expressed by tumor cells. In contrast to tumor antigens, however, OncoMimics peptides are recognized by the immune system as "non-self" and can generate a strong human cytotoxic CD8+ response steming from memory T cells, offering enormous potential to create a new class of cancer vaccines targeting solid and liquid tumors.

Enterome’s pioneering work on its OncoMimics pipeline leverages the fundamental understanding that the gut is the largest lymphoid organ in the body and is home to most of its memory T-cells. As a result, there is constant interaction and presentation of peptides and proteins secreted by gut bacteria to the body’s immune system, resulting in the formation of a pool of effector memory T cells protecting the human body against bacterial invasion. In the event that the bacterial antigens are mimics of tumor antigens, this process leads to the generation of circulating effector memory T cells with a preserved ability to recognize tumor antigens.

On May 27, 2022 Lytix Biopharma AS ("Lytix" or the "Company"), a clinical-stage company with an in situ vaccination technology platform, reported that an abstract relating to LTX-315 in combination with Adoptive Cell Therapy (ACT) has been selected for presentation at a Poster Session during American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 (Press release, Lytix Biopharma, MAY 27, 2022, View Source [SID1234615216]). LTX-315 is a first-in-class oncolytic molecule, representing a new and superior in situ therapeutic vaccination principle to boost the clonal expansion of T cells and subsequent anti-cancer immunity.

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Immune- and clinical response data from the Atlas-IT-04 trial will be presented at the poster session. The trial is an open label, exploratory, Phase II trial assessing the effect of LTX-315 when used in combination with ACT in patients with metastatic soft tissue sarcoma (STS). The prognosis of advanced STS is poor and with a high unmet medical need. In general STS have low number of tumor infiltrating T cells and do not respond to immunotherapy. The trial design includes intratumoral injections of LTX-315 ahead of surgical removal of tumors, followed by in vitro expansion of T cells as the first step. In the second step, the expanded T cells were infused back to the patients and the effect of LTX-315 on the tumor microenvironment was assessed.

"This trial demonstrates that the combination of LTX-315 and ACT is feasible and tolerable, and that CD4+ and CD8+ T cells can be expanded in vitro from STS that have been pretreated with the oncolytic molecule LTX-315", CEO of Lytix, Øystein Rekdal, comments. He adds: "We will now explore how further optimization of the treatment schedule will position LTX-315 as promising technology to invoke tumor specific T cells that can be cultured and infused as part of an adoptive transfer regimen for several subtypes of soft tissue sarcoma."

At the time of the submission of the abstract, the complete data had not been finally analyzed, and a revision of the data showed that there were three, not four, patients with stable disease as best overall response.

On May 27, 2022 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vectored immunotherapies, reported that full data obtained from the Phase 1 trial evaluating NOUS-209 has been accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, NousCom, MAY 27, 2022, View Source [SID1234615215]). ASCO (Free ASCO Whitepaper) will be held virtually and in person in Chicago from 3 to 7th June.

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NOUS-209, Nouscom’s lead product, is an off-the-shelf cancer immunotherapy targeting shared neoantigens, administered in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, for the treatment of Deficiency in Mismatch Repair/Microsatellite Instable High (dMMR/MSI-H) unresectable or metastatic gastric, colorectal and gastro-esophageal junction tumors.

Poster Presentation Details:

Title: First clinical and immunogenicity results including all subjects enrolled in a phase I study of NOUS-209, an off-the-shelf immunotherapy, with pembrolizumab, for the treatment of tumors with a deficiency in mismatch repair/microsatellite instability (dMMR/MSI)
Date & Time: 5th June 2022, 11:30 AM – 13:00 PM CDT
Abstract Number: 2515
Presenter: Marwan Fakih, M.D., Professor of Oncology, Medical Oncology Specialist at City of Hope’s Duarte California and Study Investigator
The full abstract is available here

About NOUS-209

NOUS-209 is an off-the-shelf immunotherapy for Microsatellite Instable High (MSI-H) tumors. MSI-H tumors are characterized by a defective DNA mismatch repair system, which generates highly immunogenic frame shift peptides (frameshift mutations, FSPs) that are not found on healthy tissue.

NOUS-209 is designed to comprise 209 shared FSP neoantigens, selected by Nouscom’s proprietary GENESIS (GE(netic)NE(oantigen)S(election)I(n)S(ilico)) algorithm, on the basis that an average of 50 neoantigens on any patient’s tumor will be shared with those in NOUS-209. Nouscom’s heterologous prime/boost platform clones these FSPs into Great Ape Adenoviral (GAd) and Modified Vaccinia Ankara (MVA) vectors, combined with other immunomodulators to harness the full power of the immune response, to generate the viral-vectored vaccine.

NOUS-209 is in Phase 1 clinical trial (NCT04041310), a multicenter, open label, multiple cohorts, first-in-human clinical study of NOUS-209 in combination with pembrolizumab, designed to evaluate safety, tolerability and immunogenicity and to detect preliminary evidence of anti-tumor activity.

On May 27, 2022 Jacobio Pharma (1167.HK) reported that the phase I clinical data of KRAS G12C inhibitor JAB-21822 will be presented in the form of poster at the upcoming 2022 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) from June 3, 2022 to June 7, 2022 (Press release, Jacobio Pharmaceuticals, MAY 27, 2022, View Source [SID1234615213]). Abstract was published on the ASCO (Free ASCO Whitepaper)’s website today.

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"JAB-21822 is one of Jacobio’s programs targeting on KRAS pathway, we plan to explore the JAB-21822 in colorectal cancer, pancreatic cancer, and other indications. Meanwhile, Jacobio is exploring combination therapies of JAB-21822, such as in combination with SHP2 inhibitor. We are also developing novel drugs in KRAS pathway, including KRASmulti inhibitor (JAB-23400) and KRAS G12D inhibitor (JAB-22000)," said Dr. WANG Yinxiang, Chairman and CEO of Jacobio.

About the Abstract

A phase I/II study of first-in-human trial of JAB-21822 (KRAS G12C inhibitor) in advanced solid tumors.

Format: Poster Presentation

Abstract Number: 3089

Time: Sunday, June 5, 2022 8:00 AM-11:00 AM (CDT)

Track: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

As of January 28th, 2022, 53 patients with a median age of 62 years (39-79) were enrolled in 5 different dose levels: 200mg QD, 400mg QD, 800mg QD, 400mg BID and 400mg TID. A total of 33 patients (22 non-small cell lung cancer, 9 colorectal cancer and 2 pancreatic cancer) had at least 1 post-baseline tumor assessment.

Patients with non-small cell lung cancer (400mg QD and 800mg QD), the overall response rate (ORR) and disease control rate (DCR) were 70% (7/10) and 100% (10/10), respectively.
No dosing-limiting toxicities were observed.
JAB-21822 was well tolerated with impressive preliminary efficacy in patients with heavily treated solid tumors harboring KRAS G12C mutation. The clinical trial is still ongoing and the above data is as of January 28, 2022.

More data will be posted on the poster at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting, please visit www.asco.org for more information.

About JAB-21822

JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer first-line treatment; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and Cetuximab.

On May 27, 2022 KDx Diagnostics and UroGPO reported the partnership to provide the URO17 test (Research Use Only in the US) for the detection of bladder cancer (Press release, KDx Diagnostics, MAY 27, 2022, View Source [SID1234615212]). URO17 is a non-invasive urine test with high sensitivity and negative predicted value (NPV) that can be used to determine the status of active bladder cancer and to improve patient diagnosis. This is also likely to improve the treatment path as URO17 is also now available as a Laboratory Developed Test (LDT) in the United States. UroGPO will offer reagents and information for the URO17 test to the members of their Group Purchasing Organization.

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With over 85,000 new cases of bladder cancer in the United States every year the most common symptom of bladder cancer is hematuria, or blood in the urine, and patients with hematuria need to be subjected to invasive cystoscopic procedures even though a large majority of patients with micro-hematuria will not have bladder cancer. The URO17 test, and its high sensitivity and NPV for bladder cancer, will assist in ruling these patients out for unnecessary cystoscopy and its invasive procedure and in turn reduce the work-up.

KDx Diagnostics Inc. and UroGPO Announce a Partnership to Offer the URO17 NON-INVASIVE Urine Test for Bladder Cancer

"We are very excited to partner with UroGPO, the premier urology network and group purchasing organization in the US, to make our URO17 test and information available to their network of clinical laboratories. Through UroGPO, the urology laboratories will have direct access to ordering with a special in-network pricing which will facilitate the availability of URO17 to the urologists," says Sholeh Jahanfard, President of KDx Diagnostics Inc.

"UroGPO is happy to present this new partnership to our membership. The URO17 test adds efficiency and precision to the care of patients with bladder cancer. KDx has taken steps to remove barriers of access for both physicians and patients which will ultimately benefit patient outcomes, improve quality of life, and even mortality," says Palmer DePetro, Sr. Director, Contracting at Specialty Networks.