OncoSec Initiates Phase II Clinical Program

Upon receiving Investigational Review Board (IRB) approval, OncoSec rolls out a Phase II clinical trial evaluating OncoSec’s electroporation therapy for the treatment of cutaneous T-cell lymphoma. The trial takes place at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

UCSF investigators actively recruit up to 27 patients with cutaneous T-cell lymphoma and administer the first doses of the immune-stimulating agent interleukin-12 (DNA IL-12) via electroporation. One treatment cycle consists of three treatments applied to up to four lesions on days one, five and eight, with a maximum dose of 3.0 mg DNA IL-12 per treatment cycle.

Dear R2CC Supporters:

I wanted to congratulate Team OncoSec and thank all our generous donors for making the 2012 Ride to Conquer Cancer a great success. Our team collectively raised almost $18,000 to support the BC Cancer Agency. Honorable mentions include Jim Heppell and Rebecca Bolthouse who both raised $2,740, and to Lisa Mueller, Jared Kawaoka and Brittney Hawkins who raised $2,500. I am very appreciative of our donors and sponsors helping me raise over $4,600.

We are incredibly grateful to the donors and sponsors who helped make this adventure possible:

$500+ contributions from:

Phil Johnson of Merrill Corporation, Byron Roth of Roth Capital Partners, Amitpal Sandhu of Ampri Group, Greg Trinidad of NorthStar Internet, Punit Dhillon, The Breidinger family, William & Cheryl Struve, Mr. & Mrs. Fred von Bargen, Happy Boy Farms, Lekos Electric, Pal General Engineering, David Sidoo, John Mueller, and Jim Heppell

$250+ contributions from:

Edward Borrelli, Mr. Sukhwinder Singh Rai, Associated Bio Solutions, and Doug & Michele Wurlitzer

$100+ contributions from:

Jessica Mah, Kar Lei Chiu, Dickson Tse, Larissa Kawaoka, Truda Roper, Kathy & Michael Brines, Dr. Adil Daud, Dan Turner, Alex Casden, The von Bargen family, Allan Olson & Charlotte Underwood, Bill & Elaine Vanderspek, Celia Courchene & Ian MacKay, John, Michelle & Brandon, John & Hermine Mueller, Chris & Liisa Wagner, Christina Yip, Clarence Heppell, Dave Bromley, David & Louise Raffa, Jeff Read, Gary Lenett & Karen Ergas, George David Richardson, Peter Moscone, Stephen Leckie & Karen Blair, Val Russo, Tyler & Allison Cerro, Brian McCluskey, Mark Grambart, Ms. Carole Bailey, and Khader Safi

Other contributions from:

Efrain Solis & Maribel Montiel, Jaswinder Singh, Susan Foreman, Shannon & Andy Chen, Theresa Halliday, Jessica Mah, Aaron Hawkins, Abnology, Anna Orlando, Alexa Giesen, Damian Gomez, Heather Kline, Jim Broshears, Nicole Mehara, Patrick & Lainey Crown, Phyllis Knibbs, Shellie Camarillo, Allen Myers, Allen & Karin Spiegelman, Dave Radick, Lisa Pasin, Metal & Wood Products, Peter Lyon, Ted Wheeler, Grantie Lewin, The Bostic Family, Dennis & Kim Peek, Dionna Kawaoka, Dorothy Chat, Jessica Hickey, Art & Candy Silva, Nancy Campos, Abigail Garibay, Annette & Reginald Dahlen, Anthony, Kendall & Lacey Sand, James Bolthouse, Jen Clem, Mark Wescott, Mary Draper, Jon-Mark Bolthouse, Teresa Goshorn, The Thush Family, Tony Bolthouse, Tyler Garibay, Warren Hogarth, William Garibay, Cindy Adams, Dawn Ternig, Gilberto Espinoza, Michael A Stiegel, Mrs. Kathy Moore, The Czech Family, Tina Jasso, and all others who donated anonymously, as well as those friends and family who contributed with their love, wisdom, kind words and support

Support and Gear (SAG) Vehicle: David Tamble

Cycling Kits: Hincapie Sportswear

Exhaustion, fierce headwinds, and torrential downpour did not affect the high spirits and passionate dedication of the team.

I hope you left this weekend with a feeling pride and joy, knowing that you were a part of something powerful that has great impact in helping make this world cancer free. Through your devotion to helping the B.C. Cancer Foundation, lives will be changed, families will have hope, and we will continue our battle to conquer cancer.

My Sincerest Thanks,

 

 

 

Punit Dhillon
President and CEO

OncoSec is granted a new method of use patent from the Commissioner of Patents, Commonwealth of Australia Patent Office. The patent covers the company’s OMS (OncoSec Medical System) treatment platform as a “ Method and Device for Treating Microscopic Residual Tumors Remaining in Tissues Following Surgical Resection”.

The patent offers potential for OMS technology to be used to treat the margins of solid tumors following surgical resection, thereby expanding of OncoSec’s market opportunities considerably.

OncoSec enters into an exclusive cGMP manufacturing agreement with VGXI Inc. for the production of interleukin-12 plasmid DNA (DNA IL-12). VGXI possesses a patented DNA plasmid manufacturing process essential to the production of DNA IL-12.

OncoSec administers DNA IL-12 as part of an innovative immunotherapy for treating skin cancers. With large-scale process development and clinical manufacturing of this immunotherapeutic, OncoSec has the ability to scale up production for its OMS (OncoSec Medical System) treatment activities.

Dear Shareholder:

As we near the mid-point of 2012, OncoSec is successfully executing on its objectives for the year. I want to review the key developments so you can see why all of us at OncoSec are so excited.

Financial Update

  • Strengthened balance sheet: OncoSec recently raised $7.75 million through a public offering underwritten by Rodman & Renshaw, with Roth Capital Partners acting as an advisor. We are now well financed to continue our promising clinical development programs. We currently have over $6.5 million in cash reserves to fund operations, which should be sufficient to complete our current studies.

Clinical Update

We are executing our clinical development plan based on our novel, first-in-class OMS ElectroImmunotherapy platform for the treatment of rare and deadly skin cancers including metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.

  • OMS-I100: We initiated and enrolled several patients in OMS-I100, a Phase II study for the treatment of metastatic melanoma led by the University of California at San Francisco, with additional sites at the John Wayne Cancer Institute in Santa Monica and Lakeland Comprehensive Cancer Center in Lakeland, Florida. We expect to report interim clinical data before year end.
  • OMS-I110: We initiated and enrolled several patients in OMS-I110, a Phase II study for the treatment of Merkel cell carcinoma led by the University of Washington and the Fred Hutchinson Cancer Center in Seattle, Washington. We expect to report interim clinical data before year end.
  • OMS-I120: We aim to initiate and begin enrolling patients in OMS-I120, a Phase II study for the treatment of cutaneous T-cell lymphoma (CTCL) by year-end. This study will be led by the University of California at San Francisco and include multiple centers across the US.
  • Expansion of technology platform: We are pursuing clinical and regulatory development of our OMS ElectroChemotherapy in the U.S., Europe and Asia, including the development of new indications for ElectroChemotherapy. The last several months have demonstrated our ability to create incremental value from our advanced-stage OMS ElectroChemotherapy program for the treatment of primary and recurrent localized solid tumors. Since the acquisition of a clinical data set of over 400 patients, we have compiled, reviewed, and analyzed the data and presented preliminary results from a Phase IV European head & neck cancer trial and Phase I/II breast cancer trial. The preliminary data sets from the completed Phase III recurrent head and neck cancer studies carried out in the U.S. are now being analyzed, and we intend to present this data at the 5th International Head and Neck Cancer Conference taking place July 21-25. We are defining a regulatory path with the FDA for clinical development of advanced stage skin cancer and other solid tumor indications. In addition, we are advancing a commercialization strategy focused on creating regional partnerships or establishing a global partner to develop the market potential for OMS ElectroChemotherapy in Europe, Asia and other emerging markets.

Corporate Update

  • Patent portfolio expansion: We are developing new applications of our OMS ElectroOncology for treating solid tumors and metastatic disease, with the goal of expanding our market opportunities and establishing additional patents to maintain our dominance in these areas.
  • Gaining leadership position and creating awareness: We have been able to build physician, partner, and patient awareness of the clinical development of OMS ElectroImmunotherapy for the treatment of metastatic melanoma and Merkel cell carcinoma through the media. These publications include: Xconomy, Medical Device & Diagnostic Industry, Manufacturing Chemist, and the San Diego Business Journal. OMS ElectroImmunotherapy was also featured as a “revolutionary cancer treatment” for Merkel cell carcinoma by a local NBC News affiliate in Seattle, Washington. We continue our proactive outreach to inform relevant audiences of technology and business opportunities.

OncoSec sees the initial market for its OMS ElectroImmunotherapy exceeding $500 million in the U.S. alone. Melanoma and other skin cancers are deadly diseases with very limited treatment options (i.e. limited competition). We have a highly focused effort to develop a new generation of immunotherapy products to provide better care to these patients and we are passionate about the progress of our programs.

I thank you for your ongoing support as we work toward our goal of becoming the preeminent developer of targeted oncology therapies. I look forward to updating you on our continued progress in the year ahead.

Best regards,

Punit Dhillon
President & CEO

OncoSec releases Phase IV study data demonstrating that chemotherapy delivered by electroporation compares favorably to standard outcomes associated with surgery for patients with head and neck cancer.

The study demonstrates local tumor control in 94% of primary and 57% of recurrent tumors as well as enhanced quality of life for patients treated via electroporation using the OncoSec Medical System (OMS). Data is taken from 81 subjects in a Phase IV study of primary and locally recurrent squamous cell carcinoma of the head and neck, each of whom was treated with OMS in a European trial. In terms of both tumor control and overall quality of life, the OMS system compares favorably to surgical intervention.

OncoSec announces the closing of a sale to institutional investors of an aggregate of 31,000,000 shares of its common stock at $0.25 per share in a registered public offering. Investors also receive warrants to purchase up to 31,000,000 shares of common stock at an exercise price of $0.35 per share for a term of five years.

The gross proceeds of the offering are $7.75 million, with net proceeds of approximately $7.2 million.

Oncosec initiates two additional enrolling sites for its Phase II metastatic melanoma clinical trials.

Both the John Wayne Cancer Institute in Santa Monica, CA, and Lakeland Comprehensive Cancer Center in Lakeland, FL are initiated as trial sites, and investigators begin screening patients.

A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma are enrolled in this Phase II, single-arm, open-label and multi-center study.

The first patient with metastatic melanoma is dosed during a Phase II clinical trial evaluating OncoSec’s OMS system.

After Investigational Review Board (IRB) approval is received by the University of California, San Francisco, UCSF investigators begin actively recruiting patients with stage III or IV cutaneous and in-transit metastatic melanoma for the trial. A total of up to 25 patients is enrolled in this Phase II, single-arm, open-label and multi-center study.

Physicians at the University of Washington and Seattle Cancer Care Alliance, in conjunction with the Fred Hutchinson Cancer Center, treat several patients in an open-label Phase II clinical trial evaluating OncoSec’s OMS electroporation therapy for the treatment of Merkel cell carcinoma.

The clinical trial is designed to test DNA IL-12 administered using OncoSec’s novel treatment approach for immunotherapy to patients with local and distant Merkel cell carcinoma. As many as 15 patients with local and distant Merkel cell carcinoma are enrolled in the trial.


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