On March 5, 2021 Seagen Inc. (Nasdaq:SGEN) reported that it has been notified of an unsolicited "mini-tender" offer dated February 22, 2021, made by TRC Capital Investment Corporation, an Ontario, Canada corporation, to purchase up to 1,000,000 shares of Seagen’s common stock (Press release, Seagen, MAR 5, 2021, View Source [SID1234576145]). According to TRC, its "mini-tender" offer price of $151.00 per share was approximately 4.28% below the closing price of Seagen’s common stock on February 19, 2021, the last trading day prior to the date of its offer.

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Seagen does not endorse TRC Capital’s unsolicited "mini-tender" offer and is not associated in any way with TRC Capital, its "mini-tender" offer, or its "mini-tender" offer documents. Seagen recommends that Seagen shareholders reject the offer and not tender their shares in response to this unsolicited offer, for the reasons described below.

TRC has made many similar "mini-tender" offers for the shares of other companies. "Mini-tender" offers are designed to seek less than five percent of a company’s outstanding shares, thereby avoiding many disclosure and procedural requirements of the U.S. Securities and Exchange Commission (SEC) because they are below the SEC’s threshold to provide such disclosure and procedural protections for investors.

The SEC has cautioned investors about "mini-tender" offers in an investor alert. The SEC noted that these offers "have been increasingly used to catch investors off guard" and that many investors who hear about "mini-tender" offers "surrender their securities without investigating the offer, assuming that the price offered includes the premium usually present in larger, traditional tender offers."

To read more about the risks of "mini-tender" offers, please review the alert on the SEC’s website at View Source

TRC’s "mini-tender" offer is subject to numerous conditions, including TRC obtaining sufficient financing available to consummate the offer on terms satisfactory to TRC in its reasonable discretion. Seagen urges shareholders to obtain current stock quotes for their shares of Seagen common stock, review the terms and conditions to the offer, consult with their broker or financial adviser and exercise caution with respect to TRC Capital’s "mini-tender" offer. Shareholders who have already tendered shares should consider the advisability of withdrawing their shares as permitted under TRC’s Offer to Purchase documents.

According to the offer documents, the offer is currently scheduled to expire at 12:01 a.m., Eastern time, on March 23, 2021.

Seagen requests that a copy of this news release be included with all distributions of materials relating to TRC’s "mini-tender" offer related to shares of Seagen’s common stock.

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

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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.

On March 5, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported that the company will be available for 1×1 meetings at the following upcoming conferences (Press release, Cellectar Biosciences, MAR 5, 2021, View Source [SID1234576146]):

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H.C. Wainwright Global Life Sciences Conference
Date: March 9-10, 2021
Time: Available for 1×1 meetings
To schedule, click on the link HERE

Roth Capital Partners 33rd Annual Conference
Date: March 15-17, 2021
Time: Available for 1×1 meetings
To schedule, click on the link HERE
The company’s presentation is available for on-demand viewing in the link HERE.

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.

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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.

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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."