Parteto top idea for September
BioInvent – Buy, TP 134
On the basis of positive clinical trial readouts from BI-1206 and BI-1808, the stock saw a strong increase in the past months which turned
the day of the Q2 report (29 August) into a profit-taking event with a retraction of around 9% - the report included no new material
information.
For September, we expect 2-3 further catalysts which include:
(i) safety and efficacy data of BT-001 in combination with Keytruda in solid tumors
(ii) first initial safety and PK/PD data of BI-1910 (the first-in-class TNFR-2 agonist) as a single-agent in solid tumours, and possibly
(iii) a surprise with additional single-agent data of BI-1808 in solid tumors.
We see this as a possibility as BI-1808 has surprised the company with strong early results earlier this year that led to an earlier than-communicated release. Consequently, BioInvent might continue to release positive data as it comes in instead of waiting until end of year – where we would expect either way
additional data.
As a reminder, we see single-agent data from an immuno-oncology drug in solid tumors as key to render it a potential multibillion-dollar
drug. Further, it is also the kind of data that leads to large pharma deals, which we would expect to be triggered by additional responses
of BI-1808 as a single agent. To put BI-1808’s very early and still maturing data (1 CR, 1 PR that is still improving, 1 responding patient
that had to be excluded from the trial due to second tumor and 9 patients that saw their tumor stabilize – out of a total of 26 patients)
reported in May into context: The first clinical data of the USD >20 bn/year selling drug Key
On the basis of positive clinical trial readouts from BI-1206 and BI-1808, the stock saw a strong increase in the past months which turned
the day of the Q2 report (29 August) into a profit-taking event with a retraction of around 9% - the report included no new material
information.
For September, we expect 2-3 further catalysts which include:
(i) safety and efficacy data of BT-001 in combination with Keytruda in solid tumors
(ii) first initial safety and PK/PD data of BI-1910 (the first-in-class TNFR-2 agonist) as a single-agent in solid tumours, and possibly
(iii) a surprise with additional single-agent data of BI-1808 in solid tumors.
We see this as a possibility as BI-1808 has surprised the company with strong early results earlier this year that led to an earlier than-communicated release. Consequently, BioInvent might continue to release positive data as it comes in instead of waiting until end of year – where we would expect either way
additional data.
As a reminder, we see single-agent data from an immuno-oncology drug in solid tumors as key to render it a potential multibillion-dollar
drug. Further, it is also the kind of data that leads to large pharma deals, which we would expect to be triggered by additional responses
of BI-1808 as a single agent. To put BI-1808’s very early and still maturing data (1 CR, 1 PR that is still improving, 1 responding patient
that had to be excluded from the trial due to second tumor and 9 patients that saw their tumor stabilize – out of a total of 26 patients)
reported in May into context: The first clinical data of the USD >20 bn/year selling drug Key
NordicGuy
03.09.2024 kl 13:26
4978
Spoke to an analyst. The 1808 update could be as early as early October. If there is a positive readout, he believes there will be a partner by the end of they year for 1808.
That means share price up significantly.
That means share price up significantly.
NordicGuy
09.09.2024 kl 11:22
4557
I spoke to an analyst. He believes that 1808 is the most likely partnering candidate. Such transaction should have very material value for Bioinvent. He talked about 100s millions of USD. The readout today is very positive. See Redeye note:
BioInvent has published its first results from the single-agent part of the phase IIa study of BI-1808. Although only four cutaneous T-cell lymphoma patients were evaluable, the result is highly encouraging, with a disease control rate of 100% and ORR of 75%. Three additional patients were considered non-evaluable. Even more encouraging is the fact that the three responders had had 9, 3 and 3 previous lines of treatment. Cutaneous T-cell lymphoma is a small underserved indication with a good possibility of accelerated approval. The figures presented today will almost certainly change as the number of evaluable patients increases. However, if similar numbers are presented at the final readout the next logical step would probably be a pivotal trial.
New results from BT-001 are also available, with more complete data to be presented at ESMO this week. Treatment with BT-001, in combination with pembrolizumab (Keytruda), led to an ORR of 33% in six evaluable patients who had received several lines of treatment. BT-001 as monotherapy had an ORR of 0% and disease control rate of 22% (n=18). At the same time, BT-001 was well-tolerated with no dose-limiting toxicities (DLTs) observed. The combination arm thus far is promising and clearly the way forward in this programme.
An abstract on BI-1910's phase I study was also published but the likely more informative poster will be published after the presentation at ESMO.
Overall, both readouts presented today are positive, though based on very small samples of just four and six patients. We are particularly encouraged by BI-1808, which we believe has the potential to become a lead asset (in our last update, we valued BI-1206 higher). In anticipation of the next readout (planned for late this year) from a larger number of patients, we increase the likelihood of approval of BI-1808 in CTCL to 19% (16%), which has no effect on our base case (SEK90) due to rounding.
BioInvent has published its first results from the single-agent part of the phase IIa study of BI-1808. Although only four cutaneous T-cell lymphoma patients were evaluable, the result is highly encouraging, with a disease control rate of 100% and ORR of 75%. Three additional patients were considered non-evaluable. Even more encouraging is the fact that the three responders had had 9, 3 and 3 previous lines of treatment. Cutaneous T-cell lymphoma is a small underserved indication with a good possibility of accelerated approval. The figures presented today will almost certainly change as the number of evaluable patients increases. However, if similar numbers are presented at the final readout the next logical step would probably be a pivotal trial.
New results from BT-001 are also available, with more complete data to be presented at ESMO this week. Treatment with BT-001, in combination with pembrolizumab (Keytruda), led to an ORR of 33% in six evaluable patients who had received several lines of treatment. BT-001 as monotherapy had an ORR of 0% and disease control rate of 22% (n=18). At the same time, BT-001 was well-tolerated with no dose-limiting toxicities (DLTs) observed. The combination arm thus far is promising and clearly the way forward in this programme.
An abstract on BI-1910's phase I study was also published but the likely more informative poster will be published after the presentation at ESMO.
Overall, both readouts presented today are positive, though based on very small samples of just four and six patients. We are particularly encouraged by BI-1808, which we believe has the potential to become a lead asset (in our last update, we valued BI-1206 higher). In anticipation of the next readout (planned for late this year) from a larger number of patients, we increase the likelihood of approval of BI-1808 in CTCL to 19% (16%), which has no effect on our base case (SEK90) due to rounding.
NordicGuy
11.09.2024 kl 11:26
4121
Just spoke to a professional investor on Bioinvent.
"I have not seen such strong data in cancer for a long time,"
"Bioinvent has a very strong board, a lot of cash and strong pharma investors"
"Bioinvent (share price) claim just started in my view"
"This drug will end in hands of a major pharma company soon."
I am very bullish on Bioinvent.
"I have not seen such strong data in cancer for a long time,"
"Bioinvent has a very strong board, a lot of cash and strong pharma investors"
"Bioinvent (share price) claim just started in my view"
"This drug will end in hands of a major pharma company soon."
I am very bullish on Bioinvent.
NordicGuy
11.09.2024 kl 16:22
3807
Do watch an interview with Bioinvetn CEO, on Redeye research.
Redeye is Free with registration
Redeye is Free with registration
NordicGuy
12.09.2024 kl 12:11
3378
Pareto on Bioinvent today:
First patient enrolled in BI-1206’s NHL triplet study
BioInvent just announced the enrollment of its first patient in the triple combination arm of the Phase 1/2a study for its anti-FcγRIIB antibody, BI-1206, in patients with non-Hodgkin's lymphoma (NHL). The phase 2a arm will evaluate the combination of subcutaneous BI-1206, rituximab, and acalabrutinib (Calquence), with around 30 patients from the US, Spain, Germany, and Brazil. Initial data of this trial is already expected by year-end, indicating the increasing pace that BioInvent is demonstrating across programs this year. Given the previous positive results from the BI-1206 + rituximab combination, we are optimistic that the triplet combination will provide further responses while highlighting BI-1206’s superior safety profile. Further, we expect additional adhoc data releases from BI-1808’s single-agent trial before end of the year. We reiterate our Buy rating on BINV, TP SEK 134.
First patient enrolled in BI-1206’s NHL triplet study
BioInvent just announced the enrollment of its first patient in the triple combination arm of the Phase 1/2a study for its anti-FcγRIIB antibody, BI-1206, in patients with non-Hodgkin's lymphoma (NHL). The phase 2a arm will evaluate the combination of subcutaneous BI-1206, rituximab, and acalabrutinib (Calquence), with around 30 patients from the US, Spain, Germany, and Brazil. Initial data of this trial is already expected by year-end, indicating the increasing pace that BioInvent is demonstrating across programs this year. Given the previous positive results from the BI-1206 + rituximab combination, we are optimistic that the triplet combination will provide further responses while highlighting BI-1206’s superior safety profile. Further, we expect additional adhoc data releases from BI-1808’s single-agent trial before end of the year. We reiterate our Buy rating on BINV, TP SEK 134.
NordicGuy
12.09.2024 kl 16:26
3032
Bioinvent Linkedin today:
This morning, we were glad to announce the enrollment of the first patient in triple combination arm of our anti-FcyRIIB antibody BI-1206, rituximab and Calquence® for the treatment of non-Hodgkin's lymphoma.
"The enrolment of the first patient in the study is an important milestone as we move forward to evaluate this triple combination as a potential new treatment option for patients with non-Hodgkin's lymphoma," said Martin Welschof, CEO of BioInvent. "The combination of BI-1206 and rituximab has already demonstrated promising signs of clinical efficacy with a favorable safety profile, and we have strong reasons to believe that the addition of acalabrutinib will increase response rates even further; the subcutaneous formulation of BI-1206 is expected to provide a great deal of flexibility and further improve the tolerability of the treatment."
The Phase 2a study arm will combine the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib), a selective inhibitor of Bruton's tyrosine kinase (BTK). Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. Preliminary data are expected by the end of 2024. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for this combination arm.
Read the press release:
https://lnkd.in/drWFjjKk
This morning, we were glad to announce the enrollment of the first patient in triple combination arm of our anti-FcyRIIB antibody BI-1206, rituximab and Calquence® for the treatment of non-Hodgkin's lymphoma.
"The enrolment of the first patient in the study is an important milestone as we move forward to evaluate this triple combination as a potential new treatment option for patients with non-Hodgkin's lymphoma," said Martin Welschof, CEO of BioInvent. "The combination of BI-1206 and rituximab has already demonstrated promising signs of clinical efficacy with a favorable safety profile, and we have strong reasons to believe that the addition of acalabrutinib will increase response rates even further; the subcutaneous formulation of BI-1206 is expected to provide a great deal of flexibility and further improve the tolerability of the treatment."
The Phase 2a study arm will combine the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib), a selective inhibitor of Bruton's tyrosine kinase (BTK). Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. Preliminary data are expected by the end of 2024. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for this combination arm.
Read the press release:
https://lnkd.in/drWFjjKk
NordicGuy
21.09.2024 kl 09:01
2335
Video interview with Dan Akschuti from last week Pareto Healthcare conference in Stockholm
Bioinvent is the number one pick from the conference
https://lnkd.in/gZNAzwC6
Bioinvent is the number one pick from the conference
https://lnkd.in/gZNAzwC6
NordicGuy
13.11.2024 kl 17:24
105
Beating 50 today! Do read some of the posts below. This is Pareto top idea for this year!