BIOTECH (129) VLP Therapeutics: Self-Amplifying mRNA in Virus-Like Particle

(Picture: Akahata Wataru 박사)

안녕하세요 보스턴 임박사입니다.

일본 바이오텍은 미국과 연계된 창업을 많이 하는데 이에 대한 좋은 예가 있어서 소개하고자 합니다.

VLP Therapeutics는 Akahata Wataru 박사가 NIH에서 포스닥을 하면서 연구한 Virus-Like Particle (VLP) Platform에 기반한 기술을 사용합니다. 2010년 Nature Medicine에 발표를 했습니다.

A virus-like particle vaccine for epidemic Chikungunya virus protects nonhuman primates against infection. Nat. Med. 2010, 16, 334-338. Wataru Akahata et al.

2013년 Akahata Wataru 박사등 5명이공동으로창업을 했습니다.

미국과 일본에서 연구비를 받아서 초기의 연구를 진행하다가 2021년에 $37 Million Series A를 했습니다. 현재 Self-Amplifying RNA-LNP 백신인 COVID-19 Vaccine이 임상3상을 진행 중이고 VLP 백신인 Malaria 백신이 임상2상에 있고 VLP 백신인 Dengue Vaccine이 IND-enabling study를 진행하고 있습니다.

2017년에 미국 NIH SBIR grant를 Cancer vaccine 연구과제로 받았습니다.

Development of a novel Virus Like Particle vaccine based cancer immunotherapy targeting PD L – SBIR.gov 9/20/2017

$298,729.00

Cancer immunotherapy has revolutionized today s treatments for many forms of cancers In particular blocking antibodies to immune checkpoint proteins such as programmed cell death PD and its ligand programmed cell death ligand PD L effectively unleash immune cell destruction of cancerous cells. However the high cost of these antibody-based immunotherapies their intensive therapeutic regimen and availability only at specialized medical centers make current immunotherapies impractical in all but the most advantaged societies. We hypothesize that an effective vaccine which can overcome these significant shortcomings of antibody-based immunotherapies while simultaneously mimicking their potent therapeutic benefits can impact the lives of countless more patients in particular a vaccine that induces durable levels of host antibodies against the tumor associated PD L protein will have powerful anti tumor effects by inhibiting the PD L PD immunosuppressive checkpoint interaction. We at VLP Therapeutics have developed a proprietary plug and play vaccine platform called inserted alphavirus virus like particle i VLP using the Chikungunya CHIK VLP VLPs mimic the conformation of native viruses without the viral
genome
thus capable of stimulating a robust host response absent safety issues Foreign antigens can be inserted into the surface loop domains of i VLP Due to its unique structure i VLP can efficiently present a dense array of copies of the inserted antigen on the particle surface i VLP induces highly effective immune responses to the inserted antigen and CHIK VLPs have shown acceptable safety profiles in a Phase I clinical trial. We propose to establish proof of concept of our PD L targeting vaccine s efficacy in a triple negative breast cancer TNBC like model given that TNBCs have shown some responsiveness to PD L PD antibody therapies in clinical trials and there remains a high unmet need for effective therapies against this particularly aggressive form of breast cancer which has the worst five year survival prognosis among all breast cancers and for which standard chemotherapy treatment is largely ineffective.
The goal of this proposal is to determine the extent to which vaccination with our proprietary i VLP based PD L vaccine PD L VLP can mimic the effects of passive PD L monoclonal antibody therapy This study will provide the basis for advancing this exciting approach into clinical trials To create this vaccine we propose the following Specific Aims:

  • Aim: Determine the ability of PD L VLP to stimulate the production of antibodies that bind to tumor
    associated PD L and inhibit its binding to the T cell immune checkpoint receptor PD in murine models.
  • Aim: Determine the therapeutic effects of PD L VLP vaccination in a PD PD L antibody therapy sensitive murine tumor model benchmarked against PD L monoclonal antibody treatment.
  • Aim: Determine whether potential immune related adverse events including autoimmunity can be induced by our PD L VLP vaccine Narrative Cancer immunotherapy in particular blocking antibodies to immune checkpoint proteins effectively unleash immune cell destruction of cancerous cells However their high cost intensive therapeutic regimen and limited availability only at sophisticated medical centers make current antibody based immunotherapies impractical in all but privileged societies An effective vaccine directed against the tumor associated PD L protein which mimics the therapeutic benefits of antibody based PD L immunotherapy while overcoming its significant shortcomings described above will have powerful anti tumor effects.

3월의 시리즈 A와 12월의 시리즈 A-1에 모두 SK Impact Fund가 참여를 했습니다. 코로나 팬데믹 동안에 COVID-19 Vaccine 개발로 펀딩이 될 수 있었던 것 같습니다. 일본 바이오텍 벤처는 미국과 달리 서서히 기술개발을 이어가면서 공동연구를 주로 하는 방법으로 회사가 성장을 합니다. VLP Therapeutics는 saRNA-LNP 혹은 saRNA-VLP 백신 개발을 하는데 기대가 많이 됩니다.

VLP Therapeutics raises $16M Series A for cancer treatment vaccine R&D – Press Release 3/15/2021

US-based biotech company VLP Therapeutics, Inc. (VLPT) announced on March 15 that it has raised US$16 million in a Series A funding round from MIYAKO Capital Co., Ltd., Sojitz Corporation, Konishiyasu Co., Ltd. in Japan, and three existing investors in the US (Mr. Robert G. Hisaoka, SK Impact Fund, LLC, and RJ Fund, LLC) for research and development of a cancer treatment vaccine. With this funding, VLPT aims to accelerate the project well underway in the US and move into clinical trials at the earliest date possible.

“I have a high hope for VLP Therapeutics to become a leading company with its innovative platform technologies in the fields of infectious diseases and cancer, deep-rooted with CEO Wataru Akahata’s continuing commitment to virus and vaccine research and extensive experience of clinical trials,” says Dr. Hiroyuki Misawa, director and partner of MIYAKO Capital Co., Ltd. “It is my great pleasure to back up, as a shareholder, a biotech company with such advanced technologies.”

“I am optimistic that the innovative vaccines now being developed at VLP Therapeutics will make a significant contribution to the treatment of cancer, the prevention of malaria and dengue fever, and the fight against new threats such as COVID-19. In turn, I believe this will improve health and well-being for all and advance the development of medicine,” says Masayoshi Fujimoto, president and CEO of Sojitz Corporation. “We, Sojitz Corporation, are very pleased to work with VLPT CEO Wataru Akahata, an ambitious scientist with considerable experience in vaccine R&D, as well as with the members of the research team and the company founders who are well-versed in pharmaceutical development. We will do whatever we can to help VLPT grow going forward.”

“Since its inception over 190 years ago, we, Koshishiyasu, have been devoted to making the world a better place through the sales of industrial chemicals. It is therefore our great honor to invest in the cancer treatment vaccine R&D underway at VLP Therapeutics, which is also combating malaria and Covid-19 with its novel technologies.” says Toshiyuki Konishi, president and CEO of Konishiyasu Co., Ltd. “We are confident that, by financially supporting VLPT, we can contribute to the well-being of society, and they will make further progress in their vaccine R&D efforts.”

VLP Therapeutics raises $21M Series A-1 for cancer treatment vaccine, infectious diseases vaccine R&D – PR Newswire 12/27/2021

US-based biotech company VLP Therapeutics, Inc. (VLPT) announced on December 27 that it has signed an agreement for an investment of US$21 million in a Series A-1 round from six investors, consisting of two new investors: Nobelpharma Co., Ltd. and MUFG Bank, Ltd., and four existing investors: Sojitz Corporation, MIYAKO Capital Co., Ltd., Mr. Robert G. Hisaoka and SK Impact Fund, LLC.

With this funding, VLPT aims to further accelerate the research and development of a cancer treatment vaccine as well as prophylactic vaccines against malaria, dengue, etc. and move into clinical trials at the earliest date possible. This is an additional investment following US$16 million raised in a Series A round in March 2021.

“I have long committed to the research and development of vaccines against cancer and infectious diseases so the people across the globe can lead normal lives,” says Wataru Akahata, CEO and co-founder of VLPT. “We were fortunate enough to be able to raise funding in March to facilitate our cancer treatment vaccine R&D. This additional funding will now allow us to further accelerate our other R&D efforts in infectious diseases area as well. This means a lot as it helps us to push our scientific endeavors forward at much faster pace, enabling us to get one step closer in making a greater social impact.”

About VLP Therapeutics: VLP Therapeutics, Inc. (VLPT), co-founded in 2013 by Drs. Wataru Akahata, Ryuji Ueno, and Sachiko Kuno, is a Gaithersburg, MD-based biotech company with a mission to address unmet medical needs worldwide and expand the frontiers of vaccine treatment. Led by CEO Akahata VLPT is currently engaged in research and development of a cancer treatment vaccine as well as prophylactic vaccines against malaria, dengue, etc. using VLPT’s proprietary platform technologies.

Cell Reports에 낸 논문에 saRNA-LNP COVID-19 백신의 임상1상 결과를 보고했는데 BioNTech의 백신 30 mcg과 비교하여 VLP의 3 mcg 용량으로도 동등하거나 우수함을 증명했습니다. 기존 백신과 차별점은 RBD-anchoring을 한 것이 특징입니다.

최근에 medRxiv에 낸 논문에서는 5-methylcytidine modified saRNA에 대한 연구결과를 보고했습니다.

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