Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts from the ‘Multiple Myeloma’ category

Jounce Poster AACR 2016

The AACR Poster Halls get packed quickly!

It’s time to change direction and take a look at some of the Gems from the Poster Halls at the recent American Association for Cancer Research (AACR) meeting.

One particular abstract that looked interesting related to the Aduro compound, BION–1301, which is a monoclonal antibody targeting the B cell Maturation Antigen and its ligand, A Proliferation Inducing Ligand (BCMA-APRIL) in multiple myeloma.

Increasingly, there has been a lot of clinical interest in the BCMA target, but what about APRIL?

We spoke to one of the scientists involved in the research about this novel agent:

“It is very effective at abrogating the activity of APRIL and, in particular, in our models blocks the growth, survival, drug resistance, migration and adhesion of myeloma cells both in-vitro and in-vivo in our murine models. These models have been predictive for clinical activity of other novel targeted therapies including lenalidomide and bortezomib, and so we think targeting APRIL represents a very promising strategy.”

Sounds pretty good, right?

To learn more about what they had to say about this approach, subscribers can log-in or you can sign-up in the blue box below.

Aloha! The Eddie Aikau Big Wave surf contest only happens on Waimea Bay on the North Shore of Oahu in a year when there are 40 ft swells. It’s six years since the last one took place.

Surfing Waimea Bay

Waimea Bay Surfing on Feb 10th 2016

Yesterday, at the last minute the big waves failed to show up as an expected storm took a different track.

In R&D terms this is a bit like a phase 3 trial that was expected to be positive, only at the last minute reads out negative.

Last year was an exceptional year in multiple myeloma with several new approvals. It was a “Grand Cru” year, but there is already another wave on the horizon…

Whether it’s a 40 foot Eddie Aikau wave remains to be seen, just like the bay and weather dictates the waves, clinical trial data and physician experience ultimately drive uptake.

This post continues our in-depth post-ASH analysis and pre-TANDEM coverage, with a look at the new wave in myeloma that’s coming our way.

Subscribers can login to read more or you can purchase access below.

This year has been an unprecedented Grand Cru year for the field of multiple myeloma, with no less than four drugs approved by the FDA to date… the fourth one just this morning while writing this preview!

  • Panobinostat (Farydak) in relapsed/refractory disease in combination with bortexomib plus dexamethsone after at least 2 prior therapies.
  • Daratumumab (Darzalex) received accelerated approval based on phase 2 data and is human CD38-directed monoclonal antibody that is indicated for the treatment of patients who have received at least three prior lines of therapy.
  • Ixazomib (Ninlaro) is the first oral proteasome inhibitor and is approved in combination with lenalidomide plus dexamethasone, in people who have received at least one prior treatment.
  • Elotuzumab (Empliciti) is a monoclonal antibody against CS–1/SLAMF7 approved today in combination with lenalidomide plus dexamethasone after 1–3 lines of prior therapy.

There are also many promising new agents in development and quite a few that may well not make it to market as a result of newer, better tolerated agents coming through.

To learn more about our insights on multiple myeloma, subscribers can log in or you can sign up below to read our latest ASH 2015 Preview.

Multiple myeloma (MM) has been very much in the news this week after the American Society of Clinical Oncology (ASCO) abstracts were released to much anticipation.

Myeloma is largely thought to be an incurable disease despite the option of an autologous stem cell transplant for newly diagnosed patients. That said, I have actually met some people who have had two or 3 transplants over several decades, a testament to their strength and fortitude in enduring such a challenging procedure.

This year, the news media have focused on elotuzumab (BMS/AbbVie), a CS1/SLAMF7 inhibitor that has previously shown clinical activity in earlier trials, after it was showcased in the ASCO Presscast last week. This why you see many articles on the data reported from this particular abstract.

New Orleans American QueenIt’s not the most exciting new data in this disease for me though, that honour goes to two other therapeutics of an entirely different kind. They come completely out of left field and what we saw over the last two months really caught our attention and may surprise you too.

Indeed, we saw hints of some of this data at the American Society for Gene and Cell Therapy (ASGCT) meeting last week in New Orleans.

To learn more about the exciting new developments in the field of multiple myeloma and what a leading thought leader had to say, you can sign in or sign up in the box below.

Much has been written about the success of checkpoint blockade in solid tumours over the last couple of years with the advent of anti-CTLA4 therapy (ipilimumab/Yervoy) for metastatic melanoma followed by the more recent approval of the anti-PD-1 antibodies in advanced melanoma (pembrolizumab/Keytruda and nivolumab/Opdivo) and lung cancer (nivolumab).

What about hematologic malignancies though?

At the recent American Society of Hematology (ASH) conference, we heard about the first clinical data for anti-PD1 antibodies in patients with refractory classic Hodgkins Lymphomas (cHL) and saw some impressive results. Interestingly, though, the early preclinical work was conducted in mice looking at CTLA4 blockade in a variety of tumours, both solid and liquid.

YervoyIs there a rationale for targeting CTLA4 in leukemias, lymphomas and even myeloma?  New data presented at a medical meeting in patients with heavily pre-treated and relapsed disease post stem cell transplantation suggests that this might be feasible.

Check out to today’s article to learn more about this clinical opportunity in more detail – you can log in or subscribe in the box below.

It remains exciting times in cancer immunotherapy with breakthrough new cell therapies and checkpoint inhibitors that enhance the effectiveness of T cells.

Cellectis LogoLast Friday, Paris based Cellectis filed their IPO registration statement with the Securities and Exchange Commission (Link to F-1).

They plan to raise $115M through an offering of American Depository Shares. You can read more about their allogeneic Chimeric Antigen Receptor (CAR) T cell approach in the two interviews we did with senior management last year.

Here’s an excerpt of the interview Cellectis CEO André Choulika, PhD gave Biotech Strategy Blog last year – it was the No1 post in 2014: Can Cellectis Revolutionize CAR-T cell Immunotherapy?

As multiple companies seek to move CAR-T cell therapies forward in clinical trials, what will be interesting to see is how this novel treatment fits in with existing therapies such as bone marrow transplants. Will it replace them, or be a bridge to a transplant that enables relapsed or refractory patients to have a second chance?

In addition, where are the potential opportunities beyond B-cell malignancies such as acute lymphoid leukemia (ALL) where there’s been dramatic success, particularly in children?

Dr Krishna KomanduriLast week Biotech Strategy Blog had the privilege to interview Dr Krishna Komanduri who is Director of the Adult Stem Cell Transplant Program at the University of Miami Sylvester Cancer Center and holds the Kalish Family Chair in Stem Cell Transplantation.

A physician scientist, he exudes a sense of calm professionalism – I am sure this must reassure many of his patients. Having a bone marrow transplant has been likened to jumping off a cliff in terms of what it does to one’s immune system.

In the last 2-3 years, he has dramatically increased the number of transplants at the University of Miami Sylvester Cancer Center.

Dr Komanduri (@DrKomanduri) was co-chair of the 2015 BMT Tandem meeting that took place earlier this month in San Diego. It’s the combined annual meeting of the American Society of Blood and Marrow Transplantation (ASMBT) and the Center for International Blood and Marrow Transplant Research (CIBMTR).

In a half hour interview he shared his thoughts on what was exciting at Tandem, where the field is going and some of the best abstracts at the meeting which included data on CAR-T cell therapy, GVHD and gene therapy.

Subscribers can login to read more of the interview or you can purchase access below.

PLA General HospitalThe announcement earlier this week that Cellular Biomedicine Group (NASDAQ: CBMG) has acquired rights to the Chimeric Antigen Receptor T cell (CAR-T) therapy of the PLA General Hospital in Beijing (pictured right) should come as no surprise to industry watchers. (Link to Press Release).

The share price in $CBMG has risen from $16.31 on February 4 to $23.60 as of close of business on Feb 10, 2015 in what looks like a poorly kept secret!  It looks like most of the rise in share price took place immediately prior to the company’s formal Feb 9, 2015 announcement of the Chinese deal.

CBMG Share Price


Those following the cancer immunotherapy space have known for some time that several Chinese groups are working on CAR-T cell therapies that could be a threat if licensed or acquired.

Given the significant investor interest in this space, which is almost bordering on “tulip mania,” it’s entirely foreseeable that companies looking to share in this opportunity would go looking towards China.

One investor on Twitter in response to this news asked should Chinese data be trusted?

Subscribers can login below to read more or you can purchase access.

San Francisco – “Manic Monday” is what I call Monday at the annual meeting of the American Society of Hematology. It’s when the majority of oral presentations take place in multiple parallel sessions that require you to run between meeting rooms if you want to follow a particular drug across different blood cancers.

It’s even more challenging this year by the fact the conference is in three buildings at the Moscone Center in San Francisco. While Moscone North and South are interconnected thanks to an underground atrium, to get to sessions in Moscone West from North/South you have to go out of the building, cross one or two main roads, then go up elevators to the second or third floors. Not ideal! I think ASH is now too big for the venue.

Looking back on yesterday, it was a privilege to be in the audience when Dr Kanti Rai received a well-deserved lifetime achievement award for his work in chronic lymphocytic leukemia (CLL). A visibily moved Dr Rai was given a standing ovation by the thousands present in the plenary hall.

Dr Kanti Rai ASH14 LIfetime Achievement Award

Expect the #ASH14 Twitter stream today to be like opening the tap to run a bath. I congratulate all the hematology experts who have shared data and commentary from sessions via social media. #ASH14 stands out in terms of expert engagement and a high signal to noise ratio.

If there was an award for best conference coverage of #ASH14 on Twitter I would nominate @drmiguelperales.

Not only does Dr Perales from Sloan-Kettering share tweets from the sessions that he is in that are accurate and informative, but he frequently offers links to relevant papers for those that want to learn more. In addition to showcasing his expertise, this is a really good way to use social media to educate and inform. I look forward to his commentary, particularly if I am in another session at ASH. A must follow on Twitter!

To the extent possible we’ll be providing updates to today’s live blog throughout the date, subscribers can login to read more or you can purchase access by clicking on the blue icon at the end.

San Francisco – it’s day 2 of the annual meeting of the American Society of Hematology. Yesterday, data was presented to the media on “Directing the Immune System to Attack Hard-to-Treat Blood Cancers.”

ASH 2014 San Francisco Media Briefing

The press briefing included four presentations on some the latest developments in blood cancer immunotherapy:

  • Phase 1 trial of nivolumab in classical Hodgkin Lymphoma (cHL) – Abstract 289.
  • Phase 1 trial of pembrolizumab in classical Hodgkin Lymphoma (cHL) – Abstract 290.
  • Phase 2 trial of blinatumomab in acute Lymphoblastic Leukemia (ALL) – Abstract 379
  • Phase 2 trial of CTL019 CAR-T therapy in children with acute lymphoblastic leukemia (ALL) – Abstract 380

Delegates to the meeting will hear the above abstracts presented in oral sessions tomorrow. However the media heard the results yesterday which led to stories being published about data that “researchers reported on Saturday” and described the “results presented at the American Society of Hematology,” not the results to be presented!

We also saw the publication of two New England Journal of Medicine papers to coincide with the presentations to the media yesterday.

The New England Journal published the nivolumab data in cHL. BMS seem to have a talent for obtaining publication of early PD-1 clinical trial data in the NEJM to coincide with meeting presentations.

Irrespective of when data is presented at ASH or how it is shared, data on its own is meaningless without context and interpretation. The majority of our conference coverage will be after we have heard the full presentations of data, talked to experts and can do in-depth pieces.

However, on our daily live blog (or as live as we can make it) we will be sharing rolling insights from the sessions we are in and top line thoughts on what captures our attention.

Today, for those of you looking for a photo with our antibuddies (@gene_antibody), they are having a photo opportunity – do check it out, they will be at the Genentech booth 1909 from 12 -1.30.

What Genentech are doing is fun and educational – but do remember to brush up on your antibody structures before asking for a photo, you wouldn’t want the embarrassment of not knowing which was which would you?

Subscribers can login to read more or you can purchase access by clicking on the blue icon at the end of the piece.

Coit Tower San FranciscoThe 2014 American Society of Hematology (ASH) annual meeting starts later this week in San Francisco. #ASH14 is a “must attend” given the innovation that has taken place in recent years for new treatments of blood related cancers.

One of the highlights of last year’s ASH was the data for CTL019 Chimeric Antigen Receptor CAR-T in children with acute lymphoblastic leukemia (ALL) presented by Stephan Grupp (CHOP). The data, in the opinion of many, was worthy of presentation in the plenary session of the meeting.

CAR-T cell therapy remains in the news, with the recent announcement that Seattle based Juno Therapeutics have an initial public offering (IPO) planned, and last week Kite Pharmaceuticals announced a secondary offering to raise additional funds. Last month, Houston based Bellicum Pharmaceuticals also filed an IPO to raise funds for development of their GvHD and CAR-T therapies.

It already looks a highly competitive marketplace and nobody is yet in phase 3 development. In addition to Juno, Kite, Novartis/UPenn and Bellicum, the Chinese also have CAR-T therapies in development. Other companies in the field include Cellectis, who have partnerships with Servier and Pfizer. On top of all this activity, only a week ago Janssen announced they had partnered with Transposagen Biopharmaceuticals. Wow!

In addition to ALL, CLL, and NHL, new developments are starting to emerge in myeloma, not just with CAR T cell therapies, but also checkpoint inhibitors and modified measles virus therapy.

Investor interest in immuno-oncology is certainly very high, and one has to question whether it is beginning to border on “tulip mania”? As we’ve written about on the blog, there remain a number of challenges that have to be overcome with CAR-T therapy, particularly in adults, and at the moment it’s still very much an experimental therapy.

In this post, we offer some top line thoughts on what to expect and look out for at ASH14 in Multiple Myeloma. It is consistently an area that attracts a lot of interest at the meeting and this year promises not to disappoint.

If you have to plans to be in San Francisco, do say “hello.”

Subscribers can login to read more or you can purchase access by clicking on the blue icon at the end of the post.

error: Content is protected !!