Diskusjon Triggere Porteføljer Aksjonærlister

BergenBio Fundamentale Forhold (BGBIO)

Bought some more today at 13,8 just before close. Then saw the text msg not long after close and though, fu@k. But no, as good an update as we could have hoped for and so glad that they did the emisjon in Jan. Well done RG and team.

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Veldig positivt! Og det jeg håpte stemte.

Her vises jo en av styrkene til Bemcentinib.
Virker ikke som alle tar innover seg betydning av at Bemcentinib kommer som tablett/kapsel.

En ting er pasientens livskvalitet, men dette vil jo spare sykehus (behandlingen) for enorme summer når det ikke kreves et kobbel av helsesarbeidere for å administrere doseringen.

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Veldig bra. For en fantastisk flaks med timingen av emisjonen, selskapet er nå finansielt solid i lang tid fremover. Jeg regner med at det blir litt forsinkelser av oppstart av fase3, men det er jo en bagatell for herdete biotekinvestorer.

Vi får glede oss over at det er mulig å akkumulere billige aksjer.

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Stemmer i med dere siste her… Kjempebra status-melding gitt den COVID-19 situasjonen vi har!

“The Company can confirm that all patients currently enrolled into BerGenBio’s clinical trials can remain on study and continue their treatment. As bemcentinib is orally administered once-a-day and it is very well tolerated by patients, the Company can ensure that patients are able to be issued with several months of dosage, negating the need to visit hospital pharmacies.
Patients enrolled in combination trials with low dose chemotherapy or checkpoint inhibitor drugs currently require redosing every three or six weeks respectively. However, the Company can confirm that dose adjustments will be made where labels permit, and this should not adversely impact the efficacy signal of the combination trials.”

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Litt teknisk for de som liker det

Conclusion: Our results indicate that AXL signaling supports a drug-resistant persister cell phenotype through a novel autophagy-dependent mechanism and reveals a unique immunogenic effect of AXL inhibition on drug-resistant NSCLC cells.

Februar 2020

https://www.researchgate.net/publication/338981504_AXL_Targeting_Abrogates_Autophagic_Flux_and_Induces_Immunogenic_Cell_Death_in_Drug-Resistant_Cancer_Cells

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En fersk aksjonærliste for BGBIO er tilgjengelig for Insider-medlemmer. Ikke Insider? Les mer og prøv gratis

BERGENBIO TO PRESENT AT THE UPCOMING 2020 SOLEBURY TROUT VIRTUAL INVESTOR CONFERENCE

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BerGenBio ASA: Share capital increase

Har noen sett presentasjonen?!

https://78449.themediaframe.com/dataconf/productusers/solebury/mediaframe/36522/indexl.html
Du kommer inn på presentasjonen via denne linken :point_up_2:

Har ikke hørt den selv ennå, så om det er noe nytt eller ikke vet jeg ikke.

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Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre :slight_smile:

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

  1. @Mykle (87 likes)
  1. @larsmkn (62 likes)
  1. @Boms (47 likes)

Resten av topp 10:

  1. @Ekornet (31 likes)

  2. @Pjolter (29 likes)

  3. @ezPappi (22 likes)

  4. @Flottesen (20 likes)

  5. @Savepig (16 likes)

  6. @Logdec (15 likes)

  7. @eiken (13 likes)

Gratulerer!

Jøss, her skal det ikke mye til for å komme på topp 10 lista :grin:

Vi trenger litt debatt, gravearbeid og noen oppkjøpsteorier - det er jo et spennende firma!

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Litt mer graving og diskusjon hadde vært helt topp, men er nå greit at det ikke hauses så inni hampen som på andre biotechtråder.

Jeg slenger ut en påstand:

Bergen Bio er det mest undervurderte biotek på Oslo Børs, og at det ser ikke ut til at investorer på Tek ikke forstår, eller vil forstå det.

Kjør debatt :smile:

Jeg har forsøkt å forstå bgbio og gitt opp.

Når jeg ikke forstår børsmeldingene til selskapet, eller abstraktene deres, og derfor ikke kan agere korrekt selv om jeg følger med så er det håpløst vanskelig for min del.

Så jeg følger med selskapet, men har gitt opp å forstå hva de driver med. Jeg tror det er bra, og handler kun teknisk.

Burde nok gjort mer av det samme selv!

Presentasjon er lagt ut:

Part 1 Utviklingsløp

Det er sikkert flere enn jeg som ikke alltid henger med når det gjelder hvor vi er i utviklingsløpet til en ny medisin/behandling. Om man leser denne linken så får man en grei innsikt i de forskjellige fasene og risikoen.

https://www.researchgate.net/publication/308045230_Omics-Informed_Drug_and_Biomarker_Discovery_Opportunities_Challenges_and_Future_Perspectives

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Part 2 FDA akselerert program

I denne posten tar vi for oss de forskjellige programmene som FDA har og hva som kreves for å komme raskere til mål

Fast Track
Qualifying criteria : A drug that is intended to treat a serious condition AND nonclinical or clinical data demonstrate the potential to address unmet medical need OR A drug that has been designated as a qualified infectious disease product
When to submit request: With IND or after. Ideally, no later than the pre-BLA or preNDA meeting
Timelines for FDA response: Within 60 calendar days of receipt of the request
Features: Actions to expedite development and review. Rolling review
Additional considerations : Designation may be rescinded if it no longer meets the qualifying criteria for fast track

Breakthrough Therapy
Qualifying criteria : A drug that is intended to treat a serious condition AND preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies
When to submit request: With IND or after. Ideally, no later than the end-of-phase 2 meeting
Timelines for FDA response: Within 60 calendar days of receipt of the request
Features: Intensive guidance on efficient drug development. Organizational commitment. Rolling review. Other actions to expedite review
Additional considerations : Designation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy

Accelerated Approval
Qualifying criteria: A drug that treats a serious condition AND generally provides a meaningful advantage over available therapies AND demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality (IMM) that is reasonably likely to predict an effect on IMM or other clinical benefit (i.e., an intermediate clinical endpoint)
When to submit request: The sponsor should ordinarily discuss the possibility of accelerated approval with the review division during development, supporting, for example, the use of the planned endpoint as a basis for approval and discussing the confirmatory trials, which should usually be already underway
Timelines for FDA response: Not specified
Features: Approval based on an effect on a surrogate endpoint or an intermediate clinical endpoint that is reasonably likely to predict a drug’s clinical benefit
Additional considerations : Promotional materials. Confirmatory trials to verify and describe the anticipated effect on IMM or other clinical benefit. Subject to expedited withdrawal

Priority Review
Qualifying criteria: An application (original or efficacy supplement) for a drug that treats a serious condition AND, if approved, would provide a significant improvement in safety or effectiveness OR, Any supplement that proposes a labeling change pursuant to a report on a pediatric study under 505Ab OR, An application for a drug that has been designated as a qualified infectious disease product OR, Any application or supplement for a drug submitted with a priority review voucherd
When to submit request: With original BLA, NDA, or efficacy supplement
Timelines for FDA response: Within 60 calendar days of receipt of original BLA, NDA, or efficacy supplement
Features: Shorter clock for review of marketing application (6 months compared with the 10-month standard review)
Additional considerations : Designation will be assigned at the time of original BLA, NDA, or efficacy supplement filing

Bergenbio har oppnådd Fast Track

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Part 3 Bergenbio språk

AA Accelerated approval
ADC Antibody drug conjugate
ALK Alkaline phosphatase
AML Acute myeloid leukemia
BLA Biologic license application
BT Breakthrough therapy
CAB Clinical advisory board
CBR Clinical benefit rate
CDx Companion diagnostic
CLIA Clinical Laboratory Improvement Amendments
CLL Chronic lymphocytic leukemia
CPI Checkpoint inhibitor
CR Complete response
CTL Cytotoxic T-lymphocytes
ECG Electrocardiogram
EGFR Epidermal growth factor receptor
ELISA Enzyme-linked immunosorbent assay
EMT Epithelial-to-mesenchymal transition
EU5 France, Germany, Italy, Spain, United Kingdom
FDA US Food and Drug Administration
GLP Good Laboratory Practice
IHC Immunohistochemistry
mAb Monoclonal antibody
MDS Myeloid dysplastic syndrome
NDA New drug application
NSCLC Non-small cell lung cancer
pAxl Phosphorylated
Axl Activated Axl
PD Progressive disease
PR Partial response
RCC Renal carcinoma
RP2D Recommended Phase II Dose
RTK Receptor tyrosine kinase
TAM Tyro, Axl, Mer (family of kinases)
TNBC Triple negative breast cancer
sAxl Soluble Axl
SD Stable disease
SoC Standard of Care
QTcF QT inverval, a measure of time in the heart’s electrical cycle

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Part 4 Bergenbio Patenter

De fleste biotek start-up håper nok på en avtale med BP. I denne posten skal vi se hvordan Bergenbio har prøvd å sikre seg retten til bruk av teknologien.

Patentdatabasen som er benyttet er Justia (https://patents.justia.com/search?q=bergenbio) – denne søker kun for USA. Det kan forekomme flere patenter/publiseringer for Bergenbio, men det vil medføre et større stykke arbeid for min del.

Når en patent søkes om så går det opp til 18mnd før patent søknaden offentligjøres via « Application». Deretter så kan det gå mellom 2-5år før en patent blir innvilget. Det betyr at det som oppgis her mangler muligens det som faller inn under 18mnd perioden.

Oppsummert så har jeg funnet følgende:

8 innvilgede patenter
7 som kan bli godkjent når som helst…(se Part 5)

PHARMACEUTICALLY ACTIVE COMPOUNDS
Filed: December 23, 2015
Publication number: 20180029985 @ Publication date: February 1, 2018
Patent number : 10336702 @ Date of Patent : Jul 2, 2019
Inventors: Jason John SHIERS, John Paul WATTS, Stuart Thomas ONIONS, Mohammed Abdul QUDDUS, Joseph William WRIGGLESWORTH, Colin Peter SAMBROOK-SMITH, Alan NAYLOR, Derek LONDESBROUGH

The invention is directed to compounds of general formula (I), and pharmaceutical compositions containing such compounds. The compounds and compositions have valuable pharmaceutical properties. In particular, they may be used for the treatment of cancer. Novel intermediates and novel methods of preparation are also disclosed.

Methods of detecting Akt3 and administering Ax1 inhibitor https://patents.justia.com/patent/10317405
Filed: May 2, 2013
Publication Number : 20150119475
Patent number: 10317405 @ Date of Patent: June 11, 2019
Inventors : Jim Lorens (Bergen), Crina Tiron (Bergen)

The use of Akt3 as a biomarker for detecting the occurrence of epithelial-to-mesenchymal transition (EMT) in a subject, and the use of Akt3 inhibitors to treat cancer is disclosed herein. Also disclosed are various methods for detecting the occurrence of epithelial-to-mesenchymal transition (EMT) in a subject by measuring Akt3 expression and/or activity.

ANTI-AXL ANTAGONISTIC ANTIBODIES
https://patents.justia.com/patent/10208121
Filed: December 18, 2015
Publication number: 20170349658 @ Publication date: December 7, 2017
Patent Grant number : 10208121 @ Date of Patent : Feb 19, 2019
Inventors: David Robert MICKLEM, Sergej KIPRIJANOV, James Bradley LORENS, Lavina AHMED, Linn Hodneland NILSSON, Tone SANDAL

Described are antibodies that specifically bind to the Axl protein and inhibit the interaction between Axl and the Axl-ligand, Gas6. Also disclosed are methods for the production and use of the anti-Axl antibodies.

ANTI-AXL ANTIBODIES
https://patents.justia.com/patent/9975953
Publication number: 20170107290 @ Publication date: April 20, 2017
Patent Grant number : 9975953 @ Date of Patent : May 22, 2018
Inventors: David Robert MICKLEM, Sergej KIPRIJANOV, Linn Hodneland NILSSON, Lavina AHMED, Hallvard HAUGEN

The present disclosure relates to antibodies which specifically bind to the Axl protein. Also disclosed are methods for the production and use of the anti-Axl antibodies.

ANTI-AXL ANTIBODIES https://patents.justia.com/patent/9975954
Filed: June 18, 2015
Publication number: 20170129957 @ Publication date: May 11, 2017
Patent Grant number : 9975954 @ Date of Patent : May 22, 2018
Inventors : David Robert Micklem (Bergen), Sergej Kiprijanov (Oslo), Linn Hodneland Nilsson (Bergen), Lavina Ahmed (Bergen), Hallvard Haugen (Bergen)

This application is a national phase entry pursuant to 35 U.S.C. § 371 of International Application No. PCT/EP2015/063700, filed Jun. 18, 2015, which claims the benefit of priority of Great Britain Application No. 1410826.0, filed Jun. 18, 2014, each of which is incorporated by reference herein in its entirety for any purpose.

The present disclosure relates to antibodies which specifically bind to the Axl protein. Also disclosed are methods for the production and use of the anti-Axl antibodies.

Use of kinase inhibitors
https://patents.justia.com/patent/20160339021
Filed: November 28, 2014
Publication Number : 20160339021 @ Publication Date : Nov 24, 2016
Patent number: 9801880 @ Date of Patent: October 31, 2017
Inventor: David Robert Micklem

The invention provides a compound for use for treating, preventing or managing a condition
associated with the activation, mutation and/or over-expression of one or more kinases, wherein if the condition is associated with Axl over-expression, it is also associated with the activation, mutation and/or over-expression of one or more other kinases, and wherein the compound has a structure according to formula (I) : wherein the symbols used in formula (I) are as defined herein.

Methods for Creating and Identifying Functional RNA Interference Elements
Type: Application
Filed: December 10, 2013
Publication number: 20140194322 @ Publication date: July 10, 2014
Patent Grant number : 9783801 @ Date of Patent : Oct 10, 2017
Inventors: DAVID MICKLEM, JAMES LORENS

The invention relates to the control of gene expression. Specifically, the invention provides compositions and methods for the production and use of recombinant nucleic acid molecules that have the ability to specifically downregulate an expressed target gene in vivo. In some aspects, the invention provides methods for producing a hairpin DNA molecule where part of the molecule is derived from an mRNA that is a target for a small interfering RNA (siRNA) derived from the hairpin. In other aspects, the invention provides synthetic hairpin adapter oligonucleotides that are used in the construction of siRNA-producing cassettes. In other aspects, the invention provides methods for testing for the presence or absence of specific inhibitory activity of an RNAi trigger molecule, and in still other aspects, the invention provides methods for identifying an active RNAi trigger molecule from a library of RNAi trigger molecules.

Methods for creating and identifying functional RNA interference elements
https://patents.justia.com/patent/8735064
Filed: December 23, 2008
Publication Number : 20110009281 @ Publication Date : Jan 13, 2011
Patent number: 8735064 @ Date of Patent: May 27, 2014
Inventors: David Micklem, James Lorens

The invention relates to the control of gene expression. Specifically, the invention provides compositions and methods for the production and use of recombinant nucleic acid molecules that have the ability to specifically downregulate an expressed target gene in vivo. In some aspects, the invention provides methods for producing a hairpin DNA molecule where part of the molecule is derived from an mRNA that is a target for a small interfering RNA (siRNA) derived from the hairpin. In other aspects, the invention provides synthetic hairpin adapter oligonucleotides that are used in the construction of siRNA-producing cassettes. In other aspects, the invention provides methods for testing for the presence or absence of specific inhibitory activity of an RNAi trigger molecule, and in still other aspects, the invention provides methods for identifying an active RNAi trigger molecule from a library of RNAi trigger molecules.

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