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Żywności i Leków (Food and Drug Administration; FDA) na przeprowadzenie badania klinicznego Fazy 0 w projekcie PB004 dla cząsteczki PBA-0405. 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class="post-cats-list"><span class="category-button np-cat-8"><a href="https://e--biotechnologia-pl.translate.goog/category/biotechnologia-medyczna/?_x_tr_sl=pl&_x_tr_tl=es&_x_tr_hl=en-GB&_x_tr_sch=http">Biotechnologia medyczna</a></span> </div> <div class="entry-meta"><span class="posted-on"><a href="https://e--biotechnologia-pl.translate.goog/pure-biologics-ze-zgoda-fda/?_x_tr_sl=pl&_x_tr_tl=es&_x_tr_hl=en-GB&_x_tr_sch=http" rel="bookmark"><time class="entry-date published" datetime="2023-12-28T10:42:38+01:00">2023-12-28</time><time class="updated" datetime="2024-02-18T20:23:14+01:00">2024-02-18</time></a></span><span class="byline"><span class="author vcard"><a class="url fn n" href="https://e--biotechnologia-pl.translate.goog/author/adamkuzdralinskigmail-com/?_x_tr_sl=pl&_x_tr_tl=es&_x_tr_hl=en-GB&_x_tr_sch=http">Adam Kuzdraliński</a></span></span> </div> </header> <div class="entry-content"> <p><img decoding="async" class="size-full wp-image-7787 alignleft" src="https://e--biotechnologia-pl.translate.goog/wp-content/uploads/2023/12/pobrane.png?_x_tr_sl=pl&_x_tr_tl=es&_x_tr_hl=en-GB&_x_tr_sch=http" alt="" width="225" height="225" srcset="https://e--biotechnologia-pl.translate.goog/wp-content/uploads/2023/12/pobrane.png?_x_tr_sl=pl&_x_tr_tl=es&_x_tr_hl=en-GB&_x_tr_sch=http 225w,https://e--biotechnologia-pl.translate.goog/wp-content/uploads/2023/12/pobrane-150x150.png?_x_tr_sl=pl&_x_tr_tl=es&_x_tr_hl=en-GB&_x_tr_sch=http 150w" sizes="(max-width: 225px) 100vw, 225px">Pure Biologics [WSE: PUR], innowacyjna firma biotechnologiczna odkrywająca i rozwijająca leki biologiczne oraz tworząca terapie pozaustrojowe oparte o aptamery, poinformowała o uzyskaniu zgody amerykańskiej Agencji ds. Żywności i Leków (Food and Drug Administration; FDA) na przeprowadzenie badania klinicznego Fazy 0 w projekcie PB004 dla cząsteczki PBA-0405.</p> <ul> <li>Badanie ma dostarczyć wstępnych informacji o efektywności PBA-0405, w tym aktywacji komórek odpornościowych i zabijania komórek nowotworowych. Będzie polegało na wstrzyknięciu mikrodawek cząsteczki PBA-0405 bezpośrednio do guzów pacjentów.</li> <li>Badanie będzie miało charakter wieloośrodkowy i otwarty. Przeprowadzone zostanie<br> w 8-12 szpitalach i ośrodkach w USA z udziałem 12-15 pacjentów z guzami litymi np. rakiem głowy i szyi, mięsakiem tkanek miękkich, czy potrójnie negatywnym rakiem piersi.</li> <li>Spółka oczekuje, że badanie potrwa ok. sześć miesięcy i zakończy się w połowie 2024 r. Będzie realizowane w formacie open-label, co oznacza, że Spółka będzie na bieżąco pozyskiwała informacje o postępach i wynikach badania.</li> <li>Strategicznym priorytetem Spółki pozostaje podpisanie umowy partneringowej – wyniki Fazy 0 mogą być istotnym elementem mającym wpływ na decyzje firm farmaceutycznych.</li> </ul> <p><strong>Dr Pieter Spee</strong>, wiceprezes i dyrektor naukowy Pure Biologics powiedział:</p> <p><em>– To bardzo ważny kamień milowy dla firmy i hołd dla ciężkiej pracy zespołu Pure Biologics w projekcie PB004. Widzimy ogromny potencjał dla cząsteczki PBA-0405, łączącej unikalny wzór ekspresji ROR-1 ograniczający rozwój nowotworu, ze zwalidowanym sposobem działania sprawdzonych terapii przeciwnowotworowych, takich jak Rituxan, i który naszym zdaniem jest znacznie bardziej odpowiedni dla leczenia np. przewlekłych białaczek limfocytowych (B-CLL), niż terapie ukierunkowane na ROR1 obecnie testowane w klinice. Faza 0 nie tylko dostarczy nam informacji o profilu efektywności naszej cząsteczki, ale również pozwoli skuteczniej zaplanować jej dalszy rozwój w klinice.</em></p> <p><strong>Dr Filip Jeleń</strong>, współzałożyciel, istotny akcjonariusz i Prezes Zarządu Pure Biologics powiedział:</p> <p><em>– Zgoda FDA na przeprowadzenie Fazy 0 to bardzo istotny, formalny element naszego planu. Decyzja regulatora ogranicza nasze ryzyka oraz zbliża nas do uwolnienia wytworzonej na przestrzeni lat wartości projektu PB004. Prowadzone w ostatnich kwartałach rozmowy z potencjalnymi partnerami wskazują, że wyniki Fazy 0 mogą być kluczowe dla ich procesów decyzyjnych.</em></p> <p>Spółka planuje podpisanie umowy partneringowej w modelu co-development, w którym koszty dalszego rozwoju PB004 przeniesione zostaną na partnera. W takim modelu możliwe będzie wykorzystanie w badaniu klinicznym Fazy 1 pozyskanego już, nierozwadniającego grantu Agencji Badań Medycznych o wartości 32 mln zł, co stanowi ważny argument w rozmowach partneringowych.</p> <p><strong>Projekt PB004 </strong>to potencjalny lek biologiczny. Obejmuje rozwój nowej cząsteczki terapeutycznej w formacie afukozylowanego przeciwciała klasy IgG<sub>1</sub>, które ma stymulować odpowiedź immunologiczną komórek NK wobec komórek guza posiadających antygen nowotworowy ROR-1, prowadząc do bezpośredniego ich zabijania na drodze mechanizmu ADCC (ang. Antibody-dependent cellular cytotoxicity). Cząsteczka PB004 rozwijana jest w kierunku leczenia guzów litych, w tym potrójnie negatywnego raka piersi, jak również w kierunku leczenia wybranych nowotworów hematologicznych, w tym m.in. przewlekłej białaczki limfocytowej.</p> </div> <footer class="entry-footer"> </footer> </article> <nav class="navigation post-navigation" aria-label="Wpisy"> <h2 class="screen-reader-text">Nawigacja wpisu</h2> <div class="nav-links"> <div class="nav-previous"> <a href="https://e--biotechnologia-pl.translate.goog/kawa-a-uklad-krazenia/?_x_tr_sl=pl&_x_tr_tl=es&_x_tr_hl=en-GB&_x_tr_sch=http" rel="prev">Kawa a układ krążenia</a> </div> <div class="nav-next"> <a href="https://e--biotechnologia-pl.translate.goog/polska-technologia-na-miedzynarodowej-stacji-kosmicznej/?_x_tr_sl=pl&_x_tr_tl=es&_x_tr_hl=en-GB&_x_tr_sch=http" rel="next">Polska technologia na Międzynarodowej Stacji Kosmicznej</a> </div> </div> </nav> <div class="np-related-section-wrapper"> <h2 class="np-related-title np-clearfix">Podobne 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