Unearthing Dynavax Treasures Has Nothing to Do with Greece Troubles

Today it is Greece. What About Tomorrow?

Can Greece’s crisis devastate the biotech sector? No sane individual would think so and the hysteria cannot be called other than what it is. The biotech sector is not overvalued and its value must not be insulted by unfairly downgrading great biotech revolutionary firms, while they are obviously undervalued. Those who invest their money against biotech stocks regardless of their successes love the sound of playing guitar on investors’ nerves as if it is the sound of music coming from a guitar played by Manitas De Plata’s gold fingers. God bless his soul.

The biotech industry has already changed the present before it changes the future. Indeed, it is radically changing the treatment of cancer, of autoimmune diseases, of arthritis, central nervous system diseases, fibrotic diseases, viral condemning disease, genetic disease and is on its way to treating hereditary diseases.

We decided to forget about Greece and its troubles and leave the crisis to be solved by the experts. Instead, look for today’s biotech good news.  

In the NEWS

Dow losses and Greece. Bad that Greece’s situation swallowed over 300 points from the Dow and over 100 points  and from the Nasdaq over 120 points before closing time. Resisting the hysteria in the morning were Juno (JUNO), Dynavax (DVAX), Halozyme (HALO), Biocryst (BCRX) and Agenus (AGEN) – all have stories to tell.

Immunotherapy Again and Again

The FDA, the NIH, the oncologists and desperate cancer patients are taking very seriously the revolution in cancer treatments that is occurring at the hands of the novel immunotherapy approaches.  News announced by Juno brought hope to condemned patients whose Non-Hodgkin’s lymphoma has exhausted every treatment, leaving them to face death.    


The U.S. Food and Drug Administration (FDA) accepted Juno’s (JUNO) investigational new drug (IND) application for JCAR017 for patients with relapsed/refractory (r/r) B cell non-Hodgkin lymphoma (r/r NHL). The drug JCAR017 is a chimeric antigen receptor (CAR) T cell drug targeting CD19, a protein expressed on the surface of most B cell leukemias and lymphomas.

Patients with r/r Non- Hodgkin lymphoma (r/r NHL) can now hope to join the multi-center Phase I trial exploring Juno’s drug JCAR017. The trial is scheduled to begin in 2015, having the potential to advance to a registration trial in 2016.

This is great news for Juno and for the desperate patients. The FDA decision was based on the encouraging results of JCAR017 in pediatric acute lymphoblastic leukemia, which demonstrated 91 percent of patients achieved a complete remission. Adverse events were consistent with what has been previously reported.

Prohost Comments

Good news is good news and this it is this time for patients advanced non-Hodgkin lymphoma with hope. No sane investor could believe that firms involved in developing breakthrough CAR T cell cancer treatments will not do whatever it takes to improve them, including their adverse effects and efficacy in treating many cancers other than hematologic and lymphatic cancers The effort is huge to let the CAR T cell drugs to treat a variety of cancers, including solid tumors.

Juno is walking two roads: The first is developing CAR T products and circumventing all serious adverse effects. The second is to enable their CAR T products to become as effective on solid tumors as it is on hematologic and lymphatic cancers.

The news is great. So why is JUNO is still harassed?



Will Immunotherapy Combinations Unearth This Firm’s Treasure?

The treasure is Dynavax’s (DVAX) Toll-Like Receptor agonist drug known as SD-101. 


Let us explain: Normally, immune system cells use naturally existent Toll-Like Receptors (TLRs) so they can recognize and respond to the presence of unwelcome visitors, including viruses, bacteria and other potential pathogens. The human genome encodes 10 TLR that are similar in structure, but recognize different parts of viruses or bacteria. Four of these TLR recognize either DNA or RNA and are triggered by the genomes of microorganisms taken up by cells in specialized structures called endosomes.

This innate immune response sets the stage for the generation of an adaptive immune response that comprises highly specific antibodies and T cells.

Dynavax’s valuable drug SD-101 activates specific TLRs that might stimulate specific types of the innate immune response, leading to an enhanced adaptive response. In turn, the adaptive response can accentuate the efficacy of immunotherapy, be it a vaccine, an immune checkpoint protein inhibitor, or CAR T cell drugs.

(Inhibition of specific TLR signaling can be beneficial in inflammatory and autoimmune diseases that result from inappropriate activation of the immune through TLR.)

Dynavax research has resulted in the identification of proprietary synthetic oligonucleotides (short segments of DNA), which selectively activate or inhibit these TLRs. In other words, the firm specific TLR antagonist drug would treat inflammatory and autoimmune diseases, while its TLR agonist drug will harness the immune system ability to attack and neutralize cancer cells.


An Agreement With Merck

Merck and Dynavax signed a collaborative agreement to investigate two cancer immunotherapy combinations. The first comprises Dynavax’s toll-like receptor 9 (TLR9) agonist candidate SD-101 +Merck’s approved immune checkpoint protein inhibitor drug Keytuda® (pembrolizumab) targeting PD-1.

The second combination comprises Dynavax’s SD-101 + Merck’s drug MK-1966 – an investigational anti-interleukin-10 (anti-IL-10).

Multiple studies are intended to assess the immunotherapy combination. The trials are to be launched in the second half of this year to evaluate the safety and efficacy of the combination in patients with advanced melanoma, in a Phase 1b/2 multi-center, open-label trial.

Combining SD-101 with MK-1966 in patients with solid or hematological malignancies, in a Phase I trial.

Dynavax said that synergistic activity observed by the firms’ scientists in preclinical trials conducted with SD-101 + immune checkpoint protein inhibitors.

Dynavax has agreed to sponsor and fund the SD-101 and Keytruda study, while Merck has agreed to sponsor and fund the SD-101 and MK-1966 study.

Collaborators’ Drugs

Dynavax’s Drug SD-101 is designed to trigger both innate and adaptive immune responses, including the induction of high levels of Type 1 interferon to stimulate recruitment of T-cells. SD-101 is also designed to activate plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. The drug is the subject of several Phases 1/2-oncology studies intended to assess its preliminary safety and activity.

Merck’s Drug MK-1966 blocks the activity of IL-10, which is known to down-modulate the immune activation required to kill tumor cells in the tumor micro-environment. According to Merck, preclinical data has shown that co-administration of an anti-IL-10 with a TLR9 agonist may provide clinical benefit in treating some cancers.

Merck’s Drug Keytruda is a humanized monoclonal antibody that works by blocking interaction between PD-1 and its receptor ligands, PD-L1 and PD-L2—thus increasing the immune system’s ability to fight cancer in cells that produce the pigment responsible for color in the skin. The drug is indicated for unresectable or metastatic melanoma and disease progression following treatment with ipilimumab and, for patients who are BRAF V600 mutation positive, a BRAF inhibitor.

Keytruda is being investigated as a monotherapy and in combination with other drugs in more than 100 clinical trials, across more than 30 tumor types and enrolling more than 16,000 patients. Keytruda is under review in Europe for advanced (unresectable or metastatic) melanoma, as both first-line therapy and in previously treated patients. On May 22, Merck disclosed that the drug received a recommendation of approval for that indication from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The positive opinion was based on data from more than 1,500 patients with advanced melanoma treated with Keytruda as monotherapy in three studies.

Keytruda is also under clinical studies for additional indications that include gastric cancer (Phase 2), bladder cancer (Phase 3), head and neck cancer (Phase 3) and non-small cell lung cancer (Phase 3).

Prohost Last Word Today

We feel lucky being on Earth when cancer breakthrough immunotherapy drugs are being produced and are actually saving patients condemned bodies.

As for Greece, we hope that the beautiful Greek people will rediscover their wisdom and recover their country’s wealth.

Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.

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