Yesterday kicked off the start of the 2014 JPMorgan Healthcare Conference, which is arguably the most important health-care conference of the year, bringing together pharmaceutical, biotechnology, and medical device makers all under one roof.
Just like the recently concluded Consumer Electronics Show in Las Vegas, Nev., this annual event gives health care companies a chance to demonstrate to investors and Wall Street where they've been and where they're headed next. Because earnings guidance can be somewhat irrelevant for clinical-stage biotech and medical device companies, consider this event your chance to gain guidance from some 300 top health-care companies.
Today, we're going to take a closer look at ImmunoGen's (NASDAQ:IMGN) presentation, which was given yesterday by President & CEO Daniel Junius.
Some background on ImmunoGen's past year
Last year brought its fair share of ups and downs for ImmunoGen.
The company, which bases most of its pipeline on its proprietary Targeted Antibody Payload, or TAP, technology, received its first drug approval (Kadcyla) from the Food and Drug Administration in February as a treatment for HER2-positive breast cancer. Kadcyla utilizes ImmunoGen's TAP technology to attach a chemotherapy agent (in this case Roche's (OTC:RHHBY) Herceptin) onto an antibody, releasing its toxin when it comes into contact with a signature protein found in targeted cancer cells. The result is a more potent dose of chemotherapy to targeted cancer cells and less healthy cell death, and a 5.8 month increase in median overall survival to 30.9 months in trials.
Conversely, ImmunoGen was clobbered in early November after it announced the discontinuation of a mid-stage study of IMGN901 for small-cell lung cancer. IMGN901 was the company's most advanced wholly owned compound at the time, so its ineffectiveness, based on the recommendation of the trial's independent data monitoring committee, was a big disappointment.
Now that we have a better understanding of where ImmunoGen's been, let's have a closer look at some of the most important takeaways of where it's headed next according to its CEO.
What ImmunoGen had to say
CEO Daniel Junius' presentation really hit home on the finer points of how ImmunoGen's technology works, including mentions of newer linking technologies that aid in the attaching of toxin and the location and destruction of target cancer cells, and discussed the company's three wholly owned clinical compounds (the fate of IMGN901 is still yet to be determined).
Before we take a closer look at Junius' commentary on its developing compounds, let me mention that he did note we can expect to have data from the Marianne trial of Kadcyla as a first-line treatment for metastatic HER2-positive breast cancer in the second-half of the year. Kadcyla is also being advanced as a potential treatment for gastric cancer, but it seems data on its efficacy will not be available in 2014.
The real focus of Junius' presentation, though, was ImmunoGen's three in-house compounds: IMGN853, IMGN289, and IMGN529.
IMGN853 is a folate receptor alpha that's targeting ovarian, endometrial, and adenocarcinoma non-small cell lung cancers. Unlike the other two compounds, the antibody involved with IMGN853 is merely used in targeting (i.e., non-active) purposes -- but it does sport a new toxin-linking technology. Junius notes that ImmunoGen has reached the maximum tolerated dosage (MTD) in its studies of IMGN853, but was presented with a unique challenge in that a patient's weight completely changed the dosage needed. ImmunoGen is currently in the process of perfecting its dosing strategy, while mixing up its dosing schedule and trying a once-weekly dosing of the drug. Junius said that data from these trials should be available sometime this year.
IMGN289 is also indicated for solid tumors such as head and neck cancers, as well as non-small cell lung cancer. It's an antibody-drug conjugate, or ADC, that targets epidermal growth factor receptors, or EGFRs, and it features an active antibody that plays a role beyond just targeting the cancer cell. The concern with EGFR-targeting therapies is that patients eventually develop a resistance to these therapies, thus the need for a new pathway to destroy these solid EGFR-expressing tumors. Initial studies have demonstrated that as an ADC, IMGN289 showed "significantly more activity" than either its naked antibody experiment (i.e., one without a linked toxin) or Eli Lilly (NYSE:LLY) and Bristol-Myers Squibb's (NYSE:BMY) Erbitux. Junius noted that dosing had recently begun on IMGN289, so trial data would be expected later this year.
Finally, there's IMGN529, a CD37-targeting active antibody-drug conjugate that's geared at treating late-stage non-Hodgkin lymphoma. Junius points out that the linker used in IMGN529 is identical to that of Kadcyla, so obviously there's a lot of working knowledge and success with this ADC technology. In preclinical models, turning IMGN529 into an ADC as opposed to a naked antibody improved potency beyond that of Roche and Biogen Idec's (NASDAQ:BIIB) Rituxan, according to Junius. ImmunoGen is currently in the dose-finding phase and has yet to reach MTD for IMGN529.
I'd be remiss if I didn't also note that Junius briefly discussed the company's partnership with Biotest with regard to BT-062, a non-active antibody that utilizes ImmunoGen's ADC technology in combination with Celgene's (NASDAQ:CELG) Revlimid and dexamethasone to treat late-stage multiple myeloma. The early data demonstrated that 100% of evaluable patients had stable disease or better, including those who were refractory to the combination of Revlimid and dexamethasone. At the MTD, the overall response rate was an astonishing 89%. Junius commented that Biotest is beginning to look at solid tumor applications of BT-062 as well.
Making sense of it all
On the bright side, I'm very pleased to see ImmunoGen advancing and attempting to improve its linking technology. The advantage ADCs have over commonly prescribed chemotherapies is their unique ability to deliver more potent doses of toxin directly to cancer cells. This advantage is what has allowed ImmunoGen to set up its seven current partnerships and 20 separate compounds in its pipeline.
The data from ImmunoGen's wholly owned line of compounds is encouraging, but it's admittedly a bit too early to get enthralled with. Once MTDs have been reached and data reported on all three I'll be able to change my tune in one direction or the other.
I was a bit disappointed that ImmunoGen didn't make much mention of Kadcyla other than the generalizations that they're rolling it out overseas and that we should have data on first-line indications in the second-half of this year. I was really expecting ImmunoGen to dish out at least some sort of sales projections for the drug, or at least an estimate of how well it was performing heading into the next reportable quarter.
All in all, though, no big surprises. ImmunoGen continues to be a solid watchlist company for me for two primary reasons.
First, its technology platform is unique and, through the approval of Kadcyla, proven to work. This means that it's in the perfect position to command royalties and upfront cash via partnerships to fuel ongoing research. Cash burn isn't much of a concern for ImmunoGen.
And secondly, ImmunoGen is giving investors close to two dozen chances to hit a home run. As an investor I really prefer a deep pipeline, and ImmunoGen's 20 compounds give the company a chance to swing for the fences quite a few times. If one trial fails to produce the desired results it can easily be outdone by one of 19 other trials.