Camilla Fedi’s Post

Cell therapy is the future of medicine As Kadimastem's Director of Medical Affairs, I am keenly observing the evolving landscape of cell therapy in the healthcare sector. A recent highlight is the collaboration between Vertex Pharmaceuticals and TreeFrog Therapeutics, focusing on enhancing cell therapies for type 1 diabetes. This partnership aims to harness TreeFrog's C-Stem technology to advance the production of insulin-producing pancreatic islet cells, a critical step in potentially curing this challenging disease. In our own efforts at Kadimastem, we are deeply committed to advancing similar technologies. Our work involves developing off-the-shelf, allogeneic cell products derived from human embryonic stem cells. These products are designed to address unmet needs in various diseases by replicating essential functions of human tissues, such as the pancreatic cells that manage glucose levels through insulin production. This approach not only holds promise for diabetes treatment but also underscores the broader potential of cell therapies to transform patient outcomes across multiple disease states. We are inspired by collaborations that push the boundaries of medicine and look for collaboration and partnership in order to push forward our innovations. #CellTherapy #DiabetesTreatment #MedicalInnovation #Kadimastem

<!-- Content start --> PITTSBURGH, April 2, 2024. LyGenesis, a clinical-stage biotechnology firm growing cell therapies for big unmet medical wants, introduced right this moment that the primary affected person has been dosed of their Section 2a scientific trial evaluating their first-in-class allogenic regenerative cell remedy transplanted into sufferers’ lymph nodes as a possible remedy for end-stage liver illness (ESLD). “In a medical first, we have now now dosed our first affected person in a scientific trial utilizing their very own lymph nodes as residing bioreactors to regenerate an ectopic organ,” stated Dr. Michael Hufford, Co-Founder and CEO of LyGenesis. “This remedy will probably be a outstanding regenerative drugs milestone by serving to sufferers with ESLD develop new useful ectopic livers in their very own physique. If our research is profitable and we get hold of FDA approval, our allogenic cell remedy may allow one donated liver to deal with many dozens of ESLD sufferers, which may assist to tilt the present organ supply-demand imbalance in favor of sufferers.” Dr. Richard Marshall, CEO of Juvenescence, an investor in LyGenesis famous, “This scientific trial heralds greater than an necessary milestone within the research of bench-to-bedside translational drugs, it’s a prime instance of LyGenesis’s ongoing investigational efforts to translate cutting-edge revolutionary scientific discoveries, equivalent to utilizing the lymph nodes as a bioreactor to develop functioning ectopic organs, into scientific actuality for sufferers affected by life-threatening sicknesses. LyGenesis’ platform of regenerative cell therapies extends past ESLD to Sort 1 diabetes, renal illness, and growing old.” Justin Briggs, Working Associate at Prime Movers Lab, one other investor in LyGenesis, commented, “LyGenesis’ cell remedy platform represents a very outstanding potential industrial alternative and could also be transformative for power liver failure sufferers who shouldn’t have entry to a donor liver. Their use of an endoscopic ultrasound as a low threat and low value route of cell remedy administration is one other method this pioneering expertise may present sufferers with entry to life-saving therapies and deal with advanced medical challenges by upending transplant drugs.” About LyGenesis’ Liver Cell Remedy ProgramLYG-LIV-001 is an allogeneic cell remedy regulated by the FDA as a Part 351 Human Mobile Remedy/Product and as an investigational biologic product. This biologic remedy is created ranging from donated in any other case unmatched livers. A posh, multi-step Present Good Manufacturing Practices course of fastidiously isolates and suspends hepatocytes in an answer to prepared them for transplantation into that affected person’s higher stomach lymph nodes utilizing an endoscopic ultrasound, a minimally invasive method. The lymph nodes then act as in vivo bioreactors, serving to the

One of the most painful medical issues we see are degenerative joint conditions. There's typically very little therapy that can be leveraged to relieve patient suffering. The power of cell therapy is hoping to change this. DiscGenics have been working on an allogenic cell therapy for patients experiencing lumbar degenerative disc disease and have been granted approval for a phase 3 study for a single-dose of live, manufactured progenitor cells derived from donated adult human tissue. Unlike autologous cell therapies, there is no need for patient cells to be harvested and economies of scale can be leveraged for a single donor cell line. The phase 2 studies resulted in significant improvement in pain, function, quality of life, and disc volume, suggesting a regenerative effect from the therapy. https://lnkd.in/gFE5i32c

"It was surprising how potent [the therapy] worked in the xenograft model, especially because we were using relatively low doses. In the case of the CAR-T cell therapy, we were definitely surprised that double knockout of these two genes had such a stark effect." #DahliaConsulting #BiopharmaceuticalIndustry #CommercialLifeSciences #ManagementConsultant #LifeSciencesBusinessStrategy #GlobalPharma #GlobalBioTech #SupplychainOperations #CommercialOperations #CGTcommercialization #Manufacturing #QualityAssurance #OperationalExcellence #FinancialAnalysis #OpModelDesign #LifeScience #BioTechnology #Bioprocessing #Biosimilars #BioPharmaIndustry #MedicalResearch #CDMO #GMP #GMPbatch #GMPmanufacturing #GenomeEditing #GeneTherapy #CellTherapy #Car_T #mRNA #cGMP #ClinicalGradeManufacturing #ClinicalGradeProduction #BiologicsLicenseApplication #BLA #Pharmaceuticals #RegenerativeMedicine #CRISPRMedicineNews #TCRtCellTherapies #InVivo #Xenograft #Mesothelin #PancreaticCancer #OvarianCancer #NYESO #SolidTumors

Bicara Therapeutics Announces Oversubscribed $165 Million Series C Financing Clinical-stage biotech company Bicara Therapeutics has successfully secured an oversubscribed $165 million Series C financing, co-led by Braidwell LP and TPG Life Sciences Innovations, with participation from existing and new investors, including Deerfield Management and Aisling Capital. The funding will accelerate the clinical development of Bicara's lead bifunctional antibody, BCA101, designed to inhibit EGFR and disable TGF-β at the tumor site. Positive interim clinical data presented at the 2023 ASCO Annual Meeting and ESMO Congress demonstrated BCA101's anti-tumor activity and safety profile in 1L HPV-negative recurrent/metastatic head and neck squamous cell carcinoma. With a total of $273 million raised in 2023, Bicara aims to advance cancer treatments and solidify its position in oncology innovation. Full Artice Here: https://lnkd.in/ey_zX4FA #innovation #business #lifescience #biopharma #healthcare #global #regional #collaboration #crossborder #jointventure #investing #biothechnology #bitech #phamaceuticals #capitalmarket #stockmarket #venturecapital #fundraising #globaltrade #economy #economics #creativity #technology #raredisease #drugdevelopment #drugdiscovery #pharmaindustry #biopharmaceutical #mentalhealth #oncology #nuerology #cns #autoimmune #endocrinology #cardiovascular #immunology #gynecology #pulmonology #gastroenterology #anesthesiology #urology #cardiovascular #china #japan #korea #israel #latinameica #australia #europe #usa #shanghai #BicaraTherapeutics #SeriesCFinancing #CancerTreatment #BCA101 #OncologyInnovation #BiotechInvestment 

As covered by EP, Vertex Pharmaceuticals reporting first patient dosed for VX-264 is a step forward for their #regenerativemedicine program in T1D. VX-264 is the version 2.0 counterpart to VX-880, both acquired in the deal with Semma Tx. Background on the broader program: ‘264 and ‘880 are produced from stem cells that differentiate into pancreatic islet β cell clusters, which synthesize and secrete insulin. T1D is caused by autoimmune signaling that destroys β cells, eliminating the body's foundry of insulin production, another example of #immunology and #inflammation . VX-880 represents liver transplantation of billions of stem cells that differentiate into insulin-producing β cell-like islet clusters. These are ALLOgeneic cells, thus the host mounts an immune response requiring copious immunosuppressants. VX-264 cells are encapsulated in a channel array device designed to shield the cells from the body’s immune system. Vertex has other tricks up its sleeve; in July 2022, they acquired ViaCyte for $320 M, bringing in a suite of products, including the CyT49 pluripotent hESC line differentiated into pancreatic endoderm cells, and a suite of implantable containers such as PEC-Direct, which enables direct cell contact with blood vessels. Lastly, ViaCyte had a pre-existing collaboration with CRISPR Therapeutics to engineer allogeneic cells using CRISPR/Cas9. Similar to allo CAR-T such as CTX110, the B2M locus is knocked out to avoid attack from host T cells and HLA-E is knocked-IN to avoid detection by host NK cells. Additionally, the cells have a PD-L1 knock-in to exploit the immune checkpoint in the opposite direction to IO drugs like pembrolizumab. When housed in PEC-Direct, the product is referred to as VCTX210, obviating the need for immunosuppression, thus referred to as the “hypoimmune” program, which seems to be folded under the latest program, VCTX211 (co-dev and licensing pact between Vertex and CRISPR Tx worth $320 M). The co-sponsors report completed enrollment and dosing of the first group in the Phase I/II trial. Other approaches in this space include: 🔸 Sigilon Therapeutics, Inc.’s preclinical encapsulated islet cell therapy, SIG-002; Sigilon was acquired by notable diabetes drug developer, Eli Lilly and Company in a deal that could be worth $310 M including milestones 🔸 Sernova Corp.’s Phase I/II donor derived islet cells encased in a surgically implanted ‘Cell Pouch’ 🔸 Genprex, Inc.’s AAV gene therapy GPX-002, which delivers the Pdx1 and MafA genes to stimulate in vivo reprograming of pancreatic ductal α cells into functional β-like cells 🔸 Laverock Therapeutics' iPSC therapy leveraging its proprietary GEiGS technology that enables stable, tunable, and programmable gene silencing 🔸 CellTrans’ Lantidra – the first-approved (June 28) allogeneic (donor-derived) pancreatic islet cell therapy, but which requires immunosuppression https://lnkd.in/gSgX2-Km

Biotheus Inc. and BioNTech SE Join Forces to Develop and Commercialize Bispecific Antibody Targeting PD-L1 and VEGF for Solid Tumors     Clinical-stage biotech company Biotheus Inc. has partnered with BioNTech SE to develop and commercialize their promising bispecific antibody candidate PM8002, which targets PD-L1 and VEGF for multiple solid tumor indications. BioNTech will have exclusive global rights to PM8002, except in Greater China, where Biotheus will retain rights.     Biotheus will receive an upfront payment of $55 million and potential milestone payments exceeding $1 billion, as well as royalties on future sales. PM8002, currently in Phase 2 studies in China, combines anti-PD-L1 and anti-VEGF-A antibodies and has demonstrated positive safety and tumor-fighting activity. The partnership aims to advance PM8002 through global clinical trials to make it available to more patients.    Read full article here: https://lnkd.in/e9jrXnhZ   #innovation #business #lifescience #biopharma #healthcare #global #regional #collaboration #crossborder #jointventure #investing #biothechnology #bitech #phamaceuticals #capitalmarket #stockmarket #venturecapital #fundraising #globaltrade #economy #economics #creativity #technology #raredisease #drugdevelopment #drugdiscovery #pharmaindustry #biopharmaceutical #mentalhealth #oncology #nuerology #cns #autoimmune #endocrinology #cardiovascular #immunology #gynecology #pulmonology #gastroenterology #anesthesiology #urology #cardiovascular #china #japan #korea #israel #latinameica #australia #europe #usa #shanghai #MSQVentures #China #Biotheus #BioNTech  #BiopharmaInnovation #CancerResearch #GlobalPartnership #InnovativeTherapies #MedicalAdvancements #PatientCare #BiotechBreakthroughs 

An autologous and personalized regulatory T cell therapy is safe in patients with type 1 diabetes, but does not help preserve β-cell function. The investigational personalized autologous cell therapy, dubbed CLBS03, was initially developed by Caladrius Biosciences and consists mainly of the patient’s own regulatory T cells. After harvesting, these cells are allowed to expand in vitro and are functionally enhanced using a proprietary method, which in turn allows them to regulate effector T cells. In 2022, Caladrius merged with Cend Therapeutics and called the resulting entity Lisata Therapeutics. CLBS03's development is also backed by Sanford Health. #biotech #biopharma #T1D #CellTherapy

<!-- Content start --> NEW YORK, Could 17, 2024. A examine revealed in the present day in Nature Drugs discovered {that a} novel neuroprotective drug candidate, LM11A-31, was secure and well-tolerated following dosing for 26 weeks in sufferers with gentle to reasonable Alzheimer’s illness. LM11A-31 additionally slowed the development of a number of spinal fluid and imaging biomarkers. These encouraging outcomes assist LM11A-31 being studied in a bigger trial to additional consider its security and efficacy. The examine, which obtained funding by the Alzheimer’s Drug Discovery Basis (ADDF), displays ongoing progress as the sector strikes in the direction of a broader strategy guided by the biology of growing older, constructing the arsenal of Alzheimer’s remedies wanted to enrich present anti-amyloid therapies for mixture therapy. “Research like this one are shifting us nearer to the day after we might have a capsule to assist deal with Alzheimer’s,” says Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. “A decade in the past, it was unimaginable to see a novel drug advance to this stage within the pipeline. These outcomes are indicative of the fast evolution of the sector. Neuroprotective medicine signify the kind of therapies that can outline the subsequent era of Alzheimer’s remedies, which can goal the underlying biology of the illness in a mix remedy and precision medication strategy, just like most cancers care.” Part 2a exploratory research, akin to this one, that meet their major endpoint are beneficial for producing security and tolerability information within the goal inhabitants and offering medical and biomarker information to design well-informed and rigorous section 2b and three research. “We’re tremendously inspired by the findings of this examine and look ahead to uncovering how this drug, which has downstream results on a number of aging- and resilience-related pathways, will impression the slowing of cognitive decline within the examine’s subsequent section,” says Frank Longo, MD, PhD, Founding father of PharmatrophiX, George E. and Lucy Becker Professor of Drugs and Neurology at Stanford College, and inaugural Goodes Prize honoree. “With out ADDF funding, LM11A-31 wouldn’t have reached this milestone. My 25-year-long relationship with the muse started when this molecule was first found within the lab and has catalyzed this drug by means of fundamental mechanism and preclinical research to the medical section, exhibiting the significance of advancing translational analysis that can pave the best way for brand spanking new remedies and prevention methods for the tens of millions of sufferers residing with this illness.” LM11A-31 works by activating survival pathways and inhibiting degenerative pathways of nerve cells, addressing a number of Alzheimer’s-related pathologies together with resilience towards amyloid, discount of tau pathology, and discount of microglial

Congrats to Shinobi Therapeutics on being the latest addition to this list: "The Pipeline for iPSC-Derived Cell Therapeutics in 2024" - https://lnkd.in/et9S-vf Shinobi is developing a new class of immune-evasive iPSC-derived cellular therapeutics. Its Katana platform enables a master cell bank of untargeted iPSC-derived T cells that can support rapid pipeline expansion through the introduction of CARs or TCRs. Shinobi Therapeutics, Inc. was founded in 2023 by SHIN KANEKO and Tobias Deuse, MD. The company secured $51M in a Series A financing round in December 2023 that was led by EQT Life Sciences, F-Prime Capital and Eight Roads Ventures Japan, with participation from Astellas Venture Management, Fast Track Initiative (FTI), JIC VENTURES, and D3 LLC. Shinobi is using these funds to advance its Katana iPS-T cell therapy platform and progress its first program to treat GPC3+ solid tumor cancers toward the clinic. It is an exciting company that is working on iPSC-derived solutions to solid tumors. To learn more about raising funds for regenerative medicine industry ventures, view the "Global Database of Regenerative Medicine (RM) Industry Investors, 2024 – Featuring 300+ Investors" at this link: https://lnkd.in/g8f6k5h #ipscells #stemcells #advancedtherapies Fouad Azzam, Ph.D. Dan Kemp Robert Weisskoff Carl June