On October 31, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the Investigational New Drug (IND) application for ATG-017 has received clearance from the U.S. Food and Drug Administration (FDA) (Press release, Antengene, OCT 31, 2022, View Source [SID1234622654]). The IND clearance enables Antengene to initiate the combination portion of the Phase I "ERASER" clinical trial in the United States (U.S.) to evaluate the safety, pharmacokinetics, and preliminary efficacy of ATG-017 combination therapy with nivolumab in patients with advanced solid tumors.

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ATG-017 is an oral, potent, and selective inhibitor of extracellular signal-regulated protein kinase 1 and 2 (ERK1/2). Nivolumab is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. The clinical collaboration between Antengene and Bristol Myers Squibb to evaluate ATG-017 in combination with nivolumab builds on Antengene’s preclinical data. The data, including studies presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-conference Programs in November 2021, has demonstrated that the combination of an ERK1/2 inhibitor and an immune checkpoint inhibitor (ICI) worked synergistically to produce improved efficacy in preclinical ICI-resistant in vivo mice models.

"We are excited to have received IND clearance for activation of the ERASER study in the U.S. Preclinical results with ATG-017 have been very promising both as a monotherapy and in combination with ICIs in aggressive and resistant malignancies. We are very pleased that the further clinical exploration will involve multiple geographies as we attempt to define the potential role of ATG-017 as a novel cancer treatment," said Dr. Kevin Lynch, Antengene’s Chief Medical Officer."Every day, we see advanced cancer patients with limited treatment options. We intend to initiate the study in the U.S. soon, and hope that ATG-017 will eventually offer a safe and effective new treatment option to those patients in need."

"The development of new therapies for cancer patients with refractory, relapsed, or advanced diseases is a cornerstone of Antengene’s work. ATG-017 is an exciting compound because of its attractive pharmacology, impressive preclinical activity on the RAS-MAPK pathway and the potential ability to synergize with ICIs. These attributes provide the rationale for evaluating ATG-017 as a monotherapy and in combination with ICIs such as nivolumab in patients with resistant or relapsed disease," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "We are very encouraged by this IND clearance from the U.S. FDA as it paves the way for one of Antengene’s first studies in the U.S. and marks an important milestone in the global clinical development of ATG-017. We look forward to initiating patient enrollment of the ERASER trial in the U.S."

About ATG-017

ATG-017 is an oral, potent, and selective small molecule extracellular signal-regulated kinases 1 and 2 (ERK1/2) inhibitor. ERK1/2 are related protein-serine/threonine kinases that function as terminal kinases in the RAS-MAPK signal transduction cascade. This cascade regulates a large variety of cellular processes, including proliferation. The RAS-MAPK pathway is dysregulated in more than 30% of human cancers with the most frequent alterations being observed in RAS or BRAF genes across multiple tumor types. An ERK inhibitor enables the targeting of both RAS and BRAF mutant diseases.

Antengene presented data at the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-conference Programs in November 2021 detailing compelling preclinical results showing the combination of ATG-017 and an anti-PD-L1 monoclonal antibody (atezolizumab) in an aggressive immune checkpoint resistant murine cancer model rendered "cold" tumors "hot". To date, ATG-017 has been approved in Australia and the United States to enter clinical studies in patients with advanced solid tumors or hematologic malignancies.

On October 31, 2022 Cellular Biomedicine Group Inc. (CBMG or the "Company"), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported that the Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application to proceed with Phase 1 clinical development of its novel Tumor Infiltrating Lymphocyte (TIL) product C-TIL051 for late-stage Non-Small Cell Lung Cancer (NSCLC) patients that are relapsed or refractory to anti-PD1 therapy (Press release, Cellular Biomedicine Group, OCT 31, 2022, View Source [SID1234622653]).

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C-TIL051 is an autologous adoptive cell therapy comprised of a patient’s ex vivo expanded lymphocytes using CBMG’s proprietary manufacturing process.

"This is outstanding news for NSCLC patients who are faced with limited treatment options."

"This is outstanding news for NSCLC patients who are faced with limited treatment options. C-TIL051 could potentially offer an alternative treatment and our preclinical data show that C-TIL051 might have the potential to be superior. We are working closely with clinical sites and plan to initiate the C-TIL051 Phase 1 trial soon," said Tony (Bizuo) Liu, Chairman and CEO of CBMG. "FDA clearance of the C-TIL051 IND is a significant milestone for CBMG. We plan to start manufacture of clinical batches of C-TIL051 in our GMP facility at Rockville Maryland in the near future."

About C-TIL051
C-TIL051 is manufactured and released at CBMG’s state-of-the-art GMP facility in Rockville Maryland using a proprietary process that can achieve clinical doses more rapidly and more efficiently than traditional TIL manufacturing methods. The process involves ex vivo expansion of tumor infiltrating lymphocytes in a two-step process. C-TIL051 has not been previously studied in human clinical trials however the rationale for developing C-TIL051 was based on initial NSCLC TIL studies demonstrating encouraging safety and efficacy results (NCT03215810, NCT03645928).

On October 31, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that it plans to release unaudited financial results for the third quarter ended September 30, 2022 and provide an update on recent developments prior to the open of the U.S. financial markets on Monday, November 14, 2022 (Press release, Gracell Biotechnologies, OCT 31, 2022, View Source [SID1234622652]). The management team will host a live audio webcast and conference call at 8:00 AM Eastern Time.

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On October 31, 2022 plc ("Haleon") (LSE: HLN, NYSE: HLN) reported the expiration and final results of its previously announced offers to exchange seven series of outstanding unregistered notes issued by GSK Consumer Healthcare Capital US LLC (the "US Issuer") and GSK Consumer Healthcare Capital UK plc (the "UK Issuer", and together with the US Issuer, the "Issuers") (as set out below), which was launched on September 29, 2022, pursuant to a registration rights agreement entered into at the time of the original issuance of the notes (Press release, GlaxoSmithKline, OCT 31, 2022, View Source [SID1234622651]).

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Upon the terms and subject to the conditions set forth in the prospectus and the accompanying letter of transmittal dated September 29, 2022 (the "Exchange Offer Documents"), Haleon offered to exchange in seven concurrent, but separate, offers (the "Exchange Offers") any and all of the seven series of notes identified under "Title of Series of Original Notes" in the table below (collectively, the "Original Notes"), for a like principal amount of notes of the same series that have been registered under the Securities Act of 1933, as amended (the "Securities Act"), as described under "Title of Series of Exchange Notes" in the table below (collectively, the "Exchange Notes").

The Exchange Offers expired at 5:00 p.m. (Eastern time) on October 28, 2022 (the "Expiration Date"). The "Settlement Date" with respect to the Exchange Offers will be promptly following the Expiration Date and is expected to be November 2, 2022. Upon the settlement of the Exchange Offers, holders of Original Notes who validly tendered and did not validly withdraw such notes prior to the Expiration Date will receive a like principal amount of Exchange Notes of the applicable series.

The terms of each series of Exchange Notes to be issued upon the settlement of the Exchange Offers are substantially identical to the terms of the corresponding Original Notes of such series, except that the Exchange Notes have been registered under the Securities Act and the transfer restrictions, the special mandatory redemption provisions and registration rights applicable to the Original Notes will not apply to the Exchange Notes. As previously disclosed, the sole purpose of the Exchange Offers was to offer the holders of the Original Notes the opportunity to receive Exchange Notes that have been registered under the Securities Act and are expected to be listed on the New York Stock Exchange.

A Registration Statement on Form F-4 (the "Registration Statement") relating to the issuance of the Exchange Notes was filed with the Securities and Exchange Commission ("SEC") on September 29, 2022 and declared effective on October 27, 2022. The Exchange Offers were made pursuant to the terms and subject to the conditions set forth in a prospectus filed with the SEC dated as of October 27, 2022 (as the same may be amended or supplemented, the "Prospectus"), which forms part of the Registration Statement.

Global Bondholder Services Corporation acted as Exchange Agent for the Exchange Offers. Questions or requests for assistance related to the Exchange Offers or for additional copies of the Prospectus may be directed to Global Bondholder Services Corporation at (855) 654-2014. You may also contact your broker, dealer, commercial bank, trust company or other nominee for assistance concerning the Exchange Offers.

The New Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the European Economic Area (the "EEA"). For these purposes, a "retail investor" means a person who is one (or more) of: (i) a retail client as defined in point (11) of Article 4(1) of Directive (EU) 2014/65 (as amended, "MiFID II") or (ii) a customer within the meaning of Directive (EU) 2016/97(as amended, the "Insurance Distribution Directive"), where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II. Consequently, no key information document required by Regulation (EU) No 1286/2014 (as amended, the "PRIIPs Regulation") for offering or selling the New Notes or otherwise making them available to retail investors in the EEA has been prepared and therefore offering or selling of the New Notes or otherwise making them available to any retail investor in the EEA may be unlawful under the PRIIPs Regulation.

Any offer of the New Notes in any member state of the EEA will be made pursuant to an exemption under Regulation (EU) 2017/1129 (as amended, the "Prospectus Regulation") from the requirement to publish a prospectus for offers of securities. This press release is not a prospectus for the purposes of the Prospectus Regulation.

The New Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in the United Kingdom (the "UK"). For these purposes, a "retail investor" means a person who is one (or more) of the following: (i) a retail client, as defined in point (8) of Article 2 of Regulation (EU) No 2017/565 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 (the "EUWA"); or (ii) a customer within the meaning of the provisions of the Financial Services and Markets Act 2000 (as amended, the "FSMA") and any rules or regulations made under the FSMA to implement the Insurance Distribution Directive, where that customer would not qualify as a professional client, as defined in point (8) of Article 2(1) of Regulation (EU) No 600/2014 as it forms part of UK domestic law by virtue of the EUWA. Consequently, no key information document required by Regulation (EU) No. 1286/2014 as it forms part of UK domestic law by virtue of the EUWA (as amended, the "UK PRIIPs Regulation") for offering or selling the New Notes or otherwise making them available to retail investors in the UK has been prepared and therefore offering or selling the New Notes or otherwise making them available to any retail investor in the UK may be unlawful under the UK PRIIPs Regulation.

Any offer of the New Notes in the UK will be made pursuant to an exemption under Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of EUWA (the "UK Prospectus Regulation") from the requirement to publish a prospectus for offers of securities. This press release is not a prospectus for the purposes of the UK Prospectus Regulation.

In the United Kingdom, this press release is being distributed only to, and is directed only at (i) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended, the "Order"), and/or (ii) high net worth companies (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together referred to as "relevant persons"). This press release must not be acted on or relied on in the United Kingdom by persons who are not relevant persons. In the United Kingdom, any investment or investment activity to which this press release relates is only available to, and will be engaged in with, relevant persons only.

On October 31, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the pricing of its previously announced underwritten public offering of 6,865,672 shares of Class A common stock at a price to the public of $33.50 per share (Press release, Nuvalent, OCT 31, 2022, View Source [SID1234622650]). All shares are being offered by Nuvalent. The gross proceeds to Nuvalent from the offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be approximately $230.0 million. The offering is expected to close on November 3, 2022, subject to the satisfaction of customary closing conditions. In addition, the underwriters have a 30-day option to purchase up to an additional 1,029,850 shares of Class A common stock at the public offering price less underwriting discounts and commissions.

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J.P. Morgan, Cowen, Piper Sandler and BMO Capital Markets are acting as joint book-running managers for the offering.

The shares are being offered by Nuvalent pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on August 10, 2022, and declared effective by the SEC on August 16, 2022. The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus can be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone (866) 803-9204 or by email at [email protected]; 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; Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected]; and BMO Capital Markets Corp., Attn: Equity Syndicate Department, 151 W 42nd Street, 32nd Floor, New York, NY 10036, by telephone at (800) 414-3627, or by email at [email protected].

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 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 jurisdiction.