4D pharma Announces Publication of Preclinical Research Showing Single Strain Megasphaera massiliensis improves activity of CAR-T

On July 6, 2021 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported the publication of pre-clinical research relating to its second-generation immuno-oncology LBP MRx1299 improving the activity of CAR-T (Press release, 4d Pharma, JUL 6, 2021, View Source [SID1234584624]).

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The research, conducted in collaboration with the Philipps-University Marburg, Germany, and Universitätsklinikum Würzburg, Germany, and published in Nature Communications, demonstrates the ability of the bacterium Megasphaera massiliensis or its short chain fatty acid (SCFA) metabolite pentanoate to enhance the anti-tumor activity of cytotoxic T lymphocytes (CTL) and CAR-T therapies in animal models of cancer, resulting in better tumor clearance.

4D pharma identified M. massiliensis MRx1299 using its MicroRx platform and previously showed MRx1299 to have specific histone deacetylase (HDAC) inhibitory activity and be a rare prolific producer of pentanoate. This led to discussions with the lab of Dr. Alexander Visekruna, corresponding author on the recent publication, due to their work investigating the effects of SCFAs on immune cell subsets.

"Our existing clinical oncology programs, such as the study of MRx0518 and Keytruda in refractory patients, have shown the important role our live biotherapeutics have to play in the fight against cancer in combination with immunotherapies. Using the MicroRx platform we have now shown we have the potential to improve the efficacies of cell therapies such as CAR-T," commented Dr. Imke Mulder, Research Director, 4D pharma. "This demonstrates not only the importance of Live Biotherapeutics as a new modality poised to revolutionize the treatment of a wide range of cancers, but also the power of our MicroRx platform to continue making significant discoveries and advances in this field."

"Collectively, these results suggest that low-abundant commensal bacterial species such as M. massiliensis and their selective metabolites such as pentanoate, rather than broadly distributed and abundant commensals, may be used as specific microbial biotherapeutics to enhance anti-tumor immunity and increase the efficacy of CAR-T therapy for treating tumors," commented Dr Alexander Visekruna of the Institute for Medical Microbiology and Hospital Hygiene at Philipps-University Marburg. "Combined therapies including immune checkpoint inhibitors or CAR-T and simultaneous provision of low-abundant bacteria synthesizing specific metabolites as an adjunctive agent may be therapeutically useful."

Luu et al., Nature Communications, ‘Microbial short-chain fatty acids modulate CD8+ T cell responses and improve adoptive immunotherapy for cancer’ View Source

AstraZeneca receives clearance from the European Commission for the proposed acquisition of Alexion

On July 6, 2021 AstraZeneca reported it’s proposed acquisition of Alexion Pharmaceuticals, Inc. (Alexion) has achieved an important step towards completion by having cleared the European Commission review (Press release, AstraZeneca, JUL 6, 2021, View Source [SID1234584609]).

The clearance follows competition clearances in the United States, Japan and other countries globally, with a complete list available on astrazeneca.com. Regulatory clearance in the UK is pending and remains a requirement to complete the deal.

Marc Dunoyer, Executive Director and Chief Financial Officer, said: "We are pleased to have secured clearance from the European Commission for the proposed acquisition of Alexion, a pioneer in the discovery and development of medicines for rare diseases. We are now another step closer to closing the acquisition and combining the two companies to create a leader in immunology and precision medicines. We continue to progress towards the completion of the acquisition during this quarter."

The proposed acquisition, first announced in December 2020, would enhance the Company’s scientific presence in immunology by adding Alexion’s innovative complement-technology platform and an extensive pipeline. Rare diseases represent a high-growth disease area with rapid innovation and significant unmet medical needs. Shareholders of both companies overwhelmingly supported the acquisition by their votes on 11 May 2021.

Subject to completing the acquisition, a group focusing on rare diseases will be created. This group will be named ‘Alexion, AstraZeneca Rare Disease’, and will be headquartered in Boston, US.

Rare diseases
Over 7,000 rare diseases are known today, and only approximately 5% have treatments approved by the US Food and Drug Administration.1 Demand in medicines for rare diseases 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 with the SEC on 12 April 2021 (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 a proxy statement with the SEC (the proxy statement) 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 or proxy statement 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 or the proxy statement 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 internet 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].

Important notices relating to financial advisors
Evercore Partners International LLP (Evercore), which is authorised and regulated by the Financial Conduct Authority (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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Immunome to Present at the Ladenburg Thalmann 2021 Healthcare Conference

On July 6, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell discovery engine platform to discover and develop first-in-class antibody therapeutics, reported that Purnanand Sarma, Ph.D., Immunome’s President and CEO, will present at the Ladenburg Thalmann 2021 Healthcare Conference on Tuesday, July 13, 2021, at 10:30 a.m. ET (Press release, Immunome, JUL 6, 2021, View Source [SID1234584625]).

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Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

AIM ImmunoTech to Host Investor Update Webcast on Wednesday, July 14th at 11:00 AM ET

On July 6, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that it will host an investor update webcast at 11:00 a.m. Eastern Time on Wednesday, July 14, 2021, to discuss recent accomplishments and upcoming milestones (Press release, AIM ImmunoTech, JUL 6, 2021, View Source [SID1234584642]). Investors and other interested parties are invited to submit questions to management prior to the call’s start via email to [email protected].

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The webcast may be accessed at View Source or on the Company’s website at View Source For those unable to participate at that time, a replay of the webcast will be available until Thursday, July 14, 2022 on the Company’s website.

Zealand Zealand Pharma A/S – Transaction Under Share Repurchase Program

On July 6, 2021 Zealand Pharma A/S ("Zealand") reported that initiated a share repurchase program to acquire Danish common stock for incentive programs in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (Press release, Zealand Pharmaceuticals, JUL 6, 2021, View Source [SID1234584796]).

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Zealand has entered an arrangement with Danske Bank A/S to act as exclusive manager under the program. Danske Bank A/S will buy back shares on behalf of Zealand and make related trading decisions independently of and without influence by Zealand.

Under the program, Danske Bank A/S will buy back shares on behalf of Zealand for an amount up to DKK 32,070,896. The share repurchase program is expected to be completed no later than July 29, 2021 and comprises up to 154,187 shares.

Since the announcement dated 28 June 2021, the following transactions have been made:

The details for each transaction made under the share repurchase program are included as an appendix to this announcement.

With the transactions stated above, Zealand owns a total of 113,223 shares with a nominal value of DKK 1 each as treasury shares, corresponding to 0.0026% of the total share capital. The total amount of shares in the company is 43,655,061 shares including treasury shares.