On April 2, 2022 Epsilogen Ltd. reported that it has raised £30.8 million (US$41.5 million) in an oversubscribed series B, after its lead immunoglobulin E (IgE) program delivered positive results in a phase I in advanced solid tumors (Press release, Epsilogen, APR 2, 2022, View Source [SID1234611331]). The money is to fund a phase Ib trial of the product, Mov18 IgE – the first and only IgE antibody to have made it to the clinic – in platinum-resistant ovarian cancer.

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On April 1, 2022 Nykode Therapeutics Presented the Corporate Presentaiton (Presentation, Nykode Therapeutics, APR 1, 2022, View Source [SID1234611373])

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On April 1, 2022 Akeso, Inc. (9926.HK) ( "Akeso" ), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, reported 2021 annual results (Press release, Akeso Biopharma, APR 1, 2022, View Source [SID1234611365]).

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Highlights:

Anniko (Penpulimab, AK105, PD-1) obtained market entry approval from the Chinese National Medical Products Administration (NMPA). Product sales of RMB 212 million was recorded for the year ended December 31, 2021. Licensing fee recognized was RMB128.6 million from our out-licensed product AK107 (CTLA-4) to MSD ("Merck Sharp & Dohme Corp.").
Significant progress of clinical trials made: we submitted 4 marketing applications in 2021, including one for Cadonilimab (AK104, PD-1/CTLA-4) for the treatment of relapsed or metastatic cervical cancer, and three for Penpulimab including treatments for 1L sq-NSCLC and 3L NPC. We also obtained 37 IND approvals, and advanced 2 pre-clinical stage programs into clinical stage. As of the announcement date, we have developed over 30 innovative programs in-house, 15 of which are in clinical stage (including three out-licensed products). And our total number of pivotal or Phase III trials increased to 15. Our total R&D investment for the year was RMB1.07bn (excluding share-based compensation).
As at December 31, 2021, total cash on hand and confirmed via other financing channels amounted to over RMB5bn, which will be sufficient to support research and development in the next two years.
Anniko (PD-1) approved and Cadonilimab (PD-1/CTLA-4) expected to obtain approval

On August 5, 2021, our first oncology immunotherapy product, Anniko (Penpulimab, AK105, PD-1) injection for the treatment of relapsed or refractory classic Hodgkin’s lymphoma obtained market entry approval by the NMPA in China. Product sales of RMB212 million was recorded for the year ended December 31, 2021.

In July 2021, we submitted an NDA of Anniko in combination with chemotherapy for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer ("sq-NSCLC") in China. In August, we submitted another NDA for third-line treatment of patients with metastatic nasopharyngeal carcinoma ("NPC") in China. In September, 2021, we also submitted a BLA for third-line treatment of patients with metastatic NPC to the FDA through the Real-Time Oncology Review ("RTOR") Programme.

Meanwhile, in oncology therapeutic area, we have achieved important breakthroughs on its fully in-house developed innovative products including Cadonilimab (AK104, PD-1/CTLA-4), AK112 (PD-1/VEGF) and AK117(CD47). In September 2021, we submitted another NDA in China for Cadonilimab for the treatment of relapsed or metastatic cervical cancer under priority review. As of this announcement date, Cadonilimab started three Phase III clinical trials for first-line treatment of advanced gastric adenocarcinoma or gastroesophageal junction cancer (GC/GEJ), first-line treatment of recurrent or metastatic cervical cancer, and locally advanced cervical cancer. AK112 (PD-1/VEGF) started two Phase III clinical trials for first-line treatment of PD-L1(+) NSCLC, and advanced NSCLC previously treated with EGFR-mutant Tyrosine Kinase Inhibitor (TKI) treatment. Another core product AK117 (CD47) has also started various combination therapies studies for treatment of solid tumors, and the preliminary data showed promising results.

In non-oncology therapeutic area, AK101 (IL12/23) entered into Phase III clinical study for the treatment of moderate-to-severe plaque psoriasis. AK102 (PCSK9) started Phase III clinical study for hypercholesterolemia, and a pivotal clinical study for heterozygous familial hypercholesterolemia ("HeFH").

An experienced commercialization team is ready to launch the new product

With more innovative drugs pending to obtain approval, we have already established an experienced commercialization team with proven track record of success. As of the end of 2021, our commercialization team has more than 500 team members, and all core members have successful sales and marketing experiences. It has achieved in-depth coverage of 1500+ hospitals, 500+ DTP pharmacies, and 60+ Insurance and Charity across the country.

This professional team will be responsible for the commercialization of Cadonilimab. Based on the superior efficacy and first mover advantage of Cadonilimab in clinical studies for the treatment of cervical cancer, gastric cancer, and liver cancer, we have full confidence in a successful launch of Cadonilimab.

High-quality GMP-compliant manufacturing

As of December 31, 2021, we have developed world-class GMP facilities to support large scale commercialization and R&D plans. We currently have 23,500L GMP compliant production capacity in operation, with more capacity under construction and in planning.

On April 1, 2022 Centene Corporation (NYSE: CNC) reported that following the release of its 2022 first quarter financial results on Tuesday, April 26, 2022, the Company will hold its 2022 Annual Meeting of Stockholders at 11:00 a.m. (Eastern Time)/10:00 a.m. (Central Time) in the auditorium at Centene’s headquarters, 7700 Forsyth Boulevard, St. Louis, Missouri (Press release, Centene , APR 1, 2022, View Source [SID1234611364]). At the meeting, Centene is expected to make remarks regarding the Company’s performance and future prospects. A live audio webcast of the meeting can be accessed via the Company’s website at www.centene.com under the Investors section.

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On April 1, 2022 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the closing of its previously announced underwritten public offering of 53,333,334 shares of its common stock and pre-funded warrants to purchase 18,095,238 shares of common stock, together with accompanying warrants to purchase 35,714,286 shares of common stock (Press release, Geron, APR 1, 2022, View Source [SID1234611362]). The combined offering price to the public of each share of common stock and accompanying warrant was $1.05. The combined offering price to the public of each pre-funded warrant and accompanying warrant was $1.049. The common stock and pre-funded warrants were sold in combination with an accompanying warrant to purchase 0.5 of a share of common stock issued for each share of common stock or pre-funded warrant sold. The accompanying warrant has an exercise price of $1.45 per share and expires five years from the date of issuance; however, such term will be shortened upon achievement of a regulatory milestone.

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The estimated net proceeds to Geron from this underwritten public offering are approximately $70 million, after deducting the underwriting discount and other estimated offering expenses payable by Geron. Geron currently intends to use the net proceeds from this public offering, together with its existing cash, cash equivalents, restricted cash and marketable securities, to fund potential regulatory filings in the United States and European Union for imetelstat in lower risk myelodysplastic syndromes (MDS), assuming top-line results in the IMerge Phase 3 clinical trial are supportive, and to support toward the completion of the IMpactMF clinical trial in refractory myelofibrosis and the planned exploratory studies in new indications, including IMproveMF and investigator-led trials in acute myeloid leukemia and higher risk MDS, the preclinical work in lymphoid malignancies and the discovery research program related to next generation telomerase inhibitors.

Stifel and Baird acted as joint book-running managers for the public offering and Needham & Company acted as lead manager.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock, pre-funded warrants and accompanying warrants described above was previously filed with the Securities and Exchange Commission (SEC) and subsequently declared effective by the SEC. A final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement relating to the offering may also be obtained from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected] or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Avenue, Milwaukee, Wisconsin 53202, by telephone at 800-792-2473 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will 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 the registration or qualification under the securities laws of any such state or other jurisdiction.