Meredith Hanel

The Link (previously called N1 sensor or Link 0.9) is a BCI device that is implanted into the brain to allow the user to control a computer or mobile device. The Link is connected to micron-scale threads inserted into areas of the brain to control movement. The Link transmits neural signals received from the neural threads, which contain electrodes to detect neural signals. The device uses an inductive charger that wirelessly connects to the implant to charge the battery. The shape of the Neurolink BCI device changed to be coin-shaped and fit flush with the skull, rather than the previous design resting near the ear. Musk stated that the device matches the thickness of the piece of skull that had been removed to insert it. Musk stated on X on January 29, 2024 that that Neuralink's first product is called TelapathyTelepathy.

The PRIME Study (Precise Robotically Implanted Brain-Computer Interface) is an investigational medical device clinical trial for Neuralink’s fully-implantable, wireless BCI that aims to evaluate the safety of the implant (N1) and surgical robot (R1), and the functionality of the BCI for enabling people with quadriplegia to control external devices with their thoughts. A small implant is placed in the part of the brain that controls movements which interprets neural activity. The device is designed to allow the person to operate a computer or smartphone by intending to move, without the requirement of physical movement. According to Neuralink, people who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify. The PRIME study received U.S. FDA clearance in May 2023 and began recruiting patients in September 2023. On January 28, 2024, the first person enrolled in the trial recieved an implant.

The PRIME study received U.S. FDA clearance in May 2023 and began recruiting patients in September 2023. On January 28, 2024, the first person enrolled in the trial recieved an implant. Participants in the PRIME Study will have nine visits with researchers in an 18-month period. They will then spend at least two hours a week on brain-computer interface research sessions and have 20 more research visits over the next five years.

The Link (previously called N1 sensor or Link 0.9) is a BCI device that is implanted into the brain to allow the user to control a computer or mobile device. The Link is connected to micron-scale threads inserted into areas of the brain to control movement. The Link transmits neural signals received from the neural threads, which contain electrodes to detect neural signals. The device uses an inductive charger that wirelessly connects to the implant to charge the battery. The shape of the Neurolink BCI device changed to be coin-shaped and fit flush with the skull, rather than the previous design resting near the ear. Musk stated that the device matches the thickness of the piece of skull that had been removed to insert it. Musk stated on X on January 29, 2024 that that Neuralink's first product is called Telapathy.

The PRIME Study (Precise Robotically Implanted Brain-Computer Interface) is an investigational medical device clinical trial for Neuralink’s fully-implantable, wireless BCI that aims to evaluate the safety of the implant (N1) and surgical robot (R1), and the functionality of the BCI for enabling people with quadriplegia to control external devices with their thoughts. A small implant is placed in the part of the brain that controls movements which interprets neural activity. The device is designed to allow the person to operate a computer or smartphone by intending to move, without the requirement of physical movement. According to Neuralink, people who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify. The PRIME study received U.S. FDA clearance in May 2023 and began recruiting patients in September 2023. On January 28, 2024, the first person enrolled in the trial recieved an implant.

• Bristol Myers Squibb
• Century Therapeutics

Allogeneic cell therapy is a type of cell therapy in which a patient recieves cells from a donor. Bone marrow transplants are a type of allogeneic cell therapy. Allogenic therapy products may also be called universal cell therapy product or off-the-shelf cell therapy products. Autologous cell therapy uses cells which are derived from a patient’s own cells. Allogeneic cell therapies carry the risk of immune rejection but also have potential advantages over autologous cell therapy. Since cells do not need to be extracted from the patient and prepared, allogeneic cell therapy products are more immediately available to the patient. Allogeneic cell therapy products could potentially allow less variability, more standardization and allow for an industrialized process to decrease the cost of production.

• CARTISTEM, an allogeneic umbilical cord blood–derived MSC product used in treating patients with degenerative arthritis, approved in Republic of Korea
• Ebvallo (Atara Biotherapeutics), an allogeneic T-cell immunotherapy and has been approved for EU patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease.
• Stempeucel® (developed by Stempeutics Research), allogeneic mesenchymal stem cells (MSC) derived therapy used to treat critical limb ischemia, approved by DCGI (India FDA)

Mesenchymal stromal cells (MSCs) are a heterogeneous population of cells that when expanded in vitro include stem, progenitor and differentiated cells. MSCs have been have regenerative potential and anti-inflammatory properties. However, MSC treatments in clinical trials have produced mixed results. No cell therapies using MSCs have been FDA approved.

• Allogeneic limbal transplantation for treatment of limbal stem cell deficiency (LSCD), a disease of the eye

• Appia Bio
• Artiva Biotherapeutics
• Fate Therapeutics
• Fortress Biotech
• Kite Pharma
• Mustang Bio
• Pfizer
• Precision BioSciences
• Poseida Therapeutics
• Sorrento Therapeutics
• Ziopharm Oncology

• Cellenkosis
• CHABiotech
• ElevateBio
• Fate Therapeutics
• Mesoblast (MSCs)

Allogeneic cell therapy is a type of cell therapy in which a patient recieves cells from a donor. Allogenic therapy products may also be called universal cell therapy product or off-the-shelf cell therapy products. Autologous cell therapy uses cells which are derived from a patient’s own cells. Allogeneic cell therapytherapies carry the risk of immune rejection but also have potential advantages over autologous cell therapy. Since cells do not need to be extracted from the patient and prepared, allogeneic cell therapy products are more immediately available to the patient. Allogeneic cell therapy products could potentially allow less variability, more standardization and allow for an industrialized process to decrease the cost of production.

Cancer immunotherapies are treatments that activate or strengthen immune response to cancer cells or preventing tumor cells from suppressing the body’s immune response. T cells and natural killer (NK) cells are among the immune cells with antitumour activity. Chimeric antigen receptor-engineered (CAR) T cell therapy treats a patient with T cells that are modified to have enhanced targeting toward cancer cells. CAR NK cells are NK cells with enhanced cancer targeting.

Allogene Therapeutics developed ALLO-715 and ALLO-647, two allogeneic CAR T cell therapies in cancer clinical trials as of 2023.ALLO-715 is an allogeneic, anti-BCMA CAR T cell therapy developed to treat multiple myeloma. ALLO-715, manufactured by Allogene is prepared from peripheral blood mononuclear cells from healthy donors. ALLO-715 targets BCMA, a protein expressed on the surface of mature B lymphocyte and plasma cells that plays a role in myeloma cell survival and proliferation. BCMA is a target for multiple myeloma because it is overexpressed and activated in multiple myeloma.

• ABBVie

• Allogene Therapeutics developed ALLO-715 and ALLO-647, two allogeneic CAR T cell therapies in cancer clinical trials as of 2023.ALLO-715 is an allogeneic, anti-BCMA CAR T cell therapy developed to treat multiple myeloma. ALLO-715, manufactured by Allogene is prepared from peripheral blood mononuclear cells from healthy donors. ALLO-715 targets BCMA, a protein expressed on the surface of mature B lymphocyte and plasma cells that plays a role in myeloma cell survival and proliferation. BCMA is a target for multiple myeloma because it is overexpressed and activated in multiple myeloma.
• Atara Biotherapeutics
• Bellicum Pharmaceuticals
• CARsgen Therapeutics
• Cell Design Labs
• Cellectis
• Cell Medica
• Celularity
• Celyad Oncology

TheAs firstof 2021 most CAR T therapies developed toin treatclinical cancertrials were autologous CAR T cell therapies. All FDA approved CAR T therapies (Abecma, Breyanzi, Carvykti, Kymriah, Yescarta) are autologous cell therapies. Allogeneic CAR T therapies are in preclinical and clinical development.

Allogeneic NK cells do not cause graft-versus-host disease (GVHD), giving them an advantage over allogeneic CAR T-cell therapies. Other advantages of NK cell therapies over CAR T-cell therapies include reduced cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome toxicity.

The first CAR T therapies developed to treat cancer were autologous cell therapies. All FDA approved CAR T therapies (Abecma, Breyanzi, Carvykti, Kymriah, Yescarta) are autologous cell therapies. Allogeneic CAR T therapies are in preclinical and clinical development.

Allogene Therapeutics developed ALLO-715 and ALLO-647, two allogeneic CAR T cell therapies in cancer clinical trials as of 2023.ALLO-715 is an allogeneic, anti-BCMA CAR T cell therapy developed to treat multiple myeloma. ALLO-715, manufactured by Allogene is prepared from peripheral blood mononuclear cells from healthy donors. ALLO-715 targets BCMA, a protein expressed on the surface of mature B lymphocyte and plasma cells that plays a role in myeloma cell survival and proliferation. BCMA is a target for multiple myeloma because it is overexpressed and activated in multiple myeloma.

Allogeneic cell therapy is a type of cell therapy in which a patient recieves cells from a donor. Allogenic therapy products may also be called universal cell therapy product or off-the-shelf cell therapy products. Autologous cell therapy uses cells which are derived from a patient’s own cells. Allogeneic cell therapy have potential advantages over autologous cell therapy. Since cells do not need to be extracted from the patient and prepared, allogeneic cell therapy products are more immediately available to the patient. Allogeneic cell therapy products could potentially allow less variability, more standardization and allow for an industrialized process to decrease the cost of production.

• Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat), manufactured by Stratatech Corporation, is used for treatment of deep partial-thickness burns.

Congenital athymia is disease characterized by the absence of a functioning thymus, which results in profound immunodeficiency, increased susceptibility to infections and an increased risk of graft-versus-host disease (GVHD). Most infants with congenital athymia have CHARGE syndrome or have a deletion of genetic material at chromosome 22q11.2. Infants have a higher risk of congenital athymia if they were exposed to retinoic acid during pregnancy or were born to diabetic mothers.

• Rethymic (allogeneic processed thymus tissue-agdc), manufactured by Enzyvant Therapeutics GmbH, is indicated for immune reconstitution in pediatric patients with congenital athymia.

• Clevecord, manufacturesmanufactured by Cleveland Cord Blood Center
• Hemacord, manufactured by New York Blood Center, Inc.
• HPC/Cord blood, manufactured by Clinimmune Labs, University of Colorado Cord Blood Bank
• HPC/Cord blood, manufactured by MD Anderson Cord Blood Bank
• HPC/Cord blood, manufactured by LifeSouth Community Blood Centers, Inc.
• HPC/Cord blood, manufactured by Bloodworks
• Omisirge, manufactured by Gamida Cell Ltd., is a nicotinamide modified allogeneic HPC therapy to treat hematologic malignancies as part of myeloablative treatment.

• Lantidra is an allogeneic pancreatic islet cellular therapy manufactured by CellTrans Inc.

The following products are hematopoietic progenitor cells (HPC) derived from umbilical cord blood used for treatment of disorders affecting the hematopoietic system that are inherited, acquired or resulting from myeloablative treatment.

• Allocord, manufactured by SSM Cardinal Glennon Children’s Medical Center
• Clevecord, manufactures by Cleveland Cord Blood Center
• Ducord, manufactured by Duke University School of Medicine

• GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen), manufactured by Organogenesis Incorporated is an allogeneic cellularized scaffold product indicated for topical use in a surgically created vascular wound bed in treatment of mucogingival conditions.

Natural killer (NK) cells are a type of lymphocyte, or white blood cell, that control viral infections and recognize and kill malignant cells. NK cells also produce cytokines and chemokines, secreted signaling molecules that regulate other cells in inflammatory and immune responses. The three main sources of allogeneic NK cells are 1) donor peripheral blood, 2) Cord blood or differentiation from cord blood hematopoietic stem and progenitor cells (HSPCs) or 3) induced pluripotent stem cells (iPSCs).

Allogeneic NK cells do not cause graft-versus-host disease (GVHD), giving them an advantage over CAR T-cell therapies. Other advantages of NK cell therapies over CAR T-cell therapies include reduced cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome toxicity.

Isomorphic Labs is a UK-based drug discovery company and spinout of DeepMind, a division of Google AI. Isomorphic launched in 2021 under the DeepMind parent company Alphabet with CEO Demis Hassabis. DeepMind’s AlphaFold 2 AI technology is able to predict the structure of proteins from amino acid sequences. In addition to protein folding structure, AlphaFold can predict structures of other biological molecules including protein-ligand structures, proteins bound to nucleic acids and post-translational modifications. In 2024, company entered into partnerships with Eli Lilly and Novartis to apply AI to discovery of new medications. Isomorphic plans to use AlphaFold and other AI technology to better understand biological mechanisms of drug target and rationally design novel therapeutics. The collaboration between Isomorphic and Novartis was reported to involve the development of small molecule therapeutics against three undiscosed targets.

Isomorphic Labs is a UK-based drug discovery company and spinout of DeepMind, a division of Google AI. Isomorphic launched in 2021 under the DeepMind parent company Alphabet with CEO Demis Hassabis. DeepMind’s AlphaFold 2 AI technology is able to predict the structure of proteins from amino acid sequences. In 2024, company entered into partnerships with Eli Lilly and Novartis to apply AI to discovery of new medications. Isomorphic plans to use AlphaFold and other AI technology to better understand biological mechanisms of drug target and rationally design novel therapeutics.

ElixerElixir Pharmaceuticals, no longer operating, was focused on discovery, development and commercialization of pharmaceuticals for treatment of metabolic diseases such as diabetes and obesity (https://www.crunchbase.com/organization/elixir-pharmaceuticals). (https://www.crunchbase.com/organization/elixir-pharmaceuticals)

Elixer Pharma is a pharmaceutical company based in Cairo, Egypt, founded in 2018, that aims to provide affordable pharmaceuticals across Egypt and Africa.

Elixer Pharmaceuticals, no longer operating, was focused on discovery, development and commercialization of pharmaceuticals for treatment of metabolic diseases such as diabetes and obesity. (https://www.crunchbase.com/organization/elixir-pharmaceuticals)

Elixer Pharma is a pharmaceutical company based in Cairo, Egypt, founded in 2018, that aims to provide affordable pharmaceuticals across Egypt and Africa.

Inceptive is a Palo Alto, California-based biotechnology that uses AI to design unique mRNA sequences that can be rapidly created and tested in the lab. mRNA can be thought of as “biological software”, designed to encode executable instructions within human cells. Molecules that prove successful in the lab are licensed to pharmaceutical partners for clinical development.

Inceptive was founded in 2021 by Jakob Uszkoreit, formerly a Google AI researcher that worked on Google DeepMind's AlphaFold. Inceptive builds on generative AI technology pioneered by Uszkoreit and his colleagues. Uszkoreit is credited for the idea of focusing on attention, which was the basis for a publication on transformer models and laid the foundation for subsequent AI technology. Inceptive applies similar techniques to generate biological data instead of text or images.

Inceptive partnered with a major European pharmaceutical company to develop a new mRNA vaccine against infectious disease.

Funding from NVIDIA allowed Inceptive to have access to their computing platforms and chips.

Terray Therapeutics is a biotechnology company that combines ultra-high throughput experimentation, generative AI, biology, medicinal chemistry, automation and nanotechnology to explore molecules and their targets for the purpose of discovering and developing small molecule therapeutics. The Los Angeles, CA-based company was founded in 2018. Terray Therapeutics was founded by brothers, Jacob Berlin and Eli Berlin. Jacob Berlin is CEO. Eli Berlin, who has a finance background, is CFO and COO.

Terray's methods are based on Dr. Jacob Berlin’s research. Jacob Berlin previously studied in chemistry at Harvard and Caltech, and worked as a postdoc at MIT on the design and development of molecules. Berlin, later worked on a second postdoc at Rice University, where he performed research on nano materials and ultra-miniaturization and then become a professor at the National Cancer Center, City of Hope where his research combined nanomaterial and synthetic chemistry.

Narbe Mardirossian, Head of Computational and Data Sciences, has a background in machine learning and quantum mechanics and quantum chemistry. Mardirossian previously worked at Amgen in therapeutics discovery and small molecule discovery, working on physics-based models and machine learning models. Eli Berlin’s background was all in finance, where he had 10 years of private equity and investment banking.

According to Terray, billions of biochemical interactions are measured daily and become increasingly precise with each cycle of design and experimentation. Terray’s ultra-dense microarray technology is used to created chemical datasets in which biochemical interactions between small molecules and disease causes are systematically mapped using Terray’s integrated machine learning and computational platform.

Series A funding of $60 million, was led by Madrona in 2022. Other investors include Two Sigma Ventures, Digitalis Ventures, KdT Ventures, Goldcrest Capital, XTX Ventures, Sahsen Ventures, Greentrail Capital, and the folks at Alexandria.

Terray received investment from NVIDIA’s venture capital arm, NVentures in October 2023, and announced it would leverage NVIDIA DGX Cloud to develop the world’s most comprehensive chemistry foundation models for small molecules. The company stated it planned for some of these models on NVIDIA BioNeMo cloud service for generative AI in drug discovery. Terray stated plans to make use of NVIDIA AI software stack and NVIDIA full-stack computing expertise to create ligand-based and structure-based models to move its pipeline towards the clinic.

Viome has been criticized for lackinghaving insufficient scientific evidence for its products and promoting placebos over scientifically supported healthrecommended interventions. Founder Naveen Jain has been reported to have made some statements that lack a sound basis. Jain is reported to have made the claim that every chronic disease is caused by gut issues. Jain is reported to have said that the health-care system and the pharmaceutical industry are financially invested in keeping the public as patients, not really wanting people to be well.