I coated Actinium (ATNM) in July after which once more in December. In July, I mentioned that whereas Actinium produced very sturdy information greater than a decade in the past, its path to approval has been glacially sluggish. In December, I mentioned some information from SIERRA, which they introduced at ASH. SIERRA is to announce topline information in Q3 2022, which is mostly a pivotal occasion for this firm.
Actinium is working a pivotal part 3 trial for its lead candidate Iomab-B (CD45) (apamistamab-I-131) in sufferers aged 55 and above with relapsed or refractory acute myeloid leukemia (AML). The corporate develops Antibody Radiation-Conjugates, or ARCS, which is a mixture of an antibody that latches on to most cancers cells, and a radiation-emitting molecule which then kills the cell. The concept is cute, and there have been a minimum of two different merchandise following the identical precept. Nevertheless, these haven’t been very profitable due to a wide range of causes, a few of that are mentioned on this previous article. One other report tells us how regardless of confirmed efficacy and security, these medicine did not develop into business successes:
Two anti-CD-20 radioantibody therapies: Y-90 ibritumomab tiuxetan (Zevalin) and I-131 tositutumomab (Bexxar) have been accredited within the USA within the early 2000s. The security and efficacy of each Bexxar and Zevalin have been confirmed relative to rituximab. Whereas Zevalin stays in the marketplace, gross sales are reportedly low. Bexxar exited the market in 2014 after low gross sales. Bexxar value $26K USD, ‘very costly’ by early twenty first century requirements, however low in comparison with most cancers therapies in 2016. The challenges with Bexxar within the USA market occurred at a time when personal observe oncologists obtained the vast majority of their compensation from the mark up of drug costs between the wholesale and retail costs. Oncologists may prescribe rituximab at an infusion heart, being profitable on each affected person they handled. Prescribing radioimmunotherapy meant they might lose that income stream. As well as, there have been logistical points with radiopharmaceutical remedy, notably Bexxar, which had customized dosimetry and challenges associated to make use of I-131 as an inpatient in lots of locales. Different points included US Medicare paying lower than the price of the dosimetric or therapeutic agent and a logistical association which paid not one of the suppliers a lot for his or her time. Each Bexxar and Zevalin have suffered from having a number of business homeowners of the important thing expertise. Oncologists additionally had considerations of sufferers growing myelodysplastic syndromes, which might be deadly. In time, different therapies emerged, whereas the RIT have been primarily static of their applied sciences reminiscent of Bendamustine and idelalisib.
A trial evaluating 554 sufferers randomized to chemotherapy + rituximab or chemotherapy + Bexxar confirmed comparable outcomes. Bendamustine + ritiuximab seems to be much more efficient. Zevalin stays obtainable, in addition to I-131 rituximab in Australia, however each are ‘underutilized’ relative to their efficacy. Classes from these brokers ought to serve to tell and warning the theranostics neighborhood. Theranostic brokers have to ‘work’ within the illness and ‘work’ within the market to succeed.
The important thing distinction between these therapies and ATNM’s iomab-B is that it’s given in a hospital setting, beneath the care of the treating doctor, so the commercialisation downside doesn’t exist. The important thing downside is that regardless of being on the cusp of approval for over 5 years now, it’s taking increasingly time. The corporate began the pivotal SIERRA trial in June 2016, and it was speculated to have been accomplished by 2018:
In line with ClinicalTrials.gov, the estimated last information assortment date for the first endpoint, sturdy full remission six months following HSCT, is April 2018.
Inside a yr after beginning the trial, nonetheless, and inside 3 months of saying very constructive information from the EMA which mentioned the SIERRA trial can be sufficient for approval, each the CEO and CTO left the corporate, causes undisclosed. The CEO appears by no means to have gone again to the trade. The corporate additionally had a product known as Actimab-A, which has now taken a backseat. In the meantime, interim information from SIERRA was out by early 2019. One yr later, SIERRA was nonetheless producing “encouraging” information. In April of that yr, we heard that:
The corporate expects to train an advert hoc evaluation in Q2, which might make topline main endpoint information obtainable later in 2020.
But right here we’re in 2022, and we would not have TLD but. In the meantime, the corporate has continued with dilution after dilution, together with a 30:1 reverse break up to save lots of the inventory. Later in 2020, they once more got here out with “interim” information – for such a small trial, enrollment appears to be an enormous hurdle. They’re absolutely enrolled as of September final, although – so perhaps we are going to lastly see the tip to this saga of delay.
ATNM in the present day has a market cap of $111mn and a money reserve of $82mn as of September 30, 2021 – no latest information appears to be obtainable. I haven’t got latest information for his or her bills, nonetheless, as I famous in an earlier article, they appear to be spending roughly $10mn per quarter, so that offers them a reasonably respectable runway with this low money reserve. However, $82mn for such a late-stage firm is messy and doesn’t evoke confidence.
In my earlier article, I used to be bullish on the corporate, though I did not really purchase shares, which appears fortunate looking back as a result of the inventory is down 30%. I do like the concept of a radiation emitter at a mobile degree latching on to a most cancers cell and killing it softly. That is a grand concept, and it speaks to the poor state of recent biotech that such an concept couldn’t but be fructified and dropped at the market to heal most cancers sufferers.
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