On May 10, 2021 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic myeloid malignancies, reported financial results for the first quarter ended March 31, 2021, as well as company highlights and upcoming events (Press release, Geron, MAY 10, 2021, View Source [SID1234579575]). As of March 31, 2021, the Company had $244.7 million in cash and marketable securities, which is expected to fund operations until the end of 2022.

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"We have worked diligently over the past quarter to advance our two Phase 3 clinical trials with registrational intent, and we remain laser focused on improving outcomes for patients and delivering significant value to our shareholders," said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.

"Completing 75% of the planned enrollment in our MDS trial coupled with the recent dosing of the first patient in our MF trial indicate the continued progress we are making in our two Phase 3 clinical trials for imetelstat," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "We continue to have confidence in imetelstat’s differentiating clinical benefits seen throughout the course of its development, including strong evidence of disease-modifying activity. We’re excited to have another opportunity to highlight imetelstat’s strong data profile through the two abstracts accepted for presentation at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) meeting. We look forward to achieving top-line results from our IMerge Phase 3 study and the promising path ahead for imetelstat."

Dr. Scarlett concluded, "We are excited about the progress we are making to bring this important drug to patients. We are planning for Geron to become a commercial company in 2023 with the potential launch of imetelstat in lower risk MDS. The markets for both lower risk MDS and refractory MF are highly attractive. We continue to make preparations and manage our cash appropriately to support the future buildout of our manufacturing and commercial infrastructure."

Company Highlights and Upcoming Data Presentations

Ongoing IMerge Phase 3 Clinical Trial in Myelodysplastic Syndromes (MDS)

Screening and enrollment for IMerge Phase 3 in MDS continued to progress in the first quarter. In early December 2020, the Company had completed 50% of the planned patient enrollment in IMerge Phase 3. As of the end of April 2021, enrollment has increased to 75%. The Company continues to expect the trial to be fully enrolled in the second half of 2021. Depending on the timing of full enrollment, the Company expects top-line results from IMerge Phase 3 to be available during the time period from the end of 2022 to the first half of 2023.

For further information about IMerge Phase 3, including enrollment criteria, locations, and current status, please visit ClinicalTrials.gov/NCT02598661.

Ongoing IMpactMF Phase 3 Clinical Trial in Refractory Myelofibrosis (MF)

On April 13, the Company announced that the first patient had been dosed in IMpactMF, the only Phase 3 clinical trial in MF with overall survival (OS) as a primary endpoint evaluating imetelstat, a first-in-class telomerase inhibitor. The Company plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia, and Asia. The Company continues to expect the interim analysis to occur in 2024 and the final analysis in 2025.

For further information about IMpactMF, including enrollment criteria, locations, and current status, please visit ClinicalTrials.gov/NCT04576156.

Upcoming Data Presentations

Two abstracts reporting new clinical data and analyses from the Phase 2 trials of imetelstat in lower risk MDS and refractory MF have been accepted for presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress meeting to be held virtually from June 9 – 17, 2021. Both of the abstracts will be published on May 12, 2021 at 16:00 CEST on ehaweb.org.

First Quarter 2021 Results

For the first quarter of 2021, the Company reported a net loss of $27.8 million, or $0.09 per share, compared to $16.4 million, or $0.08 per share, for the same period in 2020.

Revenues for the first quarter of 2021 were $137,000 compared to $52,000 for the same period in 2020. Royalty revenues in 2021 and 2020 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets. In connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc., which acquired Asterias Biotherapeutics, Inc.) in 2013, Geron is entitled to receive royalties on sales from certain research or commercial products utilizing Geron’s divested intellectual property.

Total operating expenses for the first quarter of 2021 were $28.6 million compared to $16.9 million for the same period in 2020. Research and development expenses for the first quarter of 2021 were $21.1 million compared to $10.8 million for the same period in 2020. The increase in research and development expenses in the first quarter of 2021 compared to the same period in 2020 primarily reflects increased clinical development costs associated with conducting two Phase 3 clinical trials, higher imetelstat manufacturing costs for producing validation batches at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes and higher personnel-related costs for additional headcount. General and administrative expenses for the first quarter of 2021 were $7.5 million compared to $6.1 million for the same period in 2020. The increase in general and administrative expenses in the first quarter of 2021 compared to the same period in 2020 primarily reflects new costs in connection with pre-commercial activities, including modernizing the internal infrastructure to support a commercial launch, and higher legal costs.

Interest income for the first quarter of 2021 was $173,000 compared to $754,000 for the same period in 2020. The decrease in interest income in the first quarter of 2021 compared to the same period in 2020 primarily reflects lower yields on the Company’s reduced marketable securities portfolio.

Interest expense for the first quarter of 2021 was $743,000 and reflects the Company’s debt facility secured in September 2020 for up to $75 million. Currently, $25.0 million has been drawn down under the facility.

Net other income for the first quarter of 2021 was $1.2 million compared to net other expense of $44,000 for the same period in 2020. During the first quarter of 2021, the Company sold all of its holdings in an equity investment resulting in a net realized gain of $1.2 million, including foreign currency translation adjustments.

2021 Financial Guidance Reaffirmed

For fiscal year 2021, the Company continues to expect its operating expense burn to range from $108 to $112 million, which includes costs for the two ongoing Phase 3 clinical trials; producing validation batches of imetelstat at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes; and preparatory activities for regulatory filings to enable drug approval and commercial readiness.

As of March 31, 2021, the Company had 63 employees. The Company plans to grow to a total of approximately 80 to 85 employees by year-end 2021, of which the majority will be development and manufacturing personnel.

Conference Call

The Company will host a conference call today, May 10, 2021 at 4:30 p.m. ET to review its first quarter financial results and provide an update on the ongoing imetelstat Phase 3 clinical trials, IMerge in MDS and IMpactMF in MF.

A live, listen-only webcast will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the conference call live via telephone by pre-registering online using the following link, View Source Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

About IMerge Phase 3

IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

IMerge Phase 3 is currently enrolling patients. For further information about IMerge Phase 3, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT02598661.

About IMpactMF

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

On May 10, 2021 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported its financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Intra-Cellular Therapies, MAY 10, 2021, View Source [SID1234579594]).

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"The acceptance of our sNDAs by the FDA is an important step towards a potential new treatment option for patients living with bipolar depression, a condition with a limited number of approved treatments. While preparing for this significant opportunity, our team will continue to execute on our commercial objectives for CAPLYTA and advance our robust pipeline," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

First Quarter Financial Highlights:

Total revenues were $15.9 million for the first quarter of 2021, compared to $1.1 million of total revenues for the first quarter of 2020. Net product revenues of CAPLYTA were $15.6 million for the first quarter of 2021, compared to $0.9 million in net product revenues of CAPLYTA for the same period in 2020.
Cost of product sales were $1.5 million in the first quarter of 2021 compared to $0.1 million for the first quarter of 2020.
Research and development (R&D) expenses for the first quarter of 2021 were $15.1 million, compared to $16.0 million for the first quarter of 2020. This decrease is due primarily to a decrease in manufacturing expense and is partially offset by an increase of lumateperone clinical and non-clinical expenses.
Selling, general and administrative (SG&A) expenses were $52.6 million for the first quarter of 2021, compared to $34.1 million for the same period in 2020. This increase is primarily due to an increase in sales related labor costs and commercialization costs.
Net loss for the quarter ended March 31, 2021 was $52.7 million compared to a net loss of $47.4 million for the quarter ended March 31, 2020.
Cash, cash equivalents, restricted cash and investment securities totaled $613.4 million at March 31, 2021, compared to $658.8 million at December 31, 2020.
COMMERCIAL HIGHLIGHTS

Despite the continued impact of COVID-19 on the healthcare system during the first quarter, our commercial organization continued to effectively engage with our prescribing audience through a hybrid model of in-person and virtual interactions, enhanced by digital marketing initiatives.
First quarter CAPLYTA results reflect strong commercial execution delivering continued prescription growth, increasing total prescriptions 23% versus the fourth quarter.
CAPLYTA market access coverage is strong with greater than 95% of covered lives in both Medicare Part D and State Medicaid, the major payer channels in schizophrenia. Our LytaLink program continues to be highly competitive and effective in supporting prescribing physicians and eligible patients’ access to CAPLYTA.
CLINICAL HIGHLIGHTS

Lumateperone – Bipolar Depression Program:

The U.S. Food and Drug Administration (FDA) has accepted for review the sNDAs for lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. The FDA has assigned a PDUFA target action date of December 17, 2021 for these applications.
At the American Psychiatric Association (APA) Annual Meeting held from May 1-3, 2021, we had several presentations describing lumateperone study results. These included results from Study ‘402, a global Phase 3 clinical trial evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with bipolar I or bipolar II disorder and analyses from Study ‘404 highlighting the efficacy results of patients with bipolar depression who exhibit mixed features. Another presentation summarized the overall safety and tolerability profile of the bipolar depression monotherapy program.
Other Lumateperone Programs

Mixed Features program: Study ‘403 evaluating lumateperone 42 mg in patients with major depressive disorder (MDD) and in patients with bipolar depression who exhibit mixed features is ongoing.
Adjunctive MDD program: Clinical conduct in two studies, Studies ‘501 and ‘502, our Phase 3 clinical trials evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD is anticipated to begin later this year.
Lumateperone Long Acting Injectable (LLAI) formulation: Study ITI-007-025, a Phase 1 single ascending dose study of LLAI, a formulation designed to be administered subcutaneously and to maintain therapeutic levels of lumateperone for at least one month is ongoing. Initial results from this study are anticipated in the second half of 2021.
CAPLYTA- Schizophrenia

Announced the publication of "Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia" (Correll et al. 2021) in the journal, Schizophrenia Research.
At APA we presented analyses from Study 303, our long-term safety schizophrenia study, evaluating the antidepressant effects of CAPLYTA in patients with schizophrenia with co-morbid depression, with and without concomitant antidepressant treatments.
Other Programs

ITI-1284 program: We introduced ITI-1284 ODT-SL, a deuterated form of lumateperone, a new molecular entity formulated as an orally disintegrating tablet for sublingual administration. We plan to initiate studies evaluating ITI-1284 ODT-SL for the treatment of behavioral disturbances in patients with dementia, the treatment of dementia-related psychosis and the treatment of certain depressive disorders in the elderly.
Phosphodiesterase type I inhibitor (PDE1) program: Our PDE1 inhibitor program is focused on diseases in which the PDE1 enzyme is over-expressed and/or abnormal immune cell function contributes to disease pathology. This suggests therapeutic potential across a variety of diseases, including neurological and cardiovascular diseases, as well as cancer.
We plan to advance our lead molecule, lenrispodun (ITI-214), into a Phase 2 clinical study in Parkinson’s disease in the second half of 2021.
At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, we presented preclinical data supporting the potential of PDE1 inhibition to enhance the anti-tumor effects of immunotherapies by altering the tumor micro-environment. Our prior studies elucidating the neuroprotective and anti-inflammatory effects of PDE1 inhibitors in the brain by regulating microglia function (brain resident macrophage-like cells) led to our exploration of similar effects outside the brain. Therefore, we hypothesized PDE1 inhibition could result in antitumor effects by controlling similar functions of macrophages in the tumor micro-environment. Our experiments indicate PDE1 inhibition prevents the migration and accumulation of monocytes and macrophages in the tumor micro-environment and could represent a novel and broadly applicable approach to the treatment of immune responsive cancers.

ITI-333 program in opioid use disorder: Study ITI-333-001, a Phase 1 single ascending dose study evaluating the safety, tolerability and pharmacokinetics of ITI-333 in healthy volunteers is ongoing. Results from this study are anticipated in the second half of 2021.
Conference Call and Webcast Details

The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company’s financial results and provide a corporate update. The live webcast and subsequent replay may be accessed by visiting the Company’s website at www.intracellulartherapies.com. Please connect to the Company’s website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international) to listen to the live conference call. The conference ID number for the live call is 3244409. Please dial in approximately 10 minutes prior to the call.

CAPLYTA (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.

Important Safety Information

Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.

Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).

Please click here to see full Prescribing Information including Boxed Warning.

About CAPLYTA (lumateperone)

CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

Lumateperone is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA is not FDA approved for these disorders.

On May 10, 2021 TYME Technologies, Inc. (Nasdaq: TYME) (the "Company" or "Tyme"), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that its abstract featuring data from the Company’s investigational therapy, SM-88, has been selected for publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually June 4-8, 2021 (Press release, TYME, MAY 10, 2021, View Source [SID1234579613]).

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Details about the abstract selected for publication can be found below:

Title: Phase II Study of SM-88 in Ewing’s and Other Sarcomas
Abstract Number: e23505
Authors: Giuseppe Del Priore, MD, MPH, Victoria S. Chua, Kitty Zheng, Ted Kim, Semmie Kim, Sant P. Chawla, MD
Session: Publication Only – Sarcoma

The Publication Only abstracts are under embargo until 5:00 p.m. ET on May 19, 2021. For more information about the Annual Meeting, please visit: asco.org.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease.

On May 10, 2021 Yale University, in partnership with Boehringer Ingelheim, reported the launch of a Biomedical Data Science Fellowship program designed to attract and support some of the brightest and most innovative minds in data science from around the world (Press release, Boehringer Ingelheim, MAY 10, 2021, View Source [SID1234579522]).

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Post-doctoral researchers awarded a three-year fellowship will have access to Yale’s robust computational resources, biomedical data repositories and faculty expertise. In addition, they will benefit from access to Boehringer Ingelheim’s corporate labs, scientists and executives. Applicants are invited to submit research proposals for consideration by June 15. If approved for a fellowship, they will be jointly mentored throughout the research process by industry experts and scientists from Boehringer Ingelheim — one of the world’s leading pharmaceutical companies — as well as Yale’s world-class researchers and scholars. Fellowship training begins Sept. 1.

"This collaboration with Boehringer Ingelheim creates a world-class data science fellowship program that will drive development of novel methods and tools to analyze and interpret the many large and complex biomedical datasets that have been created in recent years," said Yale School of Public Health Professor of Biostatistics, Genetics, Statistics, and Data Science Hongyu Zhao, PhD, principal investigator for the project.

The program will be based at the Yale Center for Biomedical Data Science (CBDS) in New Haven, Connecticut. The center is an essential part of a growing data science hub at Yale University, which has identified integrated data science as one of its primary investment areas over the next decade. CBDS is located within Yale School of Medicine and currently supports more than 100 faculty members and researchers representing such disciplines as bioinformatics, modeling, statistics, computer science, artificial intelligence, mathematics, biology, precision medicine and public health.

"In partnering with a top-tier academic and research institution like Yale, we aim to recruit and train a new generation of highly skilled data scientists to help us accelerate development of novel treatments and therapies for human disease and improve health outcomes for our patients," said Jan Nygaard Jensen, PhD, Global Head of Computational Biology and Digital Sciences at Boehringer Ingelheim.

The partnership reflects a mutual vision between Boehringer Ingelheim and Yale University. It is part of a comprehensive strategic program at Boehringer Ingelheim which will harness the power of data science to transform drug discovery and development. The aim is to catalyze the next breakthrough therapies that change lives by accelerating timelines, improving scientific and clinical success and further elevating patient centricity.

"Boehringer Ingelheim is pleased to build upon our successful relationships with Yale to foster the next generation of scientists and harness the power of data science to bring our vision of making new and better medicines for patients in need," said Clive R. Wood, PhD, Senior Corporate Senior Vice President, Global Head, Discovery Research, Boehringer Ingelheim. "We believe our shared ambition and outlook will build a world-class data science community to attract outstanding researchers and work to achieve breakthroughs that patients need."

Initially the program will award as many as three competitive fellowships per year, up to a total of nine over the first five years. In addition to receiving research funding and mentorship, program fellows will be invited to participate in campus and corporate visits, networking events and annual symposia.

A joint selection committee comprising representatives of Yale and Boehringer Ingelheim will set annual data-driven research themes for the program. These themes may include such topics as genomic analysis, biomarkers, data-driven therapeutic research, medical image informatics, precision medicine and translational medicine. The selection committee will consider proposed research projects’ alignment with prioritized themes in judging submissions and post-doctoral applicants.

Yale’s data science ecosystem is supported by a host of cutting-edge research institutions working collaboratively. In addition to CBDS, they include Yale’s Systems Biology Institute, Center for Mendelian Genomics, Center for RNA Science and Medicine, and Center for Medical Informatics. Yale’s biobanks and technology core include: the Yale BioBank GENERATIONS, VA Million Veteran Program, Center for Research Computing, Center for Genomic Health, and Center for Genomic Analysis, which houses the ninth largest genomic library in the world.

Xinxin (Katie) Zhu, MD, PhD, executive director of the Yale Center for Biomedical Data Science, said the fellowship program offers an exciting opportunity for the development of innovative data-driven approaches for different medical conditions that can be translated from the lab to the patient’s bedside. It is an especially opportune time, she said.

"The vast amount of biomedical data being generated today has created a tremendous need for highly skilled data scientists who can use this information to advance care," said Zhu.

Specialists in biomedical data science and health informatics can identify statistical associations and patterns of disease. They also can develop complex machine learning models and simulations of molecular, cellular and organismic systems to increase the probability of clinical success through precision medicine and other methods.

"This helps clinicians and pharmaceutical companies such as Boehringer Ingelheim identify potential new pathways for treatment and eradication of disease," Zhu said.

On May 10, 2021 Allergan Aesthetics, an AbbVie company (NYSE: ABBV) and Soliton (NASDAQ: SOLY) reported a definitive agreement under which Allergan Aesthetics will acquire Soliton and RESONICTM, its Rapid Acoustic Pulse device which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance and is a non-invasive treatment for the short-term improvement in the appearance of cellulite (Press release, AbbVie, MAY 10, 2021, View Source [SID1234580065]). The acquisition of Soliton expands and complements Allergan Aesthetics’ Body Contouring treatment portfolio which includes CoolSculpting Elite.

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The novel platform technology uses non-invasive rapid, high-frequency sound waves to disrupt targeted cellular structures and connective tissue, physically impacting the fibrous septae beneath the skin that contribute to the dimpled appearance of cellulite. In clinical trial data submitted to the FDA, after a single treatment session RESONICTM demonstrated significant improvement and strong patient satisfaction with 92.9 percent of subjects agreeing or strongly agreeing their cellulite appeared improved.

"There is a huge unmet need to address cellulite and effective treatments have been elusive and frustrating for consumers," said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "Soliton’s technology offers a new, completely non-invasive approach with clinically-proven results to reduce the appearance of cellulite with no patient downtime. The addition of this technology complements Allergan Aesthetics’ portfolio of body contouring treatments. Health care providers will now have another option to address consumers’ aesthetic concerns."

"Allergan Aesthetics’ brand recognition, global footprint, track record and commitment to developing best-in-class aesthetic treatments makes the Company ideally suited to maximize the commercial potential of the RESONICTM rapid acoustic pulse technology," said Walter Klemp, Executive Chairman, Soliton. "I am proud of the passion and accomplishments of the Soliton team and thankful for the ongoing support of our investors which have culminated in this transaction. We look forward to working with Allergan Aesthetics to ensure a successful completion of this transaction."

Under the terms of the transaction, Allergan Aesthetics will pay $22.60 per share in cash for each outstanding share of Soliton. Soliton’s enterprise value for the transaction is approximately $550 million and was approved by the Boards of Directors of both companies. The transaction is subject to customary closing conditions, including clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act and approval of Soliton’s shareholders. Guggenheim Securities served as financial advisor to Soliton and Hogan Lovells served as legal counsel to Soliton.

RESONICTM has also received FDA 510(k) clearance for use in conjunction with laser for tattoo removal and has demonstrated clinical results in fibrotic scars.