On December 7, 2022 Touchlight, a biotechnology company pioneering enzymatic DNA production to enable genetic medicines, reported a development and supply agreement with Odimma Therapeutics, a French biotech company focusing on personalised cancer immunotherapy (Press release, Touchlight Genetics, DEC 7, 2022, View Source [SID1234624862]).

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"The agreement between Odimma and Touchlight is an important step forward to secure Odimma’s clinical development. Not only is Touchlight’s technology producing genetic material with very favourable characteristics for a clinical use but also in a timeframe extremely adapted to a personalized immunotherapy in oncology. "

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The agreement focuses on the provision of clinical material for use in Odimma’s oncological neoantigen program. Through the deal, Odimma will gain access to Touchlight’s proprietary doggybone DNA (dbDNA) vector technology, providing them with a clinical supply of personalised dbDNA, to support and underpin the development of their candidate immunotherapy cancer treatment. The program is expected to start clinical enrolment in 2023.

Odimma’s approach of harnessing the ability of the patient’s own immune system to specifically recognize non-self-targets displayed by tumour cells represents a step change in the field of immune oncology and opens new avenues for the treatment of difficult to target tumours.

The development of the neoantigen products required for the therapy has faced unique challenges, including lead time to obtain GMP DNA and complex supply chains. Touchlight’s enzymatic production process, with its 5-day manufacturing process, will therefore strongly support Odimma in its program development. This will also allow Odimma’s clinical study to commence promptly for the benefit of patients.

Touchlight’s doggybone DNA is a minimal, linear, double stranded, covalently closed DNA vector which is produced through an enzymatic manufacturing process. It can accommodate genes of interest of more than 20kb and is linearly scalable, making it highly adaptable to support a range of genetic medicines and is ideal for the development of mRNA vaccines, therapeutics, gene therapies and beyond.

Karen Fallen, CEO, Touchlight commented: "We are delighted to be supporting Odimma on this ground-breaking program. Innovation in enzymatic DNA manufacturing is enabling advancements such as Odimma’s Immunotherapy program to deliver treatments to critically ill patients. With a rapid timeline to GMP and high-fidelity process, doggybone DNA is helping to overcome existing industry bottlenecks and the challenges associated with plasmid DNA."

Jean-Marc Limacher, MD, Chairman of Odimma Therapeutics said: "The agreement between Odimma and Touchlight is an important step forward to secure Odimma’s clinical development. Not only is Touchlight’s technology producing genetic material with very favourable characteristics for a clinical use but also in a timeframe extremely adapted to a personalized immunotherapy in oncology.

On December 7, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its gut bacterial Mimicry drug discovery platform, reported that it will present updated efficacy, immunogenicity and safety data from its Phase 2 trial of EO2401 in combination with nivolumab +/- bevacizumab, in patients with first progression/recurrence of glioblastoma (ROSALIE trial) in two poster presentations at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress which is taking place in Geneva, Switzerland, December 7-9 2022 (Press release, Enterome, DEC 7, 2022, View Source [SID1234624857]).

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EO2401 is a first-in-class OncoMimics peptide-based immunotherapy able to rapidly activate and significantly expand existing effector memory CD8+ T cells against tumor-associated driver antigens due to their strong cross-reactivity with OncoMimics peptides.

Professor Wolfgang Wick, Universitätsklinikum and German Cancer Research Center, Heidelberg (Germany) will present the two posters on Thursday December 8th at the Poster Display Session ID 44 from 12:30 to 13:15 CET.

The poster details are as follows:

Poster Details – Abstract #170P
Title: EO2401 microbiome derived therapeutic vaccine + nivolumab +/- bevacizumab, in neoadjuvant, adjuvant and non-surgery linked treatment of recurrent glioblastoma: phase 1-2 EOGBM1-18/ROSALIE study
Authors: W. Wick et al.

Link to abstract can be accessed here.

Poster Details – Abstract #185P
Title: Interim analysis of the EOGBM1-18 study: Strong immune response to therapeutic vaccination with EO2401 microbiome derived therapeutic vaccine + nivolumab
Authors: W. Wick et al.

Link to abstract can be accessed here.

In addition, Enterome will present another poster on in vitro assays and in vivo evaluations in healthy donors demonstrating that OncoMimics peptides can elicit strong immune responses against tumors through cross-reaction of pre-existing, highly prevalent (>80% in the population) CD8+ T cells against targeted Tumor-Associated Antigens (TAAs).

Poster Details – Abstract #180P
Title: Recalling pre-existing microbiota-specific T cells to target tumors
Authors: J.-M. Carpier et al.

Link to abstract can be accessed here.

About EO2401
EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics peptide-based immunotherapy. It combines three microbial-derived OncoMimics peptides that closely mimic specific cytotoxic T cell (CD8+ T cell) epitopes on the Tumor-Associated Antigens IL13Ra2, BIRC5 and FOXM1, combined with the helper peptide (CD4+ T cell epitope) Universal Cancer Peptide 2 (UCP2). EO2041 is designed to trigger the immune system into recognizing these epitopes on glioblastoma cells as foreign (non-self) and eliciting a targeted memory T-cell driven cell-killing response against the tumor cells.

About ROSALIE
ROSALIE (EOGBM1-18, NCT04116658) is a multicenter, open-label, Phase 1/2 trial investigating EO2401 in combination with nivolumab, and in combination with nivolumab/bevacizumab in patients with glioblastoma at first progression/recurrence after surgery and adjuvant radiotherapy/temozolomide. The trial is assessing safety, tolerability, immunogenicity and preliminary efficacy in more than 80 patients at centers in the US and Europe.

On December 6, 2022 Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, reported an upcoming presentation at the 7th Annual Oncolytic Virotherapy Summit, taking place in Boston, Massachusetts and virtually, December 6-8, 2022 (Press release, Calidi Biotherapeutics, DEC 7, 2022, View Source [SID1234624831]).

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Details of the presentation are below:

Title: Allogeneic Stem Cell-Based Platforms to Potentiate and Deliver Oncolytic Virus Therapies
Date: Thursday December 8th, 2022, 10:00 a.m. ET
Presenter: Boris Minev M.D., President, Medical & Scientific Affairs, Calidi Biotherapeutics

On December 6, 2022 RemedyBio, a Dublin based biotech company, inspired by functional biology for the discovery and development of new immune therapies using the power of its Nanoreactor Technology for the analysis of individual cells and cell interactions, reported their participation in INSPIRE, a €12.8 million lung cancer program (Press release, Remedy Biologics, DEC 6, 2022, View Source [SID1234644158]). In one of the largest ever grants for preclinical research in lung cancer, RemedyBio will collaborate with programme leader, OmniSpirant and other European partners spanning across biotechnology, medical devices, cancer research, academia and patient advocacy.

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With the successful award of the grant by Horizon Europe, the INSPIRE consortium are already actively working on the program deliverables, and recently met in Galway, Ireland for the official kick off meeting. As well as OmniSpirant and RemedyBio, the consortium partners include Aerogen Limited (Ireland), Trinity College Dublin (Ireland), EVerZom (France), Biopharma Excellence (Pharmalex) (Germany), Deutsches Krebsforschungszentrum (DKFZ) (Germany) and Lung Cancer Europe (LuCE) (Switzerland).
Over the next 3 years, the INSPIRE programme aims to make an important and tangible impact on Europe’s Beating Cancer Plan and the EU Mission on Cancer. The consortium partners will work to develop a novel, effective and affordable lung cancer treatment via the development of a transformative new lower cost gene therapy. This project will place Europe as a leader in the fight against lung cancer and in the development of treatments for other debilitating lung diseases.
RemedyBio’s key role in the programme will be based on using RemedyBio’s proprietary Nanoreactor technology to investigate functional cell to cell interactions between the tumour and the gene therapy, building understanding of the efficacy of the new therapy.
"We are delighted to be part of the INSPIRE consortium in order to develop new and more effective therapies that impact patients lives", said Dan Crowley, CEO of Remedy Bio. "Our Nanoreactor technology and understanding of cell to cell interaction with help to drive insight and direction with our consortium partners in developing new RNA based therapeutics for lung cancer."

On December 6, 2022-Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immuneoncology vaccines and drug delivery technologies, reported the successful completion of all GLP studies related to its anti-cancer AccuTOXTM molecule (Press release, Defence Therapeutics, DEC 6, 2022, View Source [SID1234626257]). The Company is planning to meet with the FDA in the weeks to come to obtain approval for launching its Phase I trial against solid tumors.

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AccuTOXTM: a fierce anti-cancer treatment.

In the past 16 months, Defence engineered a large library of AccumTM variants exhibiting differential effects on both immune and cancer cells. One of these lead molecules is AccuTOXTM, a small compound capable of effectively killing a large set of murine and human tumors by inducing the production of reactive oxygen species, causing immunogenic cells death as well as triggering direct DNA damage akin to chemotherapeutic agents. Interestingly, AccuTOXTM administration synergises with different immune-checkpoints (anti-PD-1, anti-CTLA4 and antiCD47) making it a highly mouldable molecule adaptable to a myriad of solid cancer indications. For instance, AccuTOXTM dosed at 16 mg/kg halts the growth of solid T-cell lymphoma, melanoma as well as breast cancer in mice with a survival rate of more than 90%. These results combined to the molecular characterization of AccuTOXTM’s mechanism of action clearly highlight the anti-neoplastic potential of this molecule as a next generation treatment for various cancer types.

GLP studies in rodents revealed no adverse effects for AccuTOXTM.

Building upon the impressive results obtained in different pre-clinical murine cancer models, a set of GLP studies was then conducted in male and female Sprague-Dawley rats to determine the toxicity potential and toxicokinetic profile of AccuTOXTM when administered through the subcutaneous route for 14 days (delivered every 48h for a total of 7 repetitive injections). Besides slight erythema/edema at the injection site, no clinical signs of morbidity or mortality were observed in both sexes using a dose as high as 30 mg/kg, which is twice as high as the therapeutic dose used in pre-clinical studies. Animals body weight, food consumption, coagulation and urine parameters were unaffected at all tested doses in both male and female rates. Hematological changes were considered minimal with no noticeable side effects to report. Furthermore, the time to reach peak plasma concentration (Tmax) was ~1h in both genders. In conclusion, AccuTOXTM exhibits no adverse effects in rats and is well tolerated even at repetitive dosing of 30 mg/kg.

AccuTOXTM is safe and well tolerated in canines.

Upon completing the GLP study in rats, Defence followed up with a second set of GLP studies in Beagle dogs. In this case, higher AccuTOXTM doses were used (up to 100 mg/kg, which is 6.2-fold higher than the therapeutic dose used in mice). Although no clinical signs were observed up to 50 mg/kg, a very slight erythema was observed at the injection site following single dosing. Repetitive dosing, on the other hand, revealed very limited erythema and hardness at injection sites, which were considered of minimal impact. No mortalities were observed in male or female dogs up to 100 mg/kg and body weights of all treated animals were consistent despite a small decrease in food consumption. No apparent changes were noticed in the conducted electrocardiograms in both genders nor in their hematological, coagulation and urinalysis parameters. Chronic inflammation was apparent at the injection sites associated with mild leukocyte infiltration. The Tmax for AccuTOX in dogs varied between 0.25 and 1h in both genders, with a detected T1/2 of ~0.553h. In sum, AccuTOXTM is safe and well tolerated by Beagles with limited local effects observed at injection sites.

A Phase I trial in the pipeline

"The AccuTOXTM program has greatly matured since its inception in mid-2021. The molecule is highly effective as an anti-cancer molecule and exhibits no toxic effects in different animal models (mice, rats and dogs). The fact that dogs can tolerate AccuTOXTM up to 100 mg/kg demonstrates a larger than expected therapeutic window for this treatment", says Mr. Plouffe, the CEO of Defence Therapeutics. Defence is currently preparing to meet with the FDA in the up-coming weeks to present its preclinical and GLP studies to get approval for initiating a Phase I trial on a basket of solid tumors. The primary objective will be to demonstrate the safety and tolerability of the drug in cancer patients, while assessing some form of potency as secondary objective. Data Bridge Market Research analyses that the solid tumors market was valued at USD 209.61 billion in 2021 and is expected to reach USD 901.27 billion by 2029, registering a CAGR of 20.0% during the forecast period of 2022 to 2029.