Carisma Presents Pre-Clinical Proof of Concept for in vivo CAR-M using mRNA platform in collaboration with Moderna at SITC
Carisma Presents Pre-Clinical Proof of Concept for in vivo CAR-M using mRNA platform in collaboration with Moderna at SITC
- Data demonstrate feasibility, tolerability, and early efficacy of mRNA/LNP in vivo CAR-M therapy in pre-clinical models of metastatic solid tumors
- Proof of concept achieved for platform under the Moderna collaboration
- "In vivo CAR-M: Redirecting endogenous myeloid cells with mRNA for cancer immunotherapy" to be presented Friday, November 3, 2023, at 11:30 am PT
PHILADELPHIA, Oct. 31, 2023 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that it will present new findings at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting regarding its first-of-its-kind collaboration with Moderna. The collaboration aims to bring together Carisma’s chimeric antigen receptor macrophage (CAR-M) platform with Moderna’s mRNA and lipid nanoparticle (LNP) technologies to generate and develop in vivo CAR-M therapeutics.
Accepted as a late-breaking presentation, “In vivo CAR-M: Redirecting endogenous myeloid cells with mRNA for cancer immunotherapy,” showcases data that demonstrate Carisma’s CAR-M therapy can be directly produced in vivo, or within the body, successfully redirecting endogenous myeloid cells against tumor-associated antigens using mRNA/LNP. The pre-clinical data demonstrate feasibility, tolerability, and efficacy against metastatic solid tumors. This novel approach to cancer immunotherapy offers an off-the-shelf solution that has the potential to increase access to CAR-based therapies and will be the basis of CAR-M programs to be developed under the Carisma and Moderna collaboration.
“The data presented at SITC is incredibly exciting as it demonstrates that we have the ability to make CAR-M directly in vivo with mRNA/LNP technology, leading to robust and targeted anti-tumor activity,” said Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma. “This off-the-shelf approach to treat cancer with engineered myeloid cells, developed in collaboration with Moderna, has the potential to transform the CAR field and be applied to numerous cancer targets and indications.”
“We are pleased to share data about the successful application of our mRNA platform to advance in vivo cell therapy,” said Lin Guey, PhD, Chief Scientific Officer of External Research Ventures at Moderna. “We look forward to the continuation of our pre-clinical work with Carisma and are optimistic that the joint scientific knowledge of both companies will accelerate the development of novel in vivo CAR-M therapies for patients.”
Details of Carisma data accepted for presentation at the SITC 38th Annual Meeting are as follows:
- “In vivo CAR-M: Redirecting endogenous myeloid cells with mRNA for cancer immunotherapy” presented on Friday, November 3, 2023, at 11:30 am PT
- “CAR-Macrophages with custom intronic shRNA exhibit enhanced efficacy against solid tumors” presented on Friday, November 3, 2023, 9:00 am – 7:00 pm PT
- “Engineered Microenvironment Converters (EM-C): Macrophages expressing synthetic cytokine receptors reverse immunosuppressive signals in solid tumors” presented on Friday, November 3, 2023, 9:00 am – 7:00 pm PT
- “A Phase 1, First in Human (FIH) study of autologous macrophages engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants (pts) with HER2 overexpressing solid tumors” presented on Friday, November 3, 2023, 9:00 am – 7:00 pm PT
Presentation and posters will be available on the SITC 38th Annual Meeting portal for registered attendees.
About Carisma
Carisma Therapeutics Inc. is a clinical stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.
Cautionary Note on Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma’s business, strategy, future operations, cash runway, the advancement of Carisma’s product candidates and product pipeline, and pre-clinical and clinical development of Carisma’s product candidates, including expectations regarding timing of initiation and results of pre-clinical and clinical trials. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “outlook,” “plan,” “project,” “potential,” “predict,” “target,” “possible,” “will,” “would,” “could,” “should,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” set forth in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Carisma’s other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
Media Inquiries:
Carisma to Present First Results From in vivo CAR-M Collaboration with Moderna at SITC 2023
Carisma to Present First Results From in vivo CAR-M Collaboration with Moderna at SITC 2023
-Late-breaking abstract to be presented on November 3rd at 11:30 am PT highlighting pre-clinical data with Moderna
-Two additional pre-clinical data abstracts highlighting next-generation enhancements to Carisma's cell therapy platform to be shared
PHILADELPHIA, Oct. 25, 2023 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that new pre-clinical data leveraging an mRNA platform to develop in-vivo chimeric antigen receptor macrophage (“CAR-M”) will be presented as a late-breaking abstract (#LBA1514) at the upcoming Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting held from Wednesday, November 1, to Sunday, November 5, 2023, in San Diego, California. Two posters highlighting next-generation enhancements to Carisma’s CAR-M platform, including a custom intronic shRNA approach and data on Engineered Microenvironment Converters (EM-C), will also be presented. Additionally, Carisma will share a trial-in-progress poster overviewing its Phase 1 first-in-human (FIH) study design of its lead program, CT-0508, sharing objectives and eligibility criteria.
Carisma will participate in the virtual SITC 2023 Annual Meeting Press Conference on Wednesday, November 1, 2023, from 12:00–1:30 pm PT.
“We are excited to present this pre-clinical data from our collaboration with Moderna for the first time,” said Steven Kelly, President and Chief Executive Officer of Carisma. “Over the past year, we have leveraged the expertise of both companies to pioneer the development of in-vivo mRNA/LNP-based cell therapy. The study is exploring the potential for an off-the-shelf treatment approach to enhance therapeutic benefit for patients living with cancer.”
Oral & Poster Presentations:
- In vivo CAR-M: Redirecting endogenous myeloid cells with mRNA for cancer immunotherapy
- Primary Author: Bindu Varghese, PhD
- Presentation Type/#: Oral – 1514
- Session Date/Time (PT): Friday, November 3, 2023, 11:30 am, Session 104: Late Breaking Abstract Session
- CAR-Macrophages with custom intronic shRNA exhibit enhanced efficacy against solid tumors
- Primary Author: Chris Sloas, PhD
- Presentation Type/#: Poster – 307
- Session Date/Time: Friday, November 3, 2023, 9:00 am – 7:00 pm
- Engineered Microenvironment Converters (EM-C): Macrophages expressing synthetic cytokine receptors reverse immunosuppressive signals in solid tumors
- Primary Author: Chris Sloas, PhD
- Presentation Type/#: Poster – 389
- Session Date/Time: Friday, November 3, 2023, 9:00 am – 7:00 pm
- A Phase 1, First in Human (FIH) study of autologous macrophages engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants (pts) with HER2 overexpressing solid tumors
- Primary Author: Kim Reiss, MD
- Presentation Type/#: Poster – 635
- Session Date/Time: Friday, November 3, 2023, 9:00 am – 7:00 pm
Presentation and posters will be available in the Journal for ImmunoTherapy of Cancer (JITC) supplement once published on Tuesday, October 31, 2023, at 9:00 am ET.
About CT-0508
CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. Carisma is selecting participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for our CAR-M. The Phase 1 clinical trial marks the first time that engineered macrophages are being studied in humans. The trial continues to enroll patients at seven clinical sites in the U.S., including (i) Penn Medicine’s Abramson Cancer Center, (ii) the University of North Carolina Lineberger Comprehensive Cancer Center, (iii) the City of Hope National Medical Center, (iv) the MD Anderson Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi) Oregon Health & Science University and (vii) Fred Hutchinson Cancer Center.
About Carisma
Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.
Cautionary Note on Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma’s business, strategy, future operations, cash runway, the advancement of Carisma’s product candidates and product pipeline, and clinical development of Carisma’s product candidates, including expectations regarding timing of initiation and results of pre-clinical and clinical trials. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “outlook,” “plan,” “project,” “potential,” “predict,” “target,” “possible,” “will,” “would,” “could,” “should,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” set forth in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Carisma’s other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
Media Inquiries:
Immatics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine® IMA203 TCR-T Monotherapy
Immatics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine® IMA203 TCR-T Monotherapy
- RMAT designation granted by FDA CBER for IMA203 cell therapy in multiple PRAME-expressing tumors including cutaneous and uveal melanoma, ovarian cancer and other cancer types
- Regulatory activities underway with an initial focus on a registration-directed trial in melanoma as step one to leverage the full breadth of PRAME
Houston, Texas and Tuebingen, Germany, October 24, 2023 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced that its IMA203 TCR-T program has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA Center for Biologics Evaluation and Research (CBER) in multiple relapsed and/or refractory HLA-A*02:01-positive and PRAME-expressing cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial sarcoma, and ovarian cancer. IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.
“The FDA RMAT designation for multiple indications underscores the broad potential of IMA203 and the benefits it may provide for advanced-stage solid tumor patients. This is an important regulatory milestone and a recognition of our clinical development progress for this program,” said Cedrik Britten, Chief Medical Officer of Immatics. “The close support from the FDA resulting from the RMAT status enhances our efforts to accelerate bringing IMA203 to cancer patients by enabling real-time discussions on patient populations, trial design and CMC.”
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation programs. An investigational cell therapy is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints for accelerated approval and potential ways to satisfy post-approval requirements, potential priority review of the biologics license application (BLA) and other opportunities to expedite development and review.
Based on publicly available information1, it is the Company’s understanding that this is the first time that FDA has granted a RMAT designation for an oncology drug candidate for more than two solid tumor indications. As of Sep 30, 2023, the U.S. FDA has received at least 238 requests for RMAT designations and granted 922.
About IMA203 and target PRAME
ACTengine® IMA203 T cells are directed against an HLA-A*02:01-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers, thereby supporting the program’s potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogeneously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform, XPRESIDENT®. Through its proprietary TCR discovery and engineering platform XCEPTOR®, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine® IMA203.
ACTengine® IMA203 TCR-T is currently being evaluated in three ongoing Phase 1b dose expansion cohorts in last-line patients: Cohort A IMA203 GEN1 monotherapy, Cohort B IMA203 in combination with an immune checkpoint inhibitor (deprioritized) and Cohort C IMA203CD8 GEN2 monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor.
About ACTengine®
ACTengine® is a personalized cell therapy approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor. The approach is also known as TCR-engineered cell therapy (TCR-T). All Immatics’ ACTengine® product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.
The ACTengine® T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth.
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About Immatics
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates, you can also follow us on Twitter, Instagram and LinkedIn.
Forward-Looking Statements:
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics’ future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics’ focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.
For more information, please contact:
| Media | |
| Eva Mulder or Charlotte Spitz | |
| Trophic Communications | |
| Phone: +31 65 2331 579 | |
| Investor Relations | |
| Sabrina Schecher, Ph.D. | |
| Senior Director, Investor Relations | |
| Phone: +49 89 262002433 | |
1 Source: https://bioinformant.com/rmat/
2 Source: FDA – https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/cumulative-cber-regenerative-medicine-advanced-therapy-rmat-designation-requests-received-fiscal
MinervaX Raises EUR 54M in Upsized Financing to Advance the Development of its Maternal Vaccine Against Group B Streptococcus
MinervaX Raises EUR 54M in Upsized Financing to Advance the Development of its Maternal Vaccine Against Group B Streptococcus
- New investment from EQT Life Sciences and OrbiMed with participation from existing investors
- MinervaX will hold financial reserves of more than €125 million, following the financing
- The financing supports the Company’s efforts to commence a Phase III clinical trial of its Maternal Vaccine against Group B Streptococcus
Copenhagen, Denmark, 11 October 2023 – MinervaX ApS, a privately held Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS), has today announced the completion of a EUR 54 million upsized financing. The financing includes investment from new investors EQT Life Sciences and OrbiMed, with participation from existing investors Novo Holdings, Pureos Ventures, Sanofi Ventures, Trill Impact Ventures, Adjuvant Capital, Wellington Partners, Industrifonden, Sunstone LifeScience Ventures, and LF Invest. Vincent Brichard of EQT Life Sciences and Tal Zaks of OrbiMed will join the MinervaX Board of Directors.
GBS is a leading cause of life-threatening infections in newborns as well as adverse pregnancy outcomes such as preterm delivery and stillbirths. Current prophylactic measures provide insufficient protection, meaning there is an urgent need to accelerate the development of a GBS vaccine. A video describing the unmet medical need for a GBS vaccine and details of MinervaX’s novel GBS maternal vaccine can be found on the Company’s website, here: https://youtu.be/HvkRJBqsjjY.
The Company is currently progressing two Phase II clinical trials in 470 pregnant persons across Denmark, United Kingdom, Uganda and South Africa. Initial data from these clinical trials are highly positive and demonstrate that the vaccine has an acceptable safety profile, is highly immunogenic and gives rise to functionally active antibodies. Details of MinervaX’s clinical trials can be found at clinicaltrials.gov under the identifiers NCT04596878 and NCT05154578. In addition to pregnant persons, MinervaX is also pursuing Phase I development of its novel GBS vaccine in Older Adults, under identifier NCT05782179.
This financing will enable MinervaX to progress its novel GBS vaccine towards Phase III clinical trials in 2024.
Per Fischer, CEO of MinervaX, said: “The addition of EQT Life Sciences and OrbiMed to our existing investor consortium further strengthens the Company’s resolve to advance our novel GBS vaccine towards Phase III clinical trials in pregnant persons. It also provides additional validation and recognition of the acceptable safety profile and strong data demonstrated in the Phase II clinical trials. We are delighted to welcome Vincent Brichard and Tal Zaks to the board of directors, who will bring invaluable vaccine expertise as we continue to address the pressing need for the development of a novel vaccine to address the unmet medical burden of Group B Streptococcus.”
Vincent Brichard, Venture Partner EQT Life Sciences, commented: “EQT Life Sciences is thrilled to take an active part in the MinervaX prophylactic vaccine against GBS with the hope to save newborns’ lives. We are impressed by the clinical data achieved so far, the quality of the team and the near-term milestones enabling MinervaX to start a registration trial.”
Tal Zaks, Partner at OrbiMed, added: “We recognize the unmet need for better protection against GBS disease for vulnerable populations and the potential for MinervaX’s vaccine to provide best-in-class efficacy. I look forward to working with the MinervaX team to support the full development of this program.”
ENDS
For further information please contact:
MinervaX
Per Fischer | Chief Executive Officer
Email:
Optimum Strategic Communications
Mary Clark / Stephen Adams/ Zoe Bolt
Email:
Tel: +44 (0) 203 882 9621
Notes to Editors:
About MinervaX
MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization, and now also for vaccination of older adults, with Phase II data suggesting superior efficacy compared with other GBS vaccine candidates in development. The latter are based on traditional capsular polysaccharide (CPS) conjugate technology. By contrast, MinervaX’s vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS (the Alpha-like protein family). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX’s vaccine will confer protection against virtually 100% of all GBS isolates. www.minervax.com
About Group B Streptococcus (GBS)
GBS is responsible for nearly 50% of all life-threatening infections in newborns. At any given time, some 15-25% of women are spontaneously colonized with GBS, and they run the risk of transmitting the bacteria to their child in the womb, during birth and/or during the first months of life. GBS colonization may lead to late abortions, premature delivery, or stillbirth and, in the newborn child, may result in sepsis, pneumonia or meningitis, all of which carry a significant risk of severe morbidity, long- term disability or death.
Currently, the only preventative strategy available involves the use of intravenously delivered prophylactic antibiotics which cannot comprehensively prevent GBS infection in utero and do not protect against late-onset infection in newborns. Not only is this approach expensive and logistically challenging, it fails to cover all, including the most severe cases in the US and Europe, and is rarely available in resource- limited settings. Finally, it carries the risk for increasing antibiotics resistance, a recognized worldwide health threat.
The development of a GBS vaccine is also endorsed by Group B Strep Support and Group B Strep International, and GBS has been prioritized by several public health organizations including the WHO. Both increased uptake of immunization among pregnant women and greater awareness of the implications of GBS suggest that a safe and effective vaccine targeting GBS would be well suited to address this unmet need.
About EQT Life Sciences
EQT Life Sciences was formed in 2022 following an integration of LSP, a leading European life sciences and healthcare venture capital firm, into the EQT platform. As LSP, the firm raised over EUR 3.0 billion (USD 3.5 billion) and supported the growth of more than 150 companies since it started to invest over 30 years ago. With a dedicated team of highly experienced investment professionals, coming from backgrounds in medicine, science, business, and finance, EQT Life Sciences backs the smartest inventors who have ideas that could truly make a difference for patients.
More info: www.eqtgroup.com
Follow EQT on LinkedIn, Twitter, YouTube and Instagram
About OrbiMed
OrbiMed is a healthcare investment firm, with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed’s team of over 100 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, London and other key global markets.
More info: www.orbimed.com
Sidekick Health announces landmark acquisition, expanding its portfolio to offer regulated Prescription Digital Therapeutics
Sidekick Health announces landmark acquisition, expanding its portfolio to offer regulated Prescription Digital Therapeutics
The acquisition of aidhere strengthens Sidekick Health’s digital health offering to patients and partners with the world’s leading PDT company
Las Vegas, October 10, 2023 – Sidekick Health, a global leader in digital health innovation, is poised to transform the landscape of digital therapeutics with the strategic acquisition of aidhere, a leading developer of prescription digital therapeutics (PDT) based in Germany.
In a significant move that underscores Sidekick Health’s commitment to furthering the impact of digital healthcare, the company is thrilled to announce its expansion into the direct prescribing space working collaboratively with healthcare providers.
This acquisition brings with it zanadio, one of the most successful PDTs launched to date. zanadio has fulfilled over 50,000 prescriptions and is recognized within Germany’s regulated nationwide DiGA (Digitale Gesundheitsanwendungen) formulary for prescribable digital apps. Achieving long-term behavioral change and significant weight loss of 8% in patients at the end of 12 months[1], and with over 10,000 doctors prescribing it, zanadio is fully reimbursed for patients with a BMI from 30 to 40 kg/m². As a permanently approved DiGA, zanadio is reimbursed by all statutory health insurers in Germany.
Sidekick Health’s CEO, Dr. Tryggvi Thorgeirsson, shared that the decision to acquire aidhere was fueled by the shared PDT vision and cultural alignment of the two organizations. “Developing and distributing prescribed therapeutics has always been core to our long-term vision, and when we were introduced to aidhere’s remarkable products and exceptional team, we knew that joining forces was the right step to take,” said Thorgeirsson.
This strategic acquisition places Sidekick Health at the forefront of the industry, while presenting exciting opportunities for the introduction of a new offering to Payer partners in the US, and the co-development of prescription digital therapeutic products with global pharmaceutical partners.
By integrating aidhere’s expertise and products into its portfolio, Sidekick Health strengthens its position as a trusted partner for global health insurers and pharmaceutical giants as it pioneers the introduction of PDTs.
In addition to the newly formed PDT business, Sidekick Health’s business is primarily centered on two areas: payers in the US and global pharma. Within the US payer landscape, the company has notably collaborated with the largest US health insurer, and is live with US insurance partners in Medicare, Medicaid and commercial populations. In the pharmaceutical sector, it has cultivated strategic partnerships with industry giants like Pfizer and Eli Lilly, with multiple live programs in both the US and Europe, and expanding to more markets in 2024.
The acquisition brings together the passion, knowledge, and experience of two industry leaders. Sidekick Health’s robust digital health ecosystem, a patient-centric platform with multi-chronic capabilities that supports over 20 disease areas, coupled with aidhere’s expertise in highly-regulated PDTs, creates a synergy poised to redefine patient-centric care. With its platform approach, Sidekick Health is positioned to emerge as a natural consolidator in the digital therapeutics space.
“aidhere has a strong and respected track record within the digital health industry, with one of the most successful PDT products in the world. This acquisition brings market-leading products and a depth of expertise in prescription digital therapeutics to Sidekick, as we enhance and build on our patient care offerings in the digital health and therapeutics space with our global partners,” said Thorgeirsson.
Sidekick Health’s recent success in closing its Series B fundraising round in May 2022 laid the foundations for the company to accelerate innovation and drive even greater impact in the digital health and therapeutics sector. Notable investors in Sidekick Health include Novator Partners, Asabys Partners, Frumtak Ventures, and Wellington Partners.
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About Sidekick Health
Sidekick Health is a digital health and therapeutics innovator founded by two passionate medical doctors on a mission to improve the health of humanity. Sidekick provides a uniquely wide range of digital health programs (including oncology, cardiovascular, metabolic, inflammatory, and other chronic conditions), engaging and empowering people to make positive changes, and improve their health outcomes and quality of life. Sidekick’s Adaptive CarePaths combine multiple programs into one, enabling multi-chronic care to support the growing number of people living with multiple chronic conditions.
Sidekick works with health insurers, including the largest U.S. health insurer, and pharmaceutical companies, including Eli Lilly and Pfizer, to improve patient outcomes, drive clinical efficiency, and lower the cost of care. Sidekick currently operates in multiple global markets and across the U.S., including patients in all insurance classes (Medicare, Medicaid, and Commercial).
Sidekick has offices in Boston, Berlin, Hamburg, Reykjavik, and Stockholm. To learn more, visit www.sidekickhealth.com.
Media Contact:
Serene Touma
Senior Director of Marketing & Communications
+49 1522 6788040
eGenesis Announces Publication in Nature of Landmark Preclinical Data Demonstrating Long-Term Survival with Genetically Engineered Porcine Kidneys
eGenesis Announces Publication in Nature of Landmark Preclinical Data Demonstrating Long-Term Survival with Genetically Engineered Porcine Kidneys
- Proof of concept study resulted in life-supporting organ function and recipient survival of over two years
- Donor kidneys carrying human transgenes resulted in longer survival time
Cambridge, Mass. (Oct 11, 2023) – eGenesis, a biotechnology company developing human-compatible (HuCo™) organs for the treatment of organ failure, today announced publication in the journal Nature of long-term survival data from a proof-of-concept study evaluating engineered porcine donor kidneys transplanted into a cynomolgus macaque model. This dataset will support advancement of the company’s lead candidate for kidney transplant,
EGEN-2784, toward clinical development.
These results represent the largest and most comprehensive preclinical dataset published in the field to date. Recipient survival in the preclinical setting has historically been measured in weeks or months. The publication titled: “Design and Testing of a Humanized Porcine Donor for
Xenotransplantation,” reported long-term survival of NHP recipients of the company’s genetically engineered porcine kidneys. In the case of one recipient, survival of over two years (758 days) was achieved.
“At eGenesis, we are focused on transformational progress for the field – improving long-term survival for transplant recipients from months to years,” said Michael Curtis, Ph.D., Chief Executive Officer of eGenesis. “Our HuCoTM organs offer the hope of a new donor source for the hundreds of thousands of individuals in need of lifesaving organ transplants. The data published in Nature illustrate our rapid advancement in engineering porcine donor organs to enhance recipient compatibility and long-term survival, a critical step toward successful translation in human clinical trials.”
The donor kidneys evaluated in this study carried three types of edits: (1) knock out of three genes involved in the synthesis of glycan antigens implicated in hyperacute rejection, (2) insertion of seven human transgenes involved in the regulation of several pathways that modulate rejection: inflammation, innate immunity, coagulation, and complement, and (3) inactivation of the endogenous retroviruses in the porcine genome.
Donor kidneys carrying human transgenes resulted in longer survival time when transplanted into NHPs. Donor kidneys containing only knock out of the three-glycan antigens experienced poor graft survival, whereas those harboring the knock outs and human transgenes resulted in more than seven times longer duration – a median of 24 days versus 176 days, respectively. The results indicate the benefit of human transgene expression in porcine kidney grafts onlong-term survival.
In vitro functional analysis showed that edited porcine kidney endothelial cells modulated inflammation in a manner that mirrored human endothelial cells, suggesting the edited cells acquired a high level of human immune compatibility. Furthermore, the evaluation of renal function biomarkers in recipients with stable grafts revealed that a single transplanted porcine kidney provided sufficient filtration of metabolites to compensate for the lack of two native kidneys.
“This is a major step forward for the field of transplantation,” said Tatsuo Kawai, M.D., Ph.D., Professor of Surgery at Harvard Medical School and A. Benedict Cosimi Chair in Transplant Surgery at Massachusetts General Hospital. “One of the biggest hurdles has been long-term survival of the genetically engineered organ in the NHP recipient, and this dataset demonstrates remarkable progress in editing the porcine genome to minimize hyperacute rejection, improve recipient compatibility and address the risk of viral transmission from donor to host. We anticipate that transplant outcomes in humans will be even more favorable, as these gene edited organs are a better match for humans, as compared with NHPs.”
The data generated in this study will support the advancement of the company’s lead candidate for kidney transplant, EGEN-2784, toward clinical development. eGenesis is also progressing programs for extracorporeal liver perfusion as well as cardiac transplant.
Organ failure is a life-threatening condition for which transplantation is considered the gold standard treatment. However, the demand for organs far outstrips supply – of the more than 100,000 individuals on the organ transplantation waitlist in the U.S., less than 40% will receive a potentially life-saving organ. In addition, the existing organ failure treatment paradigm is suboptimal for patients and the healthcare system due to organ incompatibility and variable donor organ quality.
About eGenesis
eGenesis is pioneering a genome engineering-based approach in the development of safe and effective transplantable organs. The eGenesis Genome Engineering and Production (EGEN™) Platform is the only technology of its kind to comprehensively address cross-species molecular incompatibilities and viral risk via genetic engineering. eGenesis has demonstrated durable preclinical success to date and is advancing development programs for acute liver failure, kidney transplant, and pediatric as well as adult heart transplant. Learn more at
www.egenesisbio.com.
Media Contact
Kimberly Ha
eGenesis