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On the Road Again

Route 66 sign

(LSC, Pixabay)

15 Oct. 2021. We’re taking some personal time on Friday and Saturday, 15-16 Oct., so we will have no Science & Enterprise editorial posts for those days. Regular posts will resume on Monday, 18 Oct.

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NIH Funds Brain-Computer Implant Device

Brain circuits

(NIH.gov)

14 Oct. 2021. A developer of implanted devices to record signals from brain cells received funding to advance a smaller and more durable electrode array. National Institute of Mental Health or NIMH, part of National Institutes of Health, awarded a three-year, $3.2 million grant to Paradromics Inc. in Austin, Texas to build the device.

Paradromics creates devices that connect the human brain to computer systems, enabling high-volume transfers of data between neurons in the brain and computers for diagnosing and treating brain disorders. The company says its current technology now supports more than 65,500 electrode channels sampled simultaneously. As reported by Science & Enterprise in July 2020, a team led by Paradromics founder and CEO Matt Angle demonstrated a device with high-density arrays of microwires made of platinum and irridium that sense, connect, and transfer data to and from complementary metal–oxide semiconductor, or CMOS amplifier circuits.

The researchers tested the device with lab animals, implanting the electrode array in the cerebral cortex, the outer layer of the brain that governs a person’s motor and sensory activity, and conscious thought. Angle and colleagues published their findings in February 2021 in Journal of Neural Engineering (paid subscription required). In an earlier NIMH-funded project, Paradromics built and demonstrated its microwire-to-CMOS architecture with devices of 1,200 electrodes implanted in lab rats, and more than 30,000 electrodes implanted in sheep.

Feasibility of human surgical implants

The new project, a second phase of the first award, aims to develop a more compact and efficient device with fewer electrodes for testing in sheep and humans. Paradromics proposes fabricating a sensor array with 400 to 1,600 electrodes, no more than 400 micrometers deep and one millimeter long. The company plans to test the new device for feasible implantation in humans already undergoing brain surgery, and to determine any initial reactions to the implants. Paradromics is partnering with Massachusetts General Hospital for the clinical phases of the study, working with neuroscientists Sydney Cash and Leigh Hochberg.

The company also proposes testing the device implanted in live sheep for up to six months. Those tests will look for scarring of glia cells or loss of neurons in the animals’ brains at several points during that period.

Paradromics says the new NIMH award is a major step in development of a brain-computer interface or BCI, leading to clinical trials testing the device as a way to to restore communication for patients who have lost the ability to speak due to severe paralysis. “Our mission,” says Angle in a Paradromics statement released through Cision, “is to is create a new industry where brain-computer interfaces transform unmet medical needs into solvable technical problems. This new award, together with our recent venture round, not only means that we have the resources to execute on this vision, but that others are seeing the same bright future for BCI.”

The award is a Small Business Innovation Research or SBIR grant made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. SBIR grants fund work by research companies in the U.S., and in most cases are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials. This grant is a phase 2 award that runs through August 2024.

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Crispr Licensed for Eye Disease Gene Therapies

Retinal gene therapy

(National Human Genome Research Institute, NIH)

13 Oct. 2021. A developer of inherited eye disease therapies is acquiring rights to the gene editing technology Crispr for treatments that work inside the eyes. The deal with SparingVision in Paris could bring biotechnology company Intellia Therapeutics Inc. in Cambridge, Massachusetts as much as $600 million as well as an equity stake in SparingVision.

SparingVision develops treatments for retinitis pigmentosa, a progressive genetic disorder that destroys photoreceptor cells in the retina, leading to total blindness in some cases, which affects some 1 in 4,000 people worldwide. The company has three candidate therapies for the disease, all delivered with adeno-associated viruses, or AAVs. These viruses are benign, naturally occurring microbes that infect cells, but do not integrate with the cell’s genome or cause disease, and generate at most a mild immune response. One of SparingVision’s treatment candidates code-named SPVN06 is in preclinical development, while the other two therapies are in discovery stage.

Crispr, short for clustered, regularly interspaced short palindromic repeats, is adapted from a natural process used by bacteria to protect against attack by viruses, where an enzyme that deactivates or replaces genes binds to targeted RNA molecules generated by the genome. The RNA molecules then guide an editing enzyme, known as Crispr-associated protein 9 or Cas9, to specific genes needing changes.

Intellia Therapeutics is developing treatments with Crispr-Cas9 that remove disease-causing genes or mutations, repair genes with mutations found in small regions of DNA, and insert corrected or functioning genes when mutations are found in larger DNA regions. The company says its treatments are being designed to be either administered directly to work in vivo, i.e.  inside patients’ bodies, or delivered to cells taken from the patient, then cultured outside the body and transplanted back. In June 2021, Science & Enterprise reported on early clinical trial data from Intellia demonstrating the feasibility of in vivo Crispr delivery, with few adverse effects.

Jointly study and develop new Crispr-Cas9 delivery methods

In their agreement, SparingVision gains an exclusive license to Intellia’s Crispr-Cas9 technology for up to three disease targets affecting the eyes. SparingVision will lead preclinical work and clinical trials of therapy candidates developed by the two companies. Plus, the two companies will jointly study and develop more delivery methods for Crispr-Cas9 therapies to the retina: AAVs that self-deactivate and lipid nanoparticles.

Intellia is eligible for developmental and commercial milestone payments of some $200 million for each of the three products developed under the partnership, and royalties on sales. And Intellia is receiving a 10 percent equity stake in SparingVision. Intellia also has an option to obtain commercialization rights for up to two of the new products developed by the companies, with Intellia paying SparingVision opt-in fees, reimbursing or sharing development costs, and paying royalties on sales in the U.S.

“Intellia is the first company in history ” says Stéphane Boissel, president of SparingVision, in a statement, “to present clinical data supporting precision editing of a disease-causing gene within the body following a single, systemic dose of Crispr-Cas9 and we are honored to have been selected as a strategic partner.”

“We believe,” adds Intellia CEO John Leonard, “SparingVision will be an excellent partner to expand our genome editing capabilities into the field of ophthalmology and we look forward to our new partnership.”

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Small Biz Grant to ID Digital Biomarkers for Alzheimer’s

neurons

(NIH.gov)

12 Oct. 2021. National Institutes of Health is awarding a grant to identify indicators of Alzheimer’s disease in a company’s collecting of life stories from older people. LifeBio Inc. in Marysville, Ohio is receiving a one-year, $448,462 award from National Institute on Aging, part of NIH, for advancing the company’s technology to detect digital biomarkers of early-stage Alzheimer’s disease and track its progression.

LifeBio offers a service that enables older individuals to capture their life stories through telephone interviews and interactive online apps. The life stories are used to capture personal histories, but also to offer assisted living facilities and health care providers with details of an older person’s life to help provide more personalized care. The stories can be particularly useful for individuals with cognitive or communications disabilities. In addition, LifeBio offers a related service offering weekly telephone calls to older individuals, to combat loneliness and social isolation.

The company and researchers on aging recognize the value of these collected stories for better understanding and dealing with cognitive decline in older individuals. Last year, LifeBio and Benjamin Rose Institute on Aging in Cleveland, Ohio received a two-year $2.4 million grant from NIA to develop LifeBio Memory, a technology platform for capturing and converting narrated speech into text, supplemented with images and video, to prepare personalized memory exercises. These exercises are designed to help people with dementia reconstruct memories of their lives. The company says a pilot test with Benjamin Rose Institute shows the system helps reduce depressive symptoms among participants.

“Reminiscence therapy has been an effective tool in dementia care and in addressing social determinants of health,” says LifeBio founder and CEO Beth Sanders in a company statement released through Cision. “Our current LifeBio Memory solution as well as this new tool, LifeBio-ALZ, will use artificial intelligence to take person-centered care and contextualized health to a new level.”

AI tools in a patient-centered app

The new NIA award funds enhancements in the LifeBio system to identify digital biomarkers, or indicators of Alzheimer’s disease called LifeBio-ALZ, when collecting the company’s life stories. The project calls for applying artificial intelligence tools in a patient-centered app that analyzes eye movements and responses to questions in recorded audio and video. Algorithms developed in the project will evaluate awareness, engagement, cognition, reaction time, speech patterns, and emotional state in the analyzed recordings to construct the app.

The project aims to determine feasibility and development of a prototype LifeBio-ALZ system, including a patient app. After initial verification, LifeBio-ALZ will be deployed for field testing, with collected data used to build an artificial intelligence engine that detects early-stage Alzheimer’s disease and assesses disease progression.

Brown University in Providence, Rhode Island is partnering with LifeBio on the project. “Communication changes can be difficult to measure for people living with dementia, especially when cognitive symptoms are mild,” notes Brown psychiatry professor Gary Epstein-Lubow, who adds, “We will be testing if LifeBio-ALZ can assist clinicians in better understanding speech patterns, eye movements, emotional changes, and other factors to aid in earlier detection and assessing changes over time.”

The award is a Small Business Innovation Research or SBIR grant made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. SBIR grants fund work by research companies in the U.S., and in most cases are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials. This grant is a phase 1 award that runs through August 2022.

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Consider A Franchise for Your New Business Venture

– Contributed content –

Network illustration

(Gerd Altmann, Pixabay)

12 Oct. 2021. There is an undeniable appeal to launching a business through the acquisition of a franchise. Whereas beginning a business frequently involves a great deal of uncertainty, a franchise provides proof of a proven business strategy currently in operation.

That is not to say that purchasing a franchise guarantees immediate and continuous success. Indeed, the bogus “statistic” that franchisees have a lower failure rate than other businesses is precisely that—a lie. Operating a franchise is still hard work, and there are disadvantages to starting a business that needs to adhere to someone else’s standards.

If you’re considering purchasing a franchise, you should be aware of the risks and the benefits before making your decision.

This post looks at some of the plus points of starting a franchise instead of a new business from scratch.

Support and training

You’ll have access to a thorough training program that will provide you with all of the knowledge and skills you’ll need to run a successful franchise business. The majority of franchises offer an initial training program as well as continuous assistance. Browse franchises by category to find the perfect fit for you and see what options are available.

You will also receive assistance with advertising and marketing as part of the franchise package. It can be challenging to establish an established client base as an independent business when first entering the market. Still, as part of a well-known brand promoted both locally and nationally, your small franchise will have an advantage over the competition.

Access to funding

You will be more likely to obtain bank financing if you create a franchise business rather than starting an independent company from the ground up since you will be perceived as less of a risk. If you are concerned about being accepted for the funding required to get started, partnering with a franchising company can open more doors for you.

Flexibility and control

Small franchises can, at times, be run from home. That means lower startup costs and nearly no recurring expenses. No extra employees are needed. Thus employee-related expenditures like insurance are removed, making it easier to turn a profit quickly.

It’s also an excellent option for investors who wish to escape the morning commute. You can work from your sofa or set up an office – whatever suits you and your ideal working environment.

If you buy a low-cost franchise, for example, you can probably run it part-time. So you may earn extra money while investing in your future. This is far more profitable than taking a part-time job to supplement full-time employment in the long run.

It also means you can work around personal commitments. Whether you want to spend more time with your infant or have more control over your work schedule, opening a small franchise could be a wise investment.

Instant brand recognition

Franchises are pre-loaded with a brand that customers are familiar with and trust. The process of getting customers to identify your brand is hugely time-consuming—but a franchise has a name that is recognized throughout the country. When you walk into a Wendy’s or McDonald’s, you know exactly what you’re going to receive out of the experience. That is a significant value addition.

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Lab Demonstrates 3-D Printed Tissue, Blood Vessel Implant

Tobacco plants

Tobacco plants (Beeki, Pixabay)

11 Oct. 2021. A biomedical engineering team transplanted into a lab rat synthetic tissue with blood vessels made by three-dimensional printing. Researchers from Technion – Israel Institute of Technology in Haifa reported the developments, using biocompatible 3-D printing inks made by the company Collplant Biotechnologies, last month in the journal Advanced Materials.

A team led by Technion biomedical engineering professor Shulamit Levenberg is seeking better options for clinicians and patients to replace damaged tissue from wounds or burns. Much of today’s replacement tissue is based on collagen derived from human cadavers or animal sources, which increases risks of rejection by the recipients. In addition, replacement tissue needs to contain or support regrowth of blood vessels to provide oxygen and nutrients to the wound or burn site, and support normal tissue functions.

Collplant Biotechnologies, in Rehovot, Israel, develops an engineered form of human collagen called rhCollagen, short for recombinant human collagen. The company makes rhCollagen from tobacco plants genetically engineered with five human genes. While tobacco is associated with harmful health outcomes, it is a fast-growing plant, often studied in labs as a model species. Extracting, processing, and purifying tobacco leaves, says CollPlant, returns a pristine form of human collagen — the most abundant protein in the body found mainly in skin, bones, and and muscles — that performs better and without harmful immune responses than collagen derived from animal and other human tissue.

Printed blood vessels from rhCollagen ink

One method for producing engineered replacement tissue is through 3-D printing. Collplant says its bioprinting inks made from rhCollagen can be used in several types of 3-D printers, such as ink-jet and extrusion, to produce complex scaffolds made for various cell types. The company says its bioprinting inks are already tested in multiple tissue and organ types. In October 2018, Science & Enterprise reported on a licensing deal with Collplant for one of these projects, to produce 3-D printed human lungs for transplant.

Levenberg and colleagues study regenerating human tissue, including engineered tissue that supports formation of blood vessels. In their paper, the Technion team reported on transplanting a 3-D printed tissue flap, a thick piece of tissue including blood vessels into a lab rat. Tissue flaps are used in reconstructive surgery for transferring tissue from one part of the body to another. The researchers used 3-D printing to produce scaffolds to grow new tissue, with inks made from rhCollagen to produce blood vessels. The team implanted the tissue flap and connected the engineered blood vessel to an artery in the rat’s leg. After two weeks, tests show the implanted blood vessels function normally in the rat.

Levenberg notes in a Collplant statement, “The ability to create vascularized tissue constructs using human collagen from modified plants rather than animal collagen is a very promising step towards development of fully lab-grown implantable tissues.” Yehiel Tal, CEO of Collplant adds, “The results of this study further substantiate the vast potential of rhCollagen-based bioinks for use in 3-D bioprinting applications including in-vitro 3-D models and regenerative medicine.”

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Infographic – Cruising Biotech Index Takes Late Dip

Nasdaq Biotech Index, 3rd qtr 2021

Click on image for full-size view. (Nasdaq)

9 Oct. 2021. Our last visit to the Nasdaq Biotechnology Index in early July showed the NBI rebounding in the second quarter after a plunge in early spring. A look at the index today shows the NBI, an indicator of investor sentiment in the industry, continued its choppy climb through most of the third quarter, only to start another decline in late September.

NBI opened on 1 July at 5,148 and by 9 Aug. closed at at 5,477. Starting 9 Aug., NBI bounced around until closing at 5,395 on 23 Sept. Then, the index started a decline to close at 5,085 on 30 Sept. That decline continues to yesterday, 8 Oct. when NBI closed at 4,883. For the year, NBI is still up 326 points or 2.6 percent from the beginning of 2021. By comparison, the Nasdaq Composite Index, which represents the more general investor interest in technology stocks, is up 15 percent for the year.

NBI is an index of stock prices from 267 biotechnology and pharmaceutical companies trading on the Nasdaq exchange.

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FDA Halts Off-the-Shelf T-Cell Cancer Trials

Stop sign

(dimitrisvetsikas1969, Pixabay)

8 Oct. 2021. The Food and Drug Administration stopped a company’s clinical trials of off-the-shelf engineered T-cells after a patient showed an abnormal chromosomal reaction. Allogene Therapeutics Inc. in South San Francisco says it reported the adverse reaction in one of its clinical trial patients to FDA, which then put a clinical hold on all of the company’s trials of modified T-cells.

Allogene Therapeutics is developing treatments for blood-related and solid tumor cancers with engineered T-cells, white blood cells in the immune system. T-cells are altered by adding chimeric antigen receptors, proteins attracting antibodies that bind to and destroy blood-related and solid tumor cancer cells. Most current methods producing chimeric antigen receptor T-cells, known as CAR T-cells, genetically engineer a patient’s own T-cells, then re-infuse the altered T-cells back into the individual, with successful results for blood-related cancers in some cases.

The company’s process is designed to produce off-the-shelf CAR T-cell treatments from T-cells provided by healthy donors. Allogene says this approach provides a ready supply of CAR T-cell therapies in patients, where their often critical conditions won’t allow harvesting of these cells. The process also removes the need for leukapheresis, the process of separating white blood cells in the lab from whole blood donations and returning the remainder to the patient. Allogene produces its T-cells, called AlloCAR Ts, to seek out and bind to cancer cells expressing specific characteristic proteins on their cell surfaces.

Lower than normal blood cell counts

Allogene’s lead products, code-named ALLO-501 and ALLO-501A target a protein called CD19 found on the surface of B cells — another type of white blood cell — associated with several blood-related cancers. The company says a participant in the clinical trial testing ALLO-501A among large B-cell lymphoma patients for safety and efficacy indicators showed signs of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, or ICANS, adverse reactions sometimes occurring in these kind of trials. After treatments with steroids, further tests showed the patient with pancytopenia, a condition marked by lower than normal red and white blood cells and platelets.

A subsequent bone marrow biopsy, says Allogene, indicated aplastic anemia, a condition where lower blood cell counts result from malfunctioning bone marrow, as well as ALLO-501A CAR T-cells with a chromosomal abnormality. The company does not spell out the precise abnormal characteristics in the patient’s chromosomes, but National Human Genome Research Institute, part of National Institutes of Health, says two types of abnormalities can occur: numerical and structural. Numerical abnormalities are when one of the 23 chromosome pairs is missing, or an extra chromosome is found. Structural abnormalities result from altered chromosomes, such as missing or duplicated chromosome parts or pieces transferred to other locations in chromosomes.

Allogene says FDA then put a clinical hold on all of the company’s AlloCAR T trials until the chromosomal abnormality can be further explained and its cause. “Patient safety is our highest priority,” says Allogene’s chief medical officer Rafael Amado in a company statement, “we are committed to working closely with the FDA to evaluate any potential clinical implications of this finding, and determine next steps for advancing ALLO-501A and our clinical programs.”

The company says more than 100 patients already received AlloCAR T treatments in clinical trials, and this is the first adverse reaction of its kind. Allogene says it still expects to report favorable results from its early-stage AlloCAR T studies, and eventually proceed with later-stage trials.

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Precision Neuroscience Company Starts-Up, Raises $500M

Brain activity graphic

(Gordon Johnson, Pixabay)

7 Oct. 2021. A new company is underway developing more precise therapies for psychiatric and neurodegenerative diseases based on genetics and data science. Neumora Therapeutics Inc. in Watertown, Massachusetts is founded by researchers in neuroscience at the Broad Institute and Johns Hopkins University, and raising more than $500 million in its first venture round, including a $100 million equity stake and collaboration with drug maker Amgen.

Neumora Therapeutics is developing treatments for debilitating neurological disorders that up to now do not respond consistently to most current therapies. The company says it applies advances in data science, including artificial intelligence, bringing together findings from genomics, imaging, and neuroscience databases to define more precise brain disease sub-types. Neumora calls these more precise definitions data biopsy signatures, which it maps to specific mental health traits. The company says that connecting these better defined data biopsy signatures to more precise psychiatric and neurodegenerative conditions provide a better chance for therapies to succeed.

Neumora Therapeutics’ technology is based on research by its scientific founders Morgan Sheng, co-director of psychiatric research at the Broad Institute, a genetics research center affiliated with MIT and Harvard University, and Richard Huganir, professor of neuroscience at Johns Hopkins University. Sheng studies molecular mechanisms behind the structure and flexibility of synapses, the parts of neurons sending and receiving signals, and molecular and cellular functions of neurodegeneration. Huganir studies molecular mechanisms of neurotransmitters, chemicals in the brain involved in brain signaling and their effects on synapse performance.

Match right therapeutics to the right patient populations

“Instead of the current broad classifications of brain diseases across a wide spectrum of generalized symptoms,” says Sheng in a company statement, “Neumora’s approach is driven by an ability to develop and match the right therapeutics to the right patient populations. This approach marks a major advancement in the field of neuroscience and has the potential to truly revolutionize the way we target brain diseases, similar to the way genetic sequencing and new tools have revolutionized the development of precision medicines for cancer over the past decade.”

Neumora Therapeutics was formed by life science investment company ARCH Venture Partners in Chicago, and is also leading the company’s first venture financing round, raising more than $500 million. Joining ARCH Venture Partners in the round are Venture Investments, Altitude Life Science Ventures, Catalio Capital Management, F-Prime Capital, Invus, Logos Capital, Mubadala Capital, Newpath Partners, Polaris Partners, re.Mind Capital, Softbank Vision Fund 2, Surveyor Capital, Waycross Ventures, and others.

Drug maker Amgen in Thousand Oaks, California is among the investors in Neumora Therapeutics, with a $100 million equity stake. Amgen’s subsidiary, deCode Genetics in Reykjavik, Iceland, is collaborating with Neumora to discover new insights into genomic associations with psychiatric and neurodegenerative disorders including schizophrenia and amyotrophic lateral sclerosis or ALS. In addition, Neumora is receiving an exclusive global license to current Amgen neuroscience programs addressing the proteins casein kinase 1 delta and glucocerebrosidase related to neurological disorders.

deCode Genetics is a pioneer in population genetics research. The company collects data from 160,000 volunteers in Iceland, more than half the country’s adult population. The company also assembles a genealogical database for the entire country going back 1,000 years to Iceland’s founding as an independent nation. These extensive data sets, combined with the high quality of universal health care in Iceland, says deCode, makes it possible to study most common diseases on a large scale, minimizing the selection bias that can occur in larger and more diverse populations.

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Partnership Seeks Lower-Cost Protein Drugs

Chemical atom model

(Fernando Zhiminaicela, Pixabay. https://pixabay.com/illustrations/chemical-molecular-atom-medicine-3086130/)

6 Oct. 2021. A biotechnology enterprise and company aiming to make drugs at lower prices are collaborating on new lower-cost synthetic protein drugs. The partnership brings together synthetic protein developer Absci Corp. in Vancouver, Washington with pharmaceutical company EQRx Inc. in Cambridge, Massachusetts, but financial and intellectual property terms of the agreement were not disclosed.

Absci Corp. designs synthetic antibody proteins from genetically engineered cells using artificial intelligence algorithms, trained by large datasets generated through its own development process. With diseased tissue or ribonucleic acid (RNA) sequences as a starting point, Absci says it reconstructs human antibody proteins from the tissue, then identifies corresponding antigen proteins as antibody targets. The company designs and constructs these new proteins with specialized folding and expression properties with the engineered cells. Screening and selection processes, says Absci, refine the protein design and allow for production of small quantities for further optimizing and scaling up as therapy candidates.

Absci works mainly through partnerships, and the collaboration with EQRx aims to produce synthetic proteins as therapies at lower costs to health care providers and patients. EQRx aims to re-engineer the processes of bringing drugs to market, as well as getting treatments to patients, which reduces the time needed to produce drugs, but also their prices. The company uses a fast-follow model, where their product candidates work similarly to existing drugs, but with sufficiently different chemistries to allow for their own intellectual property.

Cancer and immune-related disorders

Plus, the company aims to shorten the supply chain, selling their drugs directly to larger health care providers. Using this model, EQRx acquires current late-stage drug candidates for further development and commercialization, and now has four cancer therapies in late-stage clinical trials or awaiting regulatory review. Science & Enterprise reported on EGRx’s formation in January 2020, $500 million funding round a year later, and partnership with Exscientia, a company in the U.K. designing new drugs with artificial intelligence, in June 2021.

The new collaboration calls for the companies to jointly develop new types of protein-based therapies addressing cancer and immune-related disorders as well as other unnamed targets, but at more affordable prices to patients. Absci is providing its protein design and discovery expertise, while EQRx offers its clinical development and commercialization capabilities. While financial details are not provided, Absci has an option to make additional investments in the collaboration, in exchange for a larger percentage of product sales.

Carlos Garcia-Echeverria, who heads drug creation at EQRx notes in a statement, “Absci’s technology platform enables rapid discovery and production of well-differentiated protein-based drugs that are elusive to other discovery approaches.” Absci founder and CEO Sean McClain adds, “This collaboration with EQRx expands the reach of our AI-powered target discovery, drug design, and development technology.”

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