Palo Alto-based biotech startup to mass manufacture clinical-grade iPSCs for cell therapy

I Peace, Inc. | July 16, 2020

I Peace, Inc. (CEO: Koji Tanabe, https://ipeace.com/), a Palo Alto-based biotech startup focusing on Nobel Prize-wining technology of induced pluripotent stem cells (iPSCs) has successfully developed a novel system to mass manufacture clinical-grade iPSCs for cell therapy in a palm-size closed cassette. The system was developed in collaboration with FANUC CORPORATION (Head Office: Oshino, Yamanashi Prefecture, Japan; CEO: Kenji Yamaguchi). The technology is modular and scalable with a small footprint, paving the way for simultaneous mass production of clinical-grade iPSCs from a multitude of donors in a single facility. Induced pluripotent stem cells (iPS cells or iPSCs) are stem cells induced from somatic cells that are reprogrammed to an embryonic stem cell-like state by introducing special factors (genes). iPSCs are able to become any type of cells in the body and proliferate almost indefinitely, like an embryonic stem cell. Unlike embryonic stem cells, iPSCs can be made from matured cells in the body, such as skin or blood cells, from anyone. iPSCs-derived cell therapy generated from a patient's own cells minimizes the risk of immune rejection. It is expected to change the course of regenerative medicine, drug discovery, and personalized medicine. Unlike other stem cells such as mesenchymal stem cells (MSCs) and hematopoietic stem cells (HSCs), iPSCs can differentiate into all tissue and cell types, can be made with a small amount of cells, and can be grown to quantities necessary. These unique abilities make iPSCs unrivaled as stem cells of choice for patient-specific cell therapy and drug discovery.  For example, COVID19/SARS-CoV-2-targeted lung cells, differentiated from patient-derived iPSCs, are a valuable in vitro disease model and can be used for drug and vaccine discovery for SARS-CoV-2.

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Other News

OPKO Health Acquires ModeX Therapeutics, Gains Proprietary Immunotherapy Technology with a Focus on Oncology and Infectious Diseases

OPKO Health | May 10, 2022

OPKO Health, Inc. (NASDAQ: OPK), a multinational biopharmaceutical and diagnostics company, today announced the acquisition of ModeX Therapeutics, Inc. a privately held biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious diseases. OPKO acquired ModeX for $300 million in OPKO common stock. Founded in October 2020 with headquarters in Natick, Mass., ModeX Therapeutics has developed highly flexible multi-specific antibody technology platforms with broad targeting and functional capabilities, simpler manufacturing and potentially better specificity and safety, providing significant differentiation from competing platforms. The design of these multi-specifics is amenable to gene-based delivery by mRNA or DNA vectors. The ModeX product portfolio includes cancer immunotherapies that combine four specificities into one protein to improve targeting and immune killing, as well as masking or “stealth” technology to improve tumor-specific killing and reduce side effects. For viral diseases, the lead targets of a broad and potent multi-specific antibody portfolio include HIV and SARS-CoV-2. A vaccine for Epstein-Barr virus is also in development. The acquisition of ModeX Therapeutics significantly broadens our technology foundation and expands our product pipeline to include multi-specific multi-functional antibodies focused on a range of cancers and infectious diseases, with applicability to other therapeutic areas. We believe the promise of better outcomes for patients treated with these multi-specific antibodies represents a next generation of large molecule therapeutics and the next chapter of OPKO, We welcome ModeX’s co-founders Dr. Zerhouni and Dr. Nabel, as well as Alexis Borisy to our Board of Directors, and Dr. Zerhouni and Dr. Nabel to OPKO’s executive management team. The ModeX executive team brings to OPKO a wealth of experience, knowledge and industry contacts, which we expect will have a tremendous long-term positive impact on OPKO as we advance their technology and product pipeline and leverage potential synergies with our current portfolio in diagnostics and therapeutics.” Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. Elias Zerhouni, M.D., Co-Founder and Chairman of the Board of ModeX, has been appointed President and Vice Chairman of the Board of Directors of OPKO. Dr. Zerhouni brings extensive experience in academia, government and industry as a leading authority on emerging trends and issues in medical care and biomedical research and development. A physician scientist with an academic background in imaging and biomedical engineering, Dr. Zerhouni most recently served as President of Global Research & Development and Executive Vice President of Sanofi. Dr. Zerhouni also served as Director of the National Institutes of Health (NIH), Senior Fellow for Global Health Research at the Bill and Melinda Gates Foundation, Presidential U.S. Envoy for Science and Technology, and Professor and Chair of the Russell H. Morgan Department of Radiology and Biomedical Engineering, Executive Vice Dean and Dean for Research at the Johns Hopkins School of Medicine. Dr. Zerhouni was elected to the National Academy of Medicine and to the National Academy of Engineering. He serves on the Board of the Lasker Foundation, the Foundation for NIH, the Davos Alzheimer’s Collaborative and Research!America. He received the 2017 Scripps Executive of the Year Award for the pharmaceutical industry and the French Legion of Honor in 2008. He has been a director of Danaher Corporation since 2009. Being part of OPKO represents a transformative opportunity for both companies. We anticipate it will accelerate ModeX’s product pipeline focused on unmet needs in oncology and infectious diseases and the development of our innovative technologies, and also will take advantage of synergies with OPKO’s programs, ModeX has operated quietly since we were founded 18 months ago on the basis of over 10 years of prior foundational work. We have assembled a world-class executive team with outstanding public and private sector leadership experience to advance our programs. Our lead drug candidate is already in the clinic while several others in late preclinical stages are expected to enter clinical development in 2023. We were enticed to join OPKO by its leadership’s vision and enthusiasm for strengthening our mutual potential for breakthrough innovation.” Dr. Zerhouni. Gary Nabel, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of ModeX, has been appointed Chief Innovation Officer of OPKO and joins OPKO’s Board of Directors. Dr. Nabel, a renowned virologist and immunologist, served as Chief Scientific Officer and Senior Vice President of Sanofi where he directed the breakthrough laboratory that developed tri-specific products now in early clinical development. He is the founding director of the NIH’s Vaccine Research Center, working on vaccines and broadly neutralizing antibodies against HIV, influenza, SARS, Ebola, Chikungunya and Epstein-Barr virus. He was previously an investigator at the Howard Hughes Medical Institute at the University of Michigan. In recognition of his expertise at the forefront of virology, immunology, gene therapy and molecular biology, Dr. Nabel was elected to the National Academy of Medicine, is a fellow of the American Association of Physicians and the American Academy of Arts Sciences, and was awarded the Geoffrey Beene Builders of Science Award from Research!America. Alexis Borisy, the Lead Independent Director of ModeX, also joins OPKO’s Board of Directors. Mr. Borisy is a leading biotechnology entrepreneur and investor with more than 25 years of experience, including founding, serving as Chief Executive Officer and/or Chairman of nine NASDAQ-listed companies. He co-founded and served as either the Chief Executive Officer or Chairman of Blueprint Medicines, Foundation Medicine, Relay Therapeutics, Tango Therapeutics, Celsius Therapeutics and CombinatoRx. With the additions of Dr. Zerhouni, Dr. Nabel and Mr. Borisy to OPKO’s Board, the number of Directors expands to 13. About OPKO Health, Inc. OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies.

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MEDICAL

Anixa Biosciences Announces the Initiation of its Ovarian Cancer CAR-T Phase 1 Trial at Moffitt Cancer Center

Anixa | March 31, 2022

Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, today announced the initiation of a Phase 1 trial evaluating its novel chimeric antigen receptor T-cell (CAR-T) therapy in ovarian cancer. The CAR-T approach used for Anixa's therapy is known as chimeric endocrine receptor T-cell (CER-T) since the target of the engineered T-cells is an endocrine receptor. The Phase 1 trial at Moffitt Cancer Center will evaluate the safety and efficacy of Anixa's therapy in patients with ovarian cancer. Anixa holds an exclusive, worldwide license for the technology, which was developed at the Wistar Institute. While CAR-T therapy has shown efficacy in some hematological tumors, reproducing the same results with solid tumors, such as ovarian cancer, has proven challenging. One of the reasons for this difficulty is that effective CAR-T therapy needs a specific antigen to recognize that is only present on target cancer cells in order to avoid negatively affecting healthy cells. The CER-T therapy being evaluated in Anixa's Phase 1 study differs from traditional CAR-T in that it targets the follicle stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells in healthy adult females. We are thrilled to have partnered with world-class scientists at Moffitt Cancer Center to advance our CER-T platform and feel that this partnership provides a critical opportunity to make a significant impact on the treatment of solid tumors, We strongly believe that our unique targeting approach differentiates our CER-T platform from traditional CAR-T approaches and that CER-T has potential to work in solid tumors where other therapies have failed." Dr. Amit Kumar, President, CEO and Chairman of Anixa Biosciences. CAR-T therapies are rapidly becoming an important player in cancer therapy, and our lab has developed a technology that has the potential to target tumors by using an existing biological mechanism that is well understood. If our CER-T approach is successful, it could serve as a model for future targeted CAR-T therapies in other cancer types. The goal in cancer therapy has always been to kill cancer cells with limited damage to healthy tissue, and we look forward to seeing how this CER-T therapy may be able to accomplish that in solid tumors, which have historically proven challenging to eradicate with cell therapy." Jose R. Conejo-Garcia, M.D., Ph.D., Chair of the Department of Immunology at Moffitt Cancer Center and co-inventor of the CER-T technology. About Anixa's CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology) Anixa's chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T. About Anixa Biosciences, Inc. Anixa is a clinical-stage biotechnology company with a number of programs addressing cancer and infectious disease. Anixa's portfolio of therapeutics includes a cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology, and, with partner MolGenie GmbH, a COVID-19 program focused on compounds targeting the Mpro enzyme of SARS-CoV-2, which is largely conserved across all recently identified variants like Delta and Omicron. The company's vaccine portfolio includes a novel vaccine being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on clinical development allows the company to continually examine emerging technologies in complementary fields for further development and commercialization

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INDUSTRIAL IMPACT

Calyxt Announces Pricing of Offering Of Common Stock and Warrants and Updates Business and Risk Factor Disclosure

Cellectis Inc. | February 19, 2022

Cellectis, a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, and Calyxt, Inc. , a majority-owned subsidiary of Cellectis S.A., announced the placement to an institutional investor in an underwritten offering of (i) 3,880,000 shares of Calyxt common stock, (ii) pre-funded warrants to purchase up to 3,880,000 shares of its common stock, and (iii) common warrants to purchase up to 7,760,000 shares of its common stock. The shares of common stock and the pre-funded warrants were each sold in combination with corresponding common warrants, with one common warrant to purchase one share of common stock for each share of common stock or each pre-funded warrant sold. The pre-funded warrants will have an exercise price of $0.0001 per share of Calyxt common stock and the common warrants will have an exercise price of $1.41 per share of Calyxt common stock. The pre-funded warrants will be immediately exercisable and remain exercisable until exercised, while the common warrants will be exercisable six months after the date of issuance and will have a term of five years from the date of exercisability. The aggregate public offering price for each share of common stock or each pre-funded warrant and, in each case, an accompanying common warrant was $1.41. All securities sold in the Offering were sold by Calyxt. In connection with the Offering, Calyxt disclosed certain preliminary estimated financial information as of December 31, 2021: Calyxt’s cash and cash equivalents was $13.7 million, restricted cash was $0.6 million, total current liabilities were $4.1 million, and financing lease obligations, including current portion, were $17.9 million. This preliminary financial information, which has not been audited, is based on information currently available to Calyxt and is subject to the completion of Calyxt’s year-end financial closing procedures. It is possible that Calyxt’s independent registered public accounting firm may identify items that require Calyxt to make adjustments to the preliminary estimates set forth above and those changes could be material. In connection with the Offering, Calyxt also provided an updated description of certain aspects of its business and updated the risk factor disclosure from Calyxt’s prior filings with the U.S. Securities and Exchange Commission. About Cellectis  Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR-T cells to treat cancer patients, and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 21 years of expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to treat diseases with unmet medical needs. As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing lifesaving UCART product candidates for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple myeloma (MM). .HEAL is a new platform focusing on hemopoietic stem cells to treat blood disorders, immunodeficiencies and lysosomal storage diseases.   Cellectis headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market and on Euronext Growth.   About Calyxt Calyxt is a plant-based synthetic biology company. The Company leverages its proprietary PlantSpring™ technology platform to engineer plant metabolism to produce innovative and high value plant-based chemistries for use in customers' materials and products. As plant-based solutions, the Company's synthetic biology products can be used in helping customers meet their sustainability targets and financial goals. Calyxt's diversified offerings are primarily delivered through its proprietary BioFactory™ production system.

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INDUSTRIAL IMPACT

O2 Invests in Modular Devices, Inc.

O2 Investment Partners ( | January 24, 2022

O2 Investment Partners announced that it has partnered with Modular Devices, Inc. and its President & CEO, Greg Mink, to support the Company’s continued growth. Terms of the deal were not disclosed. Founded in 1987, Modular Devices, Inc. is a leading provider of mobile and modular medical imaging equipment labs and cleanroom solutions throughout the United States. MDI’s medical imaging solutions offer various imaging modalities through short- and long-term leases to healthcare systems of all sizes. MDI is the only company offering modular cath labs as a stock-standard product available for rent. The Company’s cleanroom division serves the pharmaceutical, biotechnology, and manufacturing sectors by providing standard and customized pre-certified ISO and USP compliant units for lease and for sale. MDI is headquartered in Indianapolis, IN. “We are experiencing rapid growth and feel that we are at a key moment in our company’s evolution. I believe that O2 is the optimal partner to continue our track record of success and capitalize on MDI’s growth initiatives in the healthcare, pharmaceutical, and biotechnology markets.” Greg Mink, President & CEO of MDI Pat Corden at O2 commented, “Greg and the MDI team have built a very exciting business with a reputation for delivering best-in-class products and services to its customers. O2 is excited to partner with MDI and looks forward to supporting the business in its next stage of development. We would also like to thank our financial partner, Maranon Capital for their support in this transaction.” MDI is the sixth platform investment for O2’s most recent fund, O2 Investment Partners Fund III. O2 and MDI are aggressively pursuing M&A opportunities to expand the Company’s product and service offering. About Modular Devices, Inc. Founded in 1987, Modular Devices, Inc. is a leading provider of mobile and modular medical imaging equipment labs and cleanroom solutions throughout the United States. MDI’s medical imaging solutions offer various imaging modalities through short- and long-term leases to healthcare systems of all sizes. MDI is the only company offering modular cath labs as a stock-standard product available for rent. The Company’s cleanroom division serves the pharmaceutical, biotechnology, and manufacturing sectors by providing standard and customized pre-certified ISO and USP compliant units for lease and for sale. MDI is headquartered in Indianapolis, IN. About O2 Investment Partners O2 Investment Partners is a Midwestern based private equity firm that seeks to acquire majority interests in lower middle market B2B services, technology, and select industrial companies. The firm invests in businesses with earnings growth potential and a clear path to the creation of shareholder value. O2 invests with a view toward partnering with management to build and grow the business and take it to its next stage of development. This requires not only a clear vision and strategic plan to create shareholder value, but a close partnership and alignment of interest with management.

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Spotlight

Want to become a biomedical engineer but not sure where to focus or how to get there? This engineering course will give you an overview of this wildly popular and vast field, as you learn about more than two dozen areas of focus and get a peek at some of the cool and exciting advances going on at top institutions. Along the way, you’ll meet more than three dozen biomedical engineers—from top names in the field to those just starting their careers.

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