Category: News

MEM-288 to be studied in patients with cancers not responding to checkpoint inhibitors including non-small cell lung cancer and triple-negative breast cancer

Initiation of patient screening in Phase 1 study of MEM-288 expected by 12/31/2021

HOUSTON, Nov. 3 (BUSINESS WIRE) – Memgen, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for MEM-288, the company’s wholly-owned cancer immunotherapy candidate for the treatment of multiple solid tumors. Memgen intends to initiate screening of patients by year-end in a Phase 1 first-in-human study.

“The FDA’s acceptance of our IND for MEM-288 is an important milestone in our pursuit of developing life-saving cancer immunotherapies in collaboration with leading cancer centers including the H. Lee Moffitt Cancer Center and the Duke Cancer Institute,” said Mark Cantwell, Ph.D., Chief Scientific Officer of Memgen. “We expect to initiate this first-in-human study in patients with non-small cell lung cancer, as well as those with other types of cancer, by year-end.”

Memgen’s Phase 1 trial is an open-label, dose escalation study designed to evaluate the safety, tolerability, biologic activity and anti-tumor effects of MEM-288. In addition to non-small cell lung cancer (NSCLC), the trial may enroll patients with triple-negative breast cancer, pancreatic cancer, head and neck cancer, melanoma, cutaneous squamous-cell carcinoma, and Merkel cell carcinoma. Except for patients with pancreatic cancer, these are patients whose disease has progressed following treatment with anti-PD-1/PD-L1 therapy, and who have tumor lesions accessible for injection.

Duke Cancer Institute and the H. Lee Moffitt Cancer will be the initial clinical trial sites. Memgen expects patient recruitment to begin by December 31, 2021. Additional information about the study, including patient inclusion and exclusion criteria, can be found at ClinicalTrials.gov under study identifier NCT05076760.

The study will evaluate the oncolytic effect of MEM-288 as well as the activation of the patients’ immune system including T-cells. While the focus of the initial Phase 1 study will be patients with NSCLC, MEM-288 has shown robust anti-tumor effects in 13 different types of cancer. Once safety and tolerability have been evaluated in this trial, Memgen plans to expand clinical development of MEM-288 across multiple cancers and in combination with an immune checkpoint inhibitor.

About MEM-288

MEM-288 is an oncolytic adenovirus encoding transgenes for human interferon beta (IFNß) and the company’s proprietary recombinant chimeric CD40 ligand. MEM-288, armed with Memgen’s proprietary CD40 ligand, leverages a validated target that powerfully activates the patient’s immune system. The company’s proprietary CD40 ligand has been evaluated in earlier clinical studies and demonstrated significant immune activation without the toxicity that had previously prevented development of safe CD40-based therapeutics. Because the CD40 system works as a master “on switch” for the immune system upstream from the immune checkpoint inhibitors, it holds promise in those patients whose disease has progressed despite treatment with immune checkpoint inhibitors.

About Memgen

Memgen is a clinical-stage biopharmaceutical company developing cancer immunotherapies to harness the power of the immune system to cure cancer. Its first-in-class immuno-oncology therapeutic candidates leverage the power of CD40 ligand, a uniquely powerful immune modulator. In tests in patients, the company’s proprietary CD40 ligand transgene has been shown to elicit powerful, antigen-specific, anti-tumor immune responses across a broad range of tumor types, without the toxicity typically seen by other approaches to activating CD40. Working with collaborators at top cancer research institutions, Memgen is advancing cancer treatments for patients who do not respond to currently available therapeutic options. For more information, visit www.memgenbio.com.

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Media contact:

Jeffrey Krasner
Emerging BioCommunications
(617) 840-9806
jeff@emergingbio.net

HOUSTON, November 18, 2020 (Newswire.com) – Memgen, a private biotechnology company developing novel treatments for cancer and COVID-19, today announced that John Poulos has joined the company’s Board of Directors.

“I am very pleased to join the board of Memgen at this transformational time in the company’s life,” noted Mr. Poulos. “Memgen’s strong and differentiated science hold promise both for patients with cancer and for an approach to COVID-19 that should be complementary to other approaches to vaccination. I look forward to helping the leadership team move these important treatments forward for the benefit of patients.”

Dr. Gregory Brown, Memgen’s CEO, also noted, “We are delighted to have John bring his extraordinary breadth of background and deep pharmaceutical expertise to bear as a member of Memgen’s board. We are confident that John will add tremendous value as a director both in supporting the company’s scientific progress and helping achieve positive business outcomes for the company.”

Mr. Poulos has a wealth of expertise in global corporate life sciences, having spent 38 years working for AbbVie and Abbott. Mr. Poulos served as Vice President, Head of Business Development and Acquisitions for AbbVie from 2013 until his retirement in 2016. John was also Group Vice President, Head of Pharmaceutical Licensing and Acquisitions for Abbott from 2005 until 2012. During his career with AbbVie and Abbott, John was instrumental in the negotiation of numerous acquisitions, including Knoll/BASF Pharma in 2001 for $6.9 billion, Kos Pharmaceuticals in 2006 for $3.7 billion, Solvay in 2010 for $6.2 billion and Pharmacyclics in 2015 for $21 billion. He also has negotiated numerous partnerships and transactions which were instrumental in building the Abbott/AbbVie pharmaceutical portfolio.

Mr. Poulos is currently President of GNK Advisors, a business development consulting firm, and on the board of Faron Pharmaceuticals Oy. Mr. Poulos earned a bachelor’s degree in marketing and an MBA in finance from Indiana University and was named the 2014 Frank Barnes Mentor Award recipient by the Licensing Executives Society.

About Memgen
Memgen is developing viral immunotherapies to harness the power of the immune system to cure cancer and to protect people from COVID-19 and other diseases.  Its first-in-class immune-oncology therapeutics are designed for the treatment of patients who do not respond to currently available therapeutic options. The Company’s lead cancer product, MEM-288, is engineered to both selectively target cancer cells and supercharge the immune system through expression of two unique and powerful immune modulators: CD40 ligand (CD40L) and the powerful cytokine interferon beta. MEM-288 has been demonstrated to generate a strong systemic anti-tumor immune response following intra-tumoral vaccination in multiple tumors. The Company expects to begin clinical testing with MEM-288 early in the coming year. Memgen’s COVID-19 vaccine adjuvant, MemVax, is designed to be used with other vaccine technologies to generate a strong, durable immune response to protect against COVID-19 and other infectious diseases. The Company’s pipeline products all utilize its proprietary CD40L transgene, MEM40, which has already been tested in human subjects and has demonstrated the ability to elicit powerful, antigen-specific anti-tumor immune responses across a broad range of tumor types. 

In this press release, unless the context requires otherwise, “Memgen”, the “Company,” “Companies,” “we,” “our,” and “us” refers to Memgen, Inc.

Investor Contact:
Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com

Media Contacts:
Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com

HOUSTON, July 28, 2020 — Memgen, Inc., a private biotechnology company developing innovative immune-based drugs for the control of infectious diseases and cancer, announced today that Dr. Thomas Monath, a world-renowned virologist and vaccinologist, has joined the Company’s Scientific Advisory Board. The addition of Dr. Monath highlights the potential of the Company’s vaccine program as it advances its COVID-19 vaccine candidate to the clinic.

Dr. Monath, Managing Partner and Chief Scientific Officer of Crozet Biopharma, has worked in leadership positions in US government agencies and in the biotechnology sector, and had primary responsibility for bringing multiple innovative vaccines into clinical development, including Ebola Zaire, cell based smallpox, dengue, Japanese encephalitis, West Nile, cytomegalovirus, influenza, live and inactivated yellow fever, Helicobacter pylori, Clostridium difficile, four of which are now licensed and commercialized.

In addition to Memgen, Tom serves on the boards of Juvaris Inc., Sentinext Plc, and US Biologic Inc. and on the Scientific Advisory Boards of RapidMicro Biosystems, GeoVax and SutroVax. Between 2006-2012, Dr. Monath was a Partner at Kleiner Perkins Caufield & Byers, a leading venture capital firm where he oversaw investments in the vaccine space. Before joining industry, Dr. Monath served in the uniformed services of US Public Health Service and the US Army, retiring as a Colonel. During that time, he was Director, Division of Vector-Borne Viral Diseases at the Centers for Disease Control and Prevention (CDC) and Chief, Virology Division at the US Army Medical Research Institute of Infectious Diseases (USAMRIID).

Tom received his AB degree from Harvard College and his MD from Harvard Medical School and is board certified in internal medicine. He has received many prestigious awards, including the Nathanial A. Young Award, the Richard M. Taylor Award, the Walter Reed Medal and the James H. Steele Award. He has served on numerous government and international committees on infectious diseases, biosecurity, WHO expert committees and the National Vaccines Advisory Committee (USA), and is Past-President of the American Society of Tropical Medicine and Hygiene and an elected Fellow of the Society. He has published over 425 scientific papers and 6 books on virology and vaccine development and has 35 patents.

Dr. Monath noted, “I am pleased and excited to join the Scientific Advisory Board of Memgen. The Company’s novel CD40 ligand technology offers differentiated potential as an immune stimulant and vaccine adjuvant, and I look forward to working with the company to develop products that will address COVID-19.”

Dr. Gregory Brown, Memgen’s CEO, stated, “We are honored and thrilled to have a professional of Dr. Monath’s stature join our Scientific Advisory Board, and to welcome him to the Memgen SAB. His expertise and insight into vaccine development will be a powerful addition to the team as we advance our COVID-19 vaccine candidates into the clinic.”

About Memgen
Memgen is developing new therapies to harness the power of the immune system to protect people from COVID-19 and other diseases, and to cure the most difficult cancers.  The Company’s pipeline products all utilize its proprietary CD40 ligand technology, MEM40, which has already been tested in people and has demonstrated the ability to elicit powerful, antigen-specific anti-tumor immune responses, while doing so safely. 

Memgen’s COVID-19 vaccine, MemVax, is designed to be used alone or in combination with other COVID-19 vaccines to generate a strong, durable immune response. MemVax is a highly specific immune stimulant that can work with COVID-19 antigens across a range of delivery approaches. Memgen has over 100,000 doses of MemVax ready to go into clinical trials, and an active file with the US FDA. Memgen plans to soon begin clinical trials of MemVax alone and in collaboration with other companies developing complementary COVID-19 vaccines.

The Company’s lead cancer immunotherapy, MEM-288, was developed in collaboration with Moffitt Cancer Center. It is an oncolytic virus engineered to selectively target cancer cells and to supercharge the immune system through expression of two unique and powerful immune modulators: MEM40 and the powerful cytokine interferon beta. MEM-288 generates a strong systemic anti-tumor immune response following intra-tumoral vaccination in multiple tumors. Memgen expects to begin clinical testing with MEM-288 in advanced cancers this year.

In this press release, unless the context requires otherwise, “Memgen”, the “Company,” “Companies,” “we,” “our,” and “us” refers to Memgen, Inc.

Investor Contact:
Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com

For Memgen: Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com

HOUSTON, June 2, 2020 /PRNewswire/ — Memgen, a private biotechnology company developing novel treatments for cancer and COVID-19, announced an abstract and upcoming poster presentation at the 2020 American Association of Cancer Research (AACR) Virtual Annual Meeting II on June 22-24, 2020.

The presentation summarizes preclinical research of Memgen’s cancer immunotherapy MEM-288, as both a single agent and combined with immune checkpoint inhibitors, in multiple tumor models. This research showed that a combination of MEM-288 with checkpoint inhibitors could reverse tumor resistance to checkpoint inhibitors alone, resulting in systemic tumor regression and 100% survival of animals. The research also showed tumor-selective lysis plus generation of systemic antitumor immunity leading to anti-metastatic activity for both MEM-288 as a single agent and combined with checkpoint inhibitors. This work was led by Amer Beg, PhD and his team at Moffitt Cancer Center. Beg has worked with Scott Antonia, MD, PhD, Director of Duke Cancer Institute Center for Cancer Immunotherapy and Mark Cantwell, PhD, Chief Scientific Officer of Memgen, to discover and develop MEM-288. Based on this and other supporting research, Memgen plans a Phase 1 clinical study of MEM-288 to treat patients with advanced lung cancer and other cancers later this year.

Details of the abstract and poster presentation are as follows:

• Title: Development of MEM-288, a dual-transgene armed and conditionally replication-enhanced oncolytic adenovirus with potent systemic antitumor immunity (Abstract #4578)
• Session Category: Immunology
• Session Title: Vaccines
• Date and Time: June 22, 2020 (9:00 a.m. – 6:00 p.m. EDT)

Abstract: https://www.abstractsonline.com/pp8/#!/9045/presentation/7619

About Memgen
Memgen is developing new therapies to harness the power of the immune system to potentially cure cancer and to protect people from COVID-19 and other diseases. The Company’s pipeline products all utilize its proprietary CD40L transgene, MEM40, which has already been tested in human subjects and has demonstrated the ability to elicit powerful, antigen-specific anti-tumor immune responses across a broad range of tumor types. 

The Company’s lead cancer immunotherapy, MEM-288, was developed in collaboration with Moffitt Cancer Center. It is an oncolytic virus engineered to selectively target cancer cells and to supercharge the immune system through expression of two unique and powerful immune modulators: MEM40 and the powerful cytokine interferon beta. MEM-288 generates a strong systemic anti-tumor immune response following intra-tumoral vaccination in multiple tumors. Memgen expects to begin clinical testing with MEM-288 in advanced cancers in the current year.

Memgen’s COVID-19 vaccine, MemVax, is an adjuvant designed to be used in combination with other COVID-19 vaccines to generate a strong, durable immune response. MemVax is a highly specific immune stimulant that can work with COVID-19 antigens across a range of delivery approaches. Memgen has over 100,000 doses of MemVax ready to go into clinical trials and an active file with the US FDA. Memgen plans to soon begin clinical trials of MemVax in collaboration with other companies developing complementary COVID-19 vaccines.

In this press release, unless the context requires otherwise, “Memgen”, the “Company,” “Companies,” “we,” “our,” and “us” refers to Memgen, LLC.

Investor Contact:
Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com

HOUSTON, TX – April 21, 2020 – Memgen, a private biotechnology company developing innovative immuno-oncology drugs and immune therapeutics, announced today that it has entered into technology licensing agreements with the Moffitt Cancer Center, a premier center for cancer research and care.

The agreements cover intellectual property developed jointly by scientists at Memgen and Moffitt, including Memgen’s lead product, MEM-288, as well as additional pipeline products. MEM-288, incorporating the new technologies, exhibits significantly enhanced tumor selectivity and strong activity against a broad range of tumor types. This work paves the way for MEM-288 to enter the clinic later this year, treating patients suffering from difficult-to-treat cancers.

“Oncolytic viruses are emerging therapeutics capable of specifically killing tumor cells and stimulating anti-tumor immunity,” said co-inventor of the technology Amer Beg, Ph.D., who is a senior member of Department of Immunology at Moffitt. “MEM-288 not only exhibits high tumor cell killing but also induces a potent anti-tumor immune response in animal models through expression of MEM40 and IFN beta. As a result, we believe that MEM-288 will have substantial benefit in cancer patients who do not respond to immune checkpoint inhibitors.”

Beg worked with Scott Antonia, MD, Ph.D., Director of Duke Cancer Institute Center for Cancer Immunotherapy and Mark Cantwell, Ph.D., Chief Scientific Officer of Memgen, to develop the technology.

Dr. Gregory Brown, Memgen’s CEO, noted, “We are very pleased to enter into these license agreements with Moffitt. Memgen and Moffitt have established a close and collaborative relationship that has already proven fruitful in generating actionable product candidates that are advancing toward the clinic.”

Haskell Adler, Ph.D., MBA, senior licensing manager in Moffitt’s Office of Innovation and Industry Alliances, added, “This deal highlights the significance of Drs. Beg and Antonia’s contributions to developing new immuno-oncology therapeutics to treat cancer patients.”

About Memgen
Memgen is a cancer immunotherapy company focused on creating drugs that harness the power of the immune system to cure cancer and other life-threatening diseases. Its first-in-class immune-oncology therapeutics are designed for the treatment of patients who do not respond to currently available therapeutic options. The Company’s lead product, MEM-288, is engineered to both selectively target cancer cells and supercharge the immune system through expression of two unique and powerful immune modulators: CD40 ligand (CD40L) and the powerful cytokine interferon beta. MEM-288 has been demonstrated to generate a strong systemic anti-tumor immune response following intra-tumoral vaccination in multiple tumors. The Company expects to begin clinical testing with MEM-288 in the current year. The Company’s pipeline products all utilize its proprietary CD40L transgene, MEM40, which has already been tested in human subjects and has demonstrated the ability to elicit powerful, antigen-specific anti-tumor immune responses across a broad range of tumor types.

In this press release, unless the context requires otherwise, “Memgen”, the “Company,” “Companies,” “we,” “our,” and “us” refers to Memgen, LLC.

Investor Contact:
Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com

Media Contact:
Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com

Houston, Texas – April 2, 2020 – Memgen, a private biotechnology company developing innovative immuno-oncology drugs, announced today that Christopher Pagano has joined the company’s Board of Directors.

“I am delighted to join the board of Memgen at this exciting time in the company’s development,” noted Mr. Pagano. “Memgen is exploiting leading-edge science to develop novel and effective treatments for cancer patients who currently face limited options, and it is gratifying to be able to contribute to moving these products closer to becoming a therapeutic reality.”

Dr. Robert Coates, Memgen’s Executive Chairman, stated, “We are pleased to be able to attract a professional of Chris’s caliber to Memgen, and welcome him to the board. Chris brings his extraordinary experience as a C-Suite financial executive at a Fortune 500 company to Memgen as well his intense interest in biotechnology. We look forward to working closely with him.”

Dr. Gregory Brown, Memgen’s CEO, also noted, “We are thrilled that Chris has joined the Memgen team, further enriching the leadership capabilities necessary to achieve our mission of delivering novel and effective cancer therapies through the clinic and to patients.”

Mr. Pagano has enjoyed a long and successful career, culminating in C-level positions with Assurant, Inc. a NYSE-traded insurance company, where he served successively as Chief Investment Officer, Chief Financial Officer, and Chief Risk Officer over twenty-three years. Previously he served as Portfolio Manager and Head of Fixed Income Asset Management at Assurance Asset Management and became its President and CIO shortly after the company’s successful IPO in 2004. He has an MBA from the University of Chicago Graduate School of Business, a BS in Economics from the University of Pennsylvania Wharton School, and has earned the Chartered Financial Analyst (CFA) designation.

About Memgen
Memgen is a cancer immunotherapy company focused on creating drugs that harness the power of the immune system to cure cancer. Its first-in-class immune-oncology therapeutics are designed for the treatment of patients who do not respond to currently available therapeutic options. The Company’s lead product, MEM-288, is engineered to both selectively target cancer cells and supercharge the immune system through expression of two unique and powerful immune modulators: CD40 ligand (CD40L) and the powerful cytokine interferon beta. MEM-288 has been demonstrated to generate a strong systemic anti-tumor immune response following intra-tumoral vaccination in multiple tumors. The Company expects to begin clinical testing with MEM-288 in the current year. The Company’s pipeline products all utilize its proprietary CD40L transgene, MEM40, which has already been tested in human subjects and has demonstrated the ability to elicit powerful, antigen-specific anti-tumor immune responses across a broad range of tumor types. 

In this press release, unless the context requires otherwise, “Memgen”, the “Company,” “Companies,” “we,” “our,” and “us” refers to Memgen, LLC.

Investor Contact:
Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com

Media Contacts:
Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com

Houston, Texas – March 17, 2020 – ​Memgen, a private biotechnology company developing innovative immuno-oncology drugs, announced today that its Board of Directors has appointed Gregory B. Brown, MD, as Chief Executive Officer. He currently serves and will remain on the Memgen board of directors. The company also announced that Robert Coates, PhD, founder and prior Chief Executive Officer, will become Executive Chairman.

“Having seen the scientific capability and execution at Memgen advance over the past four years, I am excited to assume the CEO role at such an important time in the company’s growth,” said Gregory B. Brown, Chief Executive Officer of Memgen. “As Memgen prepares to advance its lead program into clinical trials this year, based on consistently outstanding preclinical data, we have the opportunity to further develop a therapeutic that could provide meaningful benefit to cancer patients who currently have few effective options. I want to thank Bob Coates for his visionary and passionate leadership in Memgen’s early years and look forward to continuing to work closely with him in his new role as Executive Chairman.”

Dr. Coates added, “I am delighted to have someone of Greg’s caliber and experience take on the role as CEO of Memgen. The Board and I are highly confident that Greg will provide exceptional leadership to successfully advance our drug candidates and continue to propel Memgen forward.”

Dr. Brown assumes his position as CEO with a track record of success in the biotechnology, pharmaceutical and finance sectors. He was a founder and remains Vice Chairman and a member of the Senior Advisor Board of Healthcare Royalty Partners (“HCR Partners”), a private investment firm which purchases royalties and uses debt-like structures to invest in commercial or near-commercial stage biopharmaceutical assets, with $5.5 billion in cumulative capital commitments. Prior to HCR Partners, Dr. Brown was a Partner at Paul Capital Partners following a successful career in healthcare investment banking at Adams, Harkness and Hill and Vector Securities International. He began his career as a practicing thoracic and vascular surgeon in a community setting and has founded several healthcare businesses. He has served on the boards of directors of close to 20 private and public life science companies and currently serves on the boards of Aquestive Therapeutics (NASDAQ:AQST), Caladrius Biosciences, Inc. (NASDAQ:CLBS), and Faron Pharmaceuticals, Oy (LSE:FARN). He earned an MBA at Harvard Business School, an MD at SUNY Upstate Medical Center, and a BA at Yale University.

About Memgen
Memgen is a cancer immunotherapy company focused on creating drugs that harness the power of the immune system to cure cancer. Its first-in-class immune-oncology therapeutics are designed for the treatment of patients who do not respond to currently available therapeutic options. The Company’s lead product, MEM-288, is engineered to both selectively target cancer cells and supercharge the immune system through expression of two unique and powerful immune modulators: CD40 ligand (CD40L) and the powerful cytokine interferon beta. MEM-288 has been demonstrated to generate a strong, systemic anti-tumor immune response, following intra-tumoral vaccination in multiple tumors. The Company expects to begin clinical testing with MEM-288 in the current year. The Company’s pipeline products all utilize its proprietary CD40L transgene, MEM40, which has already been tested in human subjects and has demonstrated the ability to elicit powerful, antigen-specific anti-tumor immune responses across a broad range of tumor types.

In this press release, unless the context requires otherwise, “Memgen”, the “Company,” “Companies,” “we,” “our,” and “us” refers to Memgen, LLC.

Investor Contact:
Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com

Media Contacts:
Gregory B. Brown, M.D.
(203) 940-3742
gbrown@memgenbio.com