ProscaVax Update and prospectus...
Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in 2017. Since the beginning of 2016, we have been conducting a Phase 1 clinical trial evaluating our novel cancer vaccine, ProscaVax, in PSA (Prostate Specific Antigen) recurrent prostate cancer in both hormone-naïve and hormone-independent patients. The trial is being hosted at the University of California San Diego Moores Cancer Center and Veterans Hospital in La Jolla, California under the U.S. Food and Drug Administration’s Investigational New Drug (IND) program with funding from the U.S. Navy Cancer Vaccine Program. Based on the positive preliminary data, we have commenced with a significantly larger Phase 2/3 trial of ProscaVax that was initiated by our subsidiary Oncbiomune México in conjunction with our joint venture with Vitel Laboratorios S.A. de C.V. in Mexico. We acquired Vitel Laboratorios in the first quarter of 2017.
Vitel Operations
On March 10, 2017, we completed the acquisition of Vitel Laboratorios (the “Vitel Acquisition”). The Vitel Acquisition is expected to transform OncBioMune into a revenue-generating international pharmaceutical company with a more diverse product line with a particularly deep reach throughout Mexico, Central and Latin America, and relationships across Europe and Asia. The Vitel Acquisition includes the acquisition of two drugs it licenses and sells in Mexico, Bekunis® for constipation and Cirkused® for stress. Approved for sale in the fourth quarter of 2016, the two over-the-counter products have generated significant sales that have exceeded Vitel’s early projections. Vitel has a total of seven other products that are either already in the registration stage or planned for launch later in 2017.
By acquiring Vitel, we indirectly acquired Vitel’s 50% ownership interest in Oncbiomune México, an entity in which we acquired a 50% interest when we jointly launched this company with Vitel in August 2016. Oncbiomune Mexico was launched for the purposes of developing and commercializing our PROSCAVAX vaccine technology and cancer technologies in México, Central and Latin America (“MALA”) for the treatment of prostate, ovarian and various other types of cancer and includes a portfolio of owned products and licenses with OncBioMune.
Vitel has license agreements covering the Mexican market with Roha Arnzemittel, GmbH (“Roha”) for Bekunis® (for constipation) and Cirkused® (for stress), as well as licensing rights to the remainder of Roha’s pipeline at Vitel’s discretion.
Vitel also has Mexican territorial rights through licensing agreements with; Kamada for KamRab® (for rabies), KamRho® (an Rh immunization) and Glassia® (for Anti-D deficiency); Aqvida for Imatinib (for cancer), and other oncology products; QPharma for Androferti (a male fertility drug) and is currently developing two innovative orphan drugs through their own research and development.
Emerging Growth Company Status
We are an “emerging growth company” as defined in Section 2(a)(19) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As such, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We intend to take advantage of all of these exemptions.
In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)( of the Securities Act for complying with new or revised accounting standards, and delay compliance with new or revised accounting standards until those standards are applicable to private companies. We have elected to take advantage of the benefits of this extended transition period.
We could be an emerging growth company until the last day of the first fiscal year following the fifth anniversary of our first common equity offering, although circumstances could cause us to lose that status earlier if our annual revenues exceed $1.0 billion, if we issue more than $1.0 billion in non-convertible debt in any three-year period or if we become a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Company Information
Our principal office is located at 11441 Industriplex Blvd, Suite 190, Baton Rouge, LA 70809 and our phone number is (225) 227-2384. Our corporate website address is www.oncbiomune.com . Information contained on, or accessible through, our website is not a part of, and is not incorporated by reference into, this prospectus.
OncBioMune
ProscaVax Update. Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in 2017. Since the beginning of 2016, we have experienced the following significant business events.
Company has developed a mouse model to test a whole cell mouse mammary cancer vaccine. Laboratory research conducted by OncBioMune demonstrated that when mice are vaccinated either subcutaneously or intraperitoneally with a series of whole cell preparations of mouse mammary carcinoma cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF) and Interleukin-2 (IL-2) and then transplanted with the same tumor cells, the growth of the cancerous tumor is significantly inhibited. Also, the adjuvants alone (GM-CSF and IL-2) either injected subcutaneously or intraperitoneally do not inhibit growth of the tumor.
This preclinical finding further supports the efficacy of the Company’s proprietary therapeutic cancer vaccine platform. OncBioMune’s prostate cancer vaccine, ProscaVax, which is built upon the same platform, is currently being evaluated in a Phase 1 clinical trial in PSA recurrent prostate cancer in both hormone-naïve and hormone-independent patients in the United States. A Phase 2/3 clinical trial of prostate cancer patients with biochemical progression is expected to commence in Mexico during the current quarter, followed by a Phase 2 clinical trial of prostate cancer patients in active surveillance in the United States.
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Dr. Jonathan Head, our Chief Executive Officer noted that development of this mouse model will allow future studies to investigate the possible use of allogeneic mammary cell lines in a whole cell vaccine with IL-2 and GM-CSF as adjuvants. This early research is important in our efforts to expand into additional indications for our platform. Our intent is to continue studies of our technology that we believe could lead to an off-the-shelf breast cancer therapeutic vaccine and possible preventative vaccine for high-risk breast cancer patients.
The latest information from the Phase 1 clinical trial evaluating our novel cancer vaccine, ProscaVax, in PSA (Prostate Specific Antigen) recurrent prostate cancer in both hormone-naïve and hormone-independent patients. The trial is being hosted at the University of California San Diego Moores Cancer Center and Veterans Hospital in La Jolla, California under the U.S. Food and Drug Administration’s Investigational New Drug (IND) program with funding from the U.S. Navy Cancer Vaccine Program.
To date, 18 patients have been enrolled in the Phase 1a trial. A strong safety profile has been established for ProscaVax. No serious adverse events (all adverse events due to vaccine are Grade 1 with no Grade 2, 3 or 4 due to vaccine) have been reported in the trial, further validating prior research in hundreds of patients showing minimal toxicity of the Company’s vaccine technology.
Additional preliminary data from the trial shows ProscaVax to provide a meaningful clinical benefit to prostate cancer patients. These data include:
? 15 of 20 patients in the Phase 1a portion of the trial have received at least one vaccine injection and 14 patients have received all 6 vaccines
? None of the 15 patients who have had at least one vaccine have had a dose limiting adverse event (DLAE)
? None of the 14 patients who have received all 6 vaccines in the Phase 1a have had a DLAE
? 11 of 13 patients (85%) at 31 weeks post first vaccine have had an increased immune response to PSA as determined with a LBA
? 9 of 14 patients (64%) have had an increase in their PSA doubling time (slowed progression)
? Four of the 14 patients who have received all 6 vaccines have experienced disease progression (one radiological, three PSA)
The trial was originally designed as a Phase 1a/1b study with 20 patients to be enrolled in the Phase 1a portion and 28 in the Phase 1b. As previously disclosed, based upon encouraging preliminary data, we are foregoing the Phase 1b portion of the trial and advancing into a larger Phase 2/3 trial of ProscaVax that was initiated through a Joint Venture with Vitel Laboratorios in Mexico. The Phase 2/3 Trial in Mexico will be similar in design to the UCSD/VA Trial in La Jolla and will evaluate ProscaVax in PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients. This trial is scheduled to begin in the second quarter of 2017
Separately, we are working to initiate a Phase 2 trial of ProscaVax in early-stage prostate cancer patients in the “active surveillance” stage of disease at Harvard’s Beth Israel Deaconess Medical Center with additional patients from Harvard-affiliated Hospitals and Research Institutes.
We now have more data from the Phase 1 trial with a median follow up of 30 months, showing that ProscaVax has provided a safe, significant benefit to these late-stage prostate cancer patients with respect to increased immune response to PSA and increased PSA doubling time. Given that there is ample data demonstrating the safety of ProscaVax with additional data supporting its therapeutic benefit, we are moving into Phase 2 and 2/3 trials, where we believe that enrollment will progress at a quicker pace. As often happens, a Phase 1 trial moves a little more slowly than expected, but the data is very compelling and leaves us excited about moving forward with mid-stage studies.
Clinical Trials. Progress continues as 18 patients are now currently enrolled in the Phase 1a trial, 15 of whom have received at least one vaccine, 14 of whom have received all mandated vaccines. None of the patients that have received the vaccine on any level have experienced a dose limiting adverse event.
Based on the positive preliminary data, we have commenced with a significantly larger Phase 2/3 trial of ProscaVax that was initiated by our subsidiary Oncbiomune México in conjunction with our joint venture with Vitel Laboratorios S.A. de C.V. in Mexico. We acquired Vitel Laboratorios in the first quarter of 2017.
Additionally, our contract research organization partner, Theradex Oncology, is currently reviewing the protocol for its trial of ProscaVax in early-stage prostate cancer patients in the “active surveillance” stage of disease to be initiated at Harvard-affiliated Hospitals and Research Institutes.
With a strong safety profile now established for ProscaVax with no serious adverse events reported, we believe we have further validated prior research in hundreds of patients showing minimal toxicity of our vaccine technology. We believe that the additional clinical trials will further support the previously reported efficacy of ProscaVax in both early and late stage prostate cancer.
Vitel Operations
On March 10, 2017, we completed the acquisition of Vitel Laboratorios (the “Vitel Acquisition”). The Vitel Acquisition is expected to transform OncBioMune into a revenue-generating international pharmaceutical company with a more diverse product line with a particularly deep reach throughout Mexico, Central and Latin America, and relationships across Europe and Asia. The Vitel Acquisition includes the acquisition of two drugs it licenses and sells in Mexico, Bekunis® for constipation and Cirkused® for stress. Approved for sale in the fourth quarter of 2016, the two over-the-counter products have generated significant sales that have exceeded Vitel’s early projections. Vitel has a total of seven other products that are either already in the registration stage or planned for launch later in 2017.
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By acquiring Vitel, we indirectly acquired Vitel’s 50% ownership interest in Oncbiomune México, an entity in which we acquired a 50% interest when we jointly launched this company with Vitel in August 2016. Oncbiomune Mexico was launched for the purposes of developing and commercializing our PROSCAVAX vaccine technology and cancer technologies in México, Central and Latin America (“MALA”) for the treatment of prostate, ovarian and various other types of cancer and includes a portfolio of owned products and licenses with OncBioMune.
Vitel has license agreements covering the Mexican market with Roha Arnzemittel, GmbH (“Roha”) for Bekunis® (for constipation) and Cirkused® (for stress), as well as licensing rights to the remainder of Roha’s pipeline at Vitel’s discretion.
Vitel also has Mexican territorial rights through licensing agreements with; Kamada for KamRab® (for rabies), KamRho® (an Rh immunization) and Glassia® (for Anti-D deficiency); Aqvida for Imatinib (for cancer), and other oncology products; QPharma for Androferti (a male fertility drug) and is currently developing two innovative orphan drugs through their own research and development.
For Mexico, Central and Latin America, Vitel has relationships that are expected to forge development and commercialization of several products , including, Gem Pharmaceuticals for GPX-150 (for sarcoma); EOC Pharma for Telatinib (for first line oral gastric cancer treatment); and Rational Vaccines for the first and only herpes Vaccine technology for the treatment of HSV-2 and HSV-1.
In addition to its product pipeline and relationships, Vitel’s network channel partners cover a wide range of drug development and marketing. A sampling of relationships includes, CID Information Systems (marketing intelligence), Grupo Nichos (pharmaceutical salesforce, demand generation), CeroGrados (pharmaceutical warehousing, and old chain), CRO’s authorized by the Federal Commission for the Protection from Sanitary Risks (“COFEPRIS”) in Mexico and Regulatory Affairs parties that are authorized by the COFEPRIS for dossier build up and pre-inspection.
In addition to the assets we acquired through the Vitel Acquisition, our current product portfolio consists of three target therapies and a vaccine platform that allows us to create a therapeutic vaccine for any solid tumor cancer. The vaccine platform has treated over 300 patients . We are in the planning stage of a Phase 2 clinical trial of our lead product, ProscaVax®. The trial will be under the direction of Glenn Bubley, MD and the lead site will be Harvard’s Beth Israel Deaconess Medical Center, with additional other hospitals in the Harvard Health System. We anticipate that the trial will expand the results that we found in our Phase 1 clinical trial in a different patient population. We also hope to develop our other proprietary technologies, such as the paclitaxel-albumin conjugate with regard to which we plan to file an orphan drug indication within the next two years .
Intellectual Property
As a matter of regular course, we have obtained, and intend to actively seek to obtain, when appropriate, protection for our current and prospective products and proprietary technology by means of United States and foreign patents, trademarks, and applications for each of the foregoing. In addition, we rely upon trade secrets and contractual agreements to protect certain of our proprietary technology and products. ProscaVax is a novel biologic, and it is difficult to predict how competition could develop and accordingly which aspects of our related intellectual property may prove the most significant in the future. We currently have a patent application relating to protein therapeutic cancer vaccines and a provisional patent application relating to taxane- and taxoid-protein compositions. Both United States patent applications expire in 2031. In addition, we had a patent that expired in 2014 relating to vaccination of cancer patients using tumor-associated antigens mixed with interleukin-2 and granulocyte-macrophage colony stimulating factor.
Patent expiration dates may be subject to patent term extension depending on certain factors. In addition, following expiration of a basic product patent or loss of patent protection resulting from a legal challenge, it may be possible to continue to obtain commercial benefits from other characteristics such as clinical trial data, product manufacturing trade secrets, uses for products, and special formulations of the product or delivery mechanisms.
We intend to continue using our scientific experience to pursue and patent new developments to enhance our position in the cancer field. Patents, if issued, may be challenged, invalidated, declared unenforceable, circumvented or may not cover all applications we desire. Thus, any patent that we own or license from third parties may not provide adequate protection against competitors. Our pending patent applications, those we may file in the future, or those we may license from third parties may not result in issued patents. Also, patents may not provide us with adequate proprietary protection or advantages against competitors with, or who could develop, similar or competing technologies, or who could design around our patents. In addition, future legislation may impact our competitive position in the event brand-name and follow-on biologics do not receive adequate patent protection. From time to time, we have received invitations to license third-party patents.
We also rely on trade secrets and know-how that we seek to protect, in part, by using confidentiality agreements. Our policy is to require our officers, employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers and other advisors to execute confidentiality agreements. These agreements provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties except in specific limited circumstances. We also require signed confidentiality agreements from companies that receive our confidential data. For employees, consultants and contractors, we require agreements providing that all inventions conceived while rendering services to us shall be assigned to us as our exclusive property.
Competition
The biotechnology and biopharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. Pharmaceutical and biotechnology companies, academic institutions and other research organizations are actively engaged in the discovery, research and development of products designed to address prostate cancer and other indications. There are products currently under development by other companies and organizations that could compete with ProscaVax or other products that we are developing. Products such as chemotherapeutics, androgen metabolism or androgen receptor antagonists, endothelin A receptor antagonists, antisense compounds, angiogenesis inhibitors and gene therapies for cancer are also under development by a number of companies and could potentially compete with ProscaVax and our other product candidates. In addition, many universities and private and public research institutes may in the future become active in cancer research, which may be in direct competition with us. Docetaxel (also referred to by its brand name Taxotere) was approved by the FDA for the therapeutic treatment of metastatic, androgen-independent prostate cancer in 2004 and JEVTANA® (cabazitaxel) was approved in 2010 for use in men as a second line therapy following progression after initial treatment with docetaxel.
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In 2011, ZYTIGA® (abiraterone acetate) was approved for use in men with prostate cancer with progression following treatment with a chemotherapeutic regime. In 2012, ZYTIGA was approved, in combination with prednisone, to treat men with metastatic castrate-resistant prostate cancer prior to receiving chemotherapy, and Xtandi (Enzalutamide), an androgen receptor inhibitor, was approved to treat men with metastatic castrate-resistant prostate cancer who previously received docetaxel chemotherapy. In 2013, Xofigo (radium RA 223 dichloride) injection was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. Other therapies such as Bavarian Nordic’s PROSTVAC® are the subject of ongoing clinical trials in men with metastatic castrate-resistant prostate cancer. PROSTVAC®, currently in Phase 3 clinical development, is a therapeutic cancer vaccine being studied in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.
Our competitors include major pharmaceutical companies. These companies may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing. In addition, smaller competitors may collaborate with these large established companies to obtain access to their resources.
Our ability to successfully commercialize ProscaVax and our other potential products, and compete effectively with third parties will depend, in large part, on:
? the perception of physicians and other healthcare professionals of the safety, efficacy and relative benefits of ProscaVax or our other products compared to those of competing products or therapies;
? the effectiveness of our sales and marketing efforts in appropriately targeting a resonant clinical message to both oncologists and urologists;
? the willingness of physicians to adopt a new treatment regimen consisting of infusion of an immunotherapy;
? reimbursement policies for ProscaVax or our other product candidates, if developed and approved;
? the price of ProscaVax and that of other products we may develop and commercialize relative to competing products;
? our ability to manufacture ProscaVax and other products we may develop on a cost-effective commercial scale;
? our ability to accurately forecast demand for ProscaVax, and our product candidates if regulatory approvals are achieved; and
? our ability to advance our other product candidates through clinical trials and through the FDA approval process and those of non-United States regulatory authorities.
Competition among approved marketed products will be based upon, among other things, efficacy, reliability, product safety, price-value analysis, and patent position. Our competitiveness will also depend on our ability to advance our product candidates, license additional technology, maintain a proprietary position in our technologies and products, obtain required government and other approvals on a timely basis, attract and retain key personnel and enter into corporate relationships that enable us and our collaborators to develop effective products that can be manufactured cost-effectively and marketed successfully.
Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in 2017. Since the beginning of 2016, we have been conducting a Phase 1 clinical trial evaluating our novel cancer vaccine, ProscaVax, in PSA (Prostate Specific Antigen) recurrent prostate cancer in both hormone-naïve and hormone-independent patients. The trial is being hosted at the University of California San Diego Moores Cancer Center and Veterans Hospital in La Jolla, California under the U.S. Food and Drug Administration’s Investigational New Drug (IND) program with funding from the U.S. Navy Cancer Vaccine Program. Based on the positive preliminary data, we have commenced with a significantly larger Phase 2/3 trial of ProscaVax that was initiated by our subsidiary Oncbiomune México in conjunction with our joint venture with Vitel Laboratorios S.A. de C.V. in Mexico. We acquired Vitel Laboratorios in the first quarter of 2017.
Vitel Operations
On March 10, 2017, we completed the acquisition of Vitel Laboratorios (the “Vitel Acquisition”). The Vitel Acquisition is expected to transform OncBioMune into a revenue-generating international pharmaceutical company with a more diverse product line with a particularly deep reach throughout Mexico, Central and Latin America, and relationships across Europe and Asia. The Vitel Acquisition includes the acquisition of two drugs it licenses and sells in Mexico, Bekunis® for constipation and Cirkused® for stress. Approved for sale in the fourth quarter of 2016, the two over-the-counter products have generated significant sales that have exceeded Vitel’s early projections. Vitel has a total of seven other products that are either already in the registration stage or planned for launch later in 2017.
By acquiring Vitel, we indirectly acquired Vitel’s 50% ownership interest in Oncbiomune México, an entity in which we acquired a 50% interest when we jointly launched this company with Vitel in August 2016. Oncbiomune Mexico was launched for the purposes of developing and commercializing our PROSCAVAX vaccine technology and cancer technologies in México, Central and Latin America (“MALA”) for the treatment of prostate, ovarian and various other types of cancer and includes a portfolio of owned products and licenses with OncBioMune.
Vitel has license agreements covering the Mexican market with Roha Arnzemittel, GmbH (“Roha”) for Bekunis® (for constipation) and Cirkused® (for stress), as well as licensing rights to the remainder of Roha’s pipeline at Vitel’s discretion.
Vitel also has Mexican territorial rights through licensing agreements with; Kamada for KamRab® (for rabies), KamRho® (an Rh immunization) and Glassia® (for Anti-D deficiency); Aqvida for Imatinib (for cancer), and other oncology products; QPharma for Androferti (a male fertility drug) and is currently developing two innovative orphan drugs through their own research and development.
Emerging Growth Company Status
We are an “emerging growth company” as defined in Section 2(a)(19) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As such, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We intend to take advantage of all of these exemptions.
In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)( of the Securities Act for complying with new or revised accounting standards, and delay compliance with new or revised accounting standards until those standards are applicable to private companies. We have elected to take advantage of the benefits of this extended transition period.
We could be an emerging growth company until the last day of the first fiscal year following the fifth anniversary of our first common equity offering, although circumstances could cause us to lose that status earlier if our annual revenues exceed $1.0 billion, if we issue more than $1.0 billion in non-convertible debt in any three-year period or if we become a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Company Information
Our principal office is located at 11441 Industriplex Blvd, Suite 190, Baton Rouge, LA 70809 and our phone number is (225) 227-2384. Our corporate website address is www.oncbiomune.com . Information contained on, or accessible through, our website is not a part of, and is not incorporated by reference into, this prospectus.
OncBioMune
ProscaVax Update. Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in 2017. Since the beginning of 2016, we have experienced the following significant business events.
Company has developed a mouse model to test a whole cell mouse mammary cancer vaccine. Laboratory research conducted by OncBioMune demonstrated that when mice are vaccinated either subcutaneously or intraperitoneally with a series of whole cell preparations of mouse mammary carcinoma cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF) and Interleukin-2 (IL-2) and then transplanted with the same tumor cells, the growth of the cancerous tumor is significantly inhibited. Also, the adjuvants alone (GM-CSF and IL-2) either injected subcutaneously or intraperitoneally do not inhibit growth of the tumor.
This preclinical finding further supports the efficacy of the Company’s proprietary therapeutic cancer vaccine platform. OncBioMune’s prostate cancer vaccine, ProscaVax, which is built upon the same platform, is currently being evaluated in a Phase 1 clinical trial in PSA recurrent prostate cancer in both hormone-naïve and hormone-independent patients in the United States. A Phase 2/3 clinical trial of prostate cancer patients with biochemical progression is expected to commence in Mexico during the current quarter, followed by a Phase 2 clinical trial of prostate cancer patients in active surveillance in the United States.
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Dr. Jonathan Head, our Chief Executive Officer noted that development of this mouse model will allow future studies to investigate the possible use of allogeneic mammary cell lines in a whole cell vaccine with IL-2 and GM-CSF as adjuvants. This early research is important in our efforts to expand into additional indications for our platform. Our intent is to continue studies of our technology that we believe could lead to an off-the-shelf breast cancer therapeutic vaccine and possible preventative vaccine for high-risk breast cancer patients.
The latest information from the Phase 1 clinical trial evaluating our novel cancer vaccine, ProscaVax, in PSA (Prostate Specific Antigen) recurrent prostate cancer in both hormone-naïve and hormone-independent patients. The trial is being hosted at the University of California San Diego Moores Cancer Center and Veterans Hospital in La Jolla, California under the U.S. Food and Drug Administration’s Investigational New Drug (IND) program with funding from the U.S. Navy Cancer Vaccine Program.
To date, 18 patients have been enrolled in the Phase 1a trial. A strong safety profile has been established for ProscaVax. No serious adverse events (all adverse events due to vaccine are Grade 1 with no Grade 2, 3 or 4 due to vaccine) have been reported in the trial, further validating prior research in hundreds of patients showing minimal toxicity of the Company’s vaccine technology.
Additional preliminary data from the trial shows ProscaVax to provide a meaningful clinical benefit to prostate cancer patients. These data include:
? 15 of 20 patients in the Phase 1a portion of the trial have received at least one vaccine injection and 14 patients have received all 6 vaccines
? None of the 15 patients who have had at least one vaccine have had a dose limiting adverse event (DLAE)
? None of the 14 patients who have received all 6 vaccines in the Phase 1a have had a DLAE
? 11 of 13 patients (85%) at 31 weeks post first vaccine have had an increased immune response to PSA as determined with a LBA
? 9 of 14 patients (64%) have had an increase in their PSA doubling time (slowed progression)
? Four of the 14 patients who have received all 6 vaccines have experienced disease progression (one radiological, three PSA)
The trial was originally designed as a Phase 1a/1b study with 20 patients to be enrolled in the Phase 1a portion and 28 in the Phase 1b. As previously disclosed, based upon encouraging preliminary data, we are foregoing the Phase 1b portion of the trial and advancing into a larger Phase 2/3 trial of ProscaVax that was initiated through a Joint Venture with Vitel Laboratorios in Mexico. The Phase 2/3 Trial in Mexico will be similar in design to the UCSD/VA Trial in La Jolla and will evaluate ProscaVax in PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients. This trial is scheduled to begin in the second quarter of 2017
Separately, we are working to initiate a Phase 2 trial of ProscaVax in early-stage prostate cancer patients in the “active surveillance” stage of disease at Harvard’s Beth Israel Deaconess Medical Center with additional patients from Harvard-affiliated Hospitals and Research Institutes.
We now have more data from the Phase 1 trial with a median follow up of 30 months, showing that ProscaVax has provided a safe, significant benefit to these late-stage prostate cancer patients with respect to increased immune response to PSA and increased PSA doubling time. Given that there is ample data demonstrating the safety of ProscaVax with additional data supporting its therapeutic benefit, we are moving into Phase 2 and 2/3 trials, where we believe that enrollment will progress at a quicker pace. As often happens, a Phase 1 trial moves a little more slowly than expected, but the data is very compelling and leaves us excited about moving forward with mid-stage studies.
Clinical Trials. Progress continues as 18 patients are now currently enrolled in the Phase 1a trial, 15 of whom have received at least one vaccine, 14 of whom have received all mandated vaccines. None of the patients that have received the vaccine on any level have experienced a dose limiting adverse event.
Based on the positive preliminary data, we have commenced with a significantly larger Phase 2/3 trial of ProscaVax that was initiated by our subsidiary Oncbiomune México in conjunction with our joint venture with Vitel Laboratorios S.A. de C.V. in Mexico. We acquired Vitel Laboratorios in the first quarter of 2017.
Additionally, our contract research organization partner, Theradex Oncology, is currently reviewing the protocol for its trial of ProscaVax in early-stage prostate cancer patients in the “active surveillance” stage of disease to be initiated at Harvard-affiliated Hospitals and Research Institutes.
With a strong safety profile now established for ProscaVax with no serious adverse events reported, we believe we have further validated prior research in hundreds of patients showing minimal toxicity of our vaccine technology. We believe that the additional clinical trials will further support the previously reported efficacy of ProscaVax in both early and late stage prostate cancer.
Vitel Operations
On March 10, 2017, we completed the acquisition of Vitel Laboratorios (the “Vitel Acquisition”). The Vitel Acquisition is expected to transform OncBioMune into a revenue-generating international pharmaceutical company with a more diverse product line with a particularly deep reach throughout Mexico, Central and Latin America, and relationships across Europe and Asia. The Vitel Acquisition includes the acquisition of two drugs it licenses and sells in Mexico, Bekunis® for constipation and Cirkused® for stress. Approved for sale in the fourth quarter of 2016, the two over-the-counter products have generated significant sales that have exceeded Vitel’s early projections. Vitel has a total of seven other products that are either already in the registration stage or planned for launch later in 2017.
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By acquiring Vitel, we indirectly acquired Vitel’s 50% ownership interest in Oncbiomune México, an entity in which we acquired a 50% interest when we jointly launched this company with Vitel in August 2016. Oncbiomune Mexico was launched for the purposes of developing and commercializing our PROSCAVAX vaccine technology and cancer technologies in México, Central and Latin America (“MALA”) for the treatment of prostate, ovarian and various other types of cancer and includes a portfolio of owned products and licenses with OncBioMune.
Vitel has license agreements covering the Mexican market with Roha Arnzemittel, GmbH (“Roha”) for Bekunis® (for constipation) and Cirkused® (for stress), as well as licensing rights to the remainder of Roha’s pipeline at Vitel’s discretion.
Vitel also has Mexican territorial rights through licensing agreements with; Kamada for KamRab® (for rabies), KamRho® (an Rh immunization) and Glassia® (for Anti-D deficiency); Aqvida for Imatinib (for cancer), and other oncology products; QPharma for Androferti (a male fertility drug) and is currently developing two innovative orphan drugs through their own research and development.
For Mexico, Central and Latin America, Vitel has relationships that are expected to forge development and commercialization of several products , including, Gem Pharmaceuticals for GPX-150 (for sarcoma); EOC Pharma for Telatinib (for first line oral gastric cancer treatment); and Rational Vaccines for the first and only herpes Vaccine technology for the treatment of HSV-2 and HSV-1.
In addition to its product pipeline and relationships, Vitel’s network channel partners cover a wide range of drug development and marketing. A sampling of relationships includes, CID Information Systems (marketing intelligence), Grupo Nichos (pharmaceutical salesforce, demand generation), CeroGrados (pharmaceutical warehousing, and old chain), CRO’s authorized by the Federal Commission for the Protection from Sanitary Risks (“COFEPRIS”) in Mexico and Regulatory Affairs parties that are authorized by the COFEPRIS for dossier build up and pre-inspection.
In addition to the assets we acquired through the Vitel Acquisition, our current product portfolio consists of three target therapies and a vaccine platform that allows us to create a therapeutic vaccine for any solid tumor cancer. The vaccine platform has treated over 300 patients . We are in the planning stage of a Phase 2 clinical trial of our lead product, ProscaVax®. The trial will be under the direction of Glenn Bubley, MD and the lead site will be Harvard’s Beth Israel Deaconess Medical Center, with additional other hospitals in the Harvard Health System. We anticipate that the trial will expand the results that we found in our Phase 1 clinical trial in a different patient population. We also hope to develop our other proprietary technologies, such as the paclitaxel-albumin conjugate with regard to which we plan to file an orphan drug indication within the next two years .
Intellectual Property
As a matter of regular course, we have obtained, and intend to actively seek to obtain, when appropriate, protection for our current and prospective products and proprietary technology by means of United States and foreign patents, trademarks, and applications for each of the foregoing. In addition, we rely upon trade secrets and contractual agreements to protect certain of our proprietary technology and products. ProscaVax is a novel biologic, and it is difficult to predict how competition could develop and accordingly which aspects of our related intellectual property may prove the most significant in the future. We currently have a patent application relating to protein therapeutic cancer vaccines and a provisional patent application relating to taxane- and taxoid-protein compositions. Both United States patent applications expire in 2031. In addition, we had a patent that expired in 2014 relating to vaccination of cancer patients using tumor-associated antigens mixed with interleukin-2 and granulocyte-macrophage colony stimulating factor.
Patent expiration dates may be subject to patent term extension depending on certain factors. In addition, following expiration of a basic product patent or loss of patent protection resulting from a legal challenge, it may be possible to continue to obtain commercial benefits from other characteristics such as clinical trial data, product manufacturing trade secrets, uses for products, and special formulations of the product or delivery mechanisms.
We intend to continue using our scientific experience to pursue and patent new developments to enhance our position in the cancer field. Patents, if issued, may be challenged, invalidated, declared unenforceable, circumvented or may not cover all applications we desire. Thus, any patent that we own or license from third parties may not provide adequate protection against competitors. Our pending patent applications, those we may file in the future, or those we may license from third parties may not result in issued patents. Also, patents may not provide us with adequate proprietary protection or advantages against competitors with, or who could develop, similar or competing technologies, or who could design around our patents. In addition, future legislation may impact our competitive position in the event brand-name and follow-on biologics do not receive adequate patent protection. From time to time, we have received invitations to license third-party patents.
We also rely on trade secrets and know-how that we seek to protect, in part, by using confidentiality agreements. Our policy is to require our officers, employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers and other advisors to execute confidentiality agreements. These agreements provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties except in specific limited circumstances. We also require signed confidentiality agreements from companies that receive our confidential data. For employees, consultants and contractors, we require agreements providing that all inventions conceived while rendering services to us shall be assigned to us as our exclusive property.
Competition
The biotechnology and biopharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. Pharmaceutical and biotechnology companies, academic institutions and other research organizations are actively engaged in the discovery, research and development of products designed to address prostate cancer and other indications. There are products currently under development by other companies and organizations that could compete with ProscaVax or other products that we are developing. Products such as chemotherapeutics, androgen metabolism or androgen receptor antagonists, endothelin A receptor antagonists, antisense compounds, angiogenesis inhibitors and gene therapies for cancer are also under development by a number of companies and could potentially compete with ProscaVax and our other product candidates. In addition, many universities and private and public research institutes may in the future become active in cancer research, which may be in direct competition with us. Docetaxel (also referred to by its brand name Taxotere) was approved by the FDA for the therapeutic treatment of metastatic, androgen-independent prostate cancer in 2004 and JEVTANA® (cabazitaxel) was approved in 2010 for use in men as a second line therapy following progression after initial treatment with docetaxel.
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In 2011, ZYTIGA® (abiraterone acetate) was approved for use in men with prostate cancer with progression following treatment with a chemotherapeutic regime. In 2012, ZYTIGA was approved, in combination with prednisone, to treat men with metastatic castrate-resistant prostate cancer prior to receiving chemotherapy, and Xtandi (Enzalutamide), an androgen receptor inhibitor, was approved to treat men with metastatic castrate-resistant prostate cancer who previously received docetaxel chemotherapy. In 2013, Xofigo (radium RA 223 dichloride) injection was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. Other therapies such as Bavarian Nordic’s PROSTVAC® are the subject of ongoing clinical trials in men with metastatic castrate-resistant prostate cancer. PROSTVAC®, currently in Phase 3 clinical development, is a therapeutic cancer vaccine being studied in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.
Our competitors include major pharmaceutical companies. These companies may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing. In addition, smaller competitors may collaborate with these large established companies to obtain access to their resources.
Our ability to successfully commercialize ProscaVax and our other potential products, and compete effectively with third parties will depend, in large part, on:
? the perception of physicians and other healthcare professionals of the safety, efficacy and relative benefits of ProscaVax or our other products compared to those of competing products or therapies;
? the effectiveness of our sales and marketing efforts in appropriately targeting a resonant clinical message to both oncologists and urologists;
? the willingness of physicians to adopt a new treatment regimen consisting of infusion of an immunotherapy;
? reimbursement policies for ProscaVax or our other product candidates, if developed and approved;
? the price of ProscaVax and that of other products we may develop and commercialize relative to competing products;
? our ability to manufacture ProscaVax and other products we may develop on a cost-effective commercial scale;
? our ability to accurately forecast demand for ProscaVax, and our product candidates if regulatory approvals are achieved; and
? our ability to advance our other product candidates through clinical trials and through the FDA approval process and those of non-United States regulatory authorities.
Competition among approved marketed products will be based upon, among other things, efficacy, reliability, product safety, price-value analysis, and patent position. Our competitiveness will also depend on our ability to advance our product candidates, license additional technology, maintain a proprietary position in our technologies and products, obtain required government and other approvals on a timely basis, attract and retain key personnel and enter into corporate relationships that enable us and our collaborators to develop effective products that can be manufactured cost-effectively and marketed successfully.
