On August 3, 2021 Nordic Nanovector ASA (OSE: NANOV) reported an update on the timeline for PARADIGME, its ongoing pivotal Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL) (Press release, Nordic Nanovector, AUG 3, 2021, View Source [SID1234585658]). The Company, having reviewed the recent rate of patient recruitment in discussion with its clinical advisors and in light of the continuing impact from the COVID pandemic, now anticipates the preliminary three-month data readout from PARADIGME during the first half of 2022.

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The Company will host a live webcast and Q&A on Thursday, 5 August 2021, at 08.30 CEST. A link to the webcast will be available in the afternoon on Wednesday, 4 August on www.nordicnanovector.com.

The Company reports that 92 patients have been enrolled into PARADIGME as of 3 August, compared with 83 patients enrolled as of 25 May 2021 and 73 as of 17 February 2021.

While the changes to the PARADIGME protocol and initiatives implemented to improve execution of the trial have positively impacted recruitment, the ongoing COVID pandemic situation, exacerbated by the spread of the more infectious SARS-CoV-2 delta variant, continues to affect the Company’s ability to screen, enrol and treat new patients. This is because the physical condition of the patient population targeted for this study means they are at the greatest risk from COVID-19 infection. As a result, the rate of patient recruitment has been slower than anticipated.

Nordic Nanovector continues to prioritise and commit all necessary resources to the completion of PARADIGME. As part of this prioritisation, Nordic Nanovector has decided to close clinical sites at which enrolment has been particularly challenging and refocus resources on other initiatives; the trial remains open for enrolment at 85 sites. The Company’s current cash position will support its operations into H2 2022.

In addition, the Company confirms it will invest no further funds in its Archer-1 Phase 1b trial investigating Betalutin in combination with rituximab in 2nd-line FL. The findings from this study, announced on 25 May 2021, will be important to inform the future development strategy for Betalutin in 2L FL.

The Company is planning to host an R&D Day for analysts, investors and press in Q4 2021. At the event, senior management and selected external speakers will discuss the positioning of Betalutin as a potential new treatment for R/R FL and outline the strategy for its future development and commercialisation in this indication pending positive results. In addition, the Company will discuss its multiple opportunities to expand the market for Betalutin and present other projects in its portfolio.

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, commented: "The positive changes to the trial protocol and the initiatives we have implemented have increased the rate of recruitment into PARADIGME. However, they have not led to the expected acceleration in enrolment rate due to the spread of the emerging delta variant, which has meant that COVID restrictions have continued to impede the progress of PARADIGME, in common with many other clinical trials. Given this situation, we believe it is prudent to reset the anticipated timeline for completing the study, as we continue to focus on delivering preliminary top line data as soon as possible."

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