Godt nytt 
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Merge Hamlet pharma og selectimmune pharma
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Hamlet Pharma og Selectimmune Pharma er nu ét selskab jfr. seneste melding og skal fremover kendes som Hamlet Biopharma.
Hyggelig setup i monthly nå. Episodic pivot idag (+20%) med open day high på 3.08, high 3.50 med close 3.36. Kan vi bygge en base nå og akkumulere litt selgere så kan området 3.50-3.60 bli intressant for å bryta opp av den fallende trenden fra 2019 og toppen rundt ~20 kr.
Litt fundamental oppfølging her;
Fra August går Hamlet Pharma sammen med Selectimmune pharma. Ny VD på plass fra tidl. AbbVie, Abbot og nyligen SOBI.
Selectimmune har sikret seg patent på IL-1AR anankira (Kineret) som idag brukes selektivt innenfor revmatisme. Selectimmune har vist att Kineret redusere substans P, forbedrer quality of life og reduserer miksjon hos folk med interstitiell cystitt (bladder pain syndrome). Ett avtal er på plass med SOBI som bistår med legemiddelet. Pågår to st fas 2 nå, dela mot bladder pain men også residiverende cystitt. Begge indikasjoner har tidl. vist god effekt av Kineret.
Med ny VD som kommer fra SOBI, så er det ikke uaktuellt å tenkte att SOBI vil bistå med lisensiering og avtal med Hamlet biopharma når endelig studieresultat kommer dersom de påviser samme gode effekt som tidligere. Det ligger i deres interesse å utøke kinerets indikasjonsområde.
Alpha1h fikk nylig FDA godkjennelse for å starte Fas 3. Per idag ca 24 MSEK i kassa, så selskapet er i behov for mere cash. Hva det ender med får vi se.
Men samlet sett tre pågående Fas 2 + ett tiotal andre prosjekt for dagens ~350 msek.
Triggerliste:
- Studieresultat Alpha1h
- Start Fas 3
- Studieresultat BPS
- Studieresultat res. cystitt
- GBM Fox
Cash må ordnes:
- Avtal Alpha1h / Kineret (SOBI)
- Riktad emisjon
- Nyemisjon
Svært ikke at se dette som et flot bull flag under opbygning 
Sannsynligvis moment of truth denna uken.
I’m low key loving it
Investor møte kl 12.
The combined data analysis from the two clinical study parts has now been completed, including extensive laboratory analyses of patient samples. The results, which have been submitted for publication are summarized below.
- Reduction in tumor size
Treatment resulted in a complete or partial response in 82% of the tumors treated with 8.5 mM and in 45% treated with 1.7 mM of Alpha1H.
- Changes in the tumor
Treatment resulted in tumor fragmentation and release of fragments and cells into the urine. This effect increased markedly with the higher dose of Alpha1H.
The tumor cells died by apoptosis, after taking up Alpha1H.
Tissues left in the patient after treatment had lost their tumor characteristics and become more “healthy-like”, as shown by total gene expression analysis.
Clinical use of Alpha1H
A novel neoadjuvant therapy holds the promise of improving the standard of care for multiple reasons.
First, it could lead to an enhanced tumor response to subsequent treatment, facilitating more effective surgical removal.
Second, this approach might reduce the recurrence rate by targeting residual cancer cells that could otherwise lead to tumor regrowth post-surgery.
Third, by down-staging tumors, the therapy could limit the extent of cancer spread into deeper layers of the bladder wall, potentially enabling less invasive surgical interventions.
The investigational drug, Alpha1H, has the potential to be an effective neoadjuvant therapy for several key reasons.
There is limited or even no toxicity associated with the administration of Alpha1H; nonclinical studies of Alpha1H all found no evidence of symptoms or signs or effects on body weight or organ weights, gross pathology or histopathology.
An ongoing clinical trial evaluating the safety and efficacy of Alpha1H in Adult Patients with Non-Muscle Invasive Bladder Cancer Awaiting Transurethral Surgery (Study HP002-001), has found that Alpha1H is safe and well tolerated in this patient population.
Clinical data, from this trial, suggests that Alpha1H instillations result in dose-dependent effects on both tumor size and cell shedding.
Hamlet BioPharma is now proceeding with the third part of the clinical trial to optimize the design of further clinical trials in dialogue with the FDA. Overall, an effective neoadjuvant therapy could significantly enhance treatment approaches, improving outcomes and quality of life for patients with this condition.
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Hendelserik uke. Emisjons på 40 msek hvorav 30% er sikret fra oss.
Idag kom FDA Fast track godkjennelse.
Samtlige tre studieresultat kommer Q1-Q2 i 2024.
Hamlet biopharma 2.0
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