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Celldex Therapeutics Announces Fireside Chat Presentation at the H.C. Wainwright Global Life Sciences Conference

On March 5, 2021 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported the Company’s participation in a fireside chat at the H.C. Wainwright Global Life Sciences Conference (Press release, Celldex Therapeutics, MAR 5, 2021, View Source [SID1234576170]). The presentation for the virtual conference was prerecorded and will be accessible to conference attendees starting on Tuesday, March 9th 2021 at 7:00 a.m. ET.

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A webcast of the presentation will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for fourteen days following the event.

BioEclipse Therapeutics Announces First Patient Dosed in Phase 1 Dose-Escalation Clinical Trial of CRX100 in Refractory Solid Tumors

On March 5, 2021 BioEclipse Therapeutics (BioEclipse), a private clinical-stage biopharmaceutical company with a proprietary platform for developing next-generation cancer immunotherapies, reported the administration of the first dose of CRX100 to a volunteer in the ongoing Phase 1 clinical trial in patients with refractory solid tumors (Press release, BioEclipse Therapeutics, MAR 5, 2021, View Source [SID1234576163]). The trial is a first-in-human study for CRX100, BioEclipse’s lead investigational drug candidate, an intravenously delivered, multi-mechanistic therapy designed to target and destroy multiple cancer types and address disease recurrence.

The trial volunteer was administered a single dose of CRX100 at the HonorHealth Research Institute in Scottsdale, Ariz., one of two trial sites participating in a Phase 1, open-label, dose-escalation study exploring the safety, tolerability, and pharmacokinetic (PK) properties of CRX100 in patients with advanced solid tumors not responding to standard of care therapy. The study will enroll up to 24 participants 18 years or older and specifically target six potential cancer indications, including: triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, and gastric cancer. As secondary endpoints, the trial will also investigate the effect CRX100 has on a participant’s tumor progression and overall immune response.

More information about this study and general information about participating in clinical trials can be found at ClinicalTrials.gov and on our website at www.bioeclipse.com.

"With the first patient now dosed in our Phase 1 trial, we have crossed an important milestone in furthering the clinical development of CRX100, which we believe has enormous potential as a single therapeutic designed to launch a multi-mechanistic attack against multiple cancer types," stated Pamela Contag, Ph.D., President and CEO of BioEclipse. "The need for more effective treatment options, especially for patients with cancers refractory to standard therapies is both urgent and unmet. With enrollment now underway at three clinical trial sites, we look forward to reporting top line data later this year."

BioEclipse is currently focused on the treatment of recurring cancers. CRX100 was developed with technology exclusively licensed from Stanford University that combines activated immune cells, known as cytokine-induced killer (CIK) cells, with an oncolytic virus. As stand-alone agents, these two components have previously been assessed in human studies. When combined to create CRX100, the CIK cells are expected to protect the oncolytic virus and deliver it to cancer cells throughout the body. The two components are intended to work together to attack primary tumors and metastatic disease. Data from preclinical studies shows that this combination approach may also trigger a long-lasting immune response that protects against relapse and disease recurrence.

BioEclipse will collaborate with Seattle-based C3 Research Associates, a contract research firm providing clinical trial management, clinical monitoring, medical monitoring, biostatistics and data management, pharmacovigilance, as well as data monitoring for the clinical trial.

"We at C3 Research are excited to be part of this incredible study team," stated Ron Carozza, CEO and Director of Clinical Operations for C3 Research. "The dosing of the first patient is an important milestone in the clinical development of an exciting new potential therapy for cancer patients. None of this would be possible without the hard work of the project team, the clinic staff and, of course, our study participants."

Palatin Technologies to Participate in H.C. Wainwright Global Life Sciences Virtual Conference

On March 5, 2021 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, reported that Carl Spana, Ph.D., President and Chief Executive Officer, will participate in the H.C. Wainwright Global Life Sciences Virtual Conference on March 9-10, 2021 (Press release, Palatin Technologies, MAR 5, 2021, View Source [SID1234576162]). The company’s presentation will be available for on-demand viewing beginning on Tuesday, March 9, 2021 at 7:00 a.m. ET and will remain available on the Investors page under Webcasts of Palatin’s website: www.Palatin.com for approximately 30 days following the presentation.

TerSera® Presents Data on cetirizine HCL Injection (QUZYTTIR®) in the Prevention of Hypersensitivity Infusion Reactions in Patients with Breast Cancer and Other Malignancies

On March 5, 2021 TerSera Therapeutics LLC reported the presentation of data from their Phase 2 study of intravenous (IV) cetirizine versus IV diphenhydramine in the prevention of hypersensitivity infusion reactions in patients with breast cancer and other malignancies (Press release, TerSera Therapeutics, MAR 5, 2021, View Source [SID1234576161]). The data were presented in virtual poster sessions during the 38th Annual Miami Breast Cancer Conference on March 4-7, 2021.1

The Phase 2 exploratory study was a randomized, double-blind, study evaluating the prevention of infusion reactions with cetirizine hydrochloride injection 10mg/mL for IV use versus IV diphenhydramine 50 mg in 34 patients receiving paclitaxel or an anti-CD20 Ab (rituximab, its biosimilar or obinutuzumab). In the IV cetirizine group compared to the IV diphenhydramine group, the number of patients with infusion reactions were 2/17 (11.8%) versus 3/17 (17.6%); sedation scores (range 0 – 4) at 1 hour, 2 hours, and discharge were 0.5, 0.6, and 0.1 versus 1.3, 0.9, and 0.4. Time for discharge was 24 minutes less with IV cetirizine versus IV diphenhydramine. The number of treatment-related adverse events were 3 events with IV cetirizine and 6 events with IV diphenhydramine.

"We are pleased with the results of this Phase 2 study," said Nancy Joseph- Ridge, M.D., Executive Vice President of Research and Development and Chief Medical Officer of TerSera Therapeutics. "This is the first study of IV cetirizine compared to IV diphenhydramine for the prevention of infusion reactions, an investigational use of IV cetirizine."

QUZYTTIR is the first and only injectable second-generation H1 antihistamine to be approved by the U.S. Food and Drug Administration (FDA).2 QUZYTTIR is indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

QUZYTTIR is not approved for the prevention of infusion reactions.

Important Safety Information about QUZYTTIR:

INDICATIONS AND USAGE
QUZYTTIR is indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

Limitations of Use: QUZYTTIR is not recommended in pediatric patients <6 years of age with impaired renal or hepatic function.

Contraindications: Known hypersensitivity to QUZYTTIR or any of its ingredients, to levocetirizine, or hydroxyzine.

Additional Warnings and Precautions: The occurrence of somnolence/sedation has been reported in some patients. Advise patients to exercise due caution when driving or operating potentially dangerous machinery. Avoid concurrent use of QUZYTTIR with alcohol or other CNS depressants because additional reduction in alertness and additional impairment of CNS performance may occur.

Adverse Reactions: The most common adverse reactions (incidence <1%) with QUZYTTIR are dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis.

The most common adverse reactions (incidence ≥2%) with chronic dosing of oral cetirizine hydrochloride in adults are somnolence, fatigue, dry mouth, pharyngitis and dizziness. Adverse reactions observed in pediatric patients with chronic use of oral cetirizine hydrochloride are headache, pharyngitis, abdominal pain, coughing, somnolence, diarrhea, epistaxis, bronchospasm, nausea, and vomiting.

ViewRay To Participate in the 21st Annual Oppenheimer Healthcare Conference

On March 5, 2021 ViewRay, Inc. (NASDAQ: VRAY) (the "Company") reported that members of management will be participating in the 21st Annual Oppenheimer Healthcare Conference on Tuesday, March 16, 2021 (Press release, ViewRay, MAR 5, 2021, View Source [SID1234576160]). ViewRay will be conducting a virtual fireside chat at 3:50 PM ET, as well as hosting 1×1 meetings with investors.

A live webcast of the Company’s fireside chat will be available on the "Financial Events and Webinars" section of ViewRay’s investor website at: View Source A replay of the presentation will be available for the following 7 days.