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Lucid Diagnostics completes $70 million initial public offering

On October 19, 2021 Lucid Diagnostics Inc., a company that produces esophageal cancer tests based on Case Western Reserve University and University Hospitals research, reported that it has completed a $70 million initial public offering (IPO) on the Nasdaq Global Market; at the IPO price, the company’s estimated value would be $467 million (Press release, Case Western Reserve University, OCT 19, 2021, View Source [SID1234591567]).

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Gastroesophageal reflux disease (GERD) affects about 20% of people in the United States. Many individuals with chronic GERD develop Barrett’s esophagus, which can lead to highly lethal esophageal cancer, the sixth-most common cause of cancer deaths worldwide.

Lucid Diagnostics Inc. (Nasdaq: LUCD), a subsidiary of New York-based PAVmed Inc. (Nasdaq: PAVM), licensed the EsoCheck and EsoGuard technology through Case Western Reserve’s Technology Transfer Office (TTO) in 2018. The U.S. Food and Drug Administration awarded both products Breakthrough Device designation, granted to novel medical devices with the potential to provide more effective treatment and diagnosis of life-threatening or irreversibly debilitating diseases and conditions. EsoCheck received a 2020 Edison Award as one of the year’s most significant innovations in the Medical Testing category.

EsoGuard is a next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It has been shown to be highly accurate at detecting esophageal precancer and cancer. EsoGuard is commercially available in the United States and has received European CE mark certification. EsoCheck is a U.S. Food and Drug Administration-cleared and European CE Mark-certified noninvasive swallowable balloon capsule catheter device capable of performing targeted and protected sampling of surface esophageal cells in a less-than-five-minute office procedure.

The underlying technology for EsoCheck and EsoGuard was co-invented by Sanford Markowitz, the Ingalls Professor of Cancer Genetics and Medicine at the School of Medicine and an oncologist at University Hospitals (UH) Seidman Cancer Center; Amitabh Chak, a professor of medicine at the School of Medicine, gastroenterologist at the University Hospitals Digestive Health Institute and the Brenda and Marshall B. Brown Master Clinician in Innovation and Discovery at UH Seidman Cancer Center; and Joseph Willis, a professor of pathology at the School of Medicine and pathology vice-chair for translational research at UH.

Photo of the Lucid Diagnostics founders the Nasdaq desk
(From left) Chak, Markowitz and Willis at Nasdaq.
Markowitz, Chak and Willis were at Nasdaq in New York on Friday to ring the ceremonial bell, marking the close of the day’s stock trading.

"This is a wonderful milestone on a path aimed at preventing death from a miserable cancer through enabling simple early detection of the silent and curable precursor lesions," Markowitz said. "It is a culmination of years of work from an incredibly talented and committed team and is a superb example of the inventive environment and culture that the university and its Technology Transfer Office have created and fostered."

The researchers developed the technology as part of the Case Comprehensive Cancer Center’s GI SPORE Program of Research Excellence and BETRNet (Barrett’s Esophagus Translational Research Network) programs, and was first tested in patients during a clinical trial led by Chak at University Hospitals.

Translational support for the founders’ research to develop the technology came from the National Cancer Institute’s GI SPORE and BETRNet programs, the Case-Coulter Translational Research Partnership, Clinical and Translational Science Collaborative, Ohio Third Frontier, Nottingham Spirk Design Collaborative, the Case TTO, and from University Hospitals Seidman Cancer Center funds in support of SPORE clinical trials.

"The continued research accomplishments focused on public and community benefit and clinical value brought by Sandy Markowitz and his team are not only unparalleled, but bring a scientific impact halo to this school and the university that will remain a shining star for a very long period to come," said Stan Gerson, dean of the School of Medicine and the Asa and Patricia Shiverick–Jane Shiverick (Tripp) Professor of Hematological Oncology.

"This remarkable achievement reflects the incredible hard work and dedication of our colleagues to combat esophageal cancer, a devastating illness," said Mukesh Jain, the Ellery Sedgwick Chair and Distinguished Scientist and vice dean and Distinguished University Professor at the School of Medicine and chief scientific officer for the University Hospitals Health System. "This milestone also reflects the importance of the robust partnership between the two institutions that is advancing the science of health to improve the lives of patients locally and globally."

"Drs. Sandy Markowitz, Amitabh Chak and Joe Willis have partnered with PAVmed Inc. and its CEO, Dr. Lishan Aklog, to bring this transformative technology—a unique device and genetic test combination—to patients for the earliest detection and treatment of esophageal cancer," said Daniel Simon, professor of medicine at the School of Medicine and president of academic and external affairs and chief scientific officer at University Hospitals. "Case Western Reserve University and University Hospitals are committed to create partnerships to advance the health of our patients and our community."

MASORI THERAPEUTICS AND VYANT BIO, INC. ANNOUNCE NEW PARTNERSHIP

On October 19, 2021 MASORI Therapeutics, a company focused on the pharmaceutical industry is applying artificial intelligence to achieve competitive advantage through the creation of innovative market solutions and Vyant Bio, Inc. ("Vyant Bio") (Nasdaq: VYNT), an emerging global drug discovery company that identifies small and large molecule therapeutics to treat central nervous system ("CNS") and oncology-related diseases, reported they entered into an agreement to pursue co-development and out-licensing partnerships with pharmaceutical and biotechnology companies (Press release, Vyant Bio, OCT 19, 2021, View Source [SID1234591546]). The MASORI Therapeutics team has decades of experience in all areas of drug discovery and development, including building biopharmaceutical commercial infrastructures and partnerships from concept to consummation.

MASORI Therapeutics combines healthcare and best-in-class digital expertise that enables life sciences companies to leverage artificial intelligence, machine-learning, and virtual reality to achieve brand growth and better analysis, targeting, and execution. The company’s work with Vyant Bio will initially focus in Japan and will center on providing key insights into the application and intersection of their technologies to accelerate partnership-based therapeutic discovery and development.

"I am inspired by Vyant Bio’s commitment to innovation and the discovery of cures for intractable diseases," said Dane Hallberg, founder, executive chairman and chief executive officer of MASORI Therapeutics. "Vyant Bio embodies the tenets of MASORI Therapeutics, and we look forward to helping both companies drive and advance the development of new therapies that have the potential to make the greatest impact on patients."

Vyant Bio couples highly functional, complex in vitro human-based organoid platforms with advanced analytics and in vivo preclinical and regulatory expertise to bring the most promising compounds through the discovery pipeline. The company incorporates patient biology early in the discovery process to identify, validate, and de-risk new targets and compounds prior to clinical trials.

"Partnerships are central to scientific advancement, and for patients with CNS and oncology diseases, time is of the essence to uncover new treatments as quickly as possible," said Jay Roberts, president and chief executive officer of Vyant Bio. "Our relationship with MASORI Therapeutics will identify and drive drug development partnerships that leverage our capabilities to accelerate the discovery and delivery of such treatments."

Candel Therapeutics Appoints Mace L. Rothenberg, MD, as Senior Advisor to the Chief Executive Officer

On October 19, 2021 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported it has appointed Mace L. Rothenberg, MD, as a senior advisor to its President and Chief Executive Officer, Paul Peter Tak, MD, PhD, FMedSci (Press release, Candel Therapeutics, OCT 19, 2021, View Source [SID1234591544]). Dr. Rothenberg, an industry veteran with more than 30 years of experience across government, academia and industry, will help support the company’s continued growth and acceleration.

"I am delighted to welcome Mace as an advisor to Candel Therapeutics to further strengthen our team," said Dr. Tak. "His impressive background as a physician-executive along with his successful track record of regulatory approvals of numerous novel cancer therapies will bolster the company as it enters the next phase of development."

Prior to joining Candel, Dr. Rothenberg served as Chief Medical Officer of Pfizer. During that time, the company initiated, completed, and obtained emergency use authorization for its COVID-19 vaccine. Prior to that role, Dr. Rothenberg led clinical development for oncology at Pfizer for 10 years. In that period of time, his team developed and obtained regulatory approval for 11 new cancer medicines, including first-in-class medicines: IBRANCE (palbociclib) for patients with HR+/HER2- advanced breast cancer and XALKORI (crizotinib) for patients with ALK+ non-small cell lung cancer. Earlier in his career, Dr. Rothenberg was Professor of Medicine at Vanderbilt University and Ingram Professor of Cancer Research at the Vanderbilt-Ingram Cancer Center. He also served as an Associate Professor of Medicine at the University of Texas Health Science Center at San Antonio and Executive Officer of the Southwest Oncology Group.

Dr. Rothenberg is board-certified in Internal Medicine and Medical Oncology and is a Fellow of the American College of Physicians and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). He received his BA magna cum laude from the University of Pennsylvania and his MD from the New York University School of Medicine. Dr. Rothenberg completed his post-graduate training in internal medicine at Vanderbilt University and in medical oncology at the National Cancer Institute.

"Candel is at the forefront of one of the most exciting approaches in cancer immunotherapy," said Dr. Rothenberg. "I am excited by the opportunity to help Paul Peter advance the company’s promising oncology pipeline. He has built a terrific clinical development organization and I look forward to working with them in advancing Candel’s promising pipeline of compounds."

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a specific CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

About CAN-3110

CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in the healthy adult brain.

Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma. Encouraging clinical results of the ongoing phase 1 clinical trial were recently presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

KemPharm, Inc. Announces Uplisting to The Nasdaq Global Select Market

On October 19, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported that its shares of common stock have been approved for listing to The Nasdaq Global Select Market (Press release, KemPharm, OCT 19, 2021, View Source [SID1234591543]). Trading on the exchange will commence effective with the open of business on October 19, 2021, under KemPharm’s current ticker symbol, "KMPH".

"KemPharm’s advancement to The Nasdaq Global Select Market continues a year of tremendous growth and accomplishment for our company during which time we transformed our business, solidified our financial position and, most importantly with AZSTARYS, succeeded in bringing forth to market the first truly differentiated ADHD medication in years," said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "The Nasdaq Global Select Market is recognized as having the highest initial listing standards of any exchange in the world and is considered a mark of achievement and stature for qualified companies. KemPharm is honored to be amongst this class of company, and we are excited by the opportunity to attract a new echelon of potential investors to our stock."

KemPharm was previously listed on The Nasdaq Capital Market, following its uplisting to the exchange in January. The Nasdaq Global Select Market consists of 1,450 stocks that meet Nasdaq’s strict financial and liquidity requirements and corporate governance standards on both an initial and continuing basis.

About AZSTARYS:

AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.

InnoCare Announces Approval of Clinical Trial of Novel SHP2 Allosteric Inhibitor ICP-189 in China

On October 19, 2021 InnoCare Pharma (HKEX: 09969) reported that the Company has received Investigational New Drug (IND) approval from the NMPA for its SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189, which is the company’s 9th innovative drug candidate entering clinical development (Press release, InnoCare Pharma, OCT 19, 2021, View Source [SID1234591541]).

This China-based Phase Ia/Ib open, single-arm, multicenter study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ICP-189 as a monotherapy and combined treatment in patients with advanced solid tumors.

ICP-189 is being developed for the treatment of solid tumors as a single agent and/or in combinations with other antitumor agents.

Preclinical study shows that ICP-189 is a potent oral allosteric inhibitor of SHP2 with excellent selectivity over other phosphatases. SHP2 is a non-receptor protein tyrosine phosphatase involved in mediating MAPK signaling pathway and immune checkpoint pathway for the regulation of cellular proliferation and survival.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said, "We are excited to see another drug candidate for solid tumors approved for clinical trials. ICP-189 demonstrates excellent drug properties. ICP-189 is our 9th innovative drug candidate entering clinical trials, and we will make every effort to accelerate clinical development to benefit patients."