On August 3, 2021 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported the pricing of an underwritten public offering of 8,000,000 shares of its common stock at a price to the public of $18.00 per share (Press release, Avidity Biosciences, AUG 3, 2021, View Source [SID1234585657]). All of the shares to be sold in the offering are to be sold by Avidity. The gross proceeds to Avidity from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be $144.0 million. The offering is expected to close on or about August 6, 2021, subject to the satisfaction of customary closing conditions. In addition, Avidity has granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of common stock.

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Avidity intends to use the net proceeds from this offering, together with its existing cash, cash equivalents and marketable securities: to complete its Phase 1/2 MARINA trial for AOC 1001; to advance AOC 1044 and its AOC FSHD program into clinical development; to further advance its AOC platform in and beyond its muscle franchise; and towards working capital and other general corporate purposes.

Cowen, SVB Leerink, Evercore ISI and Wells Fargo Securities are acting as joint bookrunning managers for the offering.

The securities described above are being offered by Avidity pursuant to a shelf registration statement that became automatically effective upon filing with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering were filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. The offering may be made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; from SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, or by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

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

On August 3, 2021 NaviFUS’ focused ultrasound (FUS) therapy system (NaviFUS) reported that it was recently approved for use in a new clinical trial by the Taiwan Food and Drug Administration (TFDA). It will be initiated shortly at Linkou Chang Gung Memorial Hospital (Press release, NaviFUS, AUG 3, 2021, View Source [SID1234585656]). The trial will investigate the "synergy" that FUS-mediated opening of the blood-brain barrier (BBB) has on improving the therapeutic effect of radiotherapy treatment in patients with end-stage primary brain tumors. Despite suffering from repeating surgeries, radiotherapy, and chemotherapy, most of these patients will eventually face tumor recurrence. Currently, while there may not be any effective treatments guaranteed to prolong survival, NaviFUS hopes that this upcoming clinical trial can result in a new, low-risk, and "Patient Friendly" option for patients who have already exhausted first and second-line treatments or failed radiotherapy treatment previously. If this combined treatment can safely enhance the effect of radiotherapy, NaviFUS’ believes this treatment can also be extended to metastatic brain tumors from lung cancer, breast cancer, etc. The market potential for this treatment is expected to be more than $2 billion US dollars.

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The principle behind the "synergy" of this combined treatment is based on findings that the blood flow and oxygen concentration in the tumor area are often insufficient due to rapid proliferation of tumor cells. As a result of these hypoxic conditions, free radicals are not easily generated during radiation treatment, resulting in low radiotherapy efficacy; the opening of the blood-brain barrier is expected to change the tumor microenvironment by improving the blood flow and oxygen content of tumor tissues, which promotes the formation of free radicals and produces a radio-sensitization effect, so that the same dose of radiotherapy may bring better results without adding negative side effects.

NaviFUS has successively published research on how the opening of the BBB can enhance the therapeutic effect of radiotherapy last year at Focused Ultrasound Foundation’s International Symposium on Focused Ultrasound and this year at International Symposium for Therapeutic Ultrasound (ISTU 2021). In preclinical studies, preliminary results confirmed that the oxygen content of brain tissue is significantly increased after opening the BBB, resulting in an enhanced radiotherapy and tumor-inhibiting effect. Under these conditions, low radiotherapy doses may yield high-dose therapeutic effects and significantly reduced serious side effects attributed to high-dose radiotherapy.

At the same time, NaviFUS is conducting a FUS-mediated BBB opening combined with bevacizumab (Avastin) clinical trial at Linkou Chang Gung Memorial Hospital. After repeatedly opening the BBB and long-term treatment with Avastin, preliminary results have shown positive signs of superior tumor progression control at the tumor treatment sites in patients; NaviFUS plans to run a similar trial simultaneously at Stanford University, which they expect to be approved by the US FDA’s IDE review before the end of the year.

Dr. Arthur Lung, Chief Executive Officer of NaviFUS, expresses great optimism about the therapeutic potential of the NaviFUS System. "If these two non-invasive FUS treatments for brain tumors can be successfully developed, they can offer non-invasive treatment options with improved efficacy and minimal side effects." As the NaviFUS System continues its development of next-generation treatments on its platform, it has garnered much interest worldwide and has partnered with organizations conducting clinical or academic research in FUS through its Research-Only FUS device. For further inquiries on this model, please contact NaviFUS directly.

On August 3, 2021 Nanoform, an innovative nanoparticle medicine enabling company, reported that Proof of Concept studies may now be performed for Boehringer Ingelheim to assess the added value Nanoform’s award-winning CESS technology can deliver to its drug development projects (Press release, Boehringer Ingelheim, AUG 3, 2021, View Source [SID1234585655]).

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The two parties have executed a master services agreement (MSA) to initiate projects in the pre-clinical early development space with the aim of solving the ever-growing challenge of poor bioavailability and solubility in new drug candidates – a leading cause of drug development failure.

Christian Jones, CCO of Nanoform, commented: "Wider uptake of the latest technological innovations is essential to address the low success rates for new drug candidates in Pharma. We are delighted to collaborate with Boehringer Ingelheim to evaluate how our proprietary CESS platform can help more novel therapies reach the patients who need them. This is the first step toward what we hope will be a long and fruitful partnership between our companies."

On August 3, 2021 Ryvu Therapeutics (WSE: RVU), a clinical stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that it is scheduled to participate in the following investor conferences (Press release, Ryvu Therapeutics, AUG 3, 2021, View Source [SID1234585654]):

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12th Annual Wedbush PacGrow Healthcare Conference on Tuesday, August 10 – Wednesday, August 11, 2021. Ryvu will participate in a panel entitled "Synthetic Lethal (Weapon)" on August 10 at 11:30am-12pm EDT and host investor meetings during the conference.

Morgan Stanley 19th Annual Global Healthcare Conference on Thursday, September 9, 2021 – Wednesday, September 15, 2021. Ryvu will host investor meetings during the conference.

H.C. Wainwright 23rd Annual Global Investment Conference, on Monday, September 13 – Wednesday, September 15, 2021. Ryvu’s corporate presentation will be available on-demand starting on September 13 at 7:00 AM (ET), and Ryvu will host investor meetings during the conference

On August 3, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage biopharmaceutical company focused on developing target-directed, tri-specific Natural Killer (NK) cell engager therapies (TriKE) incorporating interleukin 15 (IL-15) for the treatment of cancer, reported that preclinical results for GTB-5550, its B7H3 TriKE product candidate as a prospective therapy for the treatment of several different types of cancers (Press release, GT Biopharma, AUG 3, 2021, View Source [SID1234585653]).

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GTB-5550 TriKE was evaluated in several preclinical models overexpressing B7H3, and was found to be effective at promoting NK cell killing of multiple cancer cell types. B7H3 is over-expressed on several cancer types including non-small cell lung cancer, squamous cell carcinoma, and breast, renal, pancreatic, ovarian, liver and colorectal cancers. GTB-5550 TriKE is presently undergoing GMP manufacturing scale-up in preparation for filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for evaluation in humans.

B7H3 is a member of the B7 family of immune checkpoint inhibitors which includes PD-1/PD-L1 and CTLA-4/CD80. Merck’s Keytruda (pembrolizumab) and Bristol-Myer Squibb’s YERVOY (ipilimumab) targeting the PD-1/PD-L1 and CTLA-4/CD-80 checkpoints, respectively, have demonstrated significant survival benefit and are blockbuster immune-oncology therapeutics.

B7H3 expression on cancer cells is highly associated with undesirable treatment outcomes and survival time. Targeting B7H3 on cancer cells with TriKE and redirecting NK cells to attack and kill cancer cells expressing B7H3, could result in a therapeutic treatment that limits the metastatic potential and invasiveness of certain solid tumor cancers.

Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer, commented: "We are pleased to report our GTB-5550 TriKE has passed this important development milestone, and demonstrated effectiveness in promoting redirected and target-specific killing by NK cells."