On-Conversation with John McCamant
John McCamant is the editor of the leading investment newsletter Medical Technology Stock Letter. He has established an extensive network of contacts in the investment banking and venture capital communities. His expertise in the field of biotechnology investments is a subject of media interest, and as a result, he is frequently consulted and quoted by The Washington Post, Business Week, Reuter’s, and Worth. In addition, John has been featured on CNN and CNBC. He gave us his thoughts on last week’s release of the ASCO abstracts, and even a little free advice.
OBR: We’ve all heard that this is the first time that ASCO is releasing the abstract data to everyone at the same time. Did you and your team have to pull an all-nighter?
JM: Yes and no. We did spend a lot of time digging through abstracts. However, because we are based on the West coast, we had access at 6 p.m. our time, which meant we could both get a lot of work done and still manage to get some sleep. To be perfectly honest, we are quite pleased that ASCO has “seen the light” and changed their policy to reflect the real world of clinical trial results disclosure. By real world, what we mean is that if nothing else, it is now being acknowledged that ASCO data does affect/move stock prices. In the past, this policy has disproportionately affected the smaller biotechs. The bottom line is that ASCO has a responsibility to disseminate information evenly and fairly, and the changes they made to their policy for this year represents a solid step in that direction.
The new policy makes very good sense, but does beg one question. What was ASCO waiting for? In the past, the abstract books were mailed ahead of the actual conference to ASCO members only. As a result, the accompanying clinical trial data was only available to a select few and individual stocks often began to move. The majority of investors were in the dark as to how this was happening as the information was not yet public. With the new policy, everyone has access to the available information at the same time. All one has to do is look up the abstract on the Web.
OBR: The big news in the late-breakers and plenary session presentations is embargoed until the meeting. Did this year’s batch of abstract data warrant all this attention?
JM: As mentioned above, it was their outdated policy and the fact that no other medical conferences had the same policy that has attracted so much attention. As for the abstracts themselves, they appear to not have had a major effect on stock prices this year. I would guess that it has more to do with there not being a lot of critical or surprising data, and less to do with the playing field finally being leveled. Plenary sessions are chosen for their “juice appeal,” so they should represent some of the most influential/stock moving data. In addition, late breakers will have updated/new information in them that may also be influential. Furthermore, the abstract data is generally from December/January time frame, meaning that many will have updated data at ASCO that is fresh.
OBR: Let’s dig into it, what is your take on some of the highlighted research data released last week. What companies are you focusing on for the upcoming annual ASCO meeting?
JM: We believe that Wall Street usually does a good job covering the bigger names in biotech. The following two companies are not as well covered by Wall Street and represent two of the more attractive investment opportunities within the oncology investment space:
Incyte (abstract #7004) showed data from a Phase 1/2 trial testing INCB18424 in 32 myelofibrosis (MF) patients and patients with post polycythemia veraessential thrombocytopenia myelofibrosis (Post-PV/ET MF) in which all patients were given 25 mg BID. The 25-mg dose was the starting and maximum tolerated dose (MTD)—an expanded cohort of 21 patients has also been enrolled at the MTD. All of these patients have been on drug for at least one month. Two patients had grade 4 thrombocytopenia at 50 mg, which defined the dose-limiting toxicity. This is a normal response to a high dose, and not unlike that seen with other drugs that treat blood cancers. No other significant drug-related toxicities were observed. The key result was a significant and dramatic reduction in splenomegaly, with reductions of 53% at one month (in 24 patients), and 76% at three months (in 7 patients). In addition to improved constitutional symptoms, drug-related effects reduced the dependence on transfusions and resulted in a decrease of proinflammatory cytokines—the so called “cytokine storm” that lies at the core of MF patients’ symptoms. Investigators concluded: “Treatment with [INCB18424] results in unprecedented clinical activity in MF and post-PV/ET MF without significant toxicity.”
Final thoughts: The updated presentation at ASCO will have much more data, maybe as much as four additional months worth, which we believe will result in a strong ASCO for Incyte. The data should serve to stimulate Wall Street’s interest as the company positions INCB18424 for the upcoming pivotal trials.
GenVec’s data from a Phase 1 dose escalation study of TNFerade (abstract #6067) in conjunction with chemoradiotherapy in patients with recurrent head and neck cancer (HNC) are going to be presented at this year’s ASCO meeting. In this trial, eligible patients have locoregionally recurrent, previously-radiated HNC and performance status 0-2. Patients are receiving 5 days of daily radiation along with continuous infusion of the chemotherapy agents fluorouracil (once daily for 5 days) and hydroxyurea (twice daily). (This combination chemo regimen is referred to as FHX.) Additionally, TNFerade is being administered to patients in escalating doses ranging from 4x109 to 4x1011 PU on day 2 of each cycle by direct intramural injection. Three to six patients are entered on each cohort, and treatment cycles are repeated every other week. At the time of the abstract submission, 10 patients (total) had been entered on three dose levels. Dose level 1 was expanded to 6 patients following observation of possibly related dose-limiting toxicity in one of the patients. Subsequent to this, no dose-limiting toxicity was observed, and patients are currently entered on dose level 3. Overall, the toxicities which have been observed in the trial, such as grade 3 mucositis and dermatitis, are not suggestive of an interaction between TNFerade and FHX. Once the MTD has been defined, the dose of radiation will be escalated.
The bottom line at the time of the abstract submission is that it appears as if TNFerade can be added to concomitant FHX-based chemoradiotherapy in the HNC patient population. This is important, because new treatment options are certainly needed. The simple fact is that the prognosis for patients with locoregionally recurrent HNC remains poor, and a high percentage of these patients that are re-irradiated with concomitant chemotherapy end up experiencing disease recurrence. Of course, TNFerade will not only have to show that it can merely be added to chemoradiotherapy. It will have to show that it offers the potential for improved treatment outcomes. To this end, in addition to updated toxicity data from this trial, early efficacy data from the trial are also going to be presented at ASCO.
Final thoughts: We believe that additional efficacy data in the HNC treatment setting will provide further validation of the already impressive results that TNFerade has produced in the pancreatic cancer treatment setting (its lead indication), and could provide a catalyst for GenVec’s stock.
OBR: We’ve all heard that this is the first time that ASCO is releasing the abstract data to everyone at the same time. Did you and your team have to pull an all-nighter?
JM: Yes and no. We did spend a lot of time digging through abstracts. However, because we are based on the West coast, we had access at 6 p.m. our time, which meant we could both get a lot of work done and still manage to get some sleep. To be perfectly honest, we are quite pleased that ASCO has “seen the light” and changed their policy to reflect the real world of clinical trial results disclosure. By real world, what we mean is that if nothing else, it is now being acknowledged that ASCO data does affect/move stock prices. In the past, this policy has disproportionately affected the smaller biotechs. The bottom line is that ASCO has a responsibility to disseminate information evenly and fairly, and the changes they made to their policy for this year represents a solid step in that direction.
The new policy makes very good sense, but does beg one question. What was ASCO waiting for? In the past, the abstract books were mailed ahead of the actual conference to ASCO members only. As a result, the accompanying clinical trial data was only available to a select few and individual stocks often began to move. The majority of investors were in the dark as to how this was happening as the information was not yet public. With the new policy, everyone has access to the available information at the same time. All one has to do is look up the abstract on the Web.
OBR: The big news in the late-breakers and plenary session presentations is embargoed until the meeting. Did this year’s batch of abstract data warrant all this attention?
JM: As mentioned above, it was their outdated policy and the fact that no other medical conferences had the same policy that has attracted so much attention. As for the abstracts themselves, they appear to not have had a major effect on stock prices this year. I would guess that it has more to do with there not being a lot of critical or surprising data, and less to do with the playing field finally being leveled. Plenary sessions are chosen for their “juice appeal,” so they should represent some of the most influential/stock moving data. In addition, late breakers will have updated/new information in them that may also be influential. Furthermore, the abstract data is generally from December/January time frame, meaning that many will have updated data at ASCO that is fresh.
OBR: Let’s dig into it, what is your take on some of the highlighted research data released last week. What companies are you focusing on for the upcoming annual ASCO meeting?
JM: We believe that Wall Street usually does a good job covering the bigger names in biotech. The following two companies are not as well covered by Wall Street and represent two of the more attractive investment opportunities within the oncology investment space:
Incyte (abstract #7004) showed data from a Phase 1/2 trial testing INCB18424 in 32 myelofibrosis (MF) patients and patients with post polycythemia veraessential thrombocytopenia myelofibrosis (Post-PV/ET MF) in which all patients were given 25 mg BID. The 25-mg dose was the starting and maximum tolerated dose (MTD)—an expanded cohort of 21 patients has also been enrolled at the MTD. All of these patients have been on drug for at least one month. Two patients had grade 4 thrombocytopenia at 50 mg, which defined the dose-limiting toxicity. This is a normal response to a high dose, and not unlike that seen with other drugs that treat blood cancers. No other significant drug-related toxicities were observed. The key result was a significant and dramatic reduction in splenomegaly, with reductions of 53% at one month (in 24 patients), and 76% at three months (in 7 patients). In addition to improved constitutional symptoms, drug-related effects reduced the dependence on transfusions and resulted in a decrease of proinflammatory cytokines—the so called “cytokine storm” that lies at the core of MF patients’ symptoms. Investigators concluded: “Treatment with [INCB18424] results in unprecedented clinical activity in MF and post-PV/ET MF without significant toxicity.”
Final thoughts: The updated presentation at ASCO will have much more data, maybe as much as four additional months worth, which we believe will result in a strong ASCO for Incyte. The data should serve to stimulate Wall Street’s interest as the company positions INCB18424 for the upcoming pivotal trials.
GenVec’s data from a Phase 1 dose escalation study of TNFerade (abstract #6067) in conjunction with chemoradiotherapy in patients with recurrent head and neck cancer (HNC) are going to be presented at this year’s ASCO meeting. In this trial, eligible patients have locoregionally recurrent, previously-radiated HNC and performance status 0-2. Patients are receiving 5 days of daily radiation along with continuous infusion of the chemotherapy agents fluorouracil (once daily for 5 days) and hydroxyurea (twice daily). (This combination chemo regimen is referred to as FHX.) Additionally, TNFerade is being administered to patients in escalating doses ranging from 4x109 to 4x1011 PU on day 2 of each cycle by direct intramural injection. Three to six patients are entered on each cohort, and treatment cycles are repeated every other week. At the time of the abstract submission, 10 patients (total) had been entered on three dose levels. Dose level 1 was expanded to 6 patients following observation of possibly related dose-limiting toxicity in one of the patients. Subsequent to this, no dose-limiting toxicity was observed, and patients are currently entered on dose level 3. Overall, the toxicities which have been observed in the trial, such as grade 3 mucositis and dermatitis, are not suggestive of an interaction between TNFerade and FHX. Once the MTD has been defined, the dose of radiation will be escalated.
The bottom line at the time of the abstract submission is that it appears as if TNFerade can be added to concomitant FHX-based chemoradiotherapy in the HNC patient population. This is important, because new treatment options are certainly needed. The simple fact is that the prognosis for patients with locoregionally recurrent HNC remains poor, and a high percentage of these patients that are re-irradiated with concomitant chemotherapy end up experiencing disease recurrence. Of course, TNFerade will not only have to show that it can merely be added to chemoradiotherapy. It will have to show that it offers the potential for improved treatment outcomes. To this end, in addition to updated toxicity data from this trial, early efficacy data from the trial are also going to be presented at ASCO.
Final thoughts: We believe that additional efficacy data in the HNC treatment setting will provide further validation of the already impressive results that TNFerade has produced in the pancreatic cancer treatment setting (its lead indication), and could provide a catalyst for GenVec’s stock.
posted by Don Sharpe - www.oncbiz.com at
10:18 AM
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