Realizing the dream of approval of a small biotech’s lead drug would usually lead a small development-stage firm to either walking on the road to more achievements and growth, or walking in place doing nothing but spending its revenues while no dream materializes. We have seen both possibilities occur time and time again.
Seattle Genetics (SGEN) is now a revenue generating biotech. The firm, which is one of two biotech companies that started the design and creation of conjugated monoclonal antibody therapeutics never stopped taking advantage of its products pluses. For example, its antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) directed to CD30 is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.
In The NEWS
Seattle Genetics trial activities are many and the announced results demonstrate successful outcome of the various trial of the conjugated antibody drug Adcetris when used alone and in combination with other products.
On October 2, 2017, Seattle Genetics announced that the FDA has granted Breakthrough Therapy Designation status for its lymphoma drug Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of advanced classical Hodgkin lymphoma, which the conjugated antibody has yet to be approved for. Adcetris is currently approved as second or third-line treatment for classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma after at least one failed multi-agent chemotherapy regimen in the United States as well as Europe. The Breakthrough Therapy Designation was granted to expedite the development and review of drugs that target serious or life-threatening conditions.
The FDA decision was based on the positive top-line data from the ECHELON-1 study, which was announced last June. The results show that Adcetris demonstrated statistically significant progression-free survival compared to standard of care chemotherapy. The ECHELON-1 study evaluated Adcetris in addition to Adriamycin, vinblastine and dacarbazine in patients with advanced classical Hodgkin lymphoma with no prior treatment. Full data of the study will be presented at the upcoming American Society of Hematology (ASH) annual meeting, December 9-12, 2017 in Atlanta, Georgia.
December 9 will be important for Seattle Genetics, its shareholders and for the oncology community.
The company expects to submit a supplemental biologics license application (“sBLA”) by the end of 2017.
– Last month, Seattle Genetics submitted a sBLA to expand its label to include cutaneous T-cell lymphoma following the successful completion of ALCANZA phase 3 study.
The decision is expected in December 2017.
– Another phase 3 study is currently evaluating Adcetris in frontline mature T-cell lymphomas.
– A study is also initiated to evaluate Adcetris in combination with Bristol-Myers (BMY) PD-1 checkpoint inhibitor immunotherapy product Opdivo for relapsed/refractory Hodgkin lymphoma.
THE MOST RECENT NEWS
Adcetris in sALCL
Seattle Genetics and Takeda Announced the publication of results from a pivotal phase 2 clinical trial in relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). in the Journal Blood. Of the Results:
– Estimated Five-Year Overall Survival Rate 60 Percent,
– Five-Year Progression-Free Survival Rate 39 Percent,
– In the 66 Percent of patients who achieved complete remission, both median overall survival and progression-free survival not yet reached.
– Long-Term data continue to support development strategy to establish Adcetris as foundation of therapy for CD30-expressing lymphomas.
The above positive results from several trials point to the fact that Seattle Genetics’ conjugated monoclonal antibody therapeutic Adcetris is worth a lot more than the market’s current evaluation. The number of the trials and their positive outcome are clearly demonstrating that Seattle Genetics is spending money where money should be spent to get the best out of the approved drug. This is what each and every biotech firm should really do after the initial approval of their lead drugs. The positive outcomes of the trials do not benefit only the the drug sales, the firm and the shareholders, but more importantly they benefit the patients who suffer detrimental deadly advanced diseases that that have no effective treatment options.
The positive results from the trials of Adcetris for the treatment of advanced relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) are exceptionally important, encouraging and extremely needed. It is remarkable the fact that the long-term survivors didn’t demonstrate major complications. The drug’s known complications have shown to disappear after a certain period of time.
These are Impressive positive results for Seattle Genetics clinical trials. We are now more convinced than ever before that SGEN is undervalued.
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CELYAD HAS ENCOURAGING NEWS
Early clinical finding from a phase 1b study results of the first dose-level in the hematological arm of Celyad’s (CYAD) THINK trial (THerapeutic Immunotherapy with CAR-T NKG2D) is encouraging.
At the first dose-level of Celyad’s chimeric antigen receptor CAR T-cell, CYAD-01 targeting a cell receptor NKG2D for multiple myeloma (MM) and acute myeloid leukemia (AML) has demonstrated promising results.
CYAD-01 T cells were administered without any prior conditioning chemotherapy. One AML patient has achieved a morphologic leukemia-free state (MLFS) after the administration of CYAD-01 at the H. Lee Moffitt Cancer Center and Research Institute (Florida, USA). This is the first time a relapsed, refractory AML patient has reached a MLFS with gene-engineered T cells without pre-conditioning lymphodepletion nor additional other concurrent treatment to CYAD-01 administration.
Dr. David Sallman, Assistant Member in the Malignant Hematology Department of Moffitt Cancer Center, comments, “The results provide the first clinical validity of CYAD-01 as a tumor-specific antigen-receptor and AML as a disease sensitive to gene-engineered cell therapies. As antigen targeting offers significant challenges in AML, this outcome brings hope for further use of gene-engineered T cells for patients with AML that have run out of therapeutic options…)
Christian Homsy, CEO of Celyad said that the firm will now use the collected data to move forward with the next stage of our product development: reinforcing responses in as many clinical settings as possible.”
A conference call will be held on Friday October 6, 2017 at 2:00pm (CEST) / 8:00am (EDT) to provide an update on Celyad’s clinical strategy. Christian Homsy, Chief Executive Officer, and Patrick Jeanmart, Chief Financial Officer will deliver a brief presentation followed by a Q&A session.
Participants are asked to call the assigned numbers approximately five minutes before the conference call begins. The call can be accessed by dialling the numbers below and using the passcode: 95148855
International: +44 (0) 2071 928338 Belgium: 02 793 3847 France: 0170700781
UK: 0800 2796619 US: 1 877 8709135
Celyad news is encouraging enough to validate Prohost early decision to pick up CYAD as an insightful diversified firm with solid scientific fundamentals and as a possible investment opportunity and add it to the Prohost Portfolio.
Prohost early selection was based on understanding Celyad’s T-Cell immunotherapy unique approach that builds on work conducted by Professor Charles Sentman and his team at Dartmouth College (Hanover, NH): The NKR-T platform (NKR-T stands for Natural Killer Receptor T‑cells).
There is no doubt that Professor Sentman was indeed inspired by the mechanisms of the Natural Killer Cells (NK Cells. Instead of inserting a gene that codes for an antibody in the T‑cell like in the traditional CAR approaches, Sentman inserted genes that code for NK activating receptors. These NK receptors do not bind with a specific antigen but with ligands.
In order to provide the intracellular signal that will trigger cell killing once the receptor/ligand binding has occurred, Sentman used the same signaling construct that in traditional CARs. NKR‑T also uses co-stimulatory molecules to increase the potency of the cell but instead of being integrated into the CAR construct, this molecule is already naturally expressed by T-cells, making NKR‑T construct much simpler than traditional CAR’s.
Prohost picked CYAD at $29.56 on April /19/17. The stock is trading today at $61.49. (Visit the Prohost Portfolio in the Prohost Biotech Letters at the Prohost Website.)
As for Now, we are waiting impatiently for Friday October 6 to carefully listen to what Celyad will be divulging and to the questions and answers that will follow during the conference call.
Arbutus (ABUS) and Celldex (CLDX) will be our next topics.
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