Cancer Immunotherapy Developer Galena Biopharma Can't Win for Trying
Based on its share price, you'd think Galena's clinical pipeline hit a brick wall, but that just isn't the case.
Source: National Cancer Institute.
Shareholders of small-cap cancer immunotherapy developer Galena Biopharma (NASDAQ:GALE) have suffered through a rough year. After witnessing their stock give back all of its 2014 romp higher, shareholders have had salt rubbed in their wounds, with the stock dropping an additional 30% year-to-date.
Galena's trio of woe
A lot of factors have been pressing on Galena's share price. To begin with, Galena's FDA-approved products haven't been selling as well as expected. Galena went out and acquired Abstral as a treatment for breakthrough cancer pain from Orexo, and it acquired the rights to market Zuplenz as a treatment for chemotherapy-induced nausea and vomiting, but neither appears poised to make much of a dent into the company's cash outflow. In fact, Abstral sales missed the forecast set forth by management early in the year in 2014, and this year the combination of Zuplenz and Abstral isn't on track to meet the midpoint of the expectations management laid out at the beginning of the year.
Cash is another concern for Galena, which continues to burn through its remaining cash on hand. Although Galena has arranged a purchase agreement with Lincoln Park Capital Fund that could supply it with up to $55 million in capital, Galena's primary source of capital has been issuing shares, which ultimately winds up diluting existing shareholders.
And, of course, we've got the stock market correction and the firestorm created by presidential hopeful Hillary Clinton, who last week proposed a radical plan to cut prescription drug costs if elected president. Clinton's plan entails using the government's full force to help negotiate better drug prices, as well as to cap the out-of-pocket payments of eligible drugs for individuals at $250 per month. Galena, which is developing specialized immunotherapy products to reduce or eliminate the chance of specific cancer types from recurring, will likely place a hefty price tag on its therapies if approved. Thus, Clinton's plan puts Galena, among dozens of other biotech stocks, squarely in the spotlight.
Source: National Cancer Institute.
Galena can't win for trying
However, it recently looked as if the stage was set for Galena's fortunes to make a turn for the better. In mid-September the company announced that it would be presenting phase 2a data on GALE-301, its peptide immunotherapy derived from folate binding protein that's designed to prevent the recurrence of ovarian and endometrial cancers, at the European Cancer Congress.
Initial reported data on GALE-301, presented at the American Society of Clinical Oncology's annual event at the end of May, was extremely positive, and suggested that more encouraging data was likely on the way. In its ASCO announcement, the complete response for GALE-301 was just 38% -- but for the 1,000 mcg cohort only one of 15 patients had a recurrence, compared to half of the control group cohort.
The phase 2a data released on patients that had been treated for at least 12 months, which Galena released on Sept. 28, continued to show a demonstrable outperformance for the 1,000 mcg cohort (the optimal dose). The poster abstract presented at the European Cancer Congress showed that the recurrence rate for the placebo cohort rose to 55%, while the recurrence rate for the GALE-301 1,000 mcg dose cohort also rose, but to just 13.3%. The estimated two-year disease-free survival of GALE-301 was nearly 86%, compared to just 34% for the control group.
Yet when Galena presented this news its stock scampered lower by more than 12% on the day. Again, Clinton's commentary and overall sentiment toward biotech stocks likely played some role in its underperformance. However, the rise in recurrence from one in 15 to two in 15 patients appears to not be sitting well with shareholders. The data still suggests a strong outperformance, but sometimes predominantly clinical-stage biotech companies simply can't win for trying.
Source: Galena Biopharma.
NeuVax is still the game-changer
Wall Street and investors may not be enamored with the GALE-301 data (which otherwise appeared solid), but it's ultimately the success or failure of NeuVax that holds the majority of Galena's roughly $225 million market value.
NeuVax is the company's lead immunotherapy vaccine, which is being studied as an adjuvant treatment to prevent the recurrence of breast cancer. In midstage studies NeuVax certainly hit the mark, with a mere 5.6% of NeuVax-treated patients experiencing a recurrence over a five-year period compared to a 25.9% recurrence rate in the control group. Overall, this represented a 78% risk of recurrence reduction for the NeuVax arm, and it gives the company ample momentum heading into the first of its interim analysis results for its phase 3 PRESENT trial, which is expected in the fourth quarter of this year, or perhaps in the first quarter of 2016. Final data for the study won't be available until 2018, but over the next 12-15 months we should get a pretty good idea of the general safety and efficacy of NeuVax in a much larger patient pool.
Assuming NeuVax hits its primary endpoint (and is approved by the FDA), Galena can either choose to seek out a licensing partner to alleviate some of its near-term cash concerns, or it could plan on marketing the adjuvant immunotherapy vaccine itself and potentially fund its operations with a loan or share offering until NeuVax hits the market.
If anything, shareholders will soon have an answer as to whether or not Galena's immunotherapy development platform has merit. The groundwork is certainly laid out for a possible success, but as we witnessed this past week, even a victory won't necessarily guarantee that the stock will head higher.
STOCKHOLM (AP) — The Nobel prize in medicine went Monday to three scientists hailed as "heroes in the truest sense of the word" for saving millions of lives with the creation of the world's leading malaria-fighting drug and another that has nearly wiped out two devastating tropical diseases.
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Tu Youyou — the first-ever Chinese medicine laureate — turned to ancient texts to produce artemesinin, a drug that is now the top treatment for malaria. Inspired by traditional Chinese medicine, Tu discovered that a compound from the wormwood plant was highly effective against the malaria parasite, while working on a project for the Chinese military during the Cultural Revolution.
She will share the 8 million Swedish kronor (about $960,000) award with Japanese microbiologist Satoshi Omura and William Campbell, an Irish-born U.S. scientist.
Omura and Campbell created the drug avermectin, whose derivatives have nearly rid the planet of river blindness and lymphatic filarisis, diseases caused by parasitic worms and spread by mosquitos and flies. They affect millions of people in Africa, Latin America and Asia, leaving sufferers blind or disfigured and often unable to work.
The Nobel committee said the winners, who are all in their 80s and made their breakthroughs in the 1970s and '80s, had given humankind powerful tools: "The consequences in terms of improved human health and reduced suffering are immeasurable," the committee said.
The Carter Center called the three laureates "heroes in the truest sense of the word, saving lives through medicine."
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The portraits of the winners of the Nobel Medicine …
The portraits of the winners of the Nobel Medicine Prize 2015 (L-R) Irish-born William Campbell, Sat …
Campbell, 85, is a research fellow emeritus at Drew University in Madison, New Jersey. He told the AP he made his main discovery in 1975 while working at pharmaceutical company Merck.
"It was a great team effort," said Campbell, who now lives in North Andover, Massachusetts. He said the award came as a "huge surprise."
Omura, 80, is a professor emeritus at Kitasato University in Japan and is from the central prefecture of Yamanashi. He wondered whether he deserved the prize.
"I have learned so much from microorganisms and I have depended on them, so I would much rather give the prize to microorganisms," Omura told Japanese broadcaster NHK.
Working in the 1970s, Omura isolated new strains of Streptomyces bacteria and cultured them so that they could be analyzed for their impact against harmful microorganisms, the Nobel committee said.
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William C. Campbell reacts shortly after learning that …
William C. Campbell, a parasitologist and RISE Associate with Drew University, poses near paintings …
Omura said the crucial strain was found in a soil sample from a golf course near Tokyo. He said he always carries around a plastic bag in his wallet so he can collect soil samples.
Campbell showed that one of those cultures was remarkably efficient against parasites in animals, the committee said. The bioactive agent was purified, named avermectin and modified to a compound that effectively killed parasitic larvae, leading to the creation of a new class of drugs.
Today, its derivative ivermectin is considered a highly effective preventive treatment against river blindness and lymphatic filariasis, the committee said.
"(Ivermectin) reduces the number of parasites in the blood so that when a mosquito bites someone, it cannot transmit the disease to someone else," said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. He said mass distribution campaigns have given out ivermectin for free to 450 million people in efforts to eliminate both river blindness and lymphatic filariasis.
Hotez said that in parts of Africa, adult sufferers of river blindness are often led around with a stick by a young child. Until ivermectin came along, Hotez said there was no way to effectively prevent the disease.
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Kitasato University Prof. Emeritus Satoshi Omura attends …
Kitasato University Prof. Emeritus Satoshi Omura attends a press conference at the university in Tok …
Tu, 84, is a researcher at the China Academy of Chinese Medical Sciences.
As a junior researcher, she was recruited by Chairman Mao's government to work on a military project in 1969 to find malaria drugs.
She turned to herbal medicine to discover a new malarial agent in an extract from the sweet wormwood plant. The agent, artemisinin (pronounced ar-tuh-MIHS'-ihn-ihn), was highly effective against malaria, a disease that was on the rise in the 1960s, the committee said.
Malaria is a mosquito-borne disease that still kills around 500,000 people a year, mostly in Africa, despite efforts to control it.
Colin Sutherland, a reader in parasitology at London School of Hygiene and Tropical Medicine, said that the impact of artemesinin has been profound and changed nearly every country's malaria treatment protocol.
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This photo taken Nov. 15, 2011 and released by Xinhua …
This photo taken Nov. 15, 2011 and released by Xinhua News Agency Monday, Oct. 5, 2015 shows Chinese …
Still, artemisinin resistance has already been confirmed in Cambodia, Laos, Myanmar, Thailand and Vietnam.
There have been several previous Nobel Prizes for malaria research, including the 1902 award to British army surgeon Ronald Ross, who discovered that the disease is transmitted by mosquitos.
The last time a Chinese citizen won a Nobel was in 2012, when Mo Yan got the literature award. But China has been yearning for a Nobel Prize in science. This was the first Nobel Prize given to a Chinese scientist for work carried out within China.
"This is indeed a glorious moment," said Li Chenjian, a vice provost at prestigious Peking University. "This also is an acknowledgement to the traditional Chinese medicine, for the work began with herbal medicine."
Stephen Ward, deputy director of Liverpool School of Tropical Medicine, said the prize confirms that Chinese scientists "did fantastic work in the 1960s even when they were effectively ignored by the rest of the world."
The medicine award was the first Nobel Prize to be announced. The winners of the physics, chemistry and peace prizes are set to be announced later this week. The economics prize will be announced next Monday. No date has been set yet for the literature prize, but it is expected to be announced on Thursday.
Besides the cash prize, each winner also gets a diploma and a gold medal at the annual award ceremony on Dec. 10, the anniversary of the death of prize founder Alfred Nobel.
Cheng reported from London. Associated Press writers Malin Rising in Stockholm, Malcolm Ritter in New York, Didi Tang in Beijing, Mari Yamaguchi in Tokyo, and Geoff Mulvihill in Haddonfield, New Jersey, contributed to this report.
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