Telesta Therapeutics Inc. was a

publicly traded A public company is a company whose ownership is organized via shares of share capital, stock which are intended to be freely traded on a stock exchange or in over-the-counter (finance), over-the-counter markets. A public (publicly traded) co ...

, Canadian

pharmaceutical company The pharmaceutical industry is a Medicine, medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or Self-medicate, self-administered b ...

based in

Montreal Montreal is the List of towns in Quebec, largest city in the Provinces and territories of Canada, province of Quebec, the List of the largest municipalities in Canada by population, second-largest in Canada, and the List of North American cit ...

Quebec Quebec is Canada's List of Canadian provinces and territories by area, largest province by area. Located in Central Canada, the province shares borders with the provinces of Ontario to the west, Newfoundland and Labrador to the northeast, ...

. It was acquired by ProMetic Life Sciences in 2016. CEO Michael Berendt; prior to joining Telesta, was the president and CEO of Aegera Therapeutics. Telesta was listed on the

Toronto Stock Exchange The Toronto Stock Exchange (TSX; ) is a stock exchange located in Toronto, Ontario, Canada. It is the List of stock exchanges, 10th largest exchange in the world and the third largest in North America based on market capitalization. Based in th ...

under the symbol TST.

History

As part of the strategic push to focus on late stage human therapeutics, effective May 2014, the company divested its Animal Health unit to Vétoquinol, a family-owned, global animal health company led by CEO Matthieu Frechin. In 2014, a court decision involving a group of Bioniche shareholders and the Bioniche

board of directors A board of directors is a governing body that supervises the activities of a business, a nonprofit organization, or a government agency. The powers, duties, and responsibilities of a board of directors are determined by government regulatio ...

established a precedent in the Canadian court system for conditions under which a board may choose not to select the date proposed by shareholders for an annual meeting, but rather schedule on a date of the board's choosing, thus confirming "that directors have wide latitude to manage corporate affairs." In February 2016, the

Biologics License Application A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into inters ...

of Telestra's main drug, MCNA, was rejected by the

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

. In response, the company started cutting staff, and attempted to find a buyer for its Belleville and Montreal production facilities. In August, Telesta was acquired by ProMetic Life Sciences for 14 cents a share.

Operations

, the strategic focus of Telesta was on the commercialization of "Mycobacterium phlei cell-wall - nucleic acid complex" (MCNA) for the treatment of

bladder cancer Bladder cancer is the abnormal growth of cells in the bladder. These cells can grow to form a tumor, which eventually spreads, damaging the bladder and other organs. Most people with bladder cancer are diagnosed after noticing blood in thei ...

. The company pursued but did not secure

orphan drug status An orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the condition ...

via the

United States Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

. Telesta's

Biologic license application A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into inters ...

for the drug MCNA (Mycobacterium phlei Cell Wall-Nucleic Acid Complex), formerly "Urocidin" was reviewed under the

FDA Fast Track Development Program Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical ne ...

. MCNA's safety profile is superior to the other available treatments after BCG-failure (1.5%

Adverse event In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medicati ...

for MNCA compared to >30% AEs for

Valrubicin Valrubicin (''N''-trifluoroacetyladriamycin-14-valerate, trade name Valstar) is a chemotherapy drug used to treat bladder cancer. Valrubicin is a semisynthetic analog of the anthracycline doxorubicin, and is administered by infusion directly into ...

(Valstar)). The drug MCNA had a 100% - 250% higher efficacy in the pivotal clinical trial than Valstar (<10% DFS for Valstar, 25% DFS for MCNA) and MCNA had a 35% DFS after a one-year treatment on papillary-only patients with NMIBC, which is 90% of all NMIBC cases. With MCNA there is also the unique possibility for urologists to administer the drug immediately following TURBT, as opposed to weeks after with either BCG or Mitomycyn C. This means MCNA could kill free floating cancer cells and not give them the opportunity adhere to the bladder walls, after tumors have been removed.

References

{{reflist, refs= {{cite news , department=People on the Move: Pharma , author=Slatko, Joshua , title=BMS changes senior management team , page=27 , date=December 2013 , work= Med Ad News {{cite news , author=Staff , work=

Biotech Week ''Biotech Week'' is a weekly biotechnology and pharmaceutical trade magazine. The magazine was established in 1999. It is published by NewsRX. The magazine covers a broad range of medical issues and financial related information about companies in ...

, title=Orphan Drug Designation Update and Annual General Meeting Reminder , date=19 November 2014 , url=http://www.highbeam.com/doc/1G1-394824670.html , archive-url=https://web.archive.org/web/20150329154723/http://www.highbeam.com/doc/1G1-394824670.html , url-status=dead , archive-date=29 March 2015 {{cite news , author=Staff , work=DVM Newsmagazine , publisher=Advanstar , title=Vétoquinol Acquires Animal Health Business of Bioniche Life Sciences , date=1 April 2014 , url=http://www.highbeam.com/doc/1P3-3276371811.html , archive-url=https://web.archive.org/web/20150329154849/http://www.highbeam.com/doc/1P3-3276371811.html , url-status=dead , archive-date=29 March 2015 {{cite news , work=Health & Medicine Week , publisher= NewsRx , author=Staff , title=Bioniche Life Sciences Inc. Rebrands as Telesta Therapeutics Inc , date=14 December 2014 , url=http://www.highbeam.com/doc/1G1-397889673.html , archive-url=https://web.archive.org/web/20150329154752/http://www.highbeam.com/doc/1G1-397889673.html , url-status=dead , archive-date=29 March 2015 {{cite web , url=http://web.tmxmoney.com/company.php?qm_symbol=TST , title=Company Information , website=Stock Market Quotes , publisher=

TMX Group TMX Group Limited is a Canadian financial services company that operates equities, fixed income, derivatives, and energy markets exchanges. The company provides services encompassing listings, trading, clearing, settling and depository faciliti ...

{{cite news , author=White, Guy , title=Proactive Business Judgment in Proxy Contests , date=26 April 2014 , work=Mondaq Business Briefing , publisher=Mondaq , url=http://www.highbeam.com/doc/1G1-366242735.html , archive-url=https://web.archive.org/web/20150329154732/http://www.highbeam.com/doc/1G1-366242735.html , url-status=dead , archive-date=29 March 2015 Pharmaceutical companies of Canada Companies formerly listed on the Toronto Stock Exchange