Pfizer's Hemophilia B Gene Therapy Receives First Global Approval; IASO Bio Expands Collaboration with Umoja Biopharma on Off-the-Shelf Ex Vivo and In Vivo Cell & Gene Therapies

▎Edited by the WuXi AppTec content team

Recently, the global cell and gene therapy (CGT) field has seen a series of advancements. Among them, Pfizer'sGene Therapy Beqvez

(Fidanacogene elaparvovec) has been approved by Health Canada for marketing, indicated for the treatment of adult patients aged 18 years or older with moderate to severe or severe hemophilia B. IASO Bio and Umoja Biopharma announced a further deepening of their strategic partnership to jointly develop off-the-shelf ex vivo and in vivo cell and gene therapies. This article will briefly introduce some of the important progress, for readers' reference only.

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———✦R&DProgress✦———

◇Pfizer announced that Health Canada has approved its gene therapy Beqvez (fidanacogene elaparvovec) for marketing, indicated for adults aged 18 years or older with moderate to severe or severe hemophilia B who do not have neutralizing antibodies targeting the AAV serotype Rh74 subtype.

This approval is mainly based on the single-arm, open-label Phase 3 clinical trial BENEGENE-2, which aimed to evaluate the efficacy and safety of Beqvez in treating adult male subjects (18-65 years old) with moderate to severe or severe Hemophilia B (defined as ≤2% circulating Factor IX activity). A total of 45 patients were enrolled in this trial. The analysis showed that the BENEGENE-2 trial met its primary endpoint, namelyCompared with FIX prophylactic treatment, patients who underwent Beqvez infusion achieved non-inferiority and superiority in the annualized bleeding rate (ABR) of total bleeding events. According to the positive data of BENEGENE-2 announced by Pfizer in December 2022, this gene therapy reduced the ABR by 71% and the annualized coagulation factor infusion rate by 92%.

◇

JW Therapeutics Announces that China's National Medical Products Administration (NMPA) Has Accepted the Supplemental Biologics License Application (sBLA) for Its CD19-Targeted Autologous Chimeric Antigen Receptor T (CAR-T) Cell Immunotherapy Product, Relmacabtagene Autoleucel Injection (Brand Name: Breyanzi), for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL). This marks JW Therapeutics' third marketing authorization application for Breyanzi. According to the press release, it is expected to become the first cell therapy product approved in China for the treatment of r/r MCL patients.

The New Indication Application is based on the results of a single-arm, multi-center, pivotal clinical study using Relmacabtagene Autoleucel to treat Chinese adult subjects with r/r MCL. This Phase 2 single-arm open-label study enrolled subjects with r/r MCL who had previously received treatment with anti-CD20 antibody, anthracycline or bendamustine, and Bruton's tyrosine kinase inhibitors. As of October 25, 2023, 59 subjects have completed infusion. Among the 56 evaluable subjects, Relmacabtagene Autoleucel demonstrated favorable clinical responses, achieving a high overall response rate (ORR) and complete response rate (CRR). The best ORR at 3 months was 81.36%, and the best CRR at 3 months was 66.10%. The incidence of severe (≥Grade 3) cytokine release syndrome (CRS) was 6.8%, and the incidence of severe (≥Grade 3) neurotoxicity (NT) was 6.8%.

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Bayer's Asklepios BioPharmaceutical (AskBio) announced that the investigational gene therapy AB-1005 (AAV2-GDNF) for the treatment of Parkinson's disease (PD) isPhase 1b Clinical Trial

In China, the primary endpoint was achieved, demonstrating good safety among the 11 treated patients. Based on these results, the two companies plan to initiate a Phase 2 clinical trial in the first half of 2024.

AB-1005 is a serotype 2 adeno-associated virus (AAV)-based

An investigational gene therapy using the AAV2 vector contains a transgene encoding human glial cell line-derived neurotrophic factor (GDNF). Following direct neurosurgical injection via convection-enhanced delivery monitored by magnetic resonance imaging (MRI), GDNF can achieve stable and continuous expression in localized brain regions.

The company also announced the launch of the Phase 2 clinical trial GenePHIT to evaluate the efficacy of gene therapy AB-1002 in patients with congestive heart failure (CHF). AB-1002 uses a rationally designed AAV vector with cardiac tropism to block the activity of protein phosphatase 1 associated with CHF by increasing therapeutic protein inhibitor 1.

◇Genascence Corporation announced the launch of a Phase 1b clinical trial to evaluate the safety and efficacy of its investigational gene therapy, GNSC-001, for knee osteoarthritis. The trial is expected to enroll approximately 50 patients.

GNSC-001 is an investigational gene therapy that uses a recombinant adeno-associated virus vector to express a transgene encoding the IL-1Ra protein.

IL-1Ra is a natural protein that blocks IL-1 signaling. IL-1 is considered a key factor in mediating the occurrence of osteoarthritis cases, leading to inflammation, joint pain, and cartilage damage. GNSC-001 aims to provide long-term and sustained inhibition of the IL-1 signaling pathway through a single injection into the joint.

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Sana Biotechnology Announces FDA Clearance of IND Application for SC262, an Investigational Cell Therapy, to Treat Relapsed or Refractory B-cell Malignancies in Clinical Trials

SC262 is a CD22-targeted CAR-T cell therapy designed based on Sana's hypoimmune platform.

Sana's low-immunogenicity platform aims to overcome immune rejection of allogeneic cells, allowing allogeneic CAR-T cell therapies to have longer persistence and deliver extended complete remission. The platform disrupts the expression of major histocompatibility complex (MHC) class I and II through gene editing, enabling the transplanted cells to evade detection by the adaptive immune system. However, this often makes them more susceptible to detection by the innate immune system, particularly natural killer (NK) cells. To address this, Sana’s platform provides methods to evade killing by innate immune cells, including overexpressing CD47, a protein that prevents cells from being attacked by NK cells or macrophages.

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Apertura Gene Therapy Launches Exclusive Engineered Adeno-Associated Virus Capsid Targeting Human Transferrin Receptor 1 (TfR1). This delivery system can mediate gene therapy across the blood-brain barrier with a dose 40 times lower than current central nervous system (CNS) gene therapies, achieving widespread distribution in the CNS.

This innovative capsid can bind to human TfR1 and be transported into the central nervous system through receptor-mediated transcytosis. Preclinical studies have shown that intravenously infused capsids can cross the blood-brain barrier, distribute widely within the central nervous system, and transfect neurons and astrocytes, while reducing capsid distribution in the liver.

———✦Collaboration, Financing, M&A✦———

◇Voyager Therapeutics Announces Strategic Collaboration and License Agreement with Novartis Worth up to $1.2 BillionWill jointly advance potential gene therapies for Huntington's disease (HD) and spinal muscular atrophy (SMA). Novartis will obtain a license to use Voyager's TRACER capsid for specific targets.Voyager and Novartis will collaborate to advance the preclinical gene therapy candidate for HD.

Voyager's TRACER (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) capsid discovery platform is a broadly applicable, RNA-based screening platform capable of rapidly discovering AAV capsids with robust blood-brain barrier penetration and enhanced central nervous system tropism across multiple species, including non-human primates (NHPs). In preclinical studies, capsids generated by TRACER demonstrated widespread gene expression in the CNS, including in traditionally difficult-to-target brain regions, compared to conventional AAV capsids. Additionally, no off-target expression was observed in the liver or dorsal root ganglia.

◇IASO Bio and Umoja Biopharma Jointly Announce a Series of New Collaborations on the Research, Development, and Commercialization of Novel Ex Vivo and In Vivo Cell and Gene Therapies. Previously, IASO Bio and Umoja reached an agreement in November 2022.IASO Bio and Umoja Biopharma will combine IASO Bio's chimeric antigen receptor with Umoja's proprietary platform to co-develop the next generation of off-the-shelf cell therapies.The signing of this new agreement deepened the strategic cooperation between the two parties and further promoted innovative ready-to-use cell and gene therapy solutions.

According to the agreement, IASO Bio will obtain the exclusive rights to Umoja’s Rapamycin-Activated Cytokine Receptor (RACR) platform—synthetic cytokine receptor technology—for the development of two in vitro induced pluripotent stem cell (iPSC)-derived chimeric antigen receptor (CAR) cell therapies. IASO Bio will be responsible for the global research and development, manufacturing, registration, and commercialization of these two in vitro cell therapy products. Meanwhile, Umoja will exclusively use two clinically validated CAR sequences targeting different antigens from IASO Bio, combined with Umoja's self-developed lentiviral vector-based in vivo gene delivery technology—VivoVec—to advance the development of two in vivo CAR-T candidates. This collaboration will promote the development of innovative off-the-shelf cell and gene therapies, which will be applied in the fields of oncology and autoimmune diseases.

Umoja Biopharma also announced two exclusive option and license agreements with AbbVie, potentially worth over $1.4 billion in total. The two companies will leverage Umoja's proprietary VivoVec platform to develop multiple in-situ generated CAR-T cell therapy candidates in the field of oncology.

◇

JW Therapeutics Announces Exclusive Collaboration with 2seventy bio to Co-Develop, Manufacture, and Commercialize CAR-T Cell Therapy Products for Autoimmune Diseases in Greater China

In 2022, JW Therapeutics entered into a strategic collaboration with 2seventy bio on the MAGE-A4 program. This strategic alliance represents a further expansion of their existing partnership. Built upon JW Therapeutics' capabilities in developing cellular immunotherapy technologies, the collaboration aims to accelerate the exploration and validation of T cell-based immunotherapy products for applications in the Greater China region.

◇4D Molecular Therapeutics (4DMT) and Arbor Biotechnologies Jointly Announce Strategic CollaborationFocused on advancing AAV vector-based gene editing therapies to treat CNS diseases with significant unmet needs.The two parties will collaborate to develop and commercialize up to six CRISPR/Cas gene editing therapies delivered via AAV vectors. Arbor will lead the research, development, and commercialization of the first candidate therapy in the collaboration, which aims to target a site associated with Amyotrophic Lateral Sclerosis (ALS). 4DMT will lead the research, development, and commercialization of the second candidate therapy in the collaboration.

Arbor’s innovative gene editor can target nearly all gene loci in the human genome with high specificity, and it is more compact compared to traditional gene editing systems, allowing delivery via AAV vectors. 4DMT’s proprietary vector evolution platform has designed highly targeted AAV vectors. The company will design AAV vectors targeting CNS tissues for this collaboration.

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References:

[1] Kriya Announces Gene Therapy Program for Thyroid Eye Disease. Retrieved January 5, 2024, from https://www.globenewswire.com/news-release/2024/01/05/2804678/0/en/Kriya-Announces-Gene-Therapy-Program-for-Thyroid-Eye-Disease.html

[2] AskBio Announces Initiation of Phase 2 GenePHIT Trial in Congestive Heart Failure (CHF). Retrieved January 5, 2024, from https://www.globenewswire.com/news-release/2024/01/05/2804629/0/en/AskBio-Announces-Initiation-of-Phase-2-GenePHIT-Trial-in-Congestive-Heart-Failure-CHF.html

[3] Fractyl Health Announces Nomination of RJVA-001 as First Clinical Candidate in Its Rejuva® GLP-1 Gene Therapy Platform. Retrieved January 5, 2024, from https://www.globenewswire.com/news-release/2024/01/05/2804591/0/en/Fractyl-Health-Announces-Nomination-of-RJVA-001-as-First-Clinical-Candidate-in-Its-Rejuva-GLP-1-Gene-Therapy-Platform.html

[4] Pfizer’s Hemophilia B Gene Therapy Wins Approval in Canada, FDA Decision Looms. Retrieved January 5, 2024, from https://www.biospace.com/article/pfizer-s-hemophilia-b-gene-therapy-wins-approval-in-canada-fda-decision-looms/

[5] Apertura Gene Therapy Unveils Novel Engineered AAV Capsids Targeting Human Transferrin Receptor 1 for Neurological Gene Therapy Delivery. January 5, 2024, from https://www.businesswire.com/news/home/20240104444092/en

[6] AskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson’s disease meets primary endpoint. Retrieved January 5, 2024, from https://www.globenewswire.com/news-release/2024/01/04/2803727/0/en/AskBio-Phase-Ib-trial-of-AB-1005-gene-therapy-in-patients-with-Parkinson-s-disease-meets-primary-endpoint.html

[7] IASO BIO Announces New Development Partnership with Umoja Biopharma to Develop Ex Vivo and In Vivo Cell and Gene Therapies. Retrieved January 5, 2024, from https://www.prnewswire.com/news-releases/iaso-bio-announces-new-development-partnership-with-umoja-biopharma-to-develop-ex-vivo-and-in-vivo-cell-and-gene-therapies-302025270.html

[8] Genascence Announces Initiation of Phase 1b Clinical Trial of GNSC-001 Gene Therapy for Knee Osteoarthritis (OA). Retrieved January 5, 2024, from https://www.prnewswire.com/news-releases/genascence-announces-initiation-of-phase-1b-clinical-trial-of-gnsc-001-gene-therapy-for-knee-osteoarthritis-oa-302022071.html

[9] Voyager Therapeutics Enters Capsid License Agreement and Strategic Collaboration with Novartis to Advance Novel Gene Therapies. Retrieved January 5, 2024, from https://www.globenewswire.com/news-release/2024/01/02/2802564/36461/en/Voyager-Therapeutics-Enters-Capsid-License-Agreement-and-Strategic-Collaboration-with-Novartis-to-Advance-Novel-Gene-Therapies.html

[10] Sana Biotechnology Announces FDA Clearance of Investigational New Drug Application for SC262, a Hypoimmune-modified, CD22-directed Allogeneic CAR T Therapy, for Patients with Relapsed or Refractory B-cell Malignancies. Retrieved January 5, 2024, from https://www.globenewswire.com/news-release/2024/01/05/2804686/0/en/Sana-Biotechnology-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-SC262-a-Hypoimmune-modified-CD22-directed-Allogeneic-CAR-T-Therapy-for-Patients-with-Relapsed.html

[11] JW Therapeutics Announces NMPA Acceptance of the Supplemental Biological License Application for Carteyva® in Patients with Relapsed or Refractory Mantle Cell Lymphoma. Retrieved January 5, 2024, from https://www.prnewswire.com/news-releases/jw-therapeutics-announces-nmpa-acceptance-of-the-supplemental-biological-license-application-for-carteyva-in-patients-with-relapsed-or-refractory-mantle-cell-lymphoma-302026271.html

[12] AbbVie and Umoja Biopharma Announce Strategic Collaboration to Develop Novel In-Situ CAR-T Cell Therapies. Retrieved January 5, 2024, from https://www.prnewswire.com/news-releases/abbvie-and-umoja-biopharma-announce-strategic-collaboration-to-develop-novel-in-situ-car-t-cell-therapies-302025722.html

[13] 4DMT and Arbor Biotechnologies Establish Partnership to Co-Develop and Co-Commercialize Next-Generation Genetic Medicines for CNS Diseases. Retrieved January 5, 2024, from https://www.globenewswire.com/news-release/2024/01/03/2803274/0/en/4DMT-and-Arbor-Biotechnologies-Establish-Partnership-to-Co-Develop-and-Co-Commercialize-Next-Generation-Genetic-Medicines-for-CNS-Diseases.html

[14] JW Therapeutics Announces Exclusive Strategic Collaboration with 2seventy bio to Develop CAR-T Therapeutic Products for Autoimmune Diseases. Retrieved January 5, 2024, from https://www.prnasia.com/story/432618-1.shtml

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