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).

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"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.

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]).

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"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.

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.

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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.

On August 18, 2022 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that it will issue a press release summarizing its highlights and financial results for the first half-year of 2022, followed by an analyst & investor call the following day (Press release, Molecular Partners, AUG 18, 2022, View Source [SID1234618488]). Please see more details here:

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Release date and time

August 25, 2022, 4:30 pm ET (10:30 pm CET)
Call Details:

August 26, 2022, 8:00 am ET (2:00 pm CET)
The half year 2022 results presentation will be webcast live and will be made available on the Company’s website under the investor section. The replay will be available for 90 days following the presentation.

In order to register for the H1 2022 conference call on Friday, August 26, 2pm CET / 8am ET, please dial the following numbers approximately 10 minutes before the start of the presentation

On August 18, 2022 Scandion Oncology (Scandion) reported that it will publish its Q2 2022 interim report on Thursday, August 25, 2022 before 09:00 CET (Press release, Scandion Oncology, AUG 18, 2022, View Source;2022,c3615705 [SID1234618486]).

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Scandion’s Executive Management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

Access to the event can be obtained as follows:

LIVE access on Thursday August 25, 2022 at 10:00 CET