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Paige Announces World’s First Clinical-Grade Artificial Intelligence in Pathology

On July 15, 2019 Paige, the leader in computational pathology focused on building artificial intelligence (AI) to transform the clinical diagnosis and treatment of cancer, reported the publication of an article in Nature Medicine, a leading monthly journal publishing original peer-reviewed research in all areas of medicine, describing an AI system for computational pathology that achieves clinical-grade accuracy levels (Press release, Paige AI, JUL 15, 2019, View Source [SID1234537535]). The paper provides further scientific evidence that pathologists’ work in diagnosing and treating cancer can be complemented and aided through the deployment of computational decision-support systems to improve patient care.

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The team of scientists responsible for the work described in the article developed specially-designed deep learning algorithms to build a system that can detect prostate cancer, skin cancer and breast cancer with near-perfect accuracy. These algorithms are based on a vast dataset of nearly 45,000 de-identified, digitized slide images from more than 15,000 cancer patients from 44 countries.

"After years of in-depth, comprehensive modeling, training, and testing, we are thrilled that Nature Medicine has published our paper, which demonstrates our ability to train accurate classification models at unprecedented scale, and validates our mission to create the world’s first clinical-grade, artificial intelligence in pathology," said Dr. Thomas Fuchs, Co-Founder and Chief Scientific Officer of Paige, who led the work at his lab at Memorial Sloan Kettering Cancer Center (MSK).

The paper outlines how a series of novel algorithms created using datasets ten times larger than those that have been manually curated performed better and also are more generalizable. The significance of this new development hinges on the fact that curating datasets can be prohibitively expensive and time intensive. By eliminating the need to curate datasets, Paige can now develop many more highly accurate algorithms that can be built into clinical decision support products to help pathologists around the world drive better patient care.

"The publication in Nature Medicine of the algorithm developed by Dr. Fuchs’ lab is an important milestone for Paige. It demonstrates that AI has the potential to support pathologists in delivering quantitative and more accurate diagnoses, improving treatment for patients worldwide. Leveraging even larger training sets, over the past year, Paige has created novel vendor-agnostic systems that demonstrate even better accuracy," said Dr. Christopher Kanan, lead AI scientist at Paige.

Paige plans to commercialize several of these solutions to address the most pressing needs in pathology to improve patient care. Paige has already built on the academic work described in Nature Medicine to develop a clinical product, based on technology currently under review by the U.S. Food and Drug Administration as a designated Breakthrough Device, for an intended indication different than the one described in the article.

All data collection, research, and analysis for this research was conducted exclusively at MSK in New York City, led by Dr. Fuchs and his student Gabriele Campanella. The publication of the study’s findings was the result of collaboration between numerous researchers and clinicians, and made possible by Paige’s partnership with MSK. All data were de-identified and did not contain any protected health information or label text. The full article, published in Nature Medicine on July 15, 2019 and titled "Clinical-grade Computational Pathology using Weakly Supervised Deep Learning on Whole Slide Images," can be found online at View Source

Recursion Pharmaceuticals Secures $121 Million in Series C Financing

On July 15, 2019 Recursion, a next-gen biopharma company combining automated, experimental biology with artificial intelligence to discover and develop drugs at scale, reported the closing of a $121 million Series C financing (Press release, Recursion Pharmaceuticals, JUL 15, 2019, View Source [SID1234537534]). The round was led by Baillie Gifford’s flagship investment trust, Scottish Mortgage Investment Trust PLC, with participation by new institutional investors Intermountain Ventures, Regents of the University of Minnesota, Texas Tech University System, and select angel investors. All prior institutional investors also participated in the round, including Lux Capital, Data Collective, Mubadala Ventures, Two Sigma Ventures, Obvious Ventures, Felicis Ventures, Epic Ventures, Menlo Ventures, AME Cloud Ventures, and CRV.

The new financing will support Recursion’s continued build-out of its machine learning-enabled drug discovery platform alongside new capabilities designed to radically accelerate new chemical entity chemistry and predict safety pharmacology. In addition, the Company will continue to advance its growing pipeline of pre-clinical and clinical assets, including clinical-stage programs for cerebral cavernous malformation and neurofibromatosis type 2.

"We’re very excited to see companies bringing innovation from different fields together to try to radically change healthcare," said Marina Record, Investment Manager at Baillie Gifford. "Recursion impressed us with its multidisciplinary effort and ambitious vision to improve our understanding of biology and discover new drugs in a way that is faster and cheaper. We are proud to support Chris and his team as they continue to build out their technology and take their programs through clinical development."

While Recursion plans to prioritize the advancement of treatments for rare diseases within its own pipeline, it will continue to forge strong partnerships with industry-leading pharmaceutical companies in a variety of therapeutic areas, including immuno-oncology, oncology, aging, and inflammation.

"In under two years since closing our Series B round, we have put two drugs discovered on our platform into clinical trials, had our first discoveries with Takeda optioned, grown our automated experimental bandwidth by an order of magnitude, expanded beyond rare diseases into new therapeutic areas like inflammation, infectious disease and immuno-oncology, grown our team from 64 to 150-plus and added all-stars from the biotech and tech worlds, and opened a state-of-the-art, 100,000 square-foot headquarters in downtown Salt Lake City," said Chris Gibson, PhD., CEO, Recursion.

Added Gibson: "We could not continue to scale up our business and achieve our mission of decoding biology to radically improve lives without this incredible investor syndicate. With these new resources, we will continue to drive toward a future in which drugs are developed — by people — with a new level of understanding about human biology that was simply not possible before machines."

For more information on Recursion’s unique approach to leveraging artificial intelligence for drug discovery and development, please visit www.recursionpharma.com.

Provectus Receives Notice of Allowance for Fourth Cancer Combination Therapy Patent from the United States Patent and Trademark Office

On July 15, 2019 Provectus (OTCQB: PVCT) reported that the United States Patent and Trademark Office (USPTO) has allowed US patent (USP) application 15/804,357 for the combination of intratumoral PV-10 and systemic immunomodulatory therapy (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers (Press release, Provectus Biopharmaceuticals, JUL 15, 2019, View Source [SID1234537533]). Intratumoral injection of oncolytic immunotherapy PV-10 can yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells.1-5 Drug development of PV-10 includes cutaneous melanoma and cancers of the liver, such as hepatocellular carcinoma, metastatic neuroendocrine tumors, and metastatic uveal melanoma, in both monotherapy and combination therapy settings.

This prospective new patent is the third continuation of USP 9,107,887, Provectus’ first and foundational cancer combination therapy patent granted by the USPTO in 2015. It is also related to USP 9,808,524 and USP 9,839,688, which are also continuations and the Company’s second and third cancer combination therapy patents granted by the USPTO in 2017. Pfizer, Inc. (Pfizer) is a co-assignee on all four awarded and allowed patents. No formal or informal agreement exists between Provectus and Pfizer regarding potential or possible patent economics.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "This fourth addition to Provectus’ cancer combination patent family represents our continued efforts to increase the potential commercial value of investigational cancer immunotherapy PV-10. We are grateful to Pfizer for their acquiescence as we pursue further patent protection of PV-10 as well as combinations of PV-10 with checkpoint inhibitor drugs."

Mr. Rodrigues added, "This pending new patent reinforces our clinical development strategy for combining PV-10 with checkpoint inhibitor drugs. From a cancer combination therapy perspective, global anti-PD-1 and anti-PD-L1 agents are essentially clinically interchangeable, in our view, and have no notable differences except pricing. We also believe that patients suffering from certain tumor types, like non-T cell inflamed and low tumor mutation burden ones, may benefit from the combination of PV-10, an anti-CTLA-4 drug, and an anti-PD-(L)1 drug."

About PV-10

PV-10 causes acute oncolytic destruction of injected tumors, releasing damage associated molecular pattern molecules (DAMPs) and tumor antigens that initiate an immunologic cascade where local response by the innate immune system facilitates systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. T cell function can be further augmented by combining PV-10 with immune checkpoint inhibition.

PV-10 is undergoing clinical study for adult solid tumor cancers like melanoma and cancers of the liver (including metastatic neuroendocrine tumors and metastatic uveal melanoma) and preclinical study for pediatric cancers like neuroblastoma5, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma.

Orphan drug designation status has been granted to PV-10 by the U.S. Food and Drug Administration for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

PV-10’s active pharmaceutical ingredient is rose bengal disodium (RB) (4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein disodium salt), a small molecule halogenated xanthene. PV-10 drug product is a bright rose red solution containing 10% w/v RB in 0.9% saline for injection, which is supplied in single-use glass vials containing 5 mL (to deliver) of solution and administered without dilution to solid tumors via intratumoral injection.

Provectus’ intellectual property includes a family of US and international patents that protect the process by which pharmaceutical grade RB and related xanthenes are produced, reducing the formation of previously unknown transhalogenated impurities that exist in commercial grade RB in uncontrolled amounts. The requirement to identify and control these substances is in accordance with International Conference on Harmonisation (ICH) guidelines for the manufacturing of active pharmaceutical ingredient that is suitable for clinical trial and commercial pharmaceutical use. USPs include 8,530,675 (awarded in 2013), 9,273,022 (2016), and 9,422,260 (2017), with patent expirations ranging from 2030 to 2031.

Exelixis Updates Phase 1b COSMIC-021 Trial of Cabozantinib in Combination With Atezolizumab in Patients With Advanced Solid Tumors

On July 15, 2019 Exelixis, Inc. (NASDAQ: EXEL) reported that two original cohorts are being expanded and four new cohorts are being added to the protocol for COSMIC-021, the phase 1b trial of cabozantinib (CABOMETYX) in combination with atezolizumab (TECENTRIQ) in patients with locally advanced or metastatic solid tumors (Press release, Exelixis, JUL 15, 2019, View Source [SID1234537532]).

Based on preliminary encouraging activity, as determined by response assessment per Response Evaluation Criteria in Solid Tumors (version 1.1) (RECISTv1.1), and safety data, the original immunotherapy-refractory non-small cell lung cancer (NSCLC) and metastatic castration-resistant prostate cancer (CRPC) cohorts are being expanded to 80 patients each. Additionally, four new cohorts consisting of two expansion and two exploratory cohorts are being added to COSMIC-021. The two new expansion cohorts will evaluate the combination of cabozantinib and atezolizumab in patients with metastatic CRPC who have received prior enzalutamide or abiraterone therapy, with or without prior docetaxel therapy. The two new exploratory arms evaluating single-agent cabozantinib and single-agent atezolizumab in patients with metastatic CRPC are being added to determine the individual contribution of each therapy.

"There is an urgent need for new treatments to improve outcomes for patients with NSCLC refractory to immunotherapies and patients with metastatic CRPC," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "Following encouraging early efficacy and safety data from the original lung and prostate cancer cohorts in COSMIC-021, we look forward to exploring the combination of cabozantinib and atezolizumab further in these expanded and newly added cohorts as we advance our plans to expand the broader late-stage development plan for cabozantinib."

With these additions, the trial now includes 20 expansion cohorts and four exploratory cohorts and aims to enroll up to 1,732 patients with advanced or metastatic solid tumors such as renal cell carcinoma (RCC) and urothelial carcinoma (UC), among others. The primary objective in the expansion stage of this trial remains to determine the objective response rate in each cohort.

Detailed descriptions of the expanded and new cohorts are outlined below:

Immunotherapy-Refractory NSCLC:

After reviewing the safety and efficacy data, as determined by response assessment per RECISTv1.1, of patients enrolled in the immunotherapy-refractory NSCLC cohort, 50 additional patients (80 total) with stage IV non-squamous NSCLC who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease will be enrolled at the recommended dose of cabozantinib 40 mg plus atezolizumab 1,200 mg.
An exploratory single-agent cabozantinib cohort was previously added to the protocol. This cohort evaluates the activity of cabozantinib (60 mg daily) in 30 patients with stage IV non-squamous NSCLC who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.
Metastatic CRPC:

After reviewing the safety and efficacy data, as determined by response assessment per RECISTv1.1, of patients enrolled in the metastatic CRPC cohort, 50 additional patients with metastatic CRPC (80 total) who have histologically or cytologically confirmed adenocarcinoma of the prostate are being enrolled at the recommended dose of cabozantinib 40 mg plus atezolizumab 1,200 mg. Prior treatment with one novel hormonal therapy (NHT) for castration-sensitive prostate cancer (CSPC) or metastatic CRPC is permitted. Patients may have previously received docetaxel for metastatic CSPC but no other approved or experimental systemic therapies apart from one poly (ADP-ribose) polymerase (PARP) inhibitor for metastatic prostate cancer.
A combination-therapy expansion cohort with 30 patients with metastatic CRPC who have histologically or cytologically confirmed adenocarcinoma of the prostate after prior treatment with one NHT for CSPC or metastatic CRPC are being added. Patients may have previously received docetaxel for metastatic CSPC but no other approved or experimental systemic therapies apart from one PARP inhibitor for metastatic prostate cancer.
30 patients with metastatic CRPC who have histologically or cytologically confirmed adenocarcinoma of the prostate who received docetaxel for metastatic CRPC and at least one NHT for CSPC or metastatic CRPC will be enrolled in a new combination-therapy expansion cohort at the recommended dose of cabozantinib 40 mg plus atezolizumab 1,200 mg.
An exploratory single-agent cabozantinib cohort and exploratory single-agent atezolizumab cohort with patients with metastatic CRPC who have histologically or cytologically confirmed adenocarcinoma of the prostate after prior treatment with one NHT for CSPC or metastatic CRPC are being added. Patients may have previously received docetaxel for metastatic CSPC but no other approved or experimental systemic therapies apart from one PARP inhibitor for metastatic prostate cancer. The single-agent cabozantinib cohort will initially enroll up to 30 patients, and the single agent atezolizumab cohort will initially enroll up to 10 patients.
More information about the currently enrolling cohorts in this trial is available at ClinicalTrials.gov.

TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About the COSMIC-021 Study

COSMIC-021 is a multicenter, phase 1b, open-label study that is divided into two parts: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase was designed to enroll patients either with advanced RCC with or without prior systemic therapy or with inoperable, locally advanced, metastatic or recurrent UC (including renal, pelvis, ureter, urinary bladder and urethra) after prior platinum-based therapy. Ultimately, all patients enrolled in this stage of the trial were patients with advanced RCC. The dose-escalation phase of the study determined the optimal dose of cabozantinib to be 40 mg daily when given in combination with atezolizumab (1200 mg infusion once every 3 weeks). These results were presented at the European Society for Medical Oncology 2018 Congress.

In the expansion phase, the trial is enrolling 20 expansion cohorts in 12 tumor types: RCC, UC, NSCLC, CRPC, triple-negative breast cancer, epithelial ovarian cancer, endometrial cancer, hepatocellular carcinoma, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, head and neck cancer, and differentiated thyroid cancer. Up to a total of 1,720 patients may enroll in this phase of the trial: each expansion cohort will initially enroll approximately 30 patients, and up to 10 cohorts may expand enrollment up to 1,000 additional patients in the expansion phase.

In three exploratory cohorts, approximately 30 patients each with advanced UC, CRPC, or NSCLC will be treated with cabozantinib as a single-agent. In a fourth exploratory cohort, approximately 10 patients with advanced CRPC will be treated in a single-agent atezolizumab cohort. Exploratory cohorts have the option to be expanded up to 80 patients (cabozantinib) and 30 patients (atezolizumab) total.

About CABOMETYX (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with HCC who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan.

Please see Important Safety Information below and full U.S. prescribing information at View Source

U.S. Important Safety Information

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.
Perforations and Fistulas: GastrointestinaI (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula that cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic event requiring medical intervention.
Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.
Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.
Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.
Proteinuria: Proteinuria occurred in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.
Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 28 days prior to scheduled dental surgery or invasive dental procedures. Withhold CABOMETYX for development of ONJ until complete resolution.
Wound Complications: Wound complications were reported with CABOMETYX. Stop CABOMETYX at least 28 days prior to scheduled surgery. Resume CABOMETYX after surgery based on clinical judgment of adequate wound healing. Withhold CABOMETYX in patients with dehiscence or wound healing complications requiring medical intervention.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, and vomiting.
Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.
Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.
Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.
Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

Selecta Biosciences Appoints Alison Schecter, M.D., as Chief Medical Officer

On July 15, 2019 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported the appointment of Alison Schecter, M.D., as Chief Medical Officer effective Monday, July 15, 2019 (Press release, Selecta Biosciences, JUL 15, 2019, View Source [SID1234537531]).

"Alison is an extremely accomplished senior leader with over 20 years of combined drug development, strategic management and practical clinical experience in academia and industry, successfully leading multiple clinical programs to approval," said Carsten Brunn, President and Chief Executive Officer of Selecta Biosciences. "As we remain focused on developing our immune tolerance platform, ImmTOR, for rare and serious diseases that require new treatment options, Alison’s knowledge and experience in this area will be invaluable as we continue to advance our lead program, SEL-212 for the treatment of chronic refractory gout, and as we further pursue the potential of our technology’s ability to enhance the field of gene therapy."

Dr. Schecter joins Selecta from Sanofi, where she was the Global Project Head, Rare Diseases, and was responsible for leading the Niemann-Pick Disease (ASMD) project, where her team was awarded the 2018 Cambridge Chamber of Commerce Visionary Award as well as gaining Breakthrough, Prime and Sakegake designations. She acted as the primary BD liaison between research and clinical development for internal and external programs in Rare Disease and adjacent therapeutic areas. Previously, Dr. Schecter was Global Program Head at Baxalta where she was instrumental in obtaining U.S. Food and Drug Administration (FDA) and PMDA approval for Adynovate, and for advancing the hemophilia portfolio culminating in Baxalta’s acquisition by Shire. Previously, Dr. Schecter was VP of Cardiovascular and Metabolism (CVM) External Innovation at the Northeast J&J Innovation Center in Cambridge, where she was responsible for identifying novel product opportunities and technologies. Earlier, she led translational medicine in cardiovascular and metabolism and rare disease indications at the Novartis Institutes of Biomedical Research (NIBR), leading a PoC trial for the IL-b antibody program, thus validating the NLRP3 signaling pathway for secondary prevention in cardiovascular disease. Dr. Schecter started her career in academia where she was Associate Professor in Immunology and Medicine and co-founder of the Cardiovascular Research Institute at the Icahn School of Medicine at Mount Sinai. She was the recipient of numerous NIH grants. Her work at the Icahn School of Medicine at Mount Sinai led to the identification of functional chemokine receptors on cardiac myocytes and vascular smooth muscle. Her innovative academic translational research led to a successful career in biotechnology. Dr. Schecter is a board-certified cardiologist and she completed her Internal Medicine residency at Johns Hopkins Hospital, a Cardiology fellowship at Massachusetts General Hospital and a Research Fellowship at Mount Sinai School of Medicine. She earned her medical degree from SUNY Downstate Health Science University.

"Selecta is guided by its bold vision to mitigate the immunogenicity of biological drugs making treatments such as gene therapy more effective in ways previously not possible. I am honored to join Selecta and work alongside this accomplished management team as we work to unlock the full potential of biologic therapies with ImmTOR," said Dr. Schecter. "I am very encouraged by the clinical data I have seen for the lead program SEL-212 for chronic refractory gout, and I look forward to continuing to develop Selecta’s novel platform in gene therapy, an area that I am particularly excited about as the potential to re-dose AAV gene therapies presents a tremendous opportunity to change patients’ lives."