CellProtect (evencaleucel) / Avaris, XNK Therap - LARVOL DELTA

XNK Therapeutics receives EMA scientific recommendation for evencaleucel as an Advanced Therapy Medicinal Product (PRNewswire) - "XNK Therapeutics AB...announced that evencaleucel has received a scientific recommendation from the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA). This recommendation classifies evencaleucel as a Somatic Cell Therapy Medicinal Product (sCTMP) within the category of Advanced Therapy Medicinal Products (ATMPs)....XNK's platform, which is used for the manufacturing of evencaleucel, has ideal properties to produce autologous NK cell-based drug candidates for targeting malignant diseases across a wide range of indications in mono- and combination therapy. It encompasses a unique closed manufacturing system for development of NK cell-based products. The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer."

European regulatory • Multiple Myeloma

XNK Therapeutics receives funding from Sweden's innovation agency Vinnova (PRNewswire) - "XNK Therapeutics AB...announced that it has applied for and been granted funding by Sweden's innovation agency Vinnova. The grant consists of SME support through the Competence Center for Next-generation NK Cell-based Cancer Immunotherapy (NextGenNK). The competence center is coordinated by the Karolinska Institutet and XNK has been a member since the center's inception in 2020. The funding amounts to up to 1.7 million SEK over two years and will be used in a specific preclinical program in XNK's project portfolio."

Financing • Hematological Malignancies • Multiple Myeloma • Oncology

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma (clinicaltrials.gov) - P2 | N=62 | Recruiting | Sponsor: Karolinska Institutet | Active, not recruiting ➔ Recruiting | N=15 ➔ 62

Combination therapy • Enrollment change • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: Karolinska Institutet | Recruiting ➔ Active, not recruiting | N=60 ➔ 15

Combination therapy • Enrollment change • Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

XNK Therapeutics to use generic name evencaleucel for lead candidate (PRNewswire) - "XNK Therapeutics AB...announced it will adopt the generic name evencaleucel for its lead candidate targeting multiple myeloma. Evencaleucel was recently recommended by the World Health Organization (WHO) as the International Nonproprietary Name (INN) for XNK's leading drug candidate. 'We are excited that the WHO now recognizes our leading drug candidate targeting multiple myeloma by recommending the generic name evencaleucel...XNK recently announced that the first patient with multiple myeloma was treated in a Phase II clinical study using evencaleucel, in combination with Sanofi's anti-CD38 antibody Sarclisa (isatuximab) at the Karolinska University Hospital in Stockholm. Evencaleucel will now be used in all communications going forward'."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Positive clinical results of ACP-001 presented at EHA2022 (PRNewswire) - P1/2 | N=NA | "XNK Therapeutics AB...announced that an abstract on the long-term follow-up of the Phase I/II clinical trial ACP-001 with its leading candidate drug was presented at European Hematology Association's hybrid conference EHA2022, which is held in Vienna, Austria, on June 9th-12th....Initial data from XNK's first in human trial in patients with multiple myeloma (MM) showed good safety with no serious adverse events (SAE), and the only significant treatment related adverse event (grade 2) being reactivation of varicella-zoster virus. With a substantial follow-up period, clinical long-term data including safety, second line treatment including MM efficacy and PFS2 are now presented."

P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology

XNK Therapeutics gets abstract on ACP-001 selected for presentation at EHA2022 (PRNewswire) - "XNK Therapeutics AB...announced that an abstract on the long-term follow-up of the Phase I/II clinical trial study ACP-001 with its leading candidate drug has been selected for a presentation at European Hematology Association's hybrid conference EHA2022, which is held in Vienna, Austria, on June 9th-12th."

P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology

XNK Therapeutics Reports First Patient Treated in Phase II Study in Multiple Myeloma (PRNewswire) - "XNK Therapeutics AB ('XNK') today announced that the first patient has been treated in a Phase II clinical study using XNK's leading autologous natural killer (NK) cell-based candidate drug in combination with Sanofi's anti-CD38 antibody Sarclisa (Isatuximab). 'Having the first patient treated with NK cells in this clinical study is an important milestone in the clinical development of our leading drug candidate,' said Johan Aschan, CMO of XNK Therapeutics. 'The study is progressing well, and we look forward to the results.'"

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Karolinska Institutet; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Karolinska Institutet; Initiation date: Oct 2020 ➔ Mar 2021

Clinical • Combination therapy • Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

Clinical Study of Autologous Natural Killer Cells in Multiple Myeloma (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Karolinska University Hospital; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

XNK Therapeutics receives US orphan drug status for NK cell-based immunotherapy in multiple myeloma (PRNewswire) - "XNK Therapeutics AB...announced it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its leading investigational drug candidate in the treatment of multiple myeloma (MM)....XNK has already completed its first-in-human Phase I/II clinical trial (ACP-001) in multiple myeloma at the Karolinska University Hospital in Stockholm, Sweden, showing a very good safety profile, and promising efficacy data. The company is continuing the clinical development in multiple myeloma in Europe and plans to initiate a Phase II clinical trial in the near future."

New P2 trial • Orphan drug • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Karolinska Institutet

Clinical • Combination therapy • New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Clinical Study of Autologous Natural Killer Cells in Multiple Myeloma (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Karolinska University Hospital

Clinical • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology