Business Case - Oral Pill Immunotherapeutics

Milestone Highlights:

The following highlights some key milestones achieved by Immunitor over the past 20 years that supports the scientific proof and the extraordinary potential of Immunitor’s oral pill immunotherapeutics platform products.

Immunitor’s patented oral pill immunotherapeutics target direct mucosal immune response by delivery to the body’s largest mucosal/microbiome site, where the majority of our immune cells reside.

Even though Immunitor therapeutics have not been clinically trialled in large populations, they have over the past 20 years firmly demonstrated success in many cases of late stage and terminal disease not responsive to current treatment options

The case for establishment of the Immunitor oral pill immunotherapeutics platform to produce treatment options for malignant diseases and conditions showing poor response or failure by current options and for other unmet needs is compelling.

With the science proven and the challenge of gastric degeneration overcome through the patent protected platform technology, the opportunity is in establishing Immunitor immunotherapeutic products as an exciting new disease treatment regime.

2020:  

Interim results from ongoing Phase III placebo-controlled, randomized trial of hepcortespenlisimut-L for advanced hepatocellular carcinoma indication

All patients were in advanced stage of HCC and unfit for standard therapy, i.e. surgical intervention, due to tumor size, its location, or multiplicity. Many patients had single or multiple events of recurrent lesions after surgical intervention, such as resection, transarterial embolization, radiofrequency ablation, percutaneous ethanol injection, or their combinations. At study commencement, all patients were either under palliative care or pronounced incurable, and without available treatment options – underlining the disease gravity.

As early as one month after treatment initiation, there was a clear improvement in alanine transaminase, aspartate transaminase, alkaline phosphatase, and bilirubin levels among HCC patients who received daily dose of V5, but not in the placebo group. Additionally, alpha-fetoprotein (AFP) levels among V5 recipients decreased, while in the placebo group they rose.

We have successfully used V5 since 2010 in hundreds of patients with HCC and we are confident that the outcome from this Phase III trial will be consistent with the results of the Phase II retrospective study published in 2017

https://hrjournal.net/article/view/3315

Research and Markets Cover:  COVID-19 – Therapeutic Pipeline for Vaccines – 2020

Research and Markets reports:  V-SARS: Immunitor – Immunitor is developing therapeutic vaccine V-SARS which is formulated as a pill derived from heat-inactivated plasma from COVID-19 patients administered once-per-day to at least 20 healthy volunteers for at least one month. It is currently in phase I/II stage of development.

https://www.researchandmarkets.com/reports/5129091/covid-19-novel-coronavirus-19-therapeutic

Successful TB Study in placebo-controlled, randomized, double-blind trial of tableted, therapeutic TB vaccine (V7) containing heat-killed M. vaccae administered daily for one month.

In a one-month 152 patient TB study mycobacterial clearance was observed in 68% of patients on V7 and 86.7% in those recipients with drug-sensitive and multidrug-resistant TB. Patients on V7 gained on average 2.4 kg, and improvements in haemoglobin levels, erythrocyte sedimentation rate and leukocyte counts were significantly better than in controls. Liver function tests revealed that V7 can prevent chemotherapy-induced hepatic damage.

https://pubmed.ncbi.nlm.nih.gov/31890902/

https://www.sciencedirect.com/science/article/pii/S2405579419300841

Delveinsight Research Cover – Cancer Therapeutics

Delveinsight Research Report offers in-depth insights about 10+ Active Players and the Expected launch of 15+ potential Neoantigen-based Personalized Cancer therapeutic Vaccines, including Gradalis (Vigil), OSE Immunotherapeutics (Tedopi), Immunitor (Hepko-V5), Gritstone Oncology (GRANITE (GRT-C901) + SLATE (GRT- R902)), Genocea (GEN-009), Targovax (TG01 Vaccine), Hangzhou Neoantigen Therapeutics (iNeo-Vac-P01), Neon Therapeutics (NEO-PV-01)

https://www.prnewswire.co.uk/news-releases/neoantigen-based-personalized-cancer-therapeutic-vaccines-competitive-landscape-and-market-forecast-2035-816984920.html

2019:  

V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer (GBM)

The Phase II study to determine the safety and efficacy of V-Boost in treating a type of brain cancer called Glioblastoma Multiforme (GBM). V-Boost is an immunotherapy in which the patient’s immune system will be modulated to eliminate tumor cells. V-Boost is made as an oral tablet which contains specially formulated hydrolyzed GBM antigens along with alloantigens. Patients are either newly diagnosed or with recurrent form of GBM who may have been subjected to surgery and/or chemo- or radiation therapy that ended up unsuccessful. The goal is to eradicate GBM tumor cells through daily oral administration of one pill of V-Boost immunotherapeutic vaccine, which so far has not shown any adverse reaction.

https://clinicaltrials.gov/ct2/show/NCT03916757

Immunitor Unveils Five Oral Immunotherapy Vaccines

Three of the vaccine candidates were developed to treat the most prevalent cancers in women, and are in various stages of Phase II studies:

V3-OVA NCT03556566 for ovarian cancer,

V3-CERVIX NCT03550755 for cervical cancer,

V3-MOMMO NCT03572361 for breast cancer.

Dr. Allen Bain commented: “Immunitor strives to help women who often have no treatment options and our preliminary investigations have shown very promising results.”

https://www.precisionvaccinations.com/v-endo-vaccine-candidate-endometriosis-treatment-entered-phase-12-study

2017:  

Open-label phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L

“over 90% of patients survived over 12 months and complete response rate was 16%. The response to immunotherapy as judged by decrease of tumor burden and liver cancer marker AFP was significant; 2 out of 3 patients benefited from simple once-per-day pill regimen. Vaccine was extremely safe – it has not caused any adverse effects.” Dr Allen Bain 

https://www.dovepress.com/open-label-phase-ii-clinical-trial-in-75-patients-with-advanced-hepato-peer-reviewed-fulltext-article-JHC

Immunitor V7 as an adjunct TB immunotherapy supported by Canadian government Grand Challenges

This project was a follow-up to earlier work and involved conducting a clinical trial with an oral, tableted formulation of heat-killed Mycobacterium vaccae (V7) as an adjunct immunotherapy treatment for TB. The team previously developed this product, which drastically reduced the duration of treatment, producing sputum clearance in an overwhelming majority of TB patients in as short a time as one month.

https://www.grandchallenges.ca/grantee-stars/0532-01-10/

2016:

Immunotherapy for atherosclerosis and obesity study supported by Canadian government Grand Challenges

Results produced in the V6 trials support the immune nature of seemingly unrelated metabolic diseases, such as obesity, atherosclerosis, diabetes and even hypertension.

The magnitude of clinical response to V6 in this and other trials was comparable to the results obtained in clinical trials of cholesterol and obesity drugs, but without adverse side-effects.

https://www.grandchallenges.ca/grantee-stars/0661-01-10/ 

2014:  

Immunitor’s breakthrough in cancer immunotherapy

“This outstanding clinical response highlights the therapeutic potential of our vaccine, especially when one considers the fact that all our patients were in terminal stage of the disease. To the best of our knowledge such an outcome is better than one can find in the entire cancer immunotherapy field.” Dr Aldar Bourinbaiar

https://www.prweb.com/releases/2014/06/prweb11965485.htm

2010:

Safety and Efficacy of Oral Immunomodulator in Tuberculosis (TB) and TB/HIV Patients

Treatment of multidrug-resistant TB (MDR-TB) is 100 times more expensive than treatment of drug-susceptible TB, requiring intensive clinical management for prolonged time (18-24 months) and more toxic treatment course. In prior open label study the investigators have shown that adding Immunitor V-5 can reduce treatment duration to one month and enhance by 4-5 fold the efficacy of TB drugs. Furthermore, V5 has been shown to reverse or reduce liver damage caused by chemotherapy. The cost of V5 will be very modest. The investigators propose to conduct placebo-controlled clinical trial in patients with treatment refractory TB so that the clinical benefit of V5 is confirmed.

https://clinicaltrials.gov/ct2/show/NCT01222338?term=immunitor&recrs=e&draw=2&rank=1

2008

Open-label trial of therapeutic immunization with oral V-5 Immunitor (V5) vaccine in patients with chronic hepatitis C

Every patient who entered the study had elevated liver enzyme levels, which at the end of study have decreased in 100% of analyzed patients. The AST/ALT ratio has improved from 0.93 to 1.18 (P=0.00058) indicating the reversion of progression to cirrhosis.  No adverse events were observed at any time. The favorable biochemical and clinical responses have been observed in a small number of individuals for a limited time period. Larger scale and longer studies are needed to confirm our preliminary observations.

https://pubmed.ncbi.nlm.nih.gov/18455842/

2004

Increased body weight and improved quality of life in AIDS patients following V-1 Immunitor administration

We have demonstrated earlier that oral therapeutic HIV vaccine, Immunitor V1 increases T-cell counts, decreases the viral load, and also results in weight gain and prolonged survival. To further expand this observation, we retrospectively analyzed 650 HIV-positive patients who were followed for an average of 23 weeks. Treatment with V1 resulted in a sustained and statistically significant increase in body mass across the whole population, the majority of patients (76%) were able to gain or maintain weight. In a survey of health status in a comparable but separate group of 382 patients, about 85% reported subjective improvement after V1 treatment, coinciding with the reduction or clearance of oral thrush or mucocutaneous candidiasis in 87.5% of the patients.

https://pubmed.ncbi.nlm.nih.gov/14679375/

2002

Independent Documentary

An independent documentary written, produced, and directed by New York based John Rubino highlighting the political influences and interventions, despite demonstrable and significant success in late stage HIV/AIDS, tuberculosis and hepatitis where other treatments were failing.

See Documentary here