On April 16, 2021 Shenzhen Chipscreen Biosciences, a China headquartered biopharmaceutical company developing and marketing novel drugs based on its unique technology of Chemical Genomics Drug discovery platform, reported that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with a Phase 1b/2 clinical trial of Chiauranib/CS2164, a potential treatment for multiple oncological indications including Small Cell Lung Cancer (SCLC), Ovarian Cancer, Liver Cancer, and Breast Cancer, etc (Press release, Shenzhen Chipscreen Biosciences, APR 16, 2021, View Source [SID1234578133]). Chiauranib is the third novel drug candidate discovered and developed by Chipscreen to be marketed, submitted NDA or in the late-stage phases of clinical studies.

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Chiauranib is an innovative, 3-pathway targeted kinase small molecule inhibitor with high selectivity against Auroa B /VEGFRs/CSF1R currently entering Phase III clinical trials in China. Its treatments to SCLC and Ovarian Cancer have been just designated as "breakthrough therapies" by National Medical Products Administration (NMPA) of China in the past months. The molecular mechanism of Chiauranib is to inhibit the rapid proliferation of tumor cells via targeting novel DNA replication pathway, as well as enhancement of antitumor immunity and inhibition of tumor angiogenesis concomitantly.

The primary objective of this Phase Ib/2 study in the USA is to demonstrate safety, tolerability and efficacy of Chiauranib as a monotherapy in 24 to 36 patients with SCLC.

"With this clearance of US FDA IND application for CS2164, it will certainly increase success of our global development strategy based on early efficacy and safety data obtained from China trials," said Dr. Xianping Lu, Chairman and President of Chipscreen.

On April 16, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that the Company has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (Press release, Oncopeptides, APR 16, 2021, View Source [SID1234578134]). Pending a positive validation from the EMA, melflufen will be subject to a regulatory assessment according to the standard timelines.

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"Following Oncopeptides´ launch in the US, we are broadening our geographical footprint and submitting an application for conditional marketing authorization of melflufen in Europe ahead of expectations", says Marty J Duvall, Chief Executive Officer at Oncopeptides. "This major milestone marks the commitment of our organization to bring hope to multiple myeloma patients around the world, through innovative science".

"This is vitally important and supports the development of a dedicated organization across Europe", says Andrea Passalacqua, General Manager Europe, Oncopeptides. "We believe that melflufen may address a growing medical need in patients with relapsed refractory multiple myeloma in Europe. In order to help accomplishing this, we have also introduced an Early Access Program that offers eligible patients access to melflufen ahead of a potential marketing authorization".

According to the European Medicines Agency, medicines are eligible for conditional approval if they are aimed at treating or preventing seriously debilitating or life-threatening diseases. Conditional marketing authorizations may be granted if the benefit-risk balance of the product is positive, comprehensive data can be provided, there is an unmet medical need, and the benefit to public health of making the product available outweighs the risks due to need for additional data.

On February 26th the U.S. Food and Drug Administration, FDA, approved PEPAXTO (melphalan flufenamide), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on April 16, 2021, at 08:00 (CET).

On April 16, 2021 Synlogic (Nasdaq: SYBX) a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported the pricing of its underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $3.00 per share (Press release, Synlogic, APR 16, 2021, View Source [SID1234578118]). The gross proceeds to Synlogic from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Synlogic, are expected to be $30.0 million. All shares of common stock to be sold in the offering are being sold by Synlogic. In addition, Synlogic has granted to the underwriter a 30-day option to purchase up to 1,500,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about April 20, 2021, subject to the satisfaction of customary closing conditions.

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SVB Leerink is acting as sole book-running manager for the offering.

The securities described above are being offered by Synlogic pursuant to its shelf registration statement on Form S-3 (File No. 333-226730) filed with the Securities Exchange Commission (the "SEC") on August 9, 2018 and declared effective by the SEC on August 30, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and a final prospectus supplement and the accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]. The preliminary prospectus supplement and accompanying prospectus is also available, and the final prospectus supplement and accompanying prospectus will be available, on the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall 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 other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On April 16, 2021 Oblique Therapeutics AB, a Sweden-based biotech company, reported that in collaboration with Karolinska Institutet (Stockholm, Sweden), Gothenburg University (Sweden) and several local biotechs published promising research results in the highly-acclaimed scientific journal Science Advances (AAAS) entitled: Rational Antibody design for Undruggable Targets using Kinetically Controlled Biomolecular probes (Press release, Oblique Therapeutics, APR 16, 2021, View Source [SID1234578145]). The peer-reviewed article describes how Oblique Therapeutics´ Abiprot technology can be used to discover and develop pharmacologically tailored antibodies against clinically important targets widely considered undruggable with antibodies. Two example antibodies are presented in the article. One is targeting hTRPV1, a clinically validated pain target. The second antibody is targeting KRAS, a highly relevant oncogene of critical importance in the etiology of many aggressive cancers (ex: pancreatic cancer). These early results have the potential to contribute to the development of much needed novel medicines across several therapeutic areas.

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The global antibody therapeutics market is estimated to be worth close to 200 Bn USD in 2026 (MarketWatch). Surprisingly, only about 60 antibody medicines (based on target), are currently available to patients. Important target classes such as G-protein-coupled receptors and ion channels are particularly underexploited. In contrast, there are about 1,500 known drug targets of which several are clinically or human-genetics validated. Novel medicines addressing these drug targets would bring game changing benefits to large populations of patients suffering from uncurable, untreatable, and refractory disease. A staggering example is the need for new pain medications to replace the unsatisfactory and addictive morphine and opioid regimens. But here, and in many other therapeutic areas, current antibody technologies fail to deliver meaningful medicines.

The research article in Science Advances presents a new high-tech antibody discovery approach called Abiprot, developed from nanoscience, computer technology, and proteomics. Abiprot identifies antibody binding sites on native-state, disease-relevant proteins at high resolution. The platform was developed by Oblique Therapeutics with the intention to create new antibody medicines addressing large unmet medical needs across several therapeutic areas. As an example, the paper demonstrates the first-ever stimuli-selective monoclonal antibody targeting TRPV1, prospectively developed for replacing opioids in pain management. Another example includes novel mutant-selective KRAS antibodies providing means to target the most prevalent KRAS mutated cancers.

Prof. Owe Orwar, CEO Oblique Therapeutics: "The excitement and joy of science and technological advancement is to prove that what was previously impossible or highly improbable is now possible. Even more satisfying is if the impossible or improbable translate into a hope for creating higher societal values, better health, and improved quality of life for millions of patients. Our dream is that the published technology will widen the scope of antibody therapeutics for the benefit of patients and we are very excited about what the future will hold. Science Advances, is globally ranked as the number three scientific journal in multidisciplinary sciences only after Nature (Springer Nature Limited) and Science (AAAS). To be able to publish company-critical results in Science Advances is therefore a testimony to the importance and potential impact of the study results. Since the conclusion of the published study, we have made significant advancements, and improvements in our antibody programs. For the TRPV1 antibody program we have entered into an R&D collaboration and exclusive option to licence agreement with a top-20 pharma company. A key component in our vision is to be the first-ever pharma company to bring a pain antibody medicine targeting ion channels to market".

Collaboration

The research was conducted by Oblique Therapeutics AB in collaboration with scientists from:

The Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden
View Source

About Abiprot

Abiprot is a proprietary methodology to identify epitopes on protein targets that have previously proven difficult to address with antibodies. Abiprot can identify high-affinity antibody binding sites in a given protein with single amino acid resolution while the protein resides in its native environment. It is based on using a tailored molecular reporter system and proteomics. The platform yields detailed sequence and structure information for epitope identification and development. Oblique Therapeutics is applying this technology for discovery of a new generation of selective antibody therapeutics targeting cancer and pain.

On April 16, 2021 AstraZeneca reported that proposed acquisition of Alexion Pharmaceuticals, Inc (Alexion) has achieved an important step toward completion, having cleared US Federal Trade Commission review (Press release, AstraZeneca, APR 16, 2021, View Source [SID1234578146]). This follows the conclusion of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

The announcement follows competition clearances in Canada, Brazil, Russia and other countries globally, with a full list available on astrazeneca.com. Additional global regulatory clearances are pending, including but not limited to the UK, EU and Japan.

Marc Dunoyer, Executive Director and Chief Financial Officer, said: "These clearances further advance us towards closing our acquisition of Alexion. We remain focused on the next chapter for AstraZeneca and Alexion, building on our combined expertise in immunology and precision medicines and our shared ambition to bring more innovative medicines to patients worldwide. We look forward to working closely with other global authorities as we progress toward this goal."

The proposed acquisition, first announced in December 2020, would enhance the Company’s scientific presence in immunology by adding Alexion’s innovative complement-technology platforms and strong pipeline. Rare diseases represent a high-growth disease area with rapid innovation and significant unmet medical need. The acquisition remains expected to close in Q3 2021, subject to receipt of additional global regulatory clearances and approval by shareholders of both companies with shareholder voting anticipated on 11 May 2021.

Subject to a successful completion of the acquisition, a dedicated business unit will be created, known as ‘Alexion, The AstraZeneca Rare Disease Unit’, headquartered in Boston, US. AstraZeneca will have an enhanced global footprint and broad coverage across primary, speciality and highly specialised care, and is expected to deliver double-digit revenue growth through 2025, double-digit core EPS accretion for the first three years as well as strong cash flow with an ambition to increase the dividend.

Rare diseases
Over 7,000 rare diseases are known today, and only c.5% have US Food and Drug Administration-approved treatments.1 Demand in the global rare disease space is forecasted to grow by a low double-digit percentage in the future.2

Important additional information
In connection with AstraZeneca’s proposed acquisition of Alexion (the Acquisition), AstraZeneca filed a registration statement on Form F-4 (the Registration Statement), which has been declared effective by the United States Securities and Exchange Commission, and which includes a document that serves as a prospectus of AstraZeneca and a proxy statement of Alexion (the proxy statement/prospectus). Alexion filed the proxy statement/prospectus as a proxy statement and AstraZeneca filed the proxy statement/prospectus as a prospectus with the SEC on 12 April 2021, and each party will file other documents regarding the Acquisition with the SEC. Investors and security holders of Alexion are urged to carefully read the entire Registration Statement and proxy statement/prospectus and other relevant documents filed with the SEC when they become available, because they will contain important information. Investors and security holders may obtain the Registration Statement and the proxy statement/prospectus free of charge from the SEC’s website or from AstraZeneca or Alexion as described in the paragraphs below.

The documents filed by AstraZeneca with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. These documents may also be obtained free of charge on AstraZeneca’s website at View Source under the tab "Investors". The documents filed by Alexion with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. These documents may also be obtained free of charge on Alexion’s website at View Source under the tab, "Investors" and under the heading "SEC Filings" or by contacting Alexion’s Investor Relations Department at [email protected].

Participants in the solicitation
AstraZeneca, Alexion and certain of their directors, executive officers and employees may be deemed participants in the solicitation of proxies from Alexion shareholders in connection with the Acquisition. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the shareholders of Alexion in connection with the Acquisition, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in the proxy statement/prospectus or proxy statement filed with the SEC on 12 April 2021. Information about the directors and executive officers of Alexion and their ownership of Alexion shares is set forth in Alexion’s Annual Report on Form 10-K/A, as previously filed with the SEC on 16 February 2021. Free copies of these documents may be obtained as described in the paragraphs above.

Important notices relating to financial advisors
Evercore Partners International LLP (Evercore), which is authorised and regulated by the FCA in the United Kingdom, is acting exclusively for AstraZeneca and no one else in connection with the Acquisition and the matters referred to in this announcement and will not regard any other person as a client in relation to the matters set out in this announcement (whether or not a recipient of this announcement) and will not be responsible to anyone other than AstraZeneca for providing the protections afforded to its clients, nor for providing advice in relation to the Acquisition or any other matter referred to in this announcement. Neither Evercore nor any of its subsidiaries, holding companies, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client in connection with the Acquisition or any statement contained in this announcement or otherwise. Apart from the responsibilities and liabilities, if any, which may be imposed on Evercore by the Financial Services and Markets Act 2000 (FSMA), or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither Evercore nor any of its affiliates accepts any responsibility or liability whatsoever for the contents of this announcement, and no representation, express or implied, is made by it, or purported to be made on its behalf, in relation to the contents of this announcement, including their accuracy, fairness, sufficiency, completeness or verification of any statement contained in this announcement or any other statement made or purported to be made by it, or on its behalf, in connection with AstraZeneca or the matters described in announcement, and nothing in this announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future. To the fullest extent permitted by applicable law, each of Evercore and its affiliates accordingly disclaim all and any responsibility or liability whether arising in tort, contract or otherwise (save as referred to above) which they might otherwise have in respect of this announcement or any statement contained in this announcement.

Centerview Partners UK LLP (Centerview Partners), which is authorised and regulated by the FCA in the United Kingdom, is acting exclusively for AstraZeneca and no one else in connection with the Acquisition and the matters referred to in this announcement and will not regard any other person as a client in relation to the matters set out in this announcement (whether or not a recipient of this announcement) and will not be responsible to anyone other than AstraZeneca for providing the protections afforded to its clients, nor for providing advice in relation to the Acquisition or any other matter referred to in this announcement. Neither Centerview Partners nor any of its subsidiaries, holding companies, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client in connection with the Acquisition or any statement contained in this announcement or otherwise. Apart from the responsibilities and liabilities, if any, which may be imposed on Centerview Partners by the FSMA, or the regulatory regime established thereunder, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither Centerview Partners nor any of its affiliates accepts any responsibility or liability whatsoever for the contents of this announcement, and no representation, express or implied, is made by it, or purported to be made on its behalf, in relation to the contents of this announcement, including their accuracy, fairness, sufficiency, completeness or verification of any statement contained in this announcement or any other statement made or purported to be made by it, or on its behalf, in connection with AstraZeneca or the matters described in this announcement, and nothing in this announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or the future. To the fullest extent permitted by applicable law, each of Centerview Partners and its affiliates accordingly disclaim all and any responsibility or liability whether arising in tort, contract or otherwise (save as referred to above) which they might otherwise have in respect of this announcement or any statement contained in this announcement.

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