NKGen Biotech Announces Appointment of Steven Cha, MD as Chief Medical Officer

SANTA ANA, Calif., April 15, 2021 (GLOBE NEWSWIRE) — NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, today announced that it has appointed Steven Cha, M.D. as its Chief Medical Officer. Dr. Cha will oversee the clinical development of NKGen Biotech’s lead product SNK01 as well as its pipeline of other novel NK cell therapies.

“We are extremely pleased to have Steven join the NKGen Biotech team during this rapid growth phase for the Company,” said Stephen Chen, Chief Operating Officer. “His broad expertise and leadership in oncology, early and late-stage drug development, and proficiency with business development transactions make him an ideal fit for NKGen Biotech,” he concluded.

Dr. Cha has 15 years of R&D industry experience encompassing both large and small pharmaceutical companies. Since 2018 he has served as Vice President of Oncology at Samumed LLC, a privately held clinical-stage biotechnology company. Prior to that Dr. Cha was Senior Director, Global Clinical Lead at Pfizer focused on early oncology development. In his earlier roles Dr. Cha was Head of the metastatic breast cancer franchise at Puma Biotechnology, Senior Medical Director, Clinical Development at MEI Pharma, Medical Director at Allergan where he worked on Botox in urologic disorders, and Medical Director at Amgen where he was primarily focused on Nplate and blinatumomab.

Dr. Cha joins NKGen Biotech during an exciting period as the Company advances its allogeneic program towards IND filing while continuing work on SNK01 in refractory solid tumors in both monotherapy and combination therapy partnered programs.

“NK cell therapy represents a highly promising novel treatment paradigm in oncology,” said Dr. Cha. “I am extremely enthusiastic about joining the NKGen Biotech team to work on SNK01 and the follow-on allogeneic and CAR-NK programs, which I believe have the potential to become best-in-class NK cell therapies for oncology patients.”

Dr. Cha completed a BS in Biochemistry and Cell Biology from the University of California, San Diego and obtained his M.D. from the Tufts University School of Medicine. He has also completed fellowships in Hematology and Blood and Marrow Transplant at Stanford University.

About NKGen Biotech

NKGen Biotech, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (NK) Cell therapeutics. Leveraging our proprietary cell expansion and activation technology and cutting-edge cell manufacturing expertise, we have the ability to infinitely expand natural killer cells while significantly enhancing cytotoxicity across our peripheral blood-derived products. NKGen Biotech’s lead product candidate, SNK01, is currently in Phase 1 and Phase 1/2a clinical trials for the treatment of advanced refractory solid tumors both as a monotherapy and in combination with other agents including checkpoint inhibitors and cell engagers. NKGen Biotech is committed to the vision of executing on our clinical strategies with the goal of commercializing our NK cell therapies to help save and sustain patients’ lives worldwide. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com.

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing
949-396-6830
dchua@nkgenbiotech.com

NKMax and Merck KGaA, Darmstadt, Germany Expand Clinical Collaboration to Include Phase I/IIa Trial Investigating the Combination of SNK01 with ERBITUX® (cetuximab) in Metastatic NSCLC

SEOUL, South Korea, April 13, 2021 (GLOBE NEWSWIRE) — NKMax, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, announced the expansion of its clinical trial and supply agreement with Merck KGaA, Darmstadt, Germany to conduct a Phase I/IIa open-label, single-center trial evaluating the safety and anti-tumor activity of SNK01 (autologous natural killer cells) in combination with either gemcitabine/carboplatin or gemcitabine/carboplatin plus cetuximab (ERBITUX®)* in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed after prior tyrosine kinase inhibitor (TKI) therapy. Preliminary in vitro data from an NKMax study suggested that EGFR-TKI resistant NSCLC cells highly express EGFR and are more efficiently killed by SNK01 in the presence of cetuximab through antibody-dependent cellular cytotoxicity (ADCC). Dr. Jae-Cheol Lee, M.D., Ph.D. from the Department of Oncology and Lung Cancer Center at Asan Medical Center, Seoul, Korea will be acting as principal investigator. This study was approved by Korea’s regulatory agency, MFDS, earlier this year as well as by the Asan Hospital IRB. The first patient will soon be enrolled.

“We are pleased to continue studying SNK01 in combination with well-known cancer therapies,” said Sangwoo Park, Chief Executive Officer of NKMax. “Our strategy is to first take our autologous, non-genetically modified NK cell therapy into the clinic for cancer, followed by our allogeneic program later in 2021.”

Under the terms of this agreement, NKMax will be the study sponsor, and Merck KGaA, Darmstadt, Germany will supply cetuximab for a Phase I/IIa clinical trial in NSCLC patients for weekly dosing with 250 mg/m2 cetuximab administered by intravenous injection. The trial will include patients whose disease has progressed after prior TKI therapy for EGFR, ALK or ROS1 alterations at least once will be enrolled to receive SNK01, chemotherapy, and cetuximab. The primary objective of the trial is to assess the safety and drug tolerance of SNK01 administered in combination with cytotoxic chemotherapy or cytotoxic chemotherapy plus cetuximab. The secondary objective of the trial will be to obtain efficacy assessments on the combination treatments. Both parties will have access to the clinical trial data.

NKMax has developed its own proprietary NK cell expansion and activation technology platform which allows it to produce unprecedented commercial amounts of autologous and allogenic NK cells from numerous donors which have near total expression of activating receptors like CD16, NKG2D, NKp30, and NKp46. In addition, its unique technology raises the cytotoxicity of the expanded NK cells with little loss during cryopreservation.

* ERBITUX® is not approved for any use in metastatic non-small cell lung cancer anywhere in the world.

About NKMax

NKMax Co. Ltd and its subsidiary U.S. company NKGen Biotech are clinical stage biotechnology companies dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite-fold natural killer cell expansion with greatly enhanced cytotoxicity across our autologous and allogenic products which are all derived from peripheral blood. Our first in class autologous product, SNK01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with pembrolizumab in Stage IV non-small cell lung cancer. We have also added another cohort of SNK01 in combination with pembrolizumab or avelumab in refractive PD-L1 positive or PD-L1 negative solid tumors and are planning to initiate a Phase 1 combination trial of SNK01 and AFM24 in EGFR positive solid tumors. Our companies and their commercially licensed cGMP facilities are located in Seongnam South Korea and Santa Ana, California, USA.

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing
949-396-6830
dchua@nkgenbiotech.com

NKGen Biotech Announces Appointment of Philip Moody as Chief Financial Officer

SANTA ANA, Calif., April 07, 2021 (GLOBE NEWSWIRE) — NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, today announced that it has appointed Philip Moody as its Chief Financial Officer (CFO). Mr. Moody is a highly accomplished CFO who brings critical financial leadership experience to NKGen Biotech.

“I am thrilled to welcome Philip to our leadership team,” said Stephen Chen, Chief Operating Officer. “His extensive experience in financial operations, corporate strategy and capital markets access will make an immediate positive impact during this growth phase in our company and position NKGen Biotech well for the future.”

Mr. Moody has 25 years of broad healthcare and biotech industry leadership experience. He was CFO and Executive Vice President of PaxVax, a private equity-backed specialty vaccine company. Prior to PaxVax, Mr. Moody was CFO, North America for BTG PLC, a publicly traded medical device and specialty pharmaceutical company that was acquired by Boston Scientific. Additionally, he served as CFO and Vice President of Finance and Operations for publicly traded Peplin, Inc., an oncology therapeutics company. Mr. Moody began his biotech career at Chiron Corporation where he progressed through roles of increasing responsibility to the role of CFO and Senior Vice President of Finance and Operations, Biopharmaceuticals.

“NKGen Biotech has a leading NK cell therapy platform and pipeline, along with an impressive manufacturing facility,” said Mr. Moody. ” I believe the potential for growth and value creation is tremendous. It is a great time to be joining the NKGen Biotech team to further align financial strategy with its corporate goals and position the Company for further financings.”

Mr. Moody completed a BS in Mechanical Engineering from the University of California, Berkley and studied finance at its Haas Graduate School of Business.

About NKGen Biotech

NKGen Biotech is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across both autologous and allogenic products which are all derived from peripheral blood. Our first in class autologous product, SNK01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with pembrolizumab in Stage IV non-small cell lung cancer. We have also added another cohort of SNK01 in combination with pembrolizumab or avelumab in refractive PD-L1 positive or PD-L1 negative solid tumors and are planning to initiate a Phase 1 combination trial of SNK01 and AFM24 in EGFR positive solid tumors. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. http://www.nkgenbiotech.com/

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing
949-396-6830
dchua@nkgenbiotech.com

NKMax America Announces Corporate Name Change to NKGen Biotech

SANTA ANA, Calif., April 02, 2021 (GLOBE NEWSWIRE) — NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, today announced that it has changed its corporate name to NKGen Biotech, Inc., which the Company believes best reflects its mission and strategic focus. The name change is effective immediately.

“We believe the name NKGen Biotech more accurately represents the direction our company is headed and our commitment to developing the next generation of natural killer cell immunotherapies with the potential to restore immune function in patients with cancer worldwide,” said Stephen Chen, NKGen Biotech Chief Operating Officer and Chief Technical Officer.

Mr. Chen further commented, “Our clinical programs remain on track and we plan to report full data from our Phase 1 monotherapy trial of SNK01 in refractory solid tumors in the second quarter of 2021, while advancing our partnered combination programs with Merck KGaA and Affimed throughout the year. We are excited to embark on the next steps in our journey to become the leading player in NK cell therapeutics.”

The Company’s lead drug candidate, SNK01, is an investigational autologous NK cell-based therapy which is currently being studied alone and in combination with other approved drugs for the treatment of cancer. NKGen Biotech also plans to file an IND for its allogeneic NK cell platform in 2022.

About NKGen Biotech

NKGen Biotech is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across both autologous and allogenic products which are all derived from peripheral blood. Our first in class autologous product, SNK01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with Keytruda in Stage IV non-small cell lung cancer. We have also added another cohort of SNK01 in combination with pembrolizumab or avelumab in refractive PD-L1 positive or PD-L1 negative solid tumors and are planning to initiate a Phase 1 combination trial of SNK01 and AFM24 in patients suffering from tumors known to express EGFR. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. www.nkgenbiotech.com

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing
949-396-6830
dchua@nkgenbiotech.com

Affimed and NKMax America Announce FDA Clearance of IND Application to Study the Combination of AFM24, an EGFR Targeted Innate Cell Engager, with SNK-01 Natural Killer Cell Therapy in Solid Tumors

Heidelberg, Germany and Santa Ana, Calif., March 31, 2021 – Affimed N.V. (NASDAQ: AFMD), a clinical-stage immuno-oncology company, and NKMax America Inc., a clinical stage biotech company, announced today that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for an Affimed and NKMax America co-sponsored Phase 1/2a  dose escalation and expansion study in which the two companies will investigate the combination of AFM24, an EGFR/CD16A innate cell engager (ICE®), and SNK-01, an autologous NK-cell product, in patients suffering from tumors known to express EGFR. The combination represents a novel approach to exploring innate immunity-based therapeutics to treat patients with solid tumors who failed conventional therapy with the aim to improve outcomes for high-medical need patient populations.

“This combination is part of our overall development strategy for AFM24, the first and only innate cell engager in clinical development for solid tumors. In addition to NK cell-based combinations, we are also developing AFM24 as single agent and in combination with atezolizumab in several tumor indications,” said Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. “The mechanism of action of the two compounds could be highly synergistic as AFM24 has strong binding affinity to NK cells, directing them to kill tumor cells. Moreover, this combination approach represents an opportunity to supplement patients with dysregulated innate immune systems with targeted cellular therapy.”

“The FDA clearance of our IND application for SNK-01 in combination with AFM24 is an important milestone for our Natural Killer cell therapy development program,” said Stephen Chen, Chief Operating Officer and Chief Technical Officer of NKMax America.  “We look forward to investigating this combination as part of our comprehensive strategy aimed at producing a cell therapy for patients with advanced/metastatic EGFR-expressing cancers.”

Further Information About the AFM24/SNK-01 Phase 1/2a study

The Phase 1/2a study is based on preclinical in vitro testing, combining Affimed’s ICE® AFM24 with NKMax America autologous NK-cell product SNK-01, which showed enhanced activity of NK cell induced target cell killing. The Phase 1/2a study will be an open-label, non-randomized, multi-center, US only, dose escalation trial to evaluate the combination in adult patients with EGFR-expressing tumors. The primary objective of the phase 1 study part will be to establish the safety and the recommended phase 2 dose of AFM24/SNK-01 combination, as well as to evaluate pharmacokinetics, pharmacodynamics, and preliminary activity in patients with advanced cancers expressing EGFR. The phase 2a portion of the study will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to give patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the company’s people, pipeline and partners, please visit: www.affimed.com.

About NKMax America

NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across its autologous and allogeneic products which are all derived from peripheral blood. Our first in class autologous product, SNK-01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase 1/2a combination trial with Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. www.nkmaxamerica.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of Affimed’s ROCK® platform, ICE® product candidates and AFM24, NKMax America’s NK cell technology and SNK-01, and preclinical development and clinical trials, and other factors described under the heading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and neither company assumes any obligation to update these forward-looking statements, even if new information becomes available in the future.

Affimed Investor Contact

Alex Fudukidis
Head of Investor Relations
Email: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102

NK Max America Contact

Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing
Email: dchua@nkmaxamerica.com
Tel.: +1 (949) 396-6830

NKMax America Announces Key Leadership Appointment

SANTA ANA, Calif., Feb. 04, 2021 (GLOBE NEWSWIRE) — NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, announced the appointment of Stephen Chen, MBA to Chief Operating Officer (COO).

“As our Chief Technical Officer, Stephen has been critical to establishing our cGMP-compliant manufacturing facility and is a proven and impactful leader in our dynamic organization,” said Sangwoo Park, Chairman and Chief Executive Officer of NKMax America. “In his expanded role as Chief Operating Officer we are confident that his extensive industry experience and success in building out both autologous and allogeneic platforms will be invaluable to our future growth.”

In his new role as COO, Mr. Chen will be responsible for overseeing the business operations and providing strategic leadership while retaining his current responsibilities as Chief Technical Officer. Previously, Mr. Chen had been Senior Vice President of Quality and Technical Operations, he was then promoted to Chief Technical Officer of NK Max America in 2019.

“I look forward to building on the progress we have made to date and becoming more deeply involved in the company’s strategic decision making as we transition towards becoming a fully integrated commercial entity,” said Mr. Chen.

Mr. Chen has more than 16 years in operational leadership in the areas of quality assurance, quality control, laboratory operations, and GMP manufacturing. Prior to joining NKMax, he served as Director of Quality Assurance for ARMO BioSciences and Director of Quality Assurance for Kite Pharma. Additionally, Mr. Chen was Director of Quality for Channel Technologies Group and held various quality management positions at Baxter International.

Mr. Chen earned his B.S. degree in Biochemistry/Cell Biology from University of California, San Diego and his MBA degree from the University of Southern California (USC).

 

About NKMax America

NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across its autologous and allogeneic products which are all derived from peripheral blood. Our first in class autologous product, SNK-01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. www.nkmaxamerica.com.

 

 Contact

Denise Chua, MBA, CLS, MT (ASCP)

Vice President, Marketing

Email: dchua@nkmaxamerica.com

Tel.: +1 (949) 396-6830

Affimed and NKMax America to Study the Combination of AFM24, an EGFR-Targeted Innate Cell Engager, with SNK01 Natural Killer Cell Therapy

Affimed and NKMax America to Study the Combination of AFM24, an EGFR-Targeted Innate Cell Engager, with SNK01 Natural Killer Cell Therapy

 

  • Proof of Concept study to establish safety and recommended dose of Affimed’s innate cell engager (ICE®) AFM24 in combination with NKMax America’s Natural Killer (NK) cells in solid tumors
  • Pre-clinical data substantiates synergy between Affimed’s ICE® molecules and both NKMax America’s autologous and cryopreserved allogeneic NK cell therapy products

 

Heidelberg, Germany, and Santa Ana, California, October 20, 2020 – Affimed N.V. (NASDAQ: AFMD) and NKMax America Inc., both clinical stage biotech companies focused on harnessing the power of the body’s innate immune system, announced today that they entered into a clinical collaboration agreement to investigate the combination of AFM24, a CD16A/EGFR-targeted ICE®, with the autologous NK cell product SNK01. Pursuant to the collaboration, the companies plan to explore the combination in a first-in-human proof-of-concept (POC) trial in patients with EGFR-expressing tumors. The agreement follows a previous collaboration between the two companies in the preclinical setting to better understand the combined activity of their respective platforms. The results of the preclinical collaboration have shown substantive synergy between Affimed’s ICE® molecules and NKMax America’s autologous and cryopreserved allogeneic natural killer cell products.

Under the agreement, the companies will contribute their respective product candidates and resources towards submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) and a subsequent clinical trial. The clinical trial will combine NKMax America’s SNK01 (enhanced natural killer cells) with AFM24 in the autologous setting with the option to expand the clinical trial to the allogeneic setting. The cost of the clinical study will be shared by Affimed and NKMax America. The agreement also provides for the opportunity to pursue further clinical study combinations with additional product candidates from both parties.

NKMax America has developed a proprietary NK cell expansion and activation technology platform which allows it to produce unprecedented commercial amounts of autologous and allogeneic NK cells from numerous donors that have near total expression of activating receptors like CD16A, NKG2D, NKp30 and NKp46. In addition, its unique technology increases the cytotoxicity of the expanded NK cells by nearly 8000 percent. In addition, the SNK01 product does not require lymphodepletion or cytokine support.

Using its ROCK® (Redirected Optimized Cell Killing) platform, Affimed has developed a novel pipeline of ICE® products. AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding ICE®, is unique due to its activation of innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), whereas other EGFR-directed therapies rely heavily on signal transduction inhibition. A first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study is underway evaluating AFM24 as monotherapy in patients with advanced solid EGFR-expressing malignancies whose disease has progressed after treatment with previous anticancer therapies.

“We believe combining ICE® molecules generated from our ROCK® platform with adoptive NK cell transfer can improve patient outcomes by ensuring patients have active and viable innate cells to be directed to the tumor and induce cytotoxic killing. In addition, through the high affinity binding to CD16A, our ICE® molecules can ensure delivery of potent innate cells even to those tumors with very low tumor antigen expression,” said Dr. Adi Hoess, Affimed’s Chief Executive Officer. “Studies have shown that higher numbers of NK cells are associated with improved patient responses. By combining AFM24 with the autologous NK cell product from NKMax America, we intend to provide clinically meaningful benefit to more patients suffering from EGFR-expressing solid tumors where mortality rates remain high.”

“By combining our two innovative technologies, we have the potential to rapidly develop an entirely new class of therapeutics, Chimeric Antigen-Like engaged NK cells, to better benefit patients without the need for lymphodepletion,” said Paul Song, M.D., Vice Chairman and Chief Medical Officer, NKMax America. “We believe this approach offers a better alternative to the current process of manufacturing genetically engineered cell therapies such as CAR-T and CAR-NK products, which are expensive and inefficient,” he concluded.

 

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer. Affimed’s fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, please visit www.affimed.com.

About NKMax America

NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across its autologous and allogeneic products which are all derived from peripheral blood. Our first in class autologous product, SNK-01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. www.nkmaxamerica.com.

 

Affimed Investor Contact

Alex Fudukidis

Head of Investor Relations

Email: a.fudukidis@affimed.com

Tel.: +1 (917) 436-8102

 

NK Max America Contact

Denise Chua, MBA, CLS, MT (ASCP)

Vice President, Marketing

Email: dchua@nkmaxamerica.com

Tel.: +1 (949) 396-6830

 

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of Affimed’s ROCK® platform, ICE® product candidates and AFM24, NKMax America’s NK cell technology and SNK-01, and preclinical development and clinical trials, and other factors described under the heading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and neither company assumes any obligation to update these forward-looking statements, even if new information becomes available in the future.

 

NKMax America Announces a Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer

SANTA ANA, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) — NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, announced today that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate the safety and tolerability of SNK01, the company’s autologous natural killer cell therapy in combination with avelumab (BAVENCIO®), a human anti-PD-L1 therapy co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc., in solid tumors.

Under the terms of this agreement, NKMax America will be the study sponsor, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for a new study arm that will be added to the existing US Phase I clinical trial (NCT03941262) in refractory solid tumors. Under the amendment, up to 18 patients with all solid tumor types refractory to conventional treatment and independent of PD-L1 status will be enrolled to receive SNK01 plus a checkpoint inhibitor until progression or unacceptable toxicity. Enrollment of this arm is expected to begin in September 2020. Both parties will have access to the clinical data.

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. It has been shown in preclinical models to engage both the adaptive and innate immune functions. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.

NKMax America has developed its own proprietary NK cell expansion and activation technology platform which allows it to produce unprecedented commercial amounts of autologous and allogenic NK cells from numerous donors which have near total expression of activating receptors like CD16, NKG2D, NKp30, and NKp46. In addition, its unique technology raises the cytotoxicity of the expanded NK cells nearly 8000% with little loss during cryopreservation.

“Much emerging research has identified the vital role NK cells play in tumor response to checkpoint inhibitors in both PD-L1+ and PD-L1 negative tumors. Based on strong clinical results that we presented at ASCO which demonstrated significantly improved response when our SNK01 cells were added to a checkpoint inhibitor, we believe that the IgG1 antibody nature of avelumab along with the greatly enhanced cytotoxicity and CD16 expression of our SNK01 cells may further maximize this anti-tumor potential,” said Paul Song, Vice Chairman and Chief Medical Officer.

Avelumab Approved Indications in the US

Avelumab (BAVENCIO®) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO® monotherapy include lymphopenia; in patients receiving BAVENCIO® in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.

For full US Prescribing Information and Medication Guide for BAVENCIO®, please see http://www.BAVENCIO.com.

About NKMax America
NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across its autologous, allogenic, and CAR-NK products which are all derived from peripheral blood. Our first in class autologous product, SNK01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA.

BAVENCIO® is a trademark of Merck KGaA, Darmstadt, Germany.

For more information on the company, please visit www.nkmaxamerica.com

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing
949-396-6830
dchua@nkmaxamerica.com

NKMax America Receives FDA Clearance to Amend its Current Phase I Monotherapy Trial to Include an Additional New Cohort of SNK01 + Checkpoint Inhibitor in Refractory Solid Tumors.

SANTA ANA, Calif., August 31, 2020 — NKMax America, a biotechnology company harnessing the power of the body’s innate immune system through the development of Natural Killer (NK) cell therapies, today announced that the FDA has granted permission to amend its existing Phase I trial (NCT03941262) to add a new cohort of up to 18 patients to be treated with SNK01 in combination with either Pembrolizumab or Avelumab, two established checkpoint inhibitors.

 

Based on several compassionate use IND cases in individual patients that demonstrated safety and promising activity with a combination of SNK + Pembrolizumab, the U.S. FDA encouraged the Company to submit a protocol amendment to its ongoing monotherapy trial in refractory solid tumors rather than to file an entirely new IND.

 

This fourth cohort in the trial will include all tumor types refractory to conventional therapies regardless of their PD-L1 expression as well as those who have failed prior checkpoint inhibitor therapies. The primary outcome will be safety, with objective response rate as a secondary endpoint.

 

“We are extremely grateful to the U.S. FDA for its proactive guidance, vision, and support that has expedited patient enrollment to study this promising regimen” said Paul Song, MD – Vice Chairman and Chief Medical Officer of NKMax America.

 

Patient enrollment will commence in September 2020.

 

About NKMax America

NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across its autologous and allogenic products which are all derived from peripheral blood. Our first in class autologous product, SNK-01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. www.nkmaxamerica.com.

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing
949-396-6830
dchua@nkmaxamerica.com

NKMax America Receives FDA Clearance of IND for Phase I/2a Trial of their Natural Killer Cell Therapy (SNK01) in Combination with Trastuzumab or Cetuximab for the Treatment of Advanced/Metastatic HER2- or EGFR- Expressing Cancers

SANTA ANA, Calif., June 02, 2020 (GLOBE NEWSWIRE) — NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for SNK01 in combination with trastuzumab (Herceptin) or cetuximab (Erbitux) for the treatment of advanced/metastatic HER2- or EGFR- expressing cancers.

The company plans to initiate a Phase 1/2a open-label, multi-center trial (Study SNK01-102) to evaluate the safety and anti-tumor activity of its expanded autologous natural killer cells in combination with trastuzumab or cetuximab in third quarter of this year.

“It is well known that NK cells play a vital role in antibody dependent cell-mediated cytotoxicity (ADCC) directed killing of cancer cells and that some of the poor responses to trastuzumab and cetuximab can be attributed to the inherent weakness of the innate immune system of treated patients,” said Paul Song, M.D., Vice Chairman and Chief Medical Officer of NKMax America. “Our preclinical research highlights our ability to exponentially increase NK cell cytotoxicity and generate high CD16 expression to optimize the ADCC pathway helping to overcome these limitations. Early data suggests that our NK cells can cross the blood brain barrier, so we are eager to test SNK01 in all patients with advanced/metastatic HER2- or EGFR- mutated tumors who have limited options and especially in those with brain metastases.”

About NKMax America
NKMax America Inc. is a clinical stage biotechnology company dedicated to restoring and enhancing overall immune integrity. Our proprietary natural killer cell expansion and activation technology achieves infinite fold natural killer cell expansion with greatly enhanced cytotoxicity across its autologous, allogenic, and CAR-NK products which are all derived from peripheral blood. Our first in class autologous product, SNK01, is currently in a Phase I clinical trial in advanced refractory solid tumors and in a Phase I/IIa combination trial with Keytruda in Stage IV non-small cell lung cancer. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA.

For more information on the company, please visit www.nkmaxamerica.com

Contact:
Denise Chua, MBA, CLS, MT (ASCP)
Vice President, Marketing
949-396-6830
dchua@nkmaxamerica.com