On May 27, 2022 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported financial results for the first quarter ended March 31, 2022 (Press release, Allarity Therapeutics, MAY 27, 2022, View Source [SID1234615219]).

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F irst Quarter Financial Results

Balance Sheet: As of March 31, 2022, Allarity’s cash was $14.5 million, as compared to $19.6 million as of December 31, 2021.

R&D Expenses: Research and Development (R&D) expenses were $1.3 million for the three months ended March 31, 2022, compared to $1.3 million for the quarter ended March 31, 2021.

Impairment of Intangible Assets : Impairment of Intangible Assets was $14.0 million for the three months ended March 31, 2022, compared to nil for the quarter ended March 31, 2021.

G&A Expenses: General and Administrative (G&A) expenses were $3.0 million for the three months ended March 31, 2022, as compared to $1.2 million for the three months ended March 31, 2021.

Net Loss: Net loss was $3.1 million for the three months ended March 31, 2022, compared to $3.1 million for the comparable period in 2021.

On May 27, 2022 OriCell Therapeutics Co., Ltd (OriCell), a leading innovative biopharmaceutical company pioneering novel oncology cell therapies for the unmet medical needs in in hematology and oncology, reported that an abstract detailing data from a Phase I study(POLARIS) evaluating OriCAR-017 in patients with Relapsed/Refractory Multiple Myeloma will be presented an oral session at the upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting on Sunday, June 5th (Press release, OriCell Therapeutics, MAY 27, 2022, View Source;oricell-therapeutics-announces-oral-presentation-at-2022-asco-annual-meeting-detailing-results-from-phase-i-polaris-study-of-oricar-017-301556668.html [SID1234615218]).

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About POLARIS Study

This is a Phase I first-in-human study of OriCAR-017 in patients with Relapsed/Refractory Multiple Myeloma (NCT05016778).

POLARIS study enrolled adults with measurable MM, R/R or intolerant to established MM therapies, prior BCMA-targeted therapy allowed. OriCAR-017 was administered by a single infusion at 3 dose cohorts to 9 patients. In all patients, majority of AEs were transient, manageable, and reversible. CRS only in Grade 1or2. No DLT, Neurotoxicities been observed. No death due to AE. Responses were durable and deepened overtime with 100% ORR and 100% MRD negative rate, including BCMA CAR-T relapsed patients, all patients are progression free and followed without additional therapy at the cutoff date. Updated data will be oral presented at the upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting, in McCormick Place, Chicago, IL on June 3-7, 2022.

Details for the abstract as below:

Abstract ID: 8004
Abstract Title: Phase I open-label single arm study of GPRC5D CAR T-cells (OriCAR-017) in patients with relapsed/refractory multiple myeloma (POLARIS)
Session Type/Title: Oral Abstract Session/ Hematologic Malignancies—Plasma Cell Dyscrasia
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Link：View Source

About OriCAR Technology Platform

An autologous GPRC5D-directed CAR T cell with a memory and anti-exhaustion T cells phenotype on the basis of the standard second generation CAR T cell, which improves the expansion and durability of CAR-T post-transfusion.

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.