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First study group has been dosed in Xspray Pharma’s ongoing pivotal registration studies with HyNap-Dasa

On July 03, 2020 Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) reported that all healthy volunteers now have been dosed in the first of the two studies to demonstrate that HyNap-Dasa is bioequivalent to the original drug Sprycel (dasatinib) (Press release, Xspray, JUL 30, 2020, View Source [SID1234649569]). The first group is conducted under fasting conditions and the second group is conducted under fed conditions.

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The two bioequivalence studies are performed in healthy volunteers under fasting and fed conditions, respectively. All subjects in the first study group have now been fully dosed. The second study, under fed conditions, has been initiated and is expected to be fully dosed in the coming weeks. In both studies, HyNap-Dasa bioequivalence is compared to that of the original drug Sprycel. The preliminary results from the first study are expected in August 2020.

The results of the two clinical trials, together with the results of the ongoing stability studies on the final tablets on HyNap-Dasa, will form the basis of the Company’s first market approval application in the USA.

"This means that we, in spite of the Covid-19 situation, are one step closer to the date of filing for market approval in the US with our first product candidate and we will now initiate our search for commercial partners or purchasers for HyNap-Dasa. We are currently preparing for this process together with our legal and financial advisors and I feel confident that we will be well prepared for a more intensified process following the release of the clinical results," says Per Andersson, CEO Xspray. "Completing the trials with HyNap-Dasa will free up capacity for us to work more intensively with the next products in our portfolio, an improved version of HyNap-Dasa and HyNap-Nilo, which both will follow the 505(b)(2) regulatory pathway."

Kineta to Present at July 2020 Virtual Investor Events

On July 3, 2020 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, neuroscience and biodefense reported that Kineta will be presenting at multiple virtual investor events in July 2020 (Press release, Kineta, JUL 3, 2020, View Source;utm_medium=rss&utm_campaign=kineta-presents-at-july-2020-virtual-investor-events [SID1234561700]). Shawn Iadonato, Kineta Chief Executive Officer and Craig Philips, President, will present a corporate overview at the following events:

Opal Group ESG Investment Forum 2020
July 8th, 2020 at 12:00-12:20PM Pacific Time

The Moneyshow Accredited Investors Virtual Event
July 23, 2020 at 7:40-8:10AM Pacific time

The European Commission has Granted Orphan Medicinal Product Designation in the EU for MIV-818

On July 3, 2020 Medivir AB (Nasdaq Stockholm: MVIR) reported that the European Commission, in accordance with the opinion from the European Medicines Agency (EMA), has granted orphan medicinal product designation in the EU for MIV-818 for the treatment of patients with hepatocellular carcinoma (HCC), the most common type of primary liver cancer (Press release, Medivir, JUL 3, 2020, View Source [SID1234561669]).

Orphan Medicinal Product designation provides certain regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10 000 persons in the European Union. This designation can give access to several incentives, including protocol assistance, the EU centralized authorization procedure and reduced regulatory fees and a potential for a 10-year market exclusivity in the EU.

About hepatocellular carcinoma

HCC represents the fifth most common cancer worldwide but is a rare disease in Europe and the US. Although therapies exist, treatment benefits for intermediate and advanced HCC are low and death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without the tumor-specific mutations. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

About MIV-818

MIV-818 is a pro-drug designed to selectively treat liver cancer cells and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug for patients with HCC.

Alexion Completes Acquisition of Portola

On July 2, 2020 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) reported the successful completion of its acquisition of Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) (Press release, Alexion, JUL 2, 2020, View Source [SID1234574865]). The acquisition adds Factor Xa inhibitor reversal agent Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], marketed as Ondexxya in Europe, to Alexion’s commercial portfolio. Andexxa is the first and only approved Factor Xa inhibitor reversal agent and has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding.

"This acquisition provides the opportunity to grow our commercial portfolio, which builds on the significant progress we’ve made diversifying our pipeline over the last few years," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "We are excited to add a transformative, first-in-class medicine like Andexxa, which rapidly reverses life-threatening bleeds that result from Factor Xa inhibitors, to our growing critical care portfolio. This important medicine is also a clear strategic fit with our existing expertise in hematology and neurology, and we are confident we can apply our demonstrated global commercial excellence to enhance access and broaden the number of patients helped by Andexxa."

Transaction Details

Alexion completed the acquisition through a tender offer and subsequent merger of Portola with Odyssey Merger Sub Inc., a wholly owned subsidiary of Alexion ("Buyer"). Portola is now a wholly owned subsidiary of Alexion. The tender offer for all of the outstanding shares of common stock of Portola at a price of $18.00 per share expired as scheduled, one minute following 11:59 p.m., New York City time, on July 1, 2020. American Stock Transfer & Trust Company, LLC, the depositary and paying agent for the tender offer, has advised Alexion that 62,654,962 shares of Portola common stock were validly tendered and not validly withdrawn in the tender offer, representing approximately 79.7% of the shares outstanding. In addition, the depositary has advised Alexion that, as of the offer expiration time, Notices of Guaranteed Delivery had been delivered with respect to 2,701,052 additional shares, representing approximately 3.4% of the shares outstanding. All of the conditions to the tender offer having been satisfied, Buyer has accepted for payment and will promptly pay for all shares tendered. The transaction will be funded with cash on hand.

On July 2, 2020, Alexion completed its acquisition of Portola through the merger of Buyer with and into Portola without a vote of Portola’s shareholders pursuant to Section 251(h) of the Delaware General Corporation Law. As a result of the merger, Portola became a wholly owned subsidiary of Alexion. In connection with the merger, all shares of Portola common stock outstanding immediately prior to the effective time (other than shares owned by Alexion, Buyer, Portola, any other subsidiary of Alexion or any subsidiary of Portola, or shares that are held in Portola’s treasury, or shares held by any Portola stockholder who has properly demanded and perfected appraisal rights under Delaware law) have been converted into the right to receive $18.00 per share in cash, without interest (less any required withholding taxes), the same amount paid for all shares validly tendered and not validly withdrawn in the tender offer. As a result of the merger, as of July 2, 2020, Portola common stock will cease to be traded on the NASDAQ Global Select Market.

Immatics Announces Completion of Business Combination and Listing on NASDAQ

On July 2, 2020 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported the completion of its business combination with Arya Sciences Acquisition Corp. (NASDAQ: ARYA; or "Arya"), a special purpose acquisition company (SPAC) sponsored by Perceptive Advisors (Press release, Immatics Biotechnologies, JUL 2, 2020, View Source [SID1234569528]). Today, Immatics N.V. will commence trading its shares under the symbol "IMTX" and its warrants under the symbol "IMTXW" on the Nasdaq Capital Market. Proceeds from this transaction were approximately $253 million, which included funds held in Arya’s trust account and the common stock private investment in public equity (PIPE) financing contributed by a group of leading US healthcare institutional investors. The shareholders of Arya approved the transaction on June 29, 2020, and none of Arya’s shareholders redeemed their shares in connection with the ARYA shareholder approval. The transaction had been previously approved by Immatics shareholders. Immatics’ management team, led by Chief Executive Officer Harpreet Singh, Ph.D., will continue to run the combined company.

Harpreet Singh, Ph.D., Co-Founder and CEO of Immatics, commented: "I would like to thank the team at Immatics, our partners at Perceptive, existing Immatics and Arya shareholders, the PIPE investors, and all our advisors for making this transaction a success. It will provide us runway and flexibility for our pursuit of unlocking new therapeutic options for cancer patients by advancing our clinical and pre-clinical programs for Adoptive Cell Therapies and TCR Bispecifics. Our programs are directed against a range of targets that address multiple rare as well as common cancers that have been hard to treat."

New investors supporting the transaction include Perceptive Advisors, Redmile Group, Federated Hermes Kaufmann Funds, RTW Investments and Sphera Funds, alongside existing Immatics investors dievini Hopp BioTech, AT Impf and Wellington Partners.

Adam Stone, Chief Investment Officer of Perceptive Advisors and the Chief Executive Officer of Arya, added: "Immatics’ technology platforms open up a breadth of novel targets and therapeutic strategies that could help overcome some of the challenges we have seen with immunotherapy to date. We believe that the Immatics approach could provide truly novel opportunities for patients in need and we look forward to supporting the Company as it advances its key programs addressing solid tumors."

Immatics is developing targeted immunotherapy candidates based on its suite of technologies which enables the identification of otherwise inaccessible intracellular protein targets displayed on a cell’s surface. Accessing these targets is generally recognized as an important key to unlocking hard-to-treat cancers, particularly solid tumors. Immatics is leveraging this to develop a pipeline of novel T cell receptor (TCR)-based products designed to deliver a robust and specific T cell response against cancer cells. Immatics’ international team, located in Munich and Tuebingen, Germany, as well as in Houston, Texas, is committed to advancing its proprietary therapeutic pipeline and collaboration programs with global pharmaceutical leaders to address significant unmet medical needs in oncology.

About this transaction
On March 17, 2020, Immatics, a privately held biotechnology company, entered into a definitive business combination agreement with Arya, a special purpose acquisition company (SPAC) sponsored by Perceptive Advisors, that was created for the purpose of entering into a business combination with a selected biopharmaceutical company and bringing the combined entity to the NASDAQ.

As a result of the business combination, Immatics received proceeds of approximately $253 million, prior to transaction expenses, which includes cash proceeds of approximately $149 million from Arya’s trust account and $104 million from PIPE investors led by Perceptive Advisors, other top-tier US healthcare investors and existing Immatics investors.

The description of the business combination contained herein is only a high-level summary and is qualified in its entirety by reference to the underlying documents filed with the U.S. Securities and Exchange Commission. A more detailed description of the terms of the transaction has been provided in a registration statement on Form F-4 filed with the U.S. Securities and Exchange Commission by Immatics.

Advisors
Goldman Sachs International is acting as lead financial advisor with SVB Leerink, BofA Securities, and Kempen serving as financial advisors to Immatics. Jefferies LLC is acting as lead financial and capital markets advisor to Arya as well as sole private placement agent. Chardan Capital Markets LLC is also serving as advisor to Arya. Goodwin Procter LLP and CMS Legal Services EEIG are acting as legal counsel to Immatics. Kirkland & Ellis LLP is serving as legal counsel to Arya.