Welcome to another Sunday edition of “3 Things In Biotech You Should Learn Today,” a daily digest dedicated to helping you keep up with the world of biotech and pharmaceutical research. This past week has seen an unreal amount of news, so much that it’s been hard to get up to current on this series!
Let’s jump in!
Advaxis continues to rumble for shows in late 2017
Following the news that Advaxis (NASDAQ:ADXS) will be presenting findings at ESGO 2017 this coming November, the company has continued its flatline near 52-week lows. And the recent departure of Daniel O’Connor as CEO from the company has not granted it any particular stability, not until it figures out a more permanent solution.
However, ADXS has continued to move on the scientific front. One of its more understated programs, axalimogene filolisbac in the treatment of metastatic squamous cell anal cancer, is currently in phase 2 study (the FAWCETT trial). ADXS announced that data from the first stage of this trial will be presented on a poster at the 2017 ESMO conference by Cathy Eng, who is an eminent thought leader in gastrointestinal cancers.
The press release offers only that these data show “promising activity with axalimogene filolisbac in patients with late-stage anal cancer.”
Looking forward: More than anything else, this press release demonstrates the caliber of faculty it has on board. I have great respect for Cathy Eng as a researcher, and the presser also details the publication of a review article coauthored by one Brad Monk, who is an eminent thought leader in gynecologic malignancies. It is also promising that it’ll be presenting more data on a study we’ve yet to hear much about. ESMO takes place September 8-12.
Disclaimer: I am a shareholder in Advaxis, so please take my opinion for what it’s worth in that context.
Bad news for Bristol-Myers in Hodgkin lymphoma
Bristol-Myers Squibb (NYSE:BMY) achieved a landmark success in relapsed/refractory Hodgkin lymphoma when nivolumab was approved back in spring 2016. And now questions have turned to the optimal use of this agent.
One outstanding question was how nivolumab would function in patients who had undergone an allogeneic stem cell transplant, whereby a patient’s immune system is annihilated and replaced with a donor’s bone marrow. The technique is risky, as it carries a risk of chemotherapy-related serious adverse events, as well as a risk that the patient’s bone marrow will “reject” the patient, a condition known as graft versus host disease.
Unfortunately, a recent publication in the journal Blood does not indicate promising outcomes for nivolumab following transplant in this setting. While PD-1 blockade was associated with a 77% overall response rate in the 31 patients analyzed in the retrospective study, eight of these patients died due to graft versus host disease. Over half of the patients experienced this complication to some extent following allo-transplant and nivolumab therapy.
Looking forward: To its defense, BMY has not strongly pursued the use of nivolumab in this setting. A therapy that sets the immune system on overdrive is not a particularly intuitive choice of treatment in a setting where graft versus host disease is alarming and frequent. The use has mainly been off label, and this study suggests that nivolumab should not be used routinely following transplant. The risk is too severe.
Gilead’s HIV antiviral medication is not under review in Europe
Gilead (NASDAQ:GILD) has built the entirety of its massive success on antiretroviral medications, mainly in the area of hepatitis. However, there is also growing excitement for the GILD portfolio in the area of HIV management, with bictegravir leading the pack and reaching late stages of development.
GILD recently announced that it had made another step forward with bictegravir, as its application for approval with the EMA has been accepted. This follows along its new drug application with the FDA back in mid-June based on the results of two phase 3 studies investigating a triplet regimen containing bictegravir.
So now the wait is on for decisions from the regulators on the fate of this new drug cocktail.
Looking forward: The trial results for the triplet combo in HIV appear strong, so hopefully GILD has yet another retroviral winner in its hands. As competition looms in the liver space, it needs this diversification of its drug franchises in order to continue on an upward trajectory. Certainly, a breakthrough in HIV/AIDS treatment would be a major step in the right direction.
So we take the good with the bad today. Thankfully, I don’t think the nivolumab findings will impact things too greatly, as there is an ongoing debate about the role of transplantation in the era of new therapies. However, those findings do clarify certain unanswered questions about nivolumab in Hodgkin lymphoma. Hopefully, GILD and ADXS will be able to build positive momentum on the backs of their respective news over the course of 2017!
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Have a good one!
Disclosure: I am/we are long ADXS.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.