On October 19, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), applying innovative diagnostics to transform disease management and improve patient outcomes, reported it has signed a definitive agreement to acquire Cernostics, Inc. (Cernostics), an Illumina Ventures company (Press release, Castle Biosciences, OCT 19, 2021, View Source [SID1234591522]). Cernostics specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies. Its TissueCypher Barrett’s Esophagus Assay is the first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE).

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"We are pleased to welcome Cernostics into the Castle family," said Derek Maetzold, president and CEO of Castle Biosciences. "Acquiring the TissueCypher platform is aligned with our commitment to utilizing innovative technology to provide clinically actionable information that guides disease management and improves patient outcomes. The TissueCypher Barrett’s Esophagus Assay addresses an unmet need in BE, as it is designed to objectively and accurately predict progression from non-dysplastic, indefinite for dysplasia and low-grade dysplasia BE to HGD or esophageal adenocarcinoma (EAC). This is critical, as EAC is highly lethal, with five-year survival rates under 20%1, and intervention (ablation) in patients with BE has been proven to reduce progression to EAC. Unfortunately, the incidence of esophageal cancer is increasing at one of the fastest rates of all cancers in the U.S., so we need new clinical tools to reverse this growth trend in the diagnosis of EAC.
"We believe the combined strengths of Castle and Cernostics will position us for continued growth and success as a leader in the diagnostics space, complementing our first-to-market dermatologic franchise. Beginning with a common patient-centric mind-set, our companies are strategically aligned with compatible company cultures and business models that include a strong, ongoing emphasis on growing the body of clinical evidence backing our tests. Together, we have the opportunity to accelerate our impact on patient care and thus drive value creation for shareholders."

"We are excited about joining forces with Castle, a leader in the precision diagnostics space with a strong history of commercial success," said Mike Hoerres, chief executive officer of Cernostics. "With our innovative TissueCypher platform, we have the potential to address unmet clinical needs in the gastrointestinal space, starting with BE. We believe the TissueCypher Barrett’s Esophagus Assay is a valuable tool for improving prevention of esophageal cancer, particularly, to help physicians and patients make more informed management decisions based on the unique biology of an individual patient’s esophageal biopsy."
1 Esophageal Cancer Action Network, View Source

There are approximately 4 million patients in the U.S. diagnosed with BE, and annually, approximately 400,000 endoscopies are performed on BE patients. TissueCypher Barrett’s Esophagus Assay is listed in Group 1 of Novitas’ Billing and Coding Article "Molecular Pathology and Genetic Testing" (A58917). The article becomes effective on November 8, 2021.

Transaction Terms and Other Information

Under the terms of the definitive agreement, Cernostics will become a wholly owned subsidiary of Castle Biosciences. At closing, Castle will pay $30 million in initial consideration to Cernostics security holders, which may consist entirely of cash or $20 million in cash and $10 million in common stock of Castle, at Castle’s sole discretion. The purchase price is subject to customary working capital and other adjustments. Further, up to an additional $50 million in cash and/or common stock, at Castle’s sole discretion, is payable in connection with the achievement of certain milestones based on 2022 performance. The transaction is expected to close prior to year-end 2021, subject to the delivery of certain financial statements to the Company, continued employment of certain Cernostics personnel and satisfaction of other customary conditions to closing.

Upon finalization of the transaction, Hoerres and Cernostics’ executive management team and other staff based in Pittsburgh are expected to stay with the Company. Cernostics’ laboratory and operations will remain in Pittsburgh.

Company management will host a conference call and webcast to discuss this transaction at 7:30 a.m. Eastern time today.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website: View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until Nov. 9, 2021.

To access the live conference call via phone, please dial 1 844 200 6205 from the United States and Canada, or +1 929 526 1599 internationally, at least 10 minutes prior to the start of the call, using the conference ID 781408.

There will be a brief Question & Answer session following management commentary.

About Cernostics and TissueCypher Barrett’s Esophagus Assay

Cernostics applies spatial biology and biologically-aware AI and machine learning to tissue diagnostics, delivering precision diagnostic testing to patients and gastroenterologists. This technology and platform are the core of the TissueCypher Barrett’s Esophagus Assay, the world’s first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). The

TissueCypher Barrett’s Esophagus Assay is indicated for patients with endoscopic biopsy confirmed BE that is graded non-dysplastic, indefinite for dysplasia or low-grade dysplasia. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test (LDT) with its own unique CPT PLA code (0108U), available only from Cernostics’ CLIA-certified pathology laboratory. The TissueCypher Barrett’s Esophagus Assay has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.

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".

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"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.

On October 19, 2021 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 1,580 million in the third quarter of 2021 (Press release, Genmab, OCT 19, 2021, View Source [SID1234591506]). Net trade sales were USD 841 million in the U.S. and USD 739 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC formulations, under the exclusive worldwide license to Janssen Biotech, Inc. (Janssen) to develop, manufacture and commercialize daratumumab. As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.

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About DARZALEX(daratumumab)
DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat multiple myeloma and has become a backbone therapy in the treatment of this disease. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of multiple myeloma and the first and only approved treatment for patients with light-chain (AL) amyloidosis. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). 1,2,3,4,5,6,7

Please see local country prescribing information for all labeled indication and safety information.

On October 19, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for Rhenium-186 NanoLiposome (186RNL) for the treatment of leptomeningeal metastases (LM) (Press release, Cytori Therapeutics, OCT 19, 2021, View Source [SID1234591523]). The Company expects to initiate patient accrual in a Phase 1 dose escalation trial of 186RNL (ReSPECT-LM) in the fourth quarter of 2021.

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"LM is an increasingly common secondary cancer complication, occurring as a result of increasing observed survival rates for a variety of primary solid and hematologic tumors," said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas and ReSPECT-LM Principal Investigator. "Given the excellent safety data thus far using 186RNL in recurrent glioblastoma, and the preclinical efficacy data when used in animal models of LM, we are optimistic about the potential safety and efficacy of 186RNL as a novel treatment option for LM."

The ReSPECT-LM trial is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1 study. It will evaluate the maximum tolerated dose, maximum feasible dose, safety, and efficacy of a single administration of 186RNL via intraventricular catheter for LM following standard surgical, radiation, and/or chemotherapy treatment. The primary endpoint of the study is the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration or response, progression free survival, and overall survival.

"Leptomeningeal metastasis is a neurologically devastating and fatal complication of cancer," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our latest approved IND application is part of a multifaceted plan to expand our radiotherapeutic pipeline with promising, innovative drugs to treat a variety of rare and difficult to treat cancers."

The ReSPECT-LM Phase 1 clinical trial follows preclinical studies in which tolerance to doses of 186RNL as high as 1,075 Gy was shown in animal models with LM with no observed significant toxicity. Treatment led to marked reduction in tumor burden in both C6 and MDA-231 LM models.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. LM occurs in approximately 5% of people with cancer, or 110,000 people in the U.S. each year, and is usually terminal with a median survival of approximately 2-3 months following treatment. LM occurs with cancers that are most likely to spread to the central nervous system. The most common cancers to include the leptomeninges are breast cancer, lung cancer, and melanomas.

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.

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"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.