Nventa Pharmaceuticals Corp.
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Nventa Annual Report 2005   Download PDF
 
   
 
   

On the right track to providing a new treatment for the millions already infected with HPV.

To our shareholders:

2006 was a year of significant achievement at Nventa. As a result of encouraging preclinical data on our lead program, positive discussions with the U.S. Food and Drug Administration (FDA) clarifying the development pathway of HspE7, and successful fundraising, we are now on the right track and poised to advance our lead candidate, HspE7, into clinical development.

Product pipeline advancement

Nventa’s core technology focuses on the creation of therapeutic (not preventative) vaccines, otherwise known as immunotherapeutics. Using our proprietary technology (developed at the Massachusetts Institute of Technology), we create novel CoVal™ fusions that trigger the immune system to respond to specifi c diseases. Throughout 2006, we made significant progress with our lead candidate, HspE7, a therapeutic drug candidate that targets serious diseases caused by the human papillomavirus (HPV).

While we had initially advanced the original formulation of HspE7 into multiple Phase 2 clinical trials, we discovered that by incorporating an adjuvant — a chemical compound which boosts the overall effect of our vaccine — we could achieve dramatically greater potency. As a result, during 2006, we announced our intention to pursue clinical development of a new formulation of HspE7, manufactured with a commercially viable process, which incorporates the adjuvant, Poly-ICLC.

Importantly, throughout 2006 and into early 2007, we continued to announce very encouraging clinical data around our original formulation of HspE7, demonstrating efficacy in patients with genital warts, cervical dysplasia and in patients co-infected with the HPV and HIV viruses.

In late November, we concluded a series of interactions with the FDA on our preclinical and clinical development plans around our new formulation of HspE7. We received very positive feedback from these meetings and subsequently announced that we are preparing an amendment to our original Investigational New Drug application (IND) to recommence clinical development of HspE7.

We are preparing an amendment to our original IND to recommence clinical development of HspE7.

Our first HspE7 Phase 1 trial is being designed to test its safety in patients with cervical dysplasia (CIN). As background, CIN is the abnormal growth of pre-cancerous cells that can lead to cervical cancer. Globally, approximately 400,000 cases of cervical cancer are identified each year. In addition, an estimated 1.2 million women each year are diagnosed with low grade cervical dysplasia in the U.S., with another estimated 300,000 with high grade cervical dysplasia. There are no FDA- approved drug therapies for CIN, and market research indicates that physicians are eagerly looking for an alternative to the current treatment, a type of surgery called LEEP (loop electrosurgical excision procedure), which does not treat the underlying HPV infection.

Over the past year, there has been much media attention paid to HPV as a result of the approval of the first preventative vaccine for the types of HPV that cause CIN. What this attention highlights, for those carefully watching the field, is that roughly 630 million people worldwide are already infected with HPV and many are in need of treatment rather than prevention. None of the new vaccines treats More recently, we received notice from the U.S. this infected population, nor do any address the various HPV-related diseases that result.

With our Phase 1 trial in CIN expected to finish by the end of 2007, we are planning to begin several Phase 2 studies in other HPV-related diseases in 2008. These disease areas will likely include effi cacy trials in CIN, recurrent respiratory papillomatosis (RRP), benign tumors located in the larynx and airways primarily of young children (an indication for which we received both Orphan Drug designation and Fast Track status from the FDA), and potentially genital warts. We are working to determine if pursuit of the RRP indication could be our most effi cient route to regulatory approval of our new formulation of HspE7.

630 million people worldwide are already infected with HPV and many are in need of treatment rather than prevention.

Stronger patent estate

Several patent issuances have significantly strengthened our portfolio over the past year. In mid-2006, we received notice of two European patents covering certain composition and uses of HspE7 in the treatment of HPV-related diseases.

More recently, we received notice from the U.S. Patent and Trademark Office once and for all defeating the patent challenges we had received. Two key patents were issued with minor changes, broadly covering the use of heat shock proteins fused with viral- or cancer-associated antigens and their use as immunotherapeutics.

Also in 2006, we were granted a European patent covering our CoVal™ fusion proteins to treat influenza.

Corporate and financial achievements

Throughout the year, we accomplished a great number of initiatives that not only strengthened our balance sheet, but also our senior management team, Board of Directors and corporate image. In early 2006, we received approximately C$9.0 million after completion of a non-dilutive corporate transaction. Following that, we completed a C$16.2 million financing in January of 2007. Along with further cost-cutting initiatives, these additional funds have enabled Nventa to get its lead clinical
program on the right track and we are now poised to restart clinical development of our HspE7 candidate. Together, these events have successfully and significantly enhanced our investment profile.

April of 2006 brought positive changes to our senior management team and our Board of Directors. Peter Emtage, Ph.D. joined the Company from Biomira, Inc. to serve as our Vice President of Research and Development. Already, Dr. Emtage’s experience and extensive knowledge of virology and immunology and the regulatory process have proven invaluable in restarting our clinical program. In addition, we were privileged to welcome Robert Rieder, Chairman and Chief Executive Officer of Cardiome Pharma Corp to our Board of Directors, and to appoint Jay M. Short, Ph.D., already an Nventa Board Member, as Chairman. Both bring tremendous scientific and business acumen to our Board and continue to play key roles in guiding our strategic path forward.

Lastly, in mid-2006, we created a new corporate identity, coinciding with our updated corporate vision and clinical strategy. Our new tagline from “insight to impact™” reflects our mission to apply scientific insight to discover novel biopharmaceuticals that have the potential to directly impact patients suffering from difficult-to- treat diseases with unmet medical needs.

Summary

Within Nventa, there is renewed excitement as we steer the Company on the right track. Going forward, we expect that our enthusiasm will continue to be reflected in our accomplishments and will ultimately translate into growing shareholder enthusiasm for our work. We have both you, our dedicated shareholders, and our employees to thank for your support in enabling the restart and continued development of our HspE7 program. If all of our corporate and clinical initiatives continue to progress well, 2007 promises to be a year that should build significant shareholder value.

Sincerely, Gregory M. McKee President and Chief Executive Officer May 3, 2007

 

The facts about Human Papillomavirus (HPV)

HPV infection is a sexually transmitted disease that is caused by the human papillomavirus. Most people
with HPV have no symptoms, are unaware that they are infected, and can transmit the virus to their sex partner
unknowingly, even in cases where condoms are used.

Population with HPV is large and growing

Approximately 20 million people in the U.S. are currently infected with HPV, and nearly 630 million worldwide.
At least 75 percent of sexually active men and women will acquire a genital HPV infection at some point in their
lives. About 6.2 million Americans get a new genital HPV infection each year.

High-risk types of HPV can be serious

The “high-risk” types of HPV may cause abnormal Pap tests and lead to cancer, including cervical and/or anal
cancer. The “low-risk” types may cause genital warts or cervical dysplasia, diagnosed as mild Pap abnormalities.
Pregnant women can pass HPV to their babies during vaginal delivery, causing warts to develop in the infant’s
larynx and airways. Although rare, death can occur from airway obstruction.

Need for a drug that treats HPV

The prophylactic vaccine recently introduced and others to follow do not work on the population already exposed
to HPV. In addition, market research indicates that physicians are eagerly awaiting alternatives to surgery,
which is currently the only HPV treatment for most HPV sufferers. Surgery can be painful, intrusive, expensive
and does not eliminate the infection.

The Nventa solution

Nventa is one of a few companies working on a treatment for those already infected with HPV. The Company believes its focus on the development of innovative therapeutic vaccines, also known as immunotherapies, may someday treat patients suffering from a broad spectrum of HPV-related diseases.

Nventa Pipeline

The Company plans to conduct a Phase 1 trial testing the safety of HspE7 plus adjuvant in patients with cervical dysplasia (CIN), which it expects to begin mid-2007. Once completed, Nventa is planning a Phase 2 efficacy trial in CIN patients; if enrollment goes as expected, this Phase 2 trial could be completed rather quickly and could provide the fastest path to data. In addition to the CIN Phase 2 trial, Nventa is planning additional effi cacy trials in other HPV-related indications, such as HIV positive women with LSIL* CIN, genital warts and recurrent respiratory papillomatosis (RRP). With orphan drug designation and fast-track status from the U.S. Food and Drug Administration, conducting a pivotal trial in RRP patients may be the fastest route to market.

*Dysplasias refer to precancerous lesions. The dysplasias caused by HPV infection are graded into two main categories, Low Grade Squamous Intraepithelial Lesions (“LSIL”) and High Grade Squamous Intraepithelial Lesions (“HSIL”), with HSIL being a later progression of the disease relative to LSIL.

2006 and recent Nventa achievements

Corporate and financial

01/07 Raised C$16.2 million in additional capital

12/06 Decreased overall spend by over 62 percent as a result of corporate restructuring and implementation of refocused product development strategy

06/06 Created new corporate identity coinciding with new corporate vision and clinical strategy

04/06 Strengthened Board of Directors, adding Robert Rieder and electing Dr. Jay Short as Chairman

04/06 Hired Peter Emtage, Ph.D. as new head of Research and Development

03/06 Received C$9 million in non-dilutive capital

Lead candidate HspE7

03/07 Announced data from NCI-sponsored trial in cervical dysplasia (CIN) showing 78 percent of patients achieved complete response or reduction of lesion size by more than fi fty percent

11/06 Provided clinical development strategy update and positive outcomes from interactions with the U.S. Food and Drug Administration (FDA)

09/06 Presented preclinical data demonstrating greater potency and specifi c activation of the immune response with HspE7 plus adjuvant

09/06 Announced data in clinical trial showing complete response or marked improvement in 81 percent of genital warts patients treated with HspE7

08/06 Signed Supply Agreement for Poly-ICLC adjuvant

06/06 Announced positive HspE7 data published in the journal AIDS in patients co-infected with HPV and HIV

04/06 Presented twelve-month development strategy for new formulation: HspE7 plus adjuvant

Intellectual property portfolio

03/07 Won challenge to U.S. patents; U.S. PTO reissued composition of matter and methods of use for the Company’s CoVal™ fusions

01/07 Granted European patent covering CoVal™ fusion proteins to treat influenza

06/06 Granted two European patents covering HspE7 for HPV-related diseases

Key goals for HspE7 in 2007

• File preclinical update with FDA

• Submit Phase 1 clinical trial protocol to FDA

• Obtain IRB approvals for Phase 1 clinical trial

• Initiate sites for Phase 1 clinical trial

• Start and complete Phase 1 clinical trial in CIN patients

• Prepare for Phase 2 CIN clinical trial

• Prepare for Phase 2 HIV-positive LSIL CIN clinical trial

 


 
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