XNK Therapeutics receives US orphan drug status

November 4, 2020

XNK Therapeutics AB (“XNK”) today 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).

Receiving ODD status from the FDA for the treatment of multiple myeloma is a critical next step for the development of XNK’s leading investigational drug candidate. XNK has already received ODD status in the EU.

“Obtaining an ODD by the FDA is a significant milestone for XNK and our goal of taking the present drug candidate to the next level,” said Johan Liwing, CEO of XNK Therapeutics. “This is the starting point for us to expand clinical development into the most important market globally for cancer treatment.”

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.

For more information, please contact:
Johan Liwing, CEO, XNK Therapeutics
Tel: +46 706 70 36 75
E-mail: johan.liwing@xnktherapeutics.com

About XNK Therapeutics AB
XNK Therapeutics is a clinical stage, immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company has established a leadership position in the clinical development and manufacture of autologous NK cell-based products using its proprietary technology platform. The company’s platform technology and leading investigational drug candidate have ideal properties for targeting cancers, including settings where allogeneic cell products are not readily applicable. It is foreseen that the product will bring a critical component to tomorrow’s cancer treatment strategies. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit www.xnktherapeutics.com.

About XNK Therapeutics’s technology platform
The platform 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 the NK cell-based products. The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer. The product is produced in less than three weeks. It is delivered to the clinic upon need, where the product is thawed and infused into the patient without any further processing. The product has demonstrated an up to 10-year stability in liquid nitrogen. The assets of XNK Therapeutics are protected by patents in the US, Europe and certain other jurisdictions. Additional patent applications have been filed.

About Our Therapy
The leading drug candidate from XNK Therapeutics’ technology platform was previously clinically tested in a first-in-human Phase I/II clinical trial (ACP-001). The study was performed at the Karolinska University Hospital, Stockholm, Sweden in a setting of consolidation treatment following high dose stem cell transplantation in patients newly diagnosed with multiple myeloma. The study was an open, single-arm, triple escalating dose/patient clinical trial with the primary objective of studying the product’s safety and tolerability. In the study, the therapy showed a very good safety profile, and promising efficacy data. XNK Therapeutics is continuing its clinical development in multiple myeloma and plans to initiate a Phase II clinical trial in the near future.

About multiple myeloma
Multiple myeloma, the company’s first target, is the third most frequent hematological malignancy worldwide. Multiple myeloma treatment has improved over the last two decades with the development and introduction of new agents leading to more effective treatments. Still, it remains a fatal disease in the majority of cases.

Resolutions from extraordinary general meeting in XNK Therapeutics

October 14, 2020

The extraordinary general meeting in XNK Therapeutics AB (“the Company”) was held on October 14, 2020, where the general meeting resolved in accordance with submitted proposals.

The following resolutions were passed at the general meeting:

To amend the Company’s articles of association, whereby, among other things, a record day provision was introduced in order to enable affiliation of the company’s shares with Euroclear Sweden.

To appoint PricewaterhouseCoopers AB, with the authorized public accountant Leonard Daun as principal auditor as the Company’s auditor for the period until the end of the next Annual General Meeting.

To authorize the Board of Directors to issue shares.

For more information, please contact:
Johan Liwing, CEO, XNK Therapeutics
Tel: +46 706 70 36 75
E-mail: johan.liwing@xnktherapeutics.com

About XNK Therapeutics AB
XNK Therapeutics is a clinical stage, immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company has established a leadership position in the clinical development and manufacture of autologous NK cell-based products using its proprietary technology platform. The company’s platform technology and leading investigational drug candidate have ideal properties for targeting cancers, including settings where allogeneic cell products are not readily applicable. It is foreseen that the product will bring a critical component to tomorrow’s cancer treatment strategies. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit www.xnktherapeutics.com.

XNK Therapeutics appoints Stephan Meinke as Head of R&D

May 20, 2020

XNK Therapeutics AB (“XNK”) today announced the appointment of Dr. Stephan Meinke as Head of R&D

Dr. Meinke received his doctorate degree in 2010 from the University of Heidelberg, Germany, for his work on natural killer (NK) cell signaling. Since then, he has worked as a researcher at Karolinska Institutet and the Karolinska University Hospital with a research focus on NK cell biology and transfusion immunology. He currently holds a position as assistant professor in the Cell and Gene Therapy Group, HERM, Department of Medicine, at Karolinska Institutet.

“Stephan has a strong background in the field of NK cell biology and will be a key asset for XNK as we push our technology platform forward,” says Johan Liwing, CEO of XNK Therapeutics.

For more information, please contact:
Johan Liwing, CEO, XNK Therapeutics
Tel: +46 706 70 36 75
E-mail: johan.liwing@xnktherapeutics.com

About XNK Therapeutics AB
XNK Therapeutics is a clinical stage, immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company has established a leadership position in the clinical development and manufacture of autologous NK cell-based products using its proprietary technology platform. The company’s platform technology and leading investigational drug candidate have ideal properties for targeting cancers, including settings where allogeneic cell products are not readily applicable. It is foreseen that the product will bring a critical component to tomorrow’s cancer treatment strategies. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit www.xnktherapeutics.com.

About XNK Therapeutics’s technology platform
The platform 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 the NK cell-based products. The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer. The product is produced in less than three weeks. It is delivered to the clinic upon need, where the product is thawed and infused into the patient without any further processing. The product has demonstrated an up to 10-year stability in liquid nitrogen. The assets of XNK Therapeutics are protected by patents in the US, Europe and certain other jurisdictions. Additional patent applications have been filed.

First results from the ACP-001 study presented at EHA

Today results from the first-in-human study ACP-001 was made public at the 2020 EHA meeting. 

Key findings from the study:

  • Overall survival (OS) 100% after a median follow-up time of 60 months 
  • Median progression free survival (PFS) 34 months
  • No serious adverse events

The present study demonstrates that autologous NK cell-based immunotherapy is feasible and demonstrates clinical applicability with efficacy responses in an upfront autologous HSCT-setting in multiple myeloma (MM). The treatment strategy opens for usage of autologous NK cells in clinical settings where patients are not readily eligible for allogeneic NK cell-based treatments, including MRD and maintenance treatment in MM and other forms of malignancies.

XNK Therapeutics appoints Hans Ericson as CFO

May 5, 2020

XNK Therapeutics AB (“XNK”) today announced the appointment of Hans Ericson as Chief Financial Officer

Hans Ericson is a senior finance professional with more than 20 years’ experience in international business and public traded companies. He has had a number of leading positions including at Ericsson and Elekta. Hans has also worked as a consultant in various areas, from start-ups to large research organizations, including Research Institute of Sweden (RISE).

“I am very pleased to have Hans Ericson joining the XNK team,” says Johan Liwing, CEO of XNK Therapeutics. “He brings solid experience to the company that will help us take XNK to the next level.”

For more information, please contact:
Johan Liwing, CEO, XNK Therapeutics
Tel: +46 706 70 36 75
E-mail: johan.liwing@xnktherapeutics.com

About XNK Therapeutics AB
XNK Therapeutics is a clinical stage, immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company has established a leadership position in the clinical development and manufacture of autologous NK cell-based products using its proprietary technology platform. The company’s platform technology and leading investigational drug candidate have ideal properties for targeting cancers, including settings where allogeneic cell products are not readily applicable. It is foreseen that the product will bring a critical component to tomorrow’s cancer treatment strategies. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit www.xnktherapeutics.com.

About XNK Therapeutics technology platform
The platform 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 the NK cell-based products. The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer. The product is produced in less than three weeks. It is delivered to the clinic upon need, where the product is thawed and infused into the patient without any further processing. The product has demonstrated an up to 10-year stability in liquid nitrogen. The assets of XNK Therapeutics are protected by patents in the US, Europe and certain other jurisdictions. Additional patent applications have been filed.

XNK Therapeutics appoints Johan Liwing as CEO

April 1, 2020

XNK Therapeutics AB (“XNK”) today announced its appointment of Johan Liwing as CEO of the company and prepares for the next phase of development of its technology platform and leading drug candidate.

Liwing, has over 15 years’ experience from leading positions within the life science industry in Sweden as well as internationally. During his 13 years at Janssen, a subsidiary of Johnson & Johnson, he held various positions in health economics, sales & marketing as well as observational research with increased responsibilities. In his last position at Janssen, as global senior director, he was responsible for developing the use of observational data.

After eight years as CEO of XNK, Karin Mellström will step down and remain as Senior Adviser.

“I am very happy to be part of XNK Therapeutics and I look forward to realizing the great potential within the company,” said Johan Liwing, CEO of XNK Therapeutics.  I strongly believe that XNK Therapeutics technology platform and the leading investigational drug candidate have the ideal properties for being a critical component in tomorrow’s cancer strategies.”

“We are fortunate to have Johan step in and lead XNK Therapeutics at this critical phase in the development of our autologous NK cell therapy,” said Lena Degling Wikingsson, Chairman of XNK Therapeutics. “Johan’s strategic, clinical and marketing experiences from global pharma positions and significant network will bring important knowledge and strength to the company. At the same time, I would like to give my sincere appreciation to Karin for her great efforts to lead the company to this phase.”

During Mellström’s years as CEO the company achieved several key milestones. The company secured critical patents for its technology platform and developed its first investigational drug candidate. A First-in-Human phase I/II clinical study was conducted for the leading indication, a consolidation treatment after high dose autologous stem cell transplantation in patients with multiple myeloma. The leading drug candidate was also granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma in Europe and XNK is planning to advance the clinical development and reach the market via accelerated/conditional approval. An ODD application was also submitted to the U.S. Food and Drug Administration.

For more information, please contact:
Johan Liwing, CEO, XNK Therapeutics
Tel: +46 706 70 36 75
E-mail: johan.liwing@xnktherapeutics.com

About XNK Therapeutics AB
XNK Therapeutics is a clinical stage, immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company has established a leadership position in the clinical development and manufacture of autologous NK cell-based products using its proprietary technology platform. The company’s platform technology and leading investigational drug candidate have ideal properties for targeting cancers, including settings where allogeneic cell products are not readily applicable. It is foreseen that the product will bring a critical component to tomorrow’s cancer treatment strategies. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit www.xnktherapeutics.com.

About XNK Therapeutics’s technology platform
The platform 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 the NK cell-based products. The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer. The product is produced in less than three weeks. It is delivered to the clinic upon need, where the product is thawed and infused into the patient without any further processing. The product has demonstrated an up to 10-year stability in liquid nitrogen. The assets of XNK Therapeutics are protected by patents in the US, Europe and certain other jurisdictions. Additional patent applications have been filed.

XNK Therapeutics joins Vinnova’s NextGenNK competence center

Januari 31, 2020

XNK Therapeutics AB (“XNK”) today announced it joined Sweden’s Innovation Agency’s NextGenNK competence center for the development of next-generation natural killer (NK) cell-based cancer immunotherapies

Vinnova, Sweden’s innovation agency, is making a significant investment in NextGenNK, where universities and companies will conduct world-class research and innovation in important areas for Sweden while contributing to its global sustainability goals. NextGenNK has received commitments from a consortium of key opinion leaders and experts from academia and the biotech industry to collectively collaborate to create a recognized world-class research environment in the field of NK cell-based immunotherapy targeting cancers.

XNK will work within this competence center to conduct exploratory analyses of the company’s lead investigational product and patient material. The competence center partners have a mutual interest in achieving research results regarding exploratory and immunoinformatic analyses of clinical material. NextGenNK will also support XNK with advanced phenotypic characterization and functionality testing of the Company’s leading drug candidate. The collaboration will extend over five years.

NextGenNK is led by its Director, Hans-Gustaf Ljunggren, M.D., Ph.D., Professor at the Department of Medicine at KI, former Dean of Research at KI, former Director of the Center for Infectious Medicine at KI, Board Member of XNK Therapeutics, and member of the Nobel Assembly at KI.

“We are grateful to Vinnova for recognizing the potential global impact on human health by establishing NextGenNK,” stated Dr. Ljunggren. “We propose to develop a precision-medicine strategy to direct NK cells to their cancer targets and to optimally stimulate NK cell activity in the body. By assembling leading scientists and clinicians, including those who have played key roles over the past four decades of NK cell innovation, this collaboration and discovery-network are expected to generate outcomes that go far beyond the capability of any individual partner.”

“I am excited that XNK can be part of this competence center building on the research that has been part of KI since the discovery of NK cells in the 1970s,” said Johan Liwing, CEO of XNK Therapeutics. “XNK is one of the pioneering companies within the Swedish Advanced Therapy Medicinal Products (ATMP) landscape, and we are happy to contribute and strengthen Sweden’s position in the international field of NK cell research. Furthermore, this collaboration will be critical for the clinical development of our leading drug candidate.”

For more information, please contact:
Johan Liwing, CEO, XNK Therapeutics
Tel: +46 706 70 36 75
E-mail: johan.liwing@xnktherapeutics.com

About XNK Therapeutics AB
XNK Therapeutics is a clinical-stage immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company has established a leadership position in the clinical development and manufacture of autologous NK cell-based products using its proprietary technology platform. The company’s platform technology and leading investigational drug candidate have ideal properties for targeting cancers, including settings where allogeneic cell products are not readily applicable. It is foreseen that the product will bring a critical component to tomorrow’s cancer treatment strategies. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit www.xnktherapeutics.com.

About XNK Therapeutics’ technology platform
The platform 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 the development of NK cell-based products. The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer. The product is produced in less than three weeks. It is delivered to the clinic upon need, where the product is thawed and infused into the patient without any further processing. The product has demonstrated an up to 10-year stability in liquid nitrogen. The assets of XNK Therapeutics are protected by patents in the US, Europe, and certain other jurisdictions. Additional patent applications have been filed.