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Thanksgiving 2022

Turkeys

(U.S. Department of Agriculture)

24 Nov. 2022. Today is the thanksgiving holiday in the U.S., a day of food, family, and football (Go Bills). We’ll take a break for the long holiday weekend and resume posting on Monday, 28 Nov.

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FDA Clears Digital Health Monitoring System

EmbracePlus device

EmbracePlus device (Empatica)

23 Nov. 2022. A developer of remote health tracking technology says the Food and Drug Administration cleared its continuous patient monitoring system for clinical use. Empatica, in Boston, says its Health Monitoring Platform that collects data from its own wearable device, is authorized by FDA to collect real-time data on four digital health indicators for home patient care.

Empatica says its health monitoring technology connects patients or clinical trial participants through a mobile app to the cloud, where their data are analyzed by algorithms and tracked by clinicians. Individuals using the company’s health monitoring technology wear a device resembling a smart watch called EmbracePlus that Empatica says contains sensors measuring a range of physiological indicators.

As reported by Science & Enterprise in Feb. 2018, Empatica first designed the Embrace smart watch to capture electro-dermal activity or EDA activity on the skin as an indicator of convulsive seizures in people with epilepsy. Signals captured by the watch are then analyzed with machine learning algorithms, based on research by Rosalind Picard, director of MIT’s Affective Computing group, and a founder of the company. A year later, Empatica added respiratory functions to the Embrace watch indicators to track flu cases, with funding from Biomedical Advanced Research and Development Authority in the U.S. Department of Health and Human Services.

Second venture funding round

The EmbracePlus device now tracks photoplethysmography or PPG, an optical technique for measuring blood volume under the skin, and includes an accelerometer and gyroscope, as well as temperature and EDA sensors. Data from EmbracePlus are sent via Bluetooth to a smartphone app that transfers the data to an Empatica cloud system for analysis by algorithms and visualization. Clinicians can then download the data for further analysis.

The company says its health monitoring technology is currently used for clinical trials and other research studies. The new FDA clearance, says Empatica, authorizes the system for patient care monitoring of four functions: EDA, blood oxygen saturation during rest, skin temperature, and sleep movements. The company says its system enables real-time home tracking of patients with acute or chronic conditions, as well as healthy individuals at risk of infection.

“This clearance represents a significant step forward for our scientific community,” says Empatica chief medical officer Marisa Cruz in a company statement released through Cision. “Patients, health care providers, and researchers deserve digital health products that are accurate, validated in diverse populations, and intuitive to use.”

Empatica also says the company is raising new funds in its series B or second venture funding round. The financing is led by Sanofi Ventures, the drug maker’s investment division, and life science/health care investor RA Capital Management in Boston, with participation by Black Opal Ventures. While the company is not disclosing the amount raised in the round, Crunchbase reports in August Empatica raised some $26 million in its series B funding round, from Black Opal Ventures and two other investors.

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Biomarker-Guided Depression Drug Trial Underway

Sad, depressed

(Daniel Reche, Pixabay)

22 Nov. 2022. The first participant in a clinical trial received an experimental drug to treat patients with depression that express high levels of a stress-related protein. The study is conducted by the start-up biotechnology company EmbarkNeuro in Oakland, California and Villanova, Pennsylvania, developer of the drug code-named ANC-501.

EmbarkNeuro, founded last year as Ancora Bio, is a developer of treatments for mental health disorders traced to underlying protein imbalances in the brain associated with the conditions. ANC-501 is the company’s lead product for treating people with major depressive disorder. Depression is a widespread mood condition characterized by continual feelings of sadness and loss of interest. When these feeling persist for long periods of time, the condition becomes a serious debilitating disease called clinical depression or major depressive disorder that requires treatment. National Library of Medicine says some 19 million teens and adults in the U.S. have depression.

EmbarkNeuro says ANC-501 is an oral drug designed to address an underlying factor in many people with major depressive disorder, high levels of the hormone cortisol produced by adrenal gland. High cortisol levels are a result of stress, which in most people return to normal when the stress-inducing conditions abate. In people with chronic stress, however, elevated cortisol levels can disrupt many bodily processes, including those in the brain, leading to disorders such as anxiety and depression.

Testing ANC-501 plus current treatment

ANC-501, says EmbarkNeuro, is designed to reduce cortisol levels, by blocking triggering proteins upstream from the adrenal gland. Those proteins are vasopressin 1b or V1b receptors in the pituitary gland. V1b receptors are connected to cortisol levels through an intermediary, adrenocorticotropic hormone or ACTH, also produced in the pituitary gland. The company says its preclinical tests indicate limiting V1B receptors with ANC-501 reduces depression-like behaviors in lab animals, including those with damage to a region of the brain called the hypothalamic-pituitary-adrenal or HPA axis, from extended high cortisol levels, making them resistant to some therapies.

“Rates of depression and anxiety have risen dramatically since the advent of the Covid-19 pandemic,” says EmbarkNeuro CEO Stephen Kanes in a company statement, “which has spurred extreme stress due to social isolation and exacerbated health concerns. As people with a history of adverse childhood experiences, toxic stress, or HPA axis disruption have been the hardest hit, it is more important than ever to rethink all aspects of mental health interventions and create targeted treatments
with underlying conditions in mind for patients not responsive to standard therapies.”

The mid-stage clinical trial is enrolling 20 adults from Florida and New York diagnosed with major depressive disorder, not responding to previous therapies, and show elevated cortisol levels in urine tests. Participants continue to take their current medications, but are also given ANC-501 taken as 10 milligram capsules, five times a day. The study team is tracking participants’ scores on a standard Montgomery-Asberg Depression Rating Scale for eight weeks, comparing scores during and after the trial to those taken at the start of the study. In addition, the team is looking for any adverse reactions to ANC-501 for 16 weeks.

The trial has no placebo-control or comparison group. Based on the results of this trial, EmbarkNeuro is planning a placebo-controlled clinical study for next year.

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Grant Funds Implanted Brain-Computer Spinal Injury Device

Motorized wheelchair

(Kevin Phillips, Pixabay)

21 Nov. 2022. A project to develop a brain-computer device to stimulate upper and lower limb movement in people with spinal cord injuries is receiving a €3.7 million award. The Auto-Adaptive Neuromorphic Brain Machine Interface project is a collaboration between the company Onward Medical N.V. in Eindhoven, The Netherlands, Ecole Polytechnique Fédérale de Lausanne or EPFL in Switzerland, and the biomedical research institute CEA-Clinatec in Grenoble, France.

The initiative, abbreviated NEMO-BMI, seeks to create a fully implanted neuro-stimulation device that can help people with spinal cord injuries affecting both upper and lower limbs function more normally. Spinal cord injuries are often a result of traumatic blows to the spinal column that can disrupt nerve signaling to the rest of the body. Depending on the severity and location of the injury on the spinal column, people with these injuries can lose some or all ability to use or control their limbs, both arms and legs, and some organs.

The new device is adapting an implantable system of electrodes designed by CEA-Clinatec called WIMAGINE that records neural activity and transmits the data wirelessly to an external receiver. Onward Medical says the electrode array will be implanted in the brain and integrated with the company’s ARC-IM device, also an implantable system. The ARC-IM now delivers electronic pulses to the spinal cord to stimulate nerve signals for regaining movement in limbs in patients with spinal crowd injuries. Earlier this month, Science & Enterprise reported on a clinical trial of the ARC-IM that delivers electronic stimulation to a set of nerve cells that enables patients to restore their walking after rehabilitation.

Pathfinder grant from European Innovation Council

The new award for NEMO-BMI builds on a current project to integrate the ARC-IM hardware with the WIMAGINE electrode array. The new grant funds writing of algorithms embedded in the integrated implanted device to decode and interpret recorded neural activity in the brain — such as instructions to move one or more limbs —  then translate the signals into instructions for motor nerves and muscles in the limbs. The project’s goal is a small, functional device that can be easily produced and implanted.

The new €3.7 million Pathfinder grant is from the European Innovation Council’s challenge for technologies that transform human health from episodic care of illnesses to more proactive monitoring and adaption. Onward Medical says it will receive €1 million of that amount. The current project is also funded by a €3.6 million Pathfinder award in June 2022. The European Innovation Council or EIC is an organization of the European Commission.

The NEMO-BMI project received an early endorsement as first-place winner of an annual international prize for brain-computer interfaces. The prize, awarded last month by the BCI Award Foundation, attracted some 100 entries, with 12 finalists. The first-place award for 2021 is the Stentrode, an implanted electrode device developed in Australia and first reported in Science & Enterprise in Feb. 2016.

“The additional funding from EIC as well as the first place in the 2022 Brain-Computer Interface Awards,” says Onward Medical CEO Dave Marver in a company statement, “provide strong validation of the important work Onward and our partners are doing to advance the use of BCI to improve mobility.”

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Infographic – U.S. Dominates Diabetes Drug Sales

Chart: Global diabetes drug sales

Click on image for full-size view (Statista)

19 Nov. 2022. Diabetes continues to be a worldwide scourge, affecting some 422 million people, according to World Health Organization. In the U.S., Centers for Disease Control and Prevention says more than 133 million people have diabetes, nearly one-third of the world’s total, yet almost half of the world’s diabetes drug sales volume is in the U.S.

The business research company Statista compiled these drug sales data as part of its Health Market Outlook report. The findings show sales of diabetes drugs in the U.S. last year reached $27.1 billion, just under half (46%) of the global total of $58.6 billion. Nonetheless, says WHO, the majority of people with diabetes live in low- or middle-resource regions. One reason for the large proportion of diabetes drug sales volume in the U.S. is the high price of insulin. Statista cites a Rand Corp. report showing as of 2018, insulin prices are five to 10 times higher in the U.S. than elsewhere in the world.

Diabetes is a chronic disorder where the pancreas does not create enough insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. In type 2 diabetes, which accounts for at least 90 percent of all diabetes cases, the pancreas produces some but not enough insulin, or the body cannot process insulin. Type 1 diabetes is an autoimmune disorder, where the immune system attacks beta cells in the pancreas, preventing insulin production.

For the Health Market Outlook, Statista says it collects data from a range of sources: company reports, health organizations, trade associations, reviews of industry media, economic indicators, and expert opinions. The company says it continuously reviews markets for various industries, and constructs forecasting models based on data collected from those reviews.

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Mental Health Therapy, Tech Network Gains Early Funds

Brain hemispheres graphic

(Pixabay)

18 Nov. 2022. A company building a therapy and technology network for improving access to mental health providers is raising $15 million in its first venture round. Resilience Lab, a three year-old enterprise in New York, today connects patients to some 200 therapists serving five states in the Northeast U.S., as well as offering clinicians mid-career training and technology support.

Resilience Lab seeks to make therapy for mental health conditions more readily available to people in need of those services. The company cites data showing fewer than 600,000 licensed therapists in the U.S., with 40 percent of potential mental health patients unable to find treatment.

Resilience Lab says it serves clients in New York, New Jersey, Connecticut, Pennsylvania, and Massachusetts. People seeking help, says the company, complete a questionnaire on the Resilience Lab web site, and are matched to therapists in their vicinity reflecting their identity and issues raised in their responses. Resilience Lab says it uses evidence-based algorithms and methods, both quantitative and qualitative, in this matching process. The company lists a range of therapy services for individuals, couples, and families.

The company says a key service for its therapist network is mid-career education. The Resilience Institute, says the company, aims to connect academic research with real-world practice, to build therapist skills in treatment planning, diagnostics, new treatment methods, and managing complex cases requiring multiple therapeutic approaches, through continuing education and workshops.

Need more therapists and higher-quality therapy

In addition, Resilience Lab says its technology for therapists includes software for collaboration and tracking client progress with machine learning algorithms to help improve outcomes. The company also says it provides back-office software support for therapists, such as appointments, billing, and reimbursements. Resilience Lab says its services are covered by six health insurance providers, including Aetna that last month began covering the company’s services.

“Whether due to a lack of supervised, real-world training options or completing supervised hours in roles unrelated to therapy, many social work, counseling and psychiatry graduates never become practicing therapists,” says Resilience Lab  co-founder and chief clinician Christine Carville in a company statement released through Cision. “I started Resilience Lab because I believe we can bridge the gap between academia, active therapeutic work with clients, and clinicians making a living in what they are trained, and love, to do.”

Resilience Lab is raising $15 million in its first venture round, led by technology investor Morningside in Boston and health care investor Viewside Capital Partners in Dallas. Joining the round are 20 health and technology entrepreneurs who were not disclosed.

“Digital innovation has made therapy more accessible, but it is not solving for the long-term,” notes Resilience Lab co-founder and CEO Marc Goldberg. “We need more therapists and better, higher quality therapy if we want to make a dent in the U.S. mental health care crisis.” Goldberg adds that the venture round “is a key milestone for our team, validating that our vision of fundamental and comprehensive reform in the therapist development journey is as important as digital access and back-end automation.”

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Biotech, Regeneron in $2B Cancer Antibody Deal

Cancer magnified

(PDPics, Pixabay)

17 Nov. 2022. A developer of cancer treatments triggered by tumor chemistry is partnering with biologic drug maker Regeneron on dual-action cancer immunotherapies. The deal with Regeneron Pharmaceuticals in Tarrytown, New York is expected to bring CytomX Therapeutics in South San Francisco as much as $2 billion if all terms of the agreement are fulfilled.

CytomX Therapeutics designs cancer therapies that respond to the unique chemistry of the solid tumor microenvironment, the supportive network of cells and proteins that enable the unchecked growth of tumors. The biotechnology company says its synthetic antibodies are designed to work with a range of cancer treatments, including immunotherapies, antibody drug conjugates, and T-cells altered with chimeric antigen receptors.

The CytomX process creates synthetic antibody treatments for solid tumor cancers that respond to high concentrations of protease enzymes in the microenvironment. Proteases are found throughout the body, performing a range of functions. In solid tumor cancers, proteases are more abundant in the microenvironment, providing target signatures for CytomX therapies.

The company’s technology, called Probody, adds molecules that link to tumor cells on one arm of the antibody, but those molecules are activated only when masking molecules on the other arm are broken by the typically high protease concentrations in tumor microenvironments. Probody treatments, says the company, are not triggered by healthy tissue. As a result, says CytomX, its process releases cancer killing drugs only in tumors and not in healthy cells, making it possible to deliver higher cancer-killing doses than conventional chemotherapy drugs given systemically.

Dual-targeting antibodies that resemble natural antibodies

“CytomX has pioneered the field of conditionally-activated therapeutics,” says CytomX CEO Sean McCarthy in a statement,  “through high quality and differentiated science, leading to broad experience in biologic masking strategies and a deep understanding of the protease tumor microenvironment.”

Regneneron Pharmaceuticals is partnering with CytomX to apply the Probody technology to Regeneron’s bi-specific antibodies called Veloci-Bi. Regeneron says its bi-specific or dual-targeting antibodies resemble natural antibodies, but with immunotherapy properties, allowing the arms of the antibodies to link with both tumor cells and T-cells, to activate an immune system response. The company says its pipeline includes treatments for solid tumor and blood-related cancers.

Under the agreement, CytomX and Regeneron are collaborating to identify and validate new bi-specific antibodies that activate only under certain conditions, such as in the presence of tumor microenvironments. Regeneron will fund and be responsible for preclinical and clinical development of treatment candidates from the collaboration, as well as subsequent commercialization. CytomX is receiving a an initial payment of $30 million, and is eligible for target identification, preclinical, clinical, and commercialization milestones up to $2 billion if all terms of the deal are met, as well as royalties on future product sales.

“This collaboration,” says John Lin, Regeneron’s vice-president for immuno-oncology, “will enable Regeneron and CytomX to combine our collective oncology expertise with two premier platforms, Probody and Veloci-Bi, to develop novel immunotherapies and research their potential to transform patient lives.”

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Residual Cancer Detection Company Launches, Raises $56M

Blood vials

(Ahmad Ardity, Pixabay)

16 Nov. 2022. A start-up enterprise developing personalized liquid biopsies for finding residual cancer in patients is beginning work and raising $56 million in venture funds. Haystack Oncology, in Baltimore, is founded by researchers in cancer detection and analysis at Johns Hopkins University, who previously started companies developing early cancer detection technologies.

Haystack Oncology began in 2021 to develop blood tests that provide more accurate and timely readings of continued cancer presence in patients to guide treatment decisions. The company says its liquid biopsies analyze blood samples for circulating tumor DNA, fragments of specific cancer-causing genes broken off from tumors and traveling through the blood stream. The volume of circulating tumor DNA in blood, however, is typically quite low, requiring highly sensitive methods for detection and analysis. But because liquid biopsies require only simple blood samples, they can be taken more frequently than surgical tissue biopsies and offer promising tools for early cancer detection and disease management.

Haystack Oncology’s scientific founders are Johns Hopkins University medical school faculty and cancer researchers Bert Vogelstein, Kenneth Kinzler, and Nickolas Papadopoulos. As reported by Science & Enterprise in May 2019, Vogelstein, Kinzler, and Papadopoulos founded the company Thrive Earlier Detection Corp. that applied circulating tumor DNA capture and analysis to early-stage cancer detection. In January 2021, that company was bought out by Exact Sciences, a provider of non-invasive early cancer detection tests, also co-founded by Vogelstein and Kinzler.

In this case, Haystack Oncology is applying circulating tumor DNA to measurement and characterization of minimal residual disease or MRD, the cancer remaining in a patient after treatment. Cancer patients often receive chemotherapy for MRD after primary therapy, such as tumor resection surgery, to reduce the likelihood of the cancer recurring.

First identify specific cancer-causing mutations

The Haystock technology aims to provide cancer specialists with a tool for detecting MRD in circulating DNA from a patient’s tumor in blood samples to determine the need for follow-up chemotherapy. The company uses whole exome sequencing — analysis of genes coding for proteins — from the patient’s tumor tissue to identify specific cancer-causing mutations. Subsequent Haystack blood tests then seek out precise circulating tumor DNA reflecting those mutations.

A team from Johns Hopkins tested this approach in a clinical trial among patients with stage 2 colon cancer, where the cancer spreads to the colon wall, but not to lymph nodes, and is still considered treatable. The 455 participants were randomly assigned on a two-to-one basis to receive treatments guided by precision circulating tumor DNA analysis or standard cancer care. Results of the trial, published in June 2022, show fewer patients receiving precise circulating tumor DNA analysis than standard care needed follow-up chemotherapy. Yet, patients not receiving chemotherapy survived as long as chemotherapy recipients for up to three years, without their cancers recurring.

“Detecting MRD has long been akin to looking for a needle in a haystack,” says Haystack Oncology’s CEO Dan Edelstein in a company statement. Edelstein adds, “Haystack’s mission is to deliver earlier, more precise detection of residual and recurrent tumors to personalize therapy and dramatically improve outcomes for patients with cancer.”

Haystack Oncology is raising $56 million in its first venture round, led by biomedical investor Catalio Capital Management in New York that helped start the company. Taking part in the round are medical diagnostics company Bruker, Exact Ventures — the investment arm of Exact Sciences — and Alexandria Venture Investments.

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Company to Boost Orphan Drugs in Europe

Europe at night from space

(NASA Goddard Space Flight Center, Flickr. https://www.flickr.com/photos/wwworks/2712985768)

15 Nov. 2022. A start-up enterprise seeks to make drugs for treating rare diseases more readily available to physicians and patients in Europe.  Avanzanite Bioscience B.V., a company formed last year in Amsterdam, began operations today with what it claims is a business model designed to overcome current obstacles in Europe facing rare disease drugs.

Avanzanite Bio says the vast majority of new orphan drugs launched in Europe, those designed to treat for rare diseases, fail to reach their intended patients, nor do they achieve commercial or revenue goals. The company traces much of the problem to regulatory, distribution, and marketing variations in each European country, requiring more than 30 national strategies for getting these needed treatments in the hands of physicians, even after review and approval of new drugs by European authorities. As a result, says the company, many drug makers refuse to bring their orphan drugs to Europe or leave the market altogether.

To enable more European patients to benefit from orphan drugs, says Avanzanite Bio, requires a new business model. The company plans to partner with biotech and pharmaceutical companies, to gain exclusive licenses for distributing drugs that reach late clinical trial stages or after EU approval, to treat rare diseases. Avanzanite says it can offer orphan drug makers a single point of entry to European markets without building their own distribution or marketing infrastructures in the individual countries.

As an example, Avanzanite offers its partnership with SIFI S.p.A., a developer of eye disease therapies in Catania, Italy. SIFI produces treatments for infections and inflammation in the eye, including acanthamoeba keratitis, a rare infection affecting the cornea. While considered a rare disease, acanthamoeba keratitis is more likely to occur in people with soft contact lenses, where an amoeba, a single-cell microorganism, enters and damages tissue in the cornea. The disease can lead to eye pain, vision loss, and permanent blindness.

Managing complexities of product launches

SIFI created the drug Akantior, an anti-amoebic polymer as a treatment for acanthamoeba keratitis. In a conference paper last month, researchers from the company say nearly nine in 10 participants (87%) in a late-stage clinical trial receiving Akantior clinically resolved their infections, compared to 55 percent in real-world findings, while 62 percent of participants report full vision restored.

Even while based in Italy, SIFI says it employed Avanzanite Bio to help market the drug throughout Europe. Fabrizio Chines, SIFI’s chairman and CEO says in a statement that the Avanzanite team “demonstrated an impressive track record of managing the complexities of product launches across the fragmented European marketplace, particularly regarding pricing and reimbursement, physician engagement, and technical operations.”

Avanzanite Bio is founded by pharma and biotech entrepreneurs Adam Pilch and Anant Murthy. “We’ve cracked the code in deciphering this tricky landscape,” notes Pilch, “and now, with our initial strategic partnership with SIFI, we are ready to take our transformational model to the next level by bringing new medicines to patients with rare diseases.”

The company says it’s fully authorized to distribute medicinal products throughout the European Economic Area that includes European Union states, as well as Iceland, Liechtenstein, and Norway. Avanzanite does not disclose its investors or other financial details.

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Biotech, M.D. Anderson Partner on Precision Drug Design

Network pointer

(Gerd Altmann, Pixabay)

14 Nov. 2022. A company discovering therapies with artificial intelligence is partnering with M.D. Anderson Cancer Center on new small-molecule precision medicines. Financial and intellectual property details of the agreement between M.D. Anderson in Houston, part of the University of Texas system, and Exscientia plc in Oxford, U.K. were not disclosed.

Exscientia applies artificial intelligence tools to discovery and design of precision medicines, those addressing specific molecular targets. The company’s process adapts machine learning, beginning with models using data from real-world tissue samples in patients that it says helps maintain a focus on specific molecular targets and outcomes. From there, Exscientia applies synthetic biology for identifying new therapies, with continuous assessments of potency and chemical activity in the body, fed back into algorithms to find the optimum design.

In addition, Exscientia says its approach makes possible faster and lower cost discovery of small-molecule or low molecular weight drugs. In a 2018 conference paper, an Exscientia team described its process of using A.I. techniques to first identify precise molecular targets, then screening from a smaller pool of candidates than many of today’s other drug discovery techniques. The company says its approach reduces drug-discovery timelines by 75 percent. As reported by Science & Enterprise in June 2021, Exscientia is partnering with low-cost drug developer EQRx in Cambridge, Mass. on discovery of new small-molecule therapies.

Accelerating drug discovery and development

“Artificial intelligence has opened up new possibilities in cancer research,” says Exscientia founder and CEO Andrew Hopkins in a statement, “enabling us to use deep learning multi-omics within our precision medicine platform to test potential drug candidates in Exscientia’s patient tissue models. Further, our platform holds the potential to stratify patients even in the early discovery stage, allowing us to efficiently design drug candidates that are most likely to be impactful for people with cancer.”

The new agreement calls for the Exscientia to collaborate with the Institute for Applied Cancer Science or IACS at M.D. Anderson to discover new precision small-molecule cancer treatments, based on jointly identified therapy targets. IACS is M.D. Anderson’s research center for development of new small-molecule cancer drugs, whose mission includes accelerating the drug discovery and development process. This unit, says M.D. Anderson, combines tools of computational and systems biology and chemistry with cancer biology, medicinal chemistry, and pharmacology.

The collaboration is expected to discover new precision cancer therapies for advancement into proof-of-concept clinical trials at M.D. Anderson. While the cancer center and Exscientia are expected to jointly support and contribute to each program under the collaboration, further financial details and timelines were not disclosed.

“This collaboration,” notes Philip Jones, head of IACS, ” is built upon Exscientia’s A.I.-driven precision medicine platform, the strength of M.D. Anderson’s drug discovery and development engine, and the expertise of our clinical research teams. Our ultimate goal is to decrease the time we spend in drug development and accelerate novel targeted therapies into the clinic.”

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