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

NKMax America Presents Promising Clinical Research Findings at 2020 ASCO Virtual Conference

SANTA ANA, Calif., May 29, 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 the publication of three abstracts in the ASCO Meeting Library — available in the Journal of Clinical Oncology and a poster presentation of one of the abstracts.

The 2020 ASCO Annual Meeting is a virtual event held May 29 – May 31, 2020 and represents the world’s largest gathering of oncology physicians, biotechnology executives, researchers, and investment analysts to discuss cutting-edge clinical research and therapeutics in oncology.

Abstract accepted for presentation:

Title: A randomized phase I/IIa study to evaluate the safety and efficacy of SNK-01 (autologous non-genetically modified natural killer cells with enhanced cytotoxicity) plus Pembrolizumab in patients with stage IV non-small cell lung cancer
Abstract Number: #3037
Abstract: https://meetinglibrary.asco.org/record/188811/abstract

Poster Session: Developmental Therapeutics – Immunotherapy
Presentation: https://meetinglibrary.asco.org/record/188811/video
Presented by Eo Jin Kim, M.D. (University of Ulsan and Asan Medical Center, Seoul, South Korea).

Highlights include:

  • The combination of SNK-01 and Pembrolizumab was safe without any dose limiting toxicity or significant adverse events.
  • Overall response rate (ORR) via RECIST 1.1 in the combination arm was 44% and significantly higher compared to Keytruda alone with an 8-month median progression free survival and a median overall survival that had not yet been met. Patients treated at the highest dose of NK cells had a 50% ORR.
  • Of note is that among patients with PD-L1 expression 1 – 50%, the overall response rate in the combination group was 40%.
  • Patients treated with the combination arm had no treatment related toxicity and better overall quality of life compared to 25% Grade 3-5 toxicity in the Keytruda alone arm.

Additional accepted abstracts include:

Title: Phase I study of SNK-01 (autologous non-genetically modified natural killer cells with enhanced cytotoxicity) in refractory metastatic solid tumors
Abstract Number: #e15024
Abstract: https://meetinglibrary.asco.org/record/189214/abstract

Title: Natural killer cells and their activity as a potential biomarker for predicting response to checkpoint inhibitors in non-small cell lung cancer
Abstract Number: #e15559
Abstract: https://meetinglibrary.asco.org/record/188948/abstract

“We are very excited to share our data at ASCO and believe our robust clinical program is helping to establish the key role that NK cells play in checkpoint inhibitor therapy,” said Paul Song, M.D., NKMax Vice Chairman and Chief Medical Officer, “Our diagnostic work using our proprietary NK Vue test (which measures natural killer cell activity) strongly indicates that NK cell activity may be more predictive of response to checkpoint inhibitors than PD-L1 expression or microsatellite instability.”

Dr. Song also commented, “Our combination trial with Keytruda seems to validate this as the overall response rate among patients with 1 to 50% PDL1 expression was 40% when patients received both Keytruda and SNK-01. Equally promising is how SNK-01 appears to reduce the incidence of checkpoint inhibitor associated toxicity. We look forward to expanding on these results with our next set of clinical trials.”

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, 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.

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 To Present Data from Natural Killer Cell Immunotherapy Clinical Program at the ASCO20 Virtual Scientific Program

SANTA ANA, Calif. – April 30, 2020 – NKMax America, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, today disclosed its three abstract titles related to SNK-01, an autologous NK cell adoptive immunotherapy for the upcoming 2020 American Society of Clinical Oncology (ASCO) annual meeting, being held virtually.

Abstracts accepted by ASCO highlight data from our SNK-01 clinical trials and research:

Title: A randomized phase I/IIa study to evaluate the safety and efficacy of SNK01 (autologous non-genetically modified natural killer cells with enhanced cytotoxicity) plus Pembrolizumab in patients with stage IV non-small cell lung cancer

Abstract Number: #3037

Poster Session: Developmental Therapeutics – Immunotherapy

 

Title: Phase I study of SNK01 (autologous non-genetically modified natural killer cells with enhanced cytotoxicity) in refractory metastatic solid tumors

Abstract Number: #e15024

 

Title: Natural killer cells and their activity as a potential biomarker for predicting response to checkpoint inhibitors in non-small cell lung cancer

Abstract Number: #e15559

 

“We are pleased to be given the opportunity to present some promising results of two clinical trials using our proprietary natural killer cell therapy SNK-01,  as monotherapy for advanced refractory solid tumors (clinicaltrials.gov identifier NCT0394126) and in combination with a checkpoint inhibitor for advanced lung cancer. We are also excited to present the initial results of our natural killer cell activity test as a predictive tool for checkpoint inhibitor response,” said Paul Song, M.D., Vice Chairman and Chief Medical Officer at NKMax America. “We believe that our NK cell technology platform is distinguished by its ability to achieve near total activating receptor expression and greatly enhanced cytotoxicity, as well as our ability to easily manufacture unprecedented commercial scale amounts which make it unique in this exciting space.”

Abstracts will be released by ASCO on May 13, 2020, at 5:00 PM EDT on abstracts.asco.org.

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, 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.

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

Irina Koffler
Managing Director
LifeSci Advisors, LLC
646-970-4681
ikoffler@lifesciadvisors.com

NKMax America Announces Acceptance of Three Abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting

SANTA ANA, Calif., March 31, 2020 — 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 the acceptance of three abstracts for the upcoming 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.

“We are pleased to be given the opportunity to present promising results showcasing our proprietary natural killer cell therapy, which can now be manufactured in our new cGMP-compliant facility in California,” said Dr. Paul Song, M.D., Vice Chairman and Chief Medical Officer at NKMax America. “We are getting closer to helping cancer patients by achieving our goal of bringing an innovative natural killer cell therapy and companion diagnostic to the clinic as quickly as possible.”

Abstracts will be released by ASCO on May 13, 2020, at 5:00 PM EDT on abstracts.asco.org.

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, 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.

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

Irina Koffler
Managing Director
LifeSci Advisors, LLC
646-970-4681
ikoffler@lifesciadvisors.com

NKMax America to Present at the Upcoming NIH-AACR Cancer, Autoimmunity, and Immunology Conference

SANTA ANA, Calif. – March 17, 2020 – 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 Dr. Paul Song, Vice Chairman and Chief Medical Officer of NKMax America, has been selected to present at the upcoming NIH-AACR Cancer, Autoimmunity, and Immunology Conference on March 23-24, 2020.

The conference has been changed to a virtual conference by its organizers.

Presentation Title: Use of SNK-01 (Autologous Non-Genetically Modified Natural Killer Cells with Increased Cytotoxicity) in Combination with Pembrolizumab in Solid Tumors to Improve Tumor Response and Decrease Checkpoint Inhibitor Related Toxicity.

Dr. Song will discuss the significant role that natural killer cells play in improving overall tumor response to checkpoint inhibitors for both PD-L1 positive and PD-L1 negative tumors. He will also discuss their potential to reduce checkpoint inhibitor-related toxicity. Dr. Song will highlight NKMax America’s proprietary natural killer cell expansion/activation technology and discuss NKMax’s clinical experience with combination immune checkpoint-based therapy.

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, 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.

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

Irina Koffler
Managing Director
LifeSci Advisors, LLC
646-970-4681
ikoffler@lifesciadvisors.com

NKMax America to Present at Immuno-Oncology Summit Europe 2020

SANTA ANA, Calif. – March 9, 2020 – 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 Dr. Paul Song, Vice Chairman and Chief Medical Officer of NKMax America, will present at Cambridge Healthtech Institutes 5th Annual Combination Immunotherapy: Targeting Immunotherapy Combinations for Increased Clinical Efficacy conference taking place March 11 -12, 2020.

Presentation Details:
Date: Wednesday, March 11, 2020
Time: 4:45 pm GMT
Location: Hilton London Canary Wharf, London, UK
Title: The Role of Autologous Natural Killer Cells in Combination with Immune Checkpoint Inhibitors and Antibodies in Cancer

Dr. Song will discuss the significant role that natural killer cells play in the antibody-dependent cell-mediated cytotoxicity (ADCC) pathway and as well as being a key contributor to the overall responsiveness of tumors to checkpoint inhibitors. He will highlight NKMax America’s proprietary natural killer cell expansion/activation technology and clinical experience in ADCC and immune checkpoint-based therapy.

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, SNK, 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 GMP 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

Irina Koffler
Managing Director
LifeSci Advisors, LLC
646-970-4681
ikoffler@lifesciadvisors.com

NKMax America to Present Corporate Overview at the Cowen & Company 40th Annual Health Care Conference

SANTA ANA, Calif. – March 3, 2020 – 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 Dr. Paul Song, MD, Vice Chairman and Chief Medical Officer, will present a corporate overview at the Cowen & Company 40th Annual Health Care Conference, taking place March 2-4, 2020 at the Boston Marriott Copley Place in Boston, Massachusetts.

Presentation Details:
Date: Wednesday, March 4
Time: 8 am Eastern Time
Location: MIT, 3rd floor

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, SNK, 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 GMP 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

Irina Koffler
Managing Director
LifeSci Advisors, LLC
646-970-4681
ikoffler@lifesciadvisors.com