NKGen Biotech’s Positive Phase 1 Clinical Data in Moderate Alzheimer’s Disease Advances Troculeucel into Phase 2 with First Patient Dosed in Phase 1/2a Trial
NKGen Biotech (Nasdaq: NKGN) has announced promising interim data from the Phase 1 cohort of its Phase 1/2a clinical trial for troculeucel, an autologous enhanced NK cell therapy for moderate Alzheimer's disease (AD). Two out of three patients treated with the highest dose (6 billion cells) showed improved CDR-SB cognitive scores, upgrading from moderate to mild AD after just three months.
The company has also dosed the first patient in the Phase 2 cohort, continuing with the 6 billion cell dose. The Phase 2 trial will evaluate troculeucel's efficacy in a randomized, double-blind, placebo-controlled study with 30 moderate AD patients. NKGen has activated four clinical sites across North America and expects to increase enrollment soon.
NKGen Biotech (Nasdaq: NKGN) ha annunciato dati interim promettenti dal gruppo della Fase 1 del suo studio clinico di Fase 1/2a per troculeucel, una terapia a base di cellule NK autologhe potenziate per il morbo di Alzheimer (AD) da moderato a lieve. Due dei tre pazienti trattati con la dose più alta (6 miliardi di cellule) hanno mostrato un miglioramento nei punteggi cognitivi CDR-SB, passando da AD moderato a lieve dopo solo tre mesi.
L'azienda ha anche somministrato la prima dose al paziente della Fase 2, continuando con la dose di 6 miliardi di cellule. Lo studio della Fase 2 valuterà l'efficacia di troculeucel in uno studio randomizzato, in doppio cieco e controllato con placebo su 30 pazienti con AD moderato. NKGen ha attivato quattro siti clinici in Nord America e prevede di aumentare presto l'arruolamento.
NKGen Biotech (Nasdaq: NKGN) ha anunciado datos interinos prometedores del grupo de Fase 1 de su ensayo clínico de Fase 1/2a para troculeucel, una terapia de células NK autólogas mejoradas para la enfermedad de Alzheimer (AD) moderada. Dos de los tres pacientes tratados con la dosis más alta (6 mil millones de células) mostraron una mejora en los puntajes cognitivos CDR-SB, pasando de AD moderada a leve después de solo tres meses.
La compañía también ha administrado la primera dosis al primer paciente en el grupo de Fase 2, continuando con la dosis de 6 mil millones de células. El ensayo de Fase 2 evaluará la eficacia de troculeucel en un estudio aleatorizado, doble ciego y controlado con placebo con 30 pacientes con AD moderada. NKGen ha activado cuatro sitios clínicos en América del Norte y espera aumentar pronto la inscripción.
NKGen Biotech (Nasdaq: NKGN)는 중등도 알츠하이머병(AD)을 위한 자가 NK 세포 치료제인 troculeucel의 1상/2a 임상시험 1상 군에서 유망한 중간 데이터를 발표했습니다. 가장 높은 용량(60억 세포)으로 치료받은 세 환자 중 두 명이 3개월 만에 AD가 중등도에서 경증으로 개선된 CDR-SB 인지 점수를 보였습니다.
회사는 또한 2상 군의 첫 환자에게 60억 세포 용량을 계속 투여했습니다. 2상 시험은 중등도 AD 환자 30명을 대상으로 한 무작위 이중 맹검 위약 대조 연구에서 troculeucel의 효능을 평가할 것입니다. NKGen은 북미에 네 개의 임상 사이트를 활성화했으며 곧 참여자를 늘릴 것으로 기대하고 있습니다.
NKGen Biotech (Nasdaq: NKGN) a annoncé des données intermédiaires prometteuses du groupe de Phase 1 de son essai clinique de Phase 1/2a pour troculeucel, une thérapie à base de cellules NK autologues améliorées pour la maladie d'Alzheimer (AD) modérée. Deux des trois patients traités avec la dose la plus élevée (6 milliards de cellules) ont montré une amélioration des scores cognitifs CDR-SB, passant d'une AD modérée à légère après seulement trois mois.
L'entreprise a également administré la première dose au premier patient du groupe de Phase 2, en continuant avec la dose de 6 milliards de cellules. L'essai de Phase 2 évaluera l'efficacité de troculeucel dans une étude randomisée, double aveugle et contrôlée par placebo impliquant 30 patients souffrant d'AD modérée. NKGen a activé quatre sites cliniques en Amérique du Nord et s'attend à augmenter bientôt le recrutement.
NKGen Biotech (Nasdaq: NKGN) hat vielversprechende Zwischenergebnisse aus der Phase-1-Gruppe seiner klinischen Studie Phase 1/2a für troculeucel, eine autologe, verbesserte NK-Zelltherapie für mittelschwere Alzheimer-Krankheit (AD), bekannt gegeben. Zwei von drei Patienten, die mit der höchsten Dosis (6 Milliarden Zellen) behandelt wurden, zeigten nach nur drei Monaten verbesserte CDR-SB-Kognitionsergebnisse und verbesserten sich von mittlerer zu milder AD.
Das Unternehmen hat auch den ersten Patienten in der Phase-2-Gruppe behandelt und setzt die Dosis von 6 Milliarden Zellen fort. Die Phase-2-Studie wird die Wirksamkeit von troculeucel in einer randomisierten, doppelblinden, placebo-kontrollierten Studie mit 30 Patienten mit mittelschwerer AD bewerten. NKGen hat vier klinische Standorte in Nordamerika aktiviert und erwartet bald eine Erhöhung der Studienanmeldungen.
- Two out of three patients in Phase 1 showed improved cognitive scores, upgrading from moderate to mild AD
- No drug-related adverse reactions reported in Phase 1
- First patient dosed in Phase 2 cohort
- Phase 2 trial expanded to 30 patients with randomized, double-blind, placebo-controlled design
- Four clinical sites activated across North America
- None.
Insights
The interim results from NKGen Biotech's Phase 1 trial for troculeucel in moderate Alzheimer's Disease (AD) are remarkably encouraging. Two out of three patients showed improved cognitive scores, transitioning from moderate to mild AD after just three months of treatment. This is a significant clinical improvement in a short timeframe for a disease that typically progresses.
The advancement to Phase 2 with the highest dose of 6 billion cells per treatment is noteworthy. It suggests a favorable safety profile and potential dose-dependent efficacy. The upcoming randomized, double-blind, placebo-controlled trial with 30 patients will provide more robust data on troculeucel's efficacy. If successful, this could represent a breakthrough in AD treatment, potentially slowing or reversing cognitive decline.
NKGen Biotech's progress with troculeucel is strategically significant for the company and the broader Alzheimer's treatment landscape. The positive interim data and advancement to Phase 2 could potentially accelerate the development timeline and attract investor interest. The use of autologous NK cells represents an innovative approach in AD treatment, differentiating NKGen in a highly competitive field.
However, investors should note that this is still early-stage data with a small patient sample. The upcoming Phase 2 results will be important in validating these promising findings. If troculeucel continues to show efficacy and safety, NKGen could see increased partnership opportunities or potential acquisition interest from larger pharmaceutical companies seeking to bolster their neurodegenerative disease portfolios.
Two of the first three patients in the Phase 1 cohort of the Phase 1/2a clinical trial, treated at the highest dose of 6 billion cells per treatment, were found to have improved CDR-SB cognitive scores, resulting in a clinical upgrade from moderate AD to mild AD after only three months on therapy.
First patient dosed in the Phase 2 cohort of the trial, continuing at the highest dose of 6 billion cells per treatment.
With the advancement to Phase 2 of the trial, SNK01 will now be referred to by its INN name, “troculeucel”.
SANTA ANA, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced promising early interim data from the Phase 1 cohort and the dosing of the first Phase 2 patient in the Phase 1/2a clinical trial of troculeucel, NKGen’s cryopreserved autologous enhanced NK cell therapy for the treatment of moderate Alzheimer’s disease (“AD”).
The Phase 1 cohort is already demonstrating positive interim results. Early independent review of the data shows that after only three months treatment with a dose of 6 billion cells per treatment, the three patients in the Phase 1 cohort had no drug-related adverse reactions, and exploratory efficacy analyses showed that two of the three patients went from a moderate to a mild AD rating on the Clinical Dementia Rating-Sum of Boxes (“CDR-SB”) scale. These findings further support the company’s MX04 Phase 1 AD study, where the one moderate AD patient who received the highest dose in that study (4 billion cells) also went from a moderate to a mild rating on the CDR-SB. Additionally, six-month interim cognitive data from Phase 1 cohort patients receiving troculeucel is expected to be disclosed at an upcoming national Alzheimer’s conference in Q4 2024.
Building upon positive interim Phase 1 results of troculeucel in moderate Alzheimer’s patients, the Company is pleased to have dosed its first patient in the Phase 2 randomized, double-blind, placebo-controlled trial evaluating the efficacy of troculeucel compared to placebo in patients with moderate Alzheimer’s disease. Troculeucel will be evaluated for effectiveness and additional safety in a broader cohort of 30 patients with moderate Alzheimer’s disease, employing a randomized, double-blind setup (n=20 randomly assigned to the treatment arm and n=10 to placebo). The Phase 2 trial aims to provide a thorough understanding of both the potential benefits and limitations of troculeucel in treating Alzheimer’s disease, thereby validating its potential therapeutic efficacy. NKGen has now activated four clinical sites across North America and expects to increase enrollment in the coming months.
“We continue to make great progress with our troculeucel clinical program in AD,” said Paul Y. Song, MD, Chairman and CEO of NKGen. “In the Phase 1 cohort of the Phase 1/2a study, we can proudly announce two of our first three patients have been clinically upgraded from moderate to mild AD following only three months of treatment with troculeucel. Additionally, we have recently dosed the first patient in the Phase 2 cohort, which is a significant milestone, particularly since the dose used is cryopreserved and continuing at our highest dosing of 6 billion cells per treatment. With encouraging cognitive improvements and a favorable safety profile from the trial’s Phase 1 interim analysis, dosing our first patient in Phase 2 is a crucial step towards creating a much-needed treatment option for patients facing this challenging condition. We are particularly eager to explore the enhanced cognitive benefits that ongoing usage of the higher dosing may bring in our Phase 2 trial.”
About Troculeucel (formerly SNK01)
Troculeucel is a novel cell-based, patient specific ex vivo expanded autologous natural killer (“NK”) cell, immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name (“INN”) for SNK01 assigned by the World Health Organization (“WHO”). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on our journey toward bringing this therapy to market.
About NKGen Biotech
NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com.
Forward-Looking Statements
Statements contained in this press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s plans and expected timing for developing troculeucel and SNK02, including the expected timing of completing and announcing further results from its ongoing clinical studies; and the Company’s expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the Company’s ability to execute its plans and strategies; risks related to performing clinical studies; the risk that initial and interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; the risk that the abstract will not be published as planned including delays in timing, format, or accessibility; and NKGen’s ability to raise additional funding to complete the development of its product candidates. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in the Company’s filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website at www.sec.gov and on the Company’s website under the subheading “Investors—Financial and Filings”. Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Internal Contact:
Denise Chua, MBA, CLS, MT (ASCP)
SVP, Corporate Affairs
949-396-6830
dchua@nkgenbiotech.com
External Contacts:
Chris Calabrese
Managing Director
LifeSci Advisors, LLC
ccalabrese@lifesciadvisors.com
Kevin Gardner
Managing Director
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com
FAQ
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