Thursday, July 24, 2014

Biovest International (OTC:BVTI),The Next potential winner in Cancer Immunotherapy Vaccine after Dendreon (NASDAQ:DNDN)

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Biovest International, Inc. is an emerging leader in the field of active personalized immunotherapies. In collaboration with the National Cancer Institute, Biovest has developed a patient-specific, cancer vaccine, BiovaxID®, with three clinical trials completed, including a Phase III study, demonstrating evidence of safety and efficacy for the treatment of indolent follicular non-Hodgkin’s lymphoma and mantle cell lymphoma. It is also developing an automated cell culture instrument. The company also sells hollow fiber bioreactors, cultureware, tubing sets, and other disposable products and supplies.

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Here is a recent video presentation of Biovest International. This corporate presentation was recorded during “Cancer Immunotherapy: A Long Awaited Reality”, a conference hosted by BioBusiness.TV and MD Becker Partners on October 21st, 2010, at the New York Academy of Medicine:

http://www.biobusiness.tv/report-on-location/biovest-international-presentation-at-cancer-immunotherapy-conference-1600/

Technically, Biovest International is a majority owned subsidiary company of Accentia Biopharmaceuticals, Inc. (OTC:ABPI).

A new Phase III Data Analysis for BiovaxID®, Personalized Lymphoma Vaccine, will be featured in an oral presentation at the American Society of Hematology (ASH) Annual Meeting on Monday, December 6th in Orlando, Florida.

Cancer immunotherapy represents a new revolutionary treatment modality; we expect growing interest in the investment community for the coming years.

Recently the approval of Provenge, the first active immunotherapeutic agent by Dendreon, has cleared uncertainty of clinical and regulatory paths for the whole class of such drugs. The company has nothing to do with Dendreon Corp. (NASDAQ:DNDN) in the business, but the targets of the potential products use the body’s own immune system to fight tumors strike a similar interest.

With an appropriate growth strategy in place, a very talented management team and amazing Phase III datas, Biovest International is now well positioned to deliver shareholder value in the coming months.

BiovaxID:

BiovaxID is individually manufactured from a tissue biopsy obtained from each patient’s tumor. The vaccine targets a protein unique to each patient, called an idiotype, expressed by cancerous B cells in follicular lymphoma, while sparing normal, healthy B cells that do not express the tumor protein. Additional studies will need to be conducted to determine the efficacy of BiovaxID in patients who have had rituximab therapy (a common lymphoma treatment that was not part of the treatment received by patients in this study), and to determine if the vaccine may also be useful in the treatment of other B-cell lymphomas.

BiovaxID Personalized Vaccine Prolongs Disease-Free Survival for Follicular Lymphoma.
An eight-year, randomized phase III clinical trial reported that BiovaxID, a patient-specific therapeutic vaccine, prolonged disease-free survival in previously untreated patients with follicular non-Hodgkin lymphoma. Patients who received BiovaxID experienced disease-free survival of 44.2 months, compared with 30.6 months for those who received a control vaccine—an increase of 47%.

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Development:

Biovest’s BiovaxID, which is in late-stage development for B-cell lymphoma. This cancer immunotherapy stems from work begun in 1986 during the development of a patient-specific follicular lymphoma (FL) vaccine. The cancer vaccine primes the immune system to recognize and eliminate cancerous lymphoma cells, while sparing normal B cells. In the vaccine’s cancer target, B-cell lymphoma, the process is made possible by the presence of a hallmark surface antigen of the cancer cells that is not present in noncancerous tissue. By priming the immune system with this antigen in the form of an autologous vaccine, the vaccine induces an immune response against the cancerous cells. There are about 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the United States with a comparable number in Europe.

On Tuesday, 22 Jun, Biovest International, Inc. announced that the Company is targeting mantle cell lymphoma, in addition to follicular lymphoma, as a next indication for its personalized cancer vaccine, BiovaxID. The Company reviewed positive data from an open label Phase II mantle cell lymphoma clinical trial and reported plans to meet with the FDA later this year to discuss a pathway to seek regulatory approval for this hematological indication for which there is no current consensus standard-of-care. Biovest is also currently preparing to seek approvals for BiovaxID for the treatment of follicular non-Hodgkin`s lymphoma. Biovest recently filed an application with the FDA seeking Orphan Drug status for BiovaxID for the mantle cell lymphoma indication. This aggressive form of lymphoma constitutes about 6% of all non-Hodgkin`s lymphoma cases or approximately 7,800 cases per year in the U.S. and Europe combined.

On Monday, 26 July, the FDA has granted Orphan Drug Designation to BiovaxID, Biovest’s personalized cancer vaccine, for a second lymphoma indication mantle cell lymphoma. Mantle cell lymphoma is an aggressive and lethal B-cell blood cancer for which there is no current consensus standard-of-care. Mantle cell lymphoma is the newest disease for which Biovest has announced its intent to pursue regulatory approval for and Orphan Drug Designation represents a significant development step in the Company’s regulatory strategy. The FDA previously granted Orphan Drug Designation for BiovaxID for the treatment of indolent follicular non-Hodgkin’s lymphoma. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage, patient-specific cancer vaccines vying to be among the first to reach market.

Financial:

Biovest has been in a difficult position over the last couple of years, having both positive Phase III data in hand while at the same time having financial troubles leading to Chapter 11. Biovest is now reemerging. The financial woes have prevented the company from fully capitalizing on the strength of the clinical data acquired to date. In fact, the Phase III data for BiovaxID was accepted for oral presentation at the ASCO 2009 Plenary Session. It is important to point out that out at this key session highlighting important data, only 4 presentations were accepted and Biovest was one of them. BiovaxID has the potential to be the next up to the FDA for review as a cancer immunotherapy and is designed to treat lymphoma.

On Wednesday, 17 Nov 2010, Biovest International, Inc. announced that the Company has successfully completed its reorganization, and pursuant to Biovest’s Plan of Reorganization approved by the bankruptcy court, the Company has now formally exited Chapter 11 as a fully restructured organization. As now deemed effective, the Plan of Reorganization restructured Biovest’s balance sheet by reducing outstanding debt, rescheduling debt payment obligations and reducing operating expenses. Under the Plan, stockholders retained their common shares. An important part of the confirmed restructuring was a previously announced $7 million financing for which ROTH Capital Partners, LLC acted as the exclusive placement agent. Structural changes to certain agreements are now in effect including the reduction of the outstanding royalty on BiovaxID sales from 35% to 6.30%, thus expected to enhance Biovest’s commercial and partnering opportunities.

Biovest International also received notice from the U.S. Internal Revenue Service (IRS) that it was approved to receive a Federal grant in the amount of approximately $245,000.00 under the Qualifying Therapeutic Discovery Project. The funds were awarded to support the advancement of BiovaxID®, Biovest’s late-stage, personalized cancer vaccine for the treatment of non-Hodgkin’s lymphoma.

Conclusion:

We view Biovest International as ready to capitalize on years of research and clinical experience and view BiovaxID as a revolutionary technology, which could transform cancer therapy. We believe that we are in a timeframe where investors are taking the time to finally educate themselves on the cancer immunotherapy space and would look to place their bets on the next potential Provenge.

Biovest is actually the only cancer immunotherapy product company that has Phase III data in hand that they will look to file with the FDA in 2011.
Biovest International was trading over $2 before the reorganization plan was announced, since then the share price went down to $1.30 and has now stabilized at $1.20. We believe that some debtors sold their shares just after the company has formally exited Chapter 11. We think this is now oversold, the company has many catalysts that should drive the price well over the $2 range again. Not to mention the long potential with a BLA submission and a potential fast approval of BiovaxID, we may have the same move as DNDN did ($3 to $40) in the coming months.

Full Disclosure:

-Long position on BVTI, the author owns 30.000 shares at an average price of $1.39.
-The Clever bull has NOT been compensated in any way by Biovest International to promote or write this article.

The Clever Bull team.

By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

TheCleverBull.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. The Clever Bull has not been compensated by any of the above mentioned companies. Please read our report and visit our Web site, www.thecleverbull.com, for complete risks and disclosures.



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