Vaccinogen

Last updated
Vaccinogen Inc.
Company type Public
OTCQB:  VGEN
Industry Biotechnology
Founded2007;17 years ago (2007)
FounderMichael Hanna
Headquarters Baltimore
Key people
Andrew Tussing (chairman and CEO)
ProductsOncoVAX
Website www.vaccinogeninc.com

Vaccinogen Inc. is a US biotechnology company based in Baltimore. It is currently developing a potential cancer immunotherapy called OncoVAX, where a patient's own tumor cells are used as the vaccine, adjuvanted by BCG. This product was evaluated in Phase III in colon cancer in the 1990s and another Phase III study, called ACTIVE, is currently recruiting stage II colon cancer patients. Vaccinogen calls its approach 'Active Specific Immunotherapy' or ASI.

Contents

Background

Vaccinogen originated in work done by the company's founder, Dr Michael Hanna, in the late 1970s and early 1980s when he was Director of the National Cancer Institute's Frederick Cancer Research Center in Frederick, Md. Hanna founded a company to develop what became OncoVAX and this was acquired by a company from Seattle called Intracel, but that company filed for bankruptcy in 2001. Vaccinogen was formed in 2007 to pick up the intellectual property and other assets from Intracel. [1] Dr Ben Carson was chairman of the company from August 2014 [2] until the announcement of his US presidential bid in May 2015. [3] Carson had previously served on Vaccinogen's Medical Advisory Board. [4]

OncoVAX

OncoVAX is an autologous cancer vaccine, that is, manufactured using the patient's own tumour cells. The product involves the surgical excision of the tumour and its sterilization and gamma-irradiation in order to render the tumour cells non-dividing. The patient is then administered two injections of these tumor cells mixed with the TICE strain of BCG via intradermal injection. After this, the patient receives two more injections of tumour cells but without the BCG. The first three immunizations are delivered weekly approximately a month after surgical resection of the tumor, and the fourth is given six months later. [5] At the present time the product is intended for stage II colon cancer, where tumors have penetrated into the muscles around the colon, but have not visibly spread to lymph nodes of more distant sites.

Development of OncoVAX

Hanna et al. performed three multi-institutional, prospectively randomized, controlled clinical trials of post-resection adjuvant ASI over the two decades to 2001. A meta-analysis of these studies published in the journal Vaccine found 'significant clinical benefits in patients with stage II colon cancer'. [6] Hanna et al. described the 'trials and tribulations' involved in developing OncoVAX in a 2006 paper in the journal Human Vaccines . [7]

* Pilot trial in colon and rectal cancer. Michael Hanna first took his ASI approach into the clinic in a pilot trial at Johns Hopkins Hospital that commenced in 1981. The lead investigator was Dr Herbert C. Hoover Jr., a 'distant nephew' of the 31st US President. [8] The study, which evaluated 80 colon and rectal cancer patients, finally read out data in March 1993 in the Journal of Clinical Oncology . The study found a significant improvement in survival (p=0.02) and disease-free survival (p=0.039) in all eligible colon cancer patients but no benefits in rectal cancer patients. [9]

* Phase III study in stage II and III colon cancer with first generation OncoVAX. This study in 412 patients, which compared ASI+resection vs resection alone, used a treatment regimen of only three weekly intradermal vaccine injections of 107 irradiated autologous tumor cells where the first two injections also contained 107 BCG organisms. After a 7.6-year median follow-up period there were no statistically significant differences in clinical outcomes between the treatment arms however there was a trend towards disease-free survival and overall survival for the ASI patients that had all three doses. [10]

* Phase III trial in colon cancer with second generation OncoVAX. This 254-patient study, which has allowed Vaccinogen to make efficacy claims for its current version of OncoVAX and is called the '8701' study by the company, had its results published in The Lancet in January 1999. In this study the investigators used 107 BCG organisms for the first two doses and added the booster vaccination at six months with 107 irradiated autologous tumour cells. Over a median follow-up period of 5.3 years there was a 44% risk reduction for recurrence for patients that received OncoVAX (p=0.023), but only patients who had stage II disease benefited. For these patients the risk of recurrence was cut by 61%. [11] The cost of the product was subsequently studied by medical technology assessment specialists at the Erasmus University Medical Center in Rotterdam who reported 'impressive health economics benefits' in a paper in Vaccine. [12] In 2012 the investigators revisited the data to see if there was different outcomes for patients with microsatellite unstable versus stable colon cancer. In the process they tracked event-free survival for the study population out to 15 years, finding a hazard ratio for the treatment group of 0.62 (p=0.033). [13]

OncoVAX manufacturing

OncoVAX employs a 'centralised' manufacturing process where the patient's tumour sample is shipped to a company-owned cGMP manufacturing facility in the Dutch town of Emmen for processing and then shipped back to the hospital for administration to the patient. In the 8701 study manufacturing was not carried out under cGMP conditions. Subsequent to 8701 a small 15-patient study was carried out with manufacturing taking place under cGMP (ClinicalTrials.gov identifier NCT00016133 [14] ). This study found that the immunogenicity of OncoVAX was unaffected by the manufacturing process. [15]

Planned clinical study of OncoVAX

Vaccinogen is currently enrolling patients in a confirmatory Phase III clinical study for OncoVAX called ACTIVE that will enroll 550 patients with stage II colon cancer, randomising 1:1 to receive surgery alone or surgery plus OncoVAX (ClinicalTrials.gov identifier NCT02448173 [16] ). The Primary Endpoint in this study is the Disease-Free Interval.

Vaccinogen plans to conduct a pilot program in parallel with ACTIVE to evaluate OncoVAX in combination with an adjuvant chemotherapy treatment for stage III colon cancer patients.

Human monoclonal antibodies program

In September 2015 Vaccinogen announced an exclusive two-year option with Dublin City University over a high-throughput, multiplex, analysis platform developed in the laboratory of Dr. Paul Leonard called DiCAST (Direct Clone Analysis and Selection Technology). [17] Vaccinogen intends to use DiCAST to screen patient-derived biological samples acquired after those patients have gained anti-cancer immunity in the search for new anti-cancer antibodies. [18]

Vaccinogen stock

Vaccinogen stock is traded OTC in the US. It upgraded its marketplace tier to OTCQB in October 2013. [19] The stock code is VGEN. The SEC suspended trading of this stock in September 2017. According to the letter of suspension, 'VGEN is delinquent in its periodic filings with the commission, having not filed any periodic reports since it filed a Form 10-Q for the period ended September 30, 2015, which reported a net loss available to common shareholders of $24,743,490 for the prior nine months.' [20]

Main people

Vaccinogen's Chairman and CEO is Andrew Tussing, a former investment banker who co-founded Vaccinogen with Michael Hanna in 2007. Michael Hanna remains a director. Vaccinogen's COO is Dr Peter Morsing, formerly of AstraZeneca.

Location

Vaccinogen is headquartered in Baltimore at 949 Fell Street near Fell's Point. The company moved there in February 2015 after previously having been located at Frederick, Md. [21] The company also maintains laboratories in Dublin and its manufacturing facility at Emmen. The Emmen location of Vaccinogen B.V. was declared bankrupt in 2017. [22]

Related Research Articles

Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as activation immunotherapies, while immunotherapies that reduce or suppress are classified as suppression immunotherapies. Immunotherapy is under preliminary research for its potential to treat various forms of cancer.

A cancer vaccine, or oncovaccine, is a vaccine that either treats existing cancer or prevents development of cancer. Vaccines that treat existing cancer are known as therapeutic cancer vaccines or tumor antigen vaccines. Some of the vaccines are "autologous", being prepared from samples taken from the patient, and are specific to that patient.

<span class="mw-page-title-main">Cancer immunotherapy</span> Artificial stimulation of the immune system to treat cancer

Cancer immunotherapy (immuno-oncotherapy) is the stimulation of the immune system to treat cancer, improving the immune system's natural ability to fight the disease. It is an application of the fundamental research of cancer immunology (immuno-oncology) and a growing subspecialty of oncology.

Adjuvant therapy, also known as adjunct therapy, adjuvant care, or augmentation therapy, is a therapy that is given in addition to the primary or initial therapy to maximize its effectiveness. The surgeries and complex treatment regimens used in cancer therapy have led the term to be used mainly to describe adjuvant cancer treatments. An example of such adjuvant therapy is the additional treatment usually given after surgery where all detectable disease has been removed, but where there remains a statistical risk of relapse due to the presence of undetected disease. If known disease is left behind following surgery, then further treatment is not technically adjuvant.

Mitumomab (BEC-2) is a mouse anti-BEC-2 monoclonal antibody investigated for the treatment of small cell lung carcinoma in combination with BCG vaccination. Mitumomab attacks tumour cells, while the vaccine is thought to activate the immune system. It was developed by ImClone and Merck.

Vaccine therapy is a type of treatment that uses a substance or group of substances to stimulate the immune system to destroy a tumor or infectious microorganisms such as bacteria or viruses.

CancerVax was an American pharmaceutical company founded in 1998 by Donald Morton. The company sought to develop a vaccine for cancer, and had candidates for melanoma reach phase III clinical trials. When those trials proved unsuccessful in 2005, the company soon underwent a reverse takeover with Micromet.

Autologous immune enhancement therapy (AIET) is a treatment method in which immune cells are taken out from the patient's body which are cultured and processed to activate them until their resistance to cancer is strengthened and then the cells are put back in the body. The cells, antibodies, and organs of the immune system work to protect and defend the body against not only tumor cells but also bacteria or viruses.

Active immunotherapy is a type of immunotherapy that aims to stimulate the host's immune system or a specific immune response to a disease or pathogen and is most commonly used in cancer treatments. Active immunotherapy is also used for treatment of neurodegenerative disorders, such as Alzheimer's disease, Parkinson's disease, prion disease, and multiple sclerosis. Active immunotherapies induce an immune response through direct immune system stimulation, while immunotherapies that administer antibodies directly to the system are classified as passive immunotherapies. Active immunotherapies can elicit generic and specific immune responses depending on the goal of the treatment. The categories of active immunotherapy divide into:

Neuvenge, Lapuleucel-T, is a therapeutic cancer vaccine (TCV) in development by Dendreon (DNDN). It uses the "immunotherapy platform approach" first successfully demonstrated on the U.S. Food and Drug Administration (FDA)-approved TCV Provenge. It was first tested on breast cancer patients with tumors expressing HER2/neu, and is now scheduled to be tested on bladder cancer patients.

Gustav Gaudernack is a scientist working in the development of cancer vaccines and cancer immunotherapy. He has developed various strategies in immunological treatment of cancer. He is involved in several ongoing cellular and immuno-gene therapeutic clinical trials and his research group has put major efforts into the development of various T cell-based immunotherapeutic strategies.

Racotumomab is a therapeutic cancer vaccine for the treatment of solid tumors that is currently under clinical development by ReComBio, an international public-private consortium with the participation of the Center of Molecular Immunology at Havana, Cuba (CIM) and researchers from Buenos Aires University and National University of Quilmes in Argentina. It induces the patient's immune system to generate a response against a cancer-specific molecular target with the purpose of blocking tumor growth, slowing disease progression and ultimately increasing patient survival.

CimaVax-EGF is a vaccine used to treat cancer, specifically non-small-cell lung carcinoma (NSCLC). CIMAvax-EGF is composed of recombinant human epidermal growth factor (EGF) conjugated to a protein carrier.

<span class="mw-page-title-main">Nivolumab</span> Anticancer medication

Nivolumab, sold under the brand name Opdivo, is an anti-cancer medication used to treat a number of types of cancer. This includes melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal junction cancer. It is administered intravenously.

<span class="mw-page-title-main">NeuVax</span> Vaccine

NeuVax is a peptide vaccine aimed at preventing or delaying the recurrence of breast cancer in cancer survivors who achieve remission after standard of care treatment. The product's developer is the US biotechnology company Galena Biopharma.

Eftilagimod alpha is a large-molecule cancer drug being developed by the clinical-stage biotechnology company Immutep. Efti is a soluble version of the immune checkpoint molecule LAG-3. It is an APC Activator used to increase an immune response to tumors, and is administered by subcutaneous injection. Efti has three intended clinical settings:

<span class="mw-page-title-main">Durvalumab</span> Pharmaceutical drug

Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 (CD279).

A therapeutic vaccine is a vaccine which is administered after a disease or infection has already occurred. A therapeutic vaccine works by activating the immune system of a patient to fight an infection. A therapeutic vaccine differs from a prophylactic vaccine in that prophylactic vaccines are administered to individuals as a precautionary measure to avoid the infection or disease while therapeutic vaccines are administered after the individual is already affected by the disease or infection. A therapeutic vaccine fights an existing infection in the body rather than immunizing the body for protection against future diseases and infections. Therapeutic vaccines are mostly used against viral infections. Patients affected with chronic viral infections are administered with therapeutic vaccines, as their immune system is not able to produce enough efficient antibodies.

Whole-cell vaccines are a type of vaccine that has been prepared in the laboratory from entire cells. Such vaccines simultaneously contain multiple antigens to activate the immune system. They induce antigen-specific T-cell responses.

mRNA-4157/V940 is an mRNA based cancer vaccine encapsulated in solid lipid nanoparticles. The 34 mRNA sequences in mRNA-4157/V940 vaccine were generated by an automated algorithm integrated with workflow based on massive parallel sequencing of tissue generated from cancer patients. As adjuvant therapy, mRNA-4157 monotherapy and in combination with pembrolizumab have been investigated in patients with resected solid tumors. It was also investigated in patients with HNSCC and MSS-CRC.

References

  1. ↑ Dance, Scott (February 27, 2015). "Vaccinogen brings momentum on cancer vaccine research to Baltimore". The Baltimore Sun. Retrieved 26 December 2015.
  2. ↑ Dance, Scott (August 25, 2014). "Dr. Ben Carson named chairman of Frederick biotech Vaccinogen". The Baltimore Sun. Retrieved 26 December 2015.
  3. ↑ "Vaccinogen Names Co-Founder and CEO Andrew L. Tussing as Chairman of the Board". Vaccinogeninc.com. May 5, 2015. Retrieved 26 December 2015.
  4. ↑ "Vaccinogen Names Dr. Benjamin Carson and Dr. Jan B. Vermorken to Medical Advisory Board". Vaccinogen.inc. October 24, 2013. Retrieved 26 December 2015.
  5. ↑ Hanna MG (August 1, 2012). "Immunotherapy with autologous tumor cell vaccines for treatment of occult disease in early stage colon cancer". Human Vaccines & Immunotherapeutics. 8 (8): 1156–1160. doi:10.4161/hv.20740. PMC   3551893 . PMID   22854664.
  6. ↑ Hanna MG Jr; Hoover HC Jr; Vermorken JB; Harris JE; Pinedo HM (Mar 21, 2001). "Adjuvant active specific immunotherapy of stage II and stage III colon cancer with an autologous tumor cell vaccine: first randomized phase III trials show promise". Vaccine. 19 (17–19): 2576–82. doi:10.1016/s0264-410x(00)00485-0. PMID   11257395.
  7. ↑ Hanna MG Jr; Hoover HC Jr; Pinedo HM; Finer M (July 6, 2006). "Active specific immunotherapy with autologous tumor cell vaccines for stage II colon cancer: logistics, efficacy, safety and immunological pharmacodynamics". Human Vaccines. 2 (4): 185–91. doi: 10.4161/hv.2.4.3196 . PMID   17012885. S2CID   23995771.
  8. ↑ Wlazelek, Ann (September 11, 1995). "Surgeon To Test Vaccine On Local Cancer Patients". The Morning Call. Retrieved 27 December 2015.
  9. ↑ Hoover HC Jr; Brandhorst JS; Peters LC; Surdyke MG; Takeshita Y; Madariaga J; Muenz LR; Hanna MG Jr. (Mar 1, 1993). "Adjuvant active specific immunotherapy for human colorectal cancer: 6.5-year median follow-up of a phase III prospectively randomized trial". Journal of Clinical Oncology. 11 (3): 390–9. doi:10.1200/JCO.1993.11.3.390. PMID   8445413.
  10. ↑ Harris JE; Ryan L; Hoover HC Jr.; Stuart RK; Oken MM; Benson AB 3rd; Mansour E; Haller DG; Manola J; Hanna MG Jr. (January 1, 2000). "Adjuvant active specific immunotherapy for stage II and III colon cancer with an autologous tumor cell vaccine: Eastern Cooperative Oncology Group Study E5283". Journal of Clinical Oncology. 18 (1): 148–57. doi:10.1200/JCO.2000.18.1.148. PMID   10623705.{{cite journal}}: CS1 maint: numeric names: authors list (link)
  11. ↑ Vermorken JB; Claessen AM; van Tinteren H; Gall HE; Ezinga R; Meijer S; Scheper RJ; Meijer CJ; Bloemena E; Ransom JH; Hanna MG Jr; Pinedo HM. (January 30, 1999). "Active specific immunotherapy for stage II and stage III human colon cancer: a randomised trial". Lancet. 353 (9150): 345–50. doi:10.1016/s0140-6736(98)07186-4. PMID   9950438. S2CID   14081157.
  12. ↑ Uyl-de Groot CA; Vermorken JB; Hanna MG Jr; Verboom P; Groot MT; Bonsel GJ; Meijer CJ; Pinedo HM (March 18, 2005). "Immunotherapy with autologous tumor cell-BCG vaccine in patients with colon cancer: a prospective study of medical and economic benefits". Vaccine. 23 (17–18): 2379–87. doi:10.1016/j.vaccine.2005.01.015. PMID   15755632.
  13. ↑ de Weger VA; Turksma AW; Voorham QJ; Euler Z; Bril H; van den Eertwegh AJ; Bloemena E; Pinedo HM; Vermorken JB; van Tinteren H; Meijer GA; Hooijberg E (February 1, 2012). "Clinical effects of adjuvant active specific immunotherapy differ between patients with microsatellite-stable and microsatellite-instable colon cancer". Clinical Cancer Research. 18 (3): 882–9. doi: 10.1158/1078-0432.CCR-11-1716 . PMID   22156611.
  14. ↑ "Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery". Clinicaltrials.gov. U.S. National Institutes of Health. 29 May 2013. Retrieved 28 December 2015.
  15. ↑ "OncoVAX Cancer Vaccine Clinical Results". Vaccinogeninc.com.
  16. ↑ "A Multicenter Study of Active Specific Immunotherapy With OncoVax in Patients With Stage II Colon Cancer". U.S. National Institutes of Health. 24 July 2015. Retrieved 27 December 2015.
  17. ↑ Fitzgerald V; Manning B; O'Donnell B; O'Reilly B; O'Sullivan D; O'Kennedy R; Leonard P (January 20, 2015). "Exploiting highly ordered subnanoliter volume microcapillaries as microtools for the analysis of antibody producing cells". Analytical Chemistry. 87 (2): 997–1003. doi:10.1021/ac503547j. PMID   25479183.
  18. ↑ "Vaccinogen Enhances Patient-Derived Antibody Program with Revolutionary High-Throughput Single Cell Screening and Analysis System". Vaccinogeninc.com. September 9, 2015. Retrieved 27 December 2015.
  19. ↑ "Vaccinogen Announces SEC Clearance of Form 10 Registration Statement and Upgrade to OTC.QB Market". Vaccinogeninc.com. October 17, 2013. Retrieved 26 December 2015.
  20. ↑ The Securities and Exchange Commission 2017
  21. ↑ "Vaccinogen Relocates Corporate Headquarters to Baltimore". Vaccinogen.com. February 24, 2015. Retrieved 26 December 2015.
  22. ↑ Faillissements Dossier [ dead link ]
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