BGBIO: Dobling i boks- veien videre?
I dag har altså BGBIO i en fyldig melding (se videre) lagt fram data fra fase II-studien med bemcentinib (BGB 324) på et symposium i San Francisco med klare signaler om at dette er oppmuntrende/lovende. Richard Godfrey, konsernsjef i BerGenBio, sier for eksempel i en melding at han er utrolig oppmuntret av dataene som viser at bemcentinib kan generere en positiv immunrespons, særlig hos AML- og MDS-pasienter, som tenderer til å være en svært immunkompromittert pasientgruppe.
Kursen er foreløpig opp ca. 10-12% på dagens meldinger, slik at vi snakker om en dobling fra da aksjen bunnet ut på ca. 20. Og dermed børsens store vinner i år.
Q4 legges fram 13. febr., men akkurat nå er det jo de fremragende medisinske resultatene som står i fokus, og ikke det som mest trolig blir en forventet Q4, dvs. cash burn iht. plan, og testresultater iht. plan, med noen av prosjektene faktisk foran plan.
Kursen er foreløpig opp ca. 10-12% på dagens meldinger, slik at vi snakker om en dobling fra da aksjen bunnet ut på ca. 20. Og dermed børsens store vinner i år.
Q4 legges fram 13. febr., men akkurat nå er det jo de fremragende medisinske resultatene som står i fokus, og ikke det som mest trolig blir en forventet Q4, dvs. cash burn iht. plan, og testresultater iht. plan, med noen av prosjektene faktisk foran plan.
Redigert 20.01.2021 kl 17:47
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For å få en fundert mening om veien videre, er det viktig å lese og forstå dagens meldinger, som i utgangspunktet synes sterkere enn det faktisk var lov å håpe, jfr. særlig ytterligere bekreftelse på positiv immunrespons særlig hos AML- og MDS-pasienter (som tenderer til å være en svært immunkompromittert pasientgruppe). Utlagt: Dette betyr en rå utvidelse av tidligere market cap, noe markedet nå synes å begynne å registrere.
Her er en litt nedredigert versjon av den svært lange meldingen jeg la ut på den fulle parallelle tråden min:
BerGenBio: Encouraging I-O clinical data with selective AXL inhibitor bemcentinib (BGB324) supports its potential as cornerstone of cancer therapy BGBIO.OL
BerGenBio ASA* Favourable interim safety data reported across three phase II clinical trials with bemcentinib in combination with KEYTRUDA®(pembrolizumab)
* Immune response demonstrated in AML patients treated with bemcentinib monotherapy in phase II clinical trial
The data presented strengthens the Company’s proposition that its selective, first-in-class and orally bioavailable AXL inhibitor bemcentinib may hold promise as an immunomodulatory agent, both as backbone to current and emerging immune checkpoint inhibitor regimens as well as a monotherapy by demonstrating the following:
(1) Combining bemcentinib with KEYTRUDA has thus far been well tolerated: In a poster presentation entitled: “Combination of bemcentinib (BGB324) – a first-in-class selective, oral AXL inhibitor – with pembrolizumab in patients with triple negative breast cancer and adenocarcinoma of the lung,”
Murray Yule (MD, PhD), Clinical Development Officer at BerGenBio, detailed:
* A total of 34 patients across the Company’s three trials combining bemcentinib with KEYTRUDA (Trial ref. BGBC007 in triple-negative breast cancer, trial ref. BGBC008 in non-small cell lung cancer and trial ref. BGBIL006 in melanoma) have thus far been evaluable for safety of the drug combination
* The spectrum of observed serious adverse events was similar to that reported for KEYTRUDA alone.
(2) Treatment with bemcentinib has immunomodulatory effect:
In a poster presentation entitled: “The immunomodulatory activity of bemcentinib (BGB324) – a first-in-class selective, oral AXL inhibitor in patients with relapsed/refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome.”, Professor Sonja Loges (MD, PhD), attending physician at the University Hospital in Hamburg-Eppendorf and lead investigator of the BGBC003 trial, detailed the following:
* 35 patients with relapsed/refractory (R/R) AML or myelodysplastic syndrome (MDS) received bemcentinib monotherapy as part of the BGBC003 trial. Two patients achieved complete responses with incomplete recovery of peripheral counts (CRi) and five achieved partial responses (PR). Eight patients reported disease stabilization for more than four months. Three patients remain on study at the time of data cut-off (Jan 17th 2018).
* Six out of nine patients analyzed showed a diversification of the T-cell receptor repertoire in their peripheral blood, bone marrow or both indicative of increased immune activity as a result of AXL inhibition.
Richard Godfrey, CEO of BerGenBio commented: “I am pleased that the data presented at ASCO-SITC demonstrate that our first-in-class, selective AXL inhibitor bemcentinib is well tolerated in combination with the anti-PD-1 therapy KEYTRUDA. This is fundamental data supporting the positioning of AXL inhibition as a future cornerstone of cancer therapy. I am also extremely encouraged by the data reported showing that bemcentinib can generate a positive immune response, particularly in R/R AML and MDS patients who tend to be a severely immunocompromised patient population. These data build on the recently reported favourable safety data of bemcentinib in combination with chemo- and targeted therapy as well as the first evidence of bemcentinib’s ability to reverse acquired resistance to these treatments. I look forward to reporting continued progress across our broad phase II development programme with bemcentinib at medical and scientific congresses during the upcoming months.“
About TNBC and the BGBC007 trial
Breast cancer is the most common cancer in women – it is estimated that more than 250,000 new cases will be diagnosed in the US in 2018. 20% of breast cancers lack receptors for three common hormones (oestrogen, progesterone and HER2) and are thus called triple-negative breast cancers (TNBC).
Treatment options for TNBC are limited to intense chemotherapy, but disease recurrence is frequent and aggressive. Consequently, novel treatment strategies for TNB are urgently needed.
BGBC007 is a phase II multi-centre open label study of bemcentinib (BGB324) in combination with KEYTRUDA in patients with previously treated, non-resectable TNBC or triple negative inflammatory breast cancer. Up to 56 patients will be included in the study.
About NSCLC and the BGBC008 trial
It is estimated that more than 220,000 new cases of lung cancer will be diagnosed in the US in 2018 and it is the leading cause of cancer deaths. 65% of NSCLCs are classed as adenocarcinoma of the lung. Although various treatments exist for NSCLC, they are often curtailed by acquired resistance to therapy. Novel treatments overcoming this resistance in NSCLC are urgently required.
BGBC008 is a phase II multi-centre open label study of bemcentinib (BGB324) in combination with KEYTRUDA in patients with previously treated advanced adenocarcinoma of the lung. Up to 48 patients will be included in the study.
About melanoma and the BGBIL006 trial
Melanoma is the most serious type of skin cancer and may spread to lymph nodes and distant organs if not discovered in time. Melanoma occurs when the pigment cells in the skin (melanocytes), divide uncontrollably. It is estimated that in 2016, there were almost 150,000 melanoma diagnoses in the US alone. If detected very early, melanoma has a good prognosis; for patients with advanced melanoma, however, the probability of surviving five or more years is less than 20%.
BGBIL006 is an investigator initiated, randomised phase II trial combining bemcentinib with either KEYTRUDA or dabrafenib/trametinib in patients with advanced non-resectable or metastatic melanoma who are naïve for systemic treatment. Up to 92 patients will be enrolled across three arms.
About AML and the BGBC003 trial
AML is the most common form of acute leukaemia diagnosed in over 20,000 patients in the US annually and is rapidly lethal if left untreated. Successful treatment typically requires intensive therapy or bone marrow transplantation, and relapse and resistance are common. Consequently, there is an urgent need for effective novel therapies in R/R patients, particularly those that are ineligible for intensive therapy.
BGBC003 is a phase Ib/II multi-centre open label study of bemcentinib (BGB324) as a single agent in patients with AML or MDS or in a combination with chemotherapy (cytarabine and decitabine) in AML patients. Up to 75 patients will be enrolled at centres in the US, Norway, Germany and Italy.
About the 2018 ASCO-SITC Clinical Immuno-Oncology Symposium
The ASCO-SITC Clinical Immuno-Oncology Symposium is an international conference focused on clinical and translational research in immuno-oncology and the implications for clinical care.
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Her er en litt nedredigert versjon av den svært lange meldingen jeg la ut på den fulle parallelle tråden min:
BerGenBio: Encouraging I-O clinical data with selective AXL inhibitor bemcentinib (BGB324) supports its potential as cornerstone of cancer therapy BGBIO.OL
BerGenBio ASA* Favourable interim safety data reported across three phase II clinical trials with bemcentinib in combination with KEYTRUDA®(pembrolizumab)
* Immune response demonstrated in AML patients treated with bemcentinib monotherapy in phase II clinical trial
The data presented strengthens the Company’s proposition that its selective, first-in-class and orally bioavailable AXL inhibitor bemcentinib may hold promise as an immunomodulatory agent, both as backbone to current and emerging immune checkpoint inhibitor regimens as well as a monotherapy by demonstrating the following:
(1) Combining bemcentinib with KEYTRUDA has thus far been well tolerated: In a poster presentation entitled: “Combination of bemcentinib (BGB324) – a first-in-class selective, oral AXL inhibitor – with pembrolizumab in patients with triple negative breast cancer and adenocarcinoma of the lung,”
Murray Yule (MD, PhD), Clinical Development Officer at BerGenBio, detailed:
* A total of 34 patients across the Company’s three trials combining bemcentinib with KEYTRUDA (Trial ref. BGBC007 in triple-negative breast cancer, trial ref. BGBC008 in non-small cell lung cancer and trial ref. BGBIL006 in melanoma) have thus far been evaluable for safety of the drug combination
* The spectrum of observed serious adverse events was similar to that reported for KEYTRUDA alone.
(2) Treatment with bemcentinib has immunomodulatory effect:
In a poster presentation entitled: “The immunomodulatory activity of bemcentinib (BGB324) – a first-in-class selective, oral AXL inhibitor in patients with relapsed/refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome.”, Professor Sonja Loges (MD, PhD), attending physician at the University Hospital in Hamburg-Eppendorf and lead investigator of the BGBC003 trial, detailed the following:
* 35 patients with relapsed/refractory (R/R) AML or myelodysplastic syndrome (MDS) received bemcentinib monotherapy as part of the BGBC003 trial. Two patients achieved complete responses with incomplete recovery of peripheral counts (CRi) and five achieved partial responses (PR). Eight patients reported disease stabilization for more than four months. Three patients remain on study at the time of data cut-off (Jan 17th 2018).
* Six out of nine patients analyzed showed a diversification of the T-cell receptor repertoire in their peripheral blood, bone marrow or both indicative of increased immune activity as a result of AXL inhibition.
Richard Godfrey, CEO of BerGenBio commented: “I am pleased that the data presented at ASCO-SITC demonstrate that our first-in-class, selective AXL inhibitor bemcentinib is well tolerated in combination with the anti-PD-1 therapy KEYTRUDA. This is fundamental data supporting the positioning of AXL inhibition as a future cornerstone of cancer therapy. I am also extremely encouraged by the data reported showing that bemcentinib can generate a positive immune response, particularly in R/R AML and MDS patients who tend to be a severely immunocompromised patient population. These data build on the recently reported favourable safety data of bemcentinib in combination with chemo- and targeted therapy as well as the first evidence of bemcentinib’s ability to reverse acquired resistance to these treatments. I look forward to reporting continued progress across our broad phase II development programme with bemcentinib at medical and scientific congresses during the upcoming months.“
About TNBC and the BGBC007 trial
Breast cancer is the most common cancer in women – it is estimated that more than 250,000 new cases will be diagnosed in the US in 2018. 20% of breast cancers lack receptors for three common hormones (oestrogen, progesterone and HER2) and are thus called triple-negative breast cancers (TNBC).
Treatment options for TNBC are limited to intense chemotherapy, but disease recurrence is frequent and aggressive. Consequently, novel treatment strategies for TNB are urgently needed.
BGBC007 is a phase II multi-centre open label study of bemcentinib (BGB324) in combination with KEYTRUDA in patients with previously treated, non-resectable TNBC or triple negative inflammatory breast cancer. Up to 56 patients will be included in the study.
About NSCLC and the BGBC008 trial
It is estimated that more than 220,000 new cases of lung cancer will be diagnosed in the US in 2018 and it is the leading cause of cancer deaths. 65% of NSCLCs are classed as adenocarcinoma of the lung. Although various treatments exist for NSCLC, they are often curtailed by acquired resistance to therapy. Novel treatments overcoming this resistance in NSCLC are urgently required.
BGBC008 is a phase II multi-centre open label study of bemcentinib (BGB324) in combination with KEYTRUDA in patients with previously treated advanced adenocarcinoma of the lung. Up to 48 patients will be included in the study.
About melanoma and the BGBIL006 trial
Melanoma is the most serious type of skin cancer and may spread to lymph nodes and distant organs if not discovered in time. Melanoma occurs when the pigment cells in the skin (melanocytes), divide uncontrollably. It is estimated that in 2016, there were almost 150,000 melanoma diagnoses in the US alone. If detected very early, melanoma has a good prognosis; for patients with advanced melanoma, however, the probability of surviving five or more years is less than 20%.
BGBIL006 is an investigator initiated, randomised phase II trial combining bemcentinib with either KEYTRUDA or dabrafenib/trametinib in patients with advanced non-resectable or metastatic melanoma who are naïve for systemic treatment. Up to 92 patients will be enrolled across three arms.
About AML and the BGBC003 trial
AML is the most common form of acute leukaemia diagnosed in over 20,000 patients in the US annually and is rapidly lethal if left untreated. Successful treatment typically requires intensive therapy or bone marrow transplantation, and relapse and resistance are common. Consequently, there is an urgent need for effective novel therapies in R/R patients, particularly those that are ineligible for intensive therapy.
BGBC003 is a phase Ib/II multi-centre open label study of bemcentinib (BGB324) as a single agent in patients with AML or MDS or in a combination with chemotherapy (cytarabine and decitabine) in AML patients. Up to 75 patients will be enrolled at centres in the US, Norway, Germany and Italy.
About the 2018 ASCO-SITC Clinical Immuno-Oncology Symposium
The ASCO-SITC Clinical Immuno-Oncology Symposium is an international conference focused on clinical and translational research in immuno-oncology and the implications for clinical care.
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Gud bedre... Den idioten som mente at selskapet var for høyt priset og hadde alt av interesse laaaangt fram i tid. Det var ikke meg.
Grrrr!!!
Grrrr!!!
Hehe, jeg håper nå på en viss forståelse for at jeg i månedsvis har hevdet at BGBIO blir den neste farmaaksjen som leverer, og at det var der man burde sitte. For vi som gravde dypt nok i de 10 årene med forskning som lå bak fjorårets børsnotering (april 2017) så at her var et selskap som var kommet mye lengre enn de fleste. Det har hele tiden vært et spørsmål om tid.
YNWA250505
29.01.2018 kl 10:40
4956
Klart at når ledelsen sier de er fornøyde og har oppmuntrende resultater så lykkes de. Hadde det bare vært så lett. Når ledelsen i Nano sier det samme blir de latterliggjort av Korsar og hans likemenn. Håper Bergen Bio lykkes. Håper alle som forsker på dette lykkes. Fantastisk for de som trenger dette. Men de har ikke lykkes ennå så ikke pansett hus og kjæring.
Odeven
29.01.2018 kl 10:42
4956
Bare å gratulere med en fin melding og en hyggelig gevinst for de som sitte med BGB-papirer.
Skulle gjerne hatt noen selv, men dette papiret har jeg dessverre ikke i portefølgjen.
Lykke til videre.
Dette ser virkelig lovende ut.
O.
Skulle gjerne hatt noen selv, men dette papiret har jeg dessverre ikke i portefølgjen.
Lykke til videre.
Dette ser virkelig lovende ut.
O.
YNWA250505,
tror ikke du helt forstår hva aksjevurderinger er når du begynner å skylde NANOs misere på "Korsar og hans likemenn":
Hvis BGBIO hadde levert like elendig kommunikasjon med markedet og hatt de samme (selvpåførte) problemene som NANO stamper rundt i p.t., så hadde jeg kritisert BGBIO akkurat like mye for det som jeg har gjort for NANO.
Det er dette enøyde masteklamrere aldri synes å forstå: Man må respektere trend og holde seg med aksjer som er på rett vei - og stikke raskt når en aksje viser klare svakhetstegn :-)
tror ikke du helt forstår hva aksjevurderinger er når du begynner å skylde NANOs misere på "Korsar og hans likemenn":
Hvis BGBIO hadde levert like elendig kommunikasjon med markedet og hatt de samme (selvpåførte) problemene som NANO stamper rundt i p.t., så hadde jeg kritisert BGBIO akkurat like mye for det som jeg har gjort for NANO.
Det er dette enøyde masteklamrere aldri synes å forstå: Man må respektere trend og holde seg med aksjer som er på rett vei - og stikke raskt når en aksje viser klare svakhetstegn :-)
SafeInvest
29.01.2018 kl 14:07
4749
Gratulerer Korsar!
Du fikk det «premature rykket» ditt til slutt!;)
Du fikk det «premature rykket» ditt til slutt!;)
Ja, vi kan bare notere at BGBIO er tilbake på vinnersporet, og troner øverst av de seriøse aksjer på dagens vinnerliste.
I all beskjedenhet: Også her går analyse og virkelighet hånd i hånd :-)
I all beskjedenhet: Også her går analyse og virkelighet hånd i hånd :-)
Bullandbear
01.02.2018 kl 20:07
4231
BGBIO BERGENBIO ASA
BerGenBio: Promising first clinical data in immuno-oncology
BerGenBio has presented encouraging initial clinical data of bemcentinib (BGB324) as an immuno-oncology agent at the ASCO-SITC Immuno-Oncology Symposium. Bemcentinib (first-in-class specific oral Axl inhibitor) was well tolerated in combination with Merck’s pembrolizumab (Keytruda) in patients treated to date from three different Phase II trials. Also, there is clinical evidence that bemcentinib enhances immune activity. Our base case valuation is unchanged at NOK31.34/share, but increases to NOK50.46/share when we take into account the broader potential of bemcentinib in immuno-oncology.
https://www.researchpool.com/provider/trinity-delta/bergenbio-promising-first-clinical-data-in-immuno-oncology
BerGenBio: Promising first clinical data in immuno-oncology
BerGenBio has presented encouraging initial clinical data of bemcentinib (BGB324) as an immuno-oncology agent at the ASCO-SITC Immuno-Oncology Symposium. Bemcentinib (first-in-class specific oral Axl inhibitor) was well tolerated in combination with Merck’s pembrolizumab (Keytruda) in patients treated to date from three different Phase II trials. Also, there is clinical evidence that bemcentinib enhances immune activity. Our base case valuation is unchanged at NOK31.34/share, but increases to NOK50.46/share when we take into account the broader potential of bemcentinib in immuno-oncology.
https://www.researchpool.com/provider/trinity-delta/bergenbio-promising-first-clinical-data-in-immuno-oncology
YNWA250505
05.02.2018 kl 10:18
3915
Korsar beviser igjen at hun ikke har filla peiling. Aksjene hun sitter i stuper