CancerVax

Last updated
CancerVax
Industry Pharmaceutical
Founded1998
Headquarters Delaware, USA
Area served
North America
Key people
Donald Morton, Ryan Davies (CEO) [1]
Products Vaccines

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.

Contents

Company Background

CancerVax was founded in Delaware by Dr. Donald Morton in 1998. Prior to the formation of the company, Dr. Morton researched at the John Wayne Cancer Institute. After discovering what would eventually become CancerVax's lead product candidate, Canvaxin, Donald left John Wayne Cancer Institute to start the company and push the drug through the clinical trials necessary in order to take a drug to the market. The company used specific mergers and joint ventures to attempt to humanize their antibodies and push their drugs through their pipeline. [2]

Products

While the company eventually had several drugs in their pipeline focused on melanoma, colon cancer, lung cancer, solid tumors, and ophthalmic disease, their lead candidate Canvaxin was focused on melanoma. Canvaxin was a vaccine based treatment for melanoma, and was an immunotherapeutic. In the clinical trials it has been proven an effective treatment, with a significantly greater (P<0.0001) median survival rate over than no treatment. [3] Immunotherapy in its most general form for cancer treatment uses the immune system to target tumor cells. While all cells produce cytokines and have receptor proteins on the cell surface, tumor cells may over-express them. Targeted immunotherapy towards these over expressed proteins could be an effective treatment towards different cancers. There are three types of immunotherapy, and they are briefly described below

-Passive Immunotherapy: Direct administration of monoclonal antibodies targeted to a specific cell receptor or protein to inhibit a tumor function or target the tumor itself.

-Non-Specific Active Immunotherapy: A general immune system response using cytokines and other cell signaling. Since this treatment is very general it has many complicated side effects.

-Specific Active Immunotherapy: The generation of cell-mediated and antibody immune responses focused on specific antigens expressed by the cancer cells. Canvaxin is an example of this therapy.

-CAR-T cell therapy: In 2023, the company partnered with research team from the University of California, Los Angeles to develop of a universal chimeric antigen receptor (CAR) T-cell platform. [4] [1]

Canvaxin

CancerVax partnered with Serono and released Canvaxin in 2004; [5] a therapeutic polyvalent cancer vaccine. It was an antigen-rich, allogeneic whole-cell vaccine developed in 1984 from three melanoma cell lines and is the most extensively studied melanoma vaccine to date. [6] However, on October 3, 2005, CancerVax announced the discontinuation of its Phase 3 clinical trial of Canvaxin in patients with Stage III melanoma. The decision followed the recommendation of the independent Data and Safety Monitoring Board (DSMB) with oversight responsibility for the clinical trial. The DSMB decided, based upon the data reviewed at the third interim analysis, that it was unlikely that the trial would provide significant evidence of a survival benefit for Canvaxin-treated patients versus those receiving placebo. In addition, in April 2005, the companies announced the discontinuation of their other Phase 3 clinical trial of Canvaxin in patients with Stage IV melanoma based upon a similar recommendation of the independent DSMB following its review of data from the second interim analysis of this clinical trial. [7]

The unsuccessful results of these clinical trials prompted CancerVax to say it would cut payroll by more than half to roughly 80 employees from 183. Immediately following this announcement, CancerVax's stock plunged $1.30, or 44.5%, to $1.62 and well below its 52-week low of $2.70. In less than 30 minutes after the opening bell, nearly 850,000 CancerVax shares had been traded, or more than 17 times the average daily trade for the previous three months. Shares of Serono were off 15 cents, or 0.9%, to $16.35. [8]

Competitive Strategy

CancerVax Corporation's competitive strategy revolved around targeting large disease markets with significant unmet medical needs. The company was founded by Dr. Donald Morton who utilized his research on autologous cell cancer vaccines to develop a new allogeneic cellular vaccine for cancer. Dr. Morton's employment at John Wayne Cancer Institute allowed him to perform additional research on the melanoma vaccine while still holding the commercialization rights to the vaccine. The company entered in a Cross-License agreement with John Wayne Cancer Center where in funding acquired by the center from the NIH was used to conduct Phase I and Phase II clinical trials for this product. Following promising results, JWCC applied to the NCI for research funds to undertake clinical trials with the melanoma vaccine and were granted more than $34,000,000 to carry out Phase III multi-center trials with the melanoma vaccine in patients with Stage III or Stage IV melanoma. [9] This new technology was also found to work on colon cancer and the company had plans to push forward with phase 2 trials for late-stage colon cancer.

The major advantage CancerVax enjoyed was that drug discovery was conducted at a research institute with the founder of CancerVax holding all commercialization rights to the technology that were then licensed to the company. They retained worldwide commercialization rights to Canvaxin and intended to market it through their own sales force or co-promote it in the United States while establishing strategic collaborations abroad. Manufacturing was also conducted at their own biologics manufacturing facility, with plans of expansion in 2004 and 2005 to accommodate commercial demand. In addition to Canvaxin, they planned on using the proprietary specific active immunotherapy, anti-angiogenesis and T-oligonucleotide, or telomere homolog oligonucleotide, technology platforms, as well as on human monoclonal antibody technology. [10] In 2002, they acquired Cell-Matrix, Inc., a private company with expertise in angiogenesis. This technology was believed to complement their vaccine technology and could help develop new applications for curing other diseases using active immunotherapy and anti-angiogenesis.

Reverse Merger

Three months after the poor Phase III data forced it to suspend work on Canvaxin, CancerVax agreed to team up with Micromet, a private German company, in a buyout valued at $126.7 million. [11] Cancervax used an initial public offering (IPO) in August 2003, listing on NASDAQ at $13.00 a share. In fiscal years 2004 and 2005, Cancervax recorded net losses of $56 million and 40 million, respectively. By December, 2006, the stock price had fallen to $3.46. [12] In May 2006, when Micromet was formally taken over by CancerVax in a reverse merger, a new NASDAQ-listed company was formed and renamed “Micromet Inc.” The merger was “reversed” in that although CancerVax technically acquired Micromet, shareholders of Micromet received 67.5% of the shares of the new combined company, giving them control of the newly formed Micromet Inc. The deal allowed Micromet access to leverage CancerVax's existing U.S. public company infrastructure, and added a preclinical candidate for solid tumors to their product portfolio.

CancerVax and Micromet likely chose to enter into this reverse merger because CancerVax needed a way to rebound after the failure of Canvaxin, and Micromet needed an easy way to go public. Because of high underwriting fees and the fixed costs of going public through investment banks, it is difficult for small firms to go public via an IPO because of insufficient liquidity gains. Small, private firms, like Micromet, are less likely to find hiring an underwriter to be a positive net present value project and hence gain more benefits from going public by a reverse merger rather than an IPO.v Micromet Inc. started trading on NASDAQ on May 9, 2006, opening at $9.33 and closed at 6.54 with a volume of 40,925 shares traded. Micromet announced in 2008 that it was seeking to raise $40 million through issuing additional stock [13]

In March 2021,CancerVAX raised a $2 million round from undisclosed investors in March 2021. They also launched a StartEngine campaign to raise funds. [14]

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 and a growing subspecialty of oncology.

Agenus Inc. is a Lexington, Massachusetts-based biotechnology company focused on immunotherapy including immuno-oncology, a field that uses the immune system to control or cure cancer. The company is developing checkpoint modulators (CPMs), patient-specific anti-cancer vaccines, and adjuvants desugned for use with various vaccines. CPM development is a particularly fast-moving field, since early products have produced unprecedented clinical benefits for patients.

<span class="mw-page-title-main">Monoclonal antibody therapy</span> Form of immunotherapy

Monoclonal antibodies (mAbs) have varied therapeutic uses. It is possible to create a mAb that binds specifically to almost any extracellular target, such as cell surface proteins and cytokines. They can be used to render their target ineffective, to induce a specific cell signal, to cause the immune system to attack specific cells, or to bring a drug to a specific cell type.

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

Ipilimumab, sold under the brand name Yervoy, is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.

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.

Immunotransplant is a maneuver used to make vaccines more powerful. It refers to the process of infusing vaccine-primed T lymphocytes into lymphodepleted recipients for the purpose of enhancing the proliferation and function of those T cells and increasing immune protection induced by that vaccine.

Adoptive cell transfer (ACT) is the transfer of cells into a patient. The cells may have originated from the patient or from another individual. The cells are most commonly derived from the immune system with the goal of improving immune functionality and characteristics. In autologous cancer immunotherapy, T cells are extracted from the patient, genetically modified and cultured in vitro and returned to the same patient. Comparatively, allogeneic therapies involve cells isolated and expanded from a donor separate from the patient receiving the cells.

SCIB1 is a genetically-engineered cancer vaccine being developed by Scancell Holdings Plc as a treatment for melanoma. Scancell's first cancer vaccine, SCIB1, is being developed for the treatment of melanoma and is in Phase I/II clinical trials. SCIB1 is a plasmid DNA which encodes a human antibody molecule engineered to express two cytotoxic T cell epitopes derived from the melanoma antigens Tyrosinase-Related Protein 2 (TRP2) and gp100 plus two helper T cell epitopes. Following immunisation, the engineered antibody is expressed and taken up by dendritic cells, resulting in the development of immune responses against tumour cells expressing the TRP2 and gp100 antigens. The major advantage of the Immunobody® technology is that the Fc component of the engineered antibody will be recognised by the high affinity CD64 receptor present on dendritic cells, leading to a significant enhancement of both the frequency and avidity of the T cell immune response. The induction of high avidity T cells against TRP-2 and gp100 destroys both primary and metastatic tumours, leading to longer progression free survival. Phase I/II clinical trial of SCIB1 Scancell is conducting a Phase I/II clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The trial is being carried out at clinical sites in Nottingham, Manchester, Guildford, Leeds and Southampton. The trial is an open label, non-randomised study to determine the safety and tolerability of four doses of SCIB1 administered intramuscularly using an electroporation device. The study will also assess immune effects and anti-tumour activity in patients with melanoma. The trial is being conducted in patients with both unresected and resected disease. Patients with Stage III or Stage IV melanoma received up to five doses of the SCIB1 vaccine over a 6-month period. In addition, some patients are being given long term treatment every 3–6 months for up to 5 years. The results to date have been highly encouraging. All 20 patients with resected tumours are still alive, and only five have progressed. This compares very favourably with data from historical controls.

Peptide-based synthetic vaccines are subunit vaccines made from peptides. The peptides mimic the epitopes of the antigen that triggers direct or potent immune responses. Peptide vaccines can not only induce protection against infectious pathogens and non-infectious diseases but also be utilized as therapeutic cancer vaccines, where peptides from tumor-associated antigens are used to induce an effective anti-tumor T-cell response.

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.

<span class="mw-page-title-main">Pembrolizumab</span> Pharmaceutical drug used in cancer treatment

Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer. It is administered by slow intravenous injection.

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

Immutep Ltd is a biotechnology company working primarily in the field of cancer immunotherapy using the LAG3 immune control mechanism. The company was originally built on CVac, a therapeutic cancer vaccine. In late 2014 the privately held French immunotherapy company Immutep SA was purchased by Prima Biotech.

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:

Imugene Ltd is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Imugene's unique platform technologies seeks to harness the body's immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies.

The immune-related response criteria (irRC) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment, where the compound being evaluated is an immuno-oncology drug. Immuno-oncology, part of the broader field of cancer immunotherapy, involves agents which harness the body's own immune system to fight cancer. Traditionally, patient responses to new cancer treatments have been evaluated using two sets of criteria, the WHO criteria and the response evaluation criteria in solid tumors (RECIST). The immune-related response criteria, first published in 2009, arose out of observations that immuno-oncology drugs would fail in clinical trials that measured responses using the WHO or RECIST Criteria, because these criteria could not account for the time gap in many patients between initial treatment and the apparent action of the immune system to reduce the tumor burden.

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.

<span class="mw-page-title-main">Cellular adoptive immunotherapy</span> Cellular adoptive immunotherapy

Cellular adoptive immunotherapy is a type of immunotherapy. Immune cells such as T-cells are usually isolated from patients for expansion or engineering purposes and reinfused back into patients to fight diseases using their own immune system. A major application of cellular adoptive therapy is cancer treatment, as the immune system plays a vital role in the development and growth of cancer. The primary types of cellular adoptive immunotherapies are T cell therapies. Other therapies include CAR-T therapy, CAR-NK therapy, macrophage-based immunotherapy and dendritic cell therapy.

References

  1. 1 2 Robinson, Robin (June 22, 2023). "CancerVax CEO Sees a Home Run With Breakthrough Universal Cancer Vaccine". www.healthleadersmedia.com.
  2. ↑ CancerVax to merge with German firm , Accessed 11 October 2008.
  3. ↑ 2003 Cancervax Annual Report , Accessed 11 October 2008.
  4. ↑ Deswal, Phalguni (12 September 2023). "CancerVAX joins forces with UCLA to develop a universal CAR-T cell therapy". Pharmaceutical Technology.
  5. ↑ Canvaxin Collaboration, Accessed 11 October 2008.
  6. ↑ Hsueh, E. C., & Morton, D. L. (2003). Antigen-based immunotherapy of melanoma: Canvaxin therapeutic polyvalent cancer vaccine. Seminars in Cancer Biology, 13(6), 401-407.
  7. ↑ CancerVax Announces Results of Phase 3 Clinical Trials of Canvaxin(TM) in Patients With Stage III and Stage IV Melanoma. Market Wire, March 2006.
  8. ↑ Steyer, R. (2005) CancerVax Ends Canvaxin Research Archived 2008-12-02 at the Wayback Machine , Accessed 11 October 2008.
  9. ↑ Agreement of Lease Assignment, Accessed 11 October 2008.
  10. ↑ 2003 SEC Form 10-K, Accessed 12 October 2008.
  11. ↑ CancerVax agrees to merge with Micromet, Accessed 11 October 2008.
  12. ↑ Adjei, F., Cyree, K.B., Walker, M.M. (2008). The determinants and survival of reverse mergers vs IPOs. Journal of Economics and Finance, 32(2), 176-194. Retrieved October 10, 2008, from ABI/INFORM Global database.
  13. ↑ Micromet plans to sell $40 million in stock [ permanent dead link ], Accessed 12 October 2008.
  14. ↑ Kamps, Haje Jan (3 November 2023). "The CancerVAX crowdfunding campaign on StartEngine". TechCrunch .
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