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Sirnaomics Doses the First Patient in Phase I/II Clinical Study of RNAi Therapeutic STP705 for Treatment of Facial Squamous Cell Skin Cancer In Situ

On August 18, 2022 Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the Company has dosed the first patient in a Phase I/II clinical study of STP705, the Company’s leading siRNA (small interfering RNA) drug candidate, for the treatment of patients with facial squamous cell skin cancer in situ (isSCC) (Press release, Sirnaomics, AUG 18, 2022, View Source [SID1234618495]).

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The open label, dose escalation study is designed to evaluate the safety, tolerability, and efficacy of various doses of STP705 administered by intralesional injection and to determine the recommended dose. The study will also analyze biomarkers common to isSCC formation pathways, including TGF-β1 and COX-2. The primary endpoint is to determine the number of patients with histological clearance (HC) of facial isSCC lesions at the end of treatment with STP705. HC is defined as the absence of detectable evidence of the isSCC tumor cell nests as determined by central pathology review. A total of 30 patients, divided into three cohorts of 10 patients each, will receive a given dose once per week for six weeks. Cohort A will receive a 30 μg dose, Cohort B a 60 μg dose, and Cohort C a 90 μg dose.

"We expect that the study of STP705 as a treatment for facial isSCC to yield positive results given previous studies of STP705 that have shown to be safe and effective as a cancer treatment," said Dr. Patrick Lu, founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "Our drug has the potential to offer millions of patients with these non-melanoma facial lesions a non-surgical, non-invasive alternative to traditional lesion removal."

"With surgical removal being the only available treatment for isSCC currently, patients have normally found the results to be painful and aesthetically unpleasing on the face. By dosing our first patient in this Phase I/II study, we can begin to evaluate the safety and effectiveness of STP705 in eradicating these cancerous lesions," said Michael Molyneaux M.D., Executive Director and Chief Medical Officer of Sirnaomics. "Formulating this clinical trial as a dose escalation study also gives us the opportunity to determine which dose is the best suited in removing the cancer without adverse events."

The study started in the United States in August 2022, and is expected to be completed in Q1 2023. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT05421013.

About STP705
Sirnaomics’ leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in seven clinical trials for different indications: a Phase IIb for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), a Phase I/II for facial isSCC, a Phase I for liver cancer (basket), and a Phase I for medical cosmetology treatment.

Medtronic announces cash dividend for second quarter of fiscal year 2023

On August 18, 2022 The board of directors of Medtronic plc (NYSE:MDT) reported that approved the fiscal year 2023 second quarter cash dividend of $0.68 per ordinary share, representing an 8% increase over the prior year (Press release, Medtronic, AUG 18, 2022, View Source [SID1234618494]). This quarterly declaration is consistent with the dividend announcement made by the company in May 2022. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 45 consecutive years. The dividend is payable on October 14, 2022, to shareholders of record at the close of business on September 23, 2022.

RefleXion Announces Multi System Contract with Select Healthcare

On August 18, 2022 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT), a new modality that uses emissions generated from the cancer itself to direct radiotherapy, reported a three-system contract with Select Healthcare, a developer of affiliated cancer facilities throughout the United States (Press release, RefleXion Medical, AUG 18, 2022, View Source [SID1234618493]). The multi-year, multi-site contract will create new free-standing treatment centers that showcase the dual modality of the RefleXion X1 platform for treating all stages of cancer with external beam radiotherapy (EBRT).

"The creation of these initial three new free-standing radiotherapy centers will bring RefleXion’s novel BgRT to local communities so that patients with solid tumor cancers can receive state-of-the-art cancer care near their home," said Matthew Cutler, CEO, president and founder of Select Healthcare Solutions. "The X1 is the only system to offer breakthrough motion management for moving tumors using biological guidance and anatomic guidance for earlier stage cancers. We envision that this future capability will be attractive to our physician partners because it brings radiotherapy as a new treatment option to patients with late-stage cancer."

The RefleXion X1 machine with BgRT is designed to overcome the technical limitations that restrict radiotherapy to one or two tumors. Instead, it will one day allow radiotherapy to reach more tumors during the same treatment session, even those tumors that move due to patient motion, such as breathing or digestion.

"We applaud the Select Healthcare vision of bringing advanced cancer care to patients being treated at the community level through the establishment of these new centers," said Todd Powell, president and CEO of RefleXion. "As we move forward commercializing the X1 and our future release of BgRT, we are proud to count Select Healthcare among our early customers."

BgRT uses emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope, known as a PET tracer, to guide EBRT. As the PET tracer binds to the tumor cells, it produces emissions that signal the cancer’s location. The RefleXion X1 machine design integrates PET arcs with a linear accelerator to detect these emissions and then direct radiotherapy to each tumor.

European Commission Approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer

On August 18, 2022 Celltrion Healthcare reported that the European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin, for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer (Press release, Celltrion, AUG 18, 2022, View Source [SID1234618492]).

"The European Commission’s approval of Vegzelma will increase access to treatment for patients living with certain types of cancer at an affordable price," said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. "With proven similarities in efficacy and safety compared to the reference product Avastin, Vegzelma will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year."

The EC approval of Vegzelma follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2022.

Today’s approval is based on the totality of evidence, including the phase III pivotal trial in patients with metastatic or recurrent non-squamous non-small cell lung cancer. Results showed that, as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.2

Vegzelma (CT-P16) is Celltrion’s third oncology biosimilar approved for use in the EU, following the approval of Truxima (biosimilar rituximab) and Herzuma (biosimilar trastuzumab). Vegzelma was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA) in September 2021. Approval is expected during the third quarter of 2022.

Navidea Biopharmaceuticals Announces Extension of Subscription Period to August 24, 2022 and Updated Terms of its Previously Announced Rights Offering

On August 18, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that it has extended the initial rights offering subscription period until 5:00 PM Eastern time on Wednesday, August 24, 2022 and has updated certain pricing information for its rights offering (Press release, Navidea Biopharmaceuticals, AUG 18, 2022, View Source [SID1234618489]). Each subscription right will entitle the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one (1) share of the Company’s newly created Series I Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of Navidea’s common stock at a conversion price of $0.45 per share) and one (1) warrant to purchase 2,222 shares of Navidea’s common stock with an exercise price of $0.50 per share. The warrants will be exercisable for 5 years after the date of issuance.

All record holders of rights that wish to participate in the rights offering must deliver a properly completed and signed subscription rights certificate, together with payment of the full subscription price for the units the holder wishes to purchase pursuant to both the basic subscription right and the over-subscription privilege to the Subscription Agent, to be received before 5:00 PM Eastern Time on August 24, 2022. The completed rights certificate and payment should be delivered to the Subscription Agent as follows:

Brentwood, NY 11717-0718

Edgewood, NY 11717

Navidea has engaged Maxim Group LLC as dealer-manager for the proposed rights offering. Questions about the rights offering or requests for copies of the final prospectus and prospectus supplement, when available, may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

The Company’s registration statement on Form S-1 (Registration No. 333-262691) was declared effective by the Securities and Exchange Commission ("SEC") on August 3, 2022. The prospectus and prospectus supplement dated August 18, 2022 relating to and describing the terms of the rights offering have been filed with the SEC as a part of the registration statement and are available on the SEC’s web site at View Source Copies of the final prospectus and prospectus supplement for the rights offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.