Athenex, Texas Children’s Cancer Center, and the Center for Cell and Gene Therapy at Baylor College of Medicine to Present Phase 1 Clinical Data for KUR-501, an autologous GD2 CAR-NKT Cell Therapy for Relapsed/Refractory High Risk Neuroblastoma at the ASG

On May 2, 2022 Athenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company will present at the upcoming ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting, taking place May 16-19, 2022, in Washington, D.C (Press release, Athenex, MAY 2, 2022, View Source [SID1234613349]). The abstract associated with the presentation is now available on the conference website.

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Details of the presentations are as follows:

Oral Presentation Details

Abstract 54: Anti-GD2 CAR NKT cells are safe and produce antitumor responses in patients with relapsed/refractory neuroblastoma
Date/Time: Monday, May 16, 2022, 2:30 PM – 2:45 PM ET
Session: Gene and Cell Therapy Trials in Progress
Presenter: Dr. Andras Heczey, Baylor College of Medicine
Location: Room 201, Walter E. Washington Convention Center, 801 Mt Vernon Pl NW Washington, D.C.

"Observing evidence of a dose response is extremely encouraging, and we are excited to see two out of three responses at 100 million cells/m2," said Dan Lang, M.D., President of Athenex Cell Therapy. "We are hopeful that we will see additional responses as we move to higher doses. We and our partners at Baylor College of Medicine (BCM) and Texas Children’s Hospital (TCH) continue to be motivated by the data and look forward to our next update."

About KUR-501

KUR-501, is an autologous NKT cell CAR product that targets GD2, a tumor-associated antigen that is expressed on almost all neuroblastomas as well as melanomas, some sarcomas, and a variety of other tumors. GINAKIT2, a phase 1 single arm clinical study (NCT03294954) of KUR-501, in patients with refractory or recurrent high-risk neuroblastoma will evaluate up to six dose levels of KUR-501 following lymphodepletion with cyclophosphamide and fludarabine.

Neuroblastoma, a pediatric cancer of the sympathetic nervous system, typically the adrenal gland, is associated with a poor prognosis in children with high-risk disease and is a significant unmet medical need. The KUR-501 development program will provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target.

The GINAKIT2 study is supported by Athenex, Inc., which acquired Kuur Therapeutics in May 2021, as well as by Alex’s Lemonade Stand Foundation. This study is currently recruiting patients at BCM/TCH.

iBio Announces Presentation Highlighting Superior Glycosylation for Antibodies Produced in Plants

On May 2, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported that it will present a poster at the 18th Annual Protein & Antibody Engineering Summit (PEGS) Boston Conference & Expo, May 2-5 (Press release, iBioPharma, MAY 2, 2022, View Source [SID1234614060]).

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Rachel Jordan, PhD, a senior product manager at iBio, will present the poster (#P061), titled "Plant-Made Antibodies Show Superior Glycosylation Homogeneity While Retaining Pharmacokinetic Properties," which highlights:

The production of a single uniform G0 glycosylation pattern, lacking fucose and xylose, of NISTmAb and rituximab when compared to Chinese Hamster Ovary (CHO) cell culture produced antibodies, which contain more heterogeneous glycosylation patterns.
Comparability of in vivo rodent pharmacokinetic profiles for NISTmAb and rituximab produced using mammalian cell culture and the FastPharming System.
How rapid, scalable transient expression in plants of high-quality mAbs for in vivo studies can significantly shorten the time to achieve in vivo proof-of-concept.
More information about producing consistent, high-quality antibodies in the FastPharming System may be accessed in a whitepaper here.

Lilly Declares Second-Quarter 2022 Dividend

On May 2, 2022 The board of directors of Eli Lilly and Company (NYSE: LLY) reported that it has declared a dividend for the second quarter of 2022 of $0.98 per share on outstanding common stock (Press release, Eli Lilly, MAY 2, 2022, View Source [SID1234613281]).

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The dividend is payable on June 10, 2022 to shareholders of record at the close of business on May 16, 2022.

DBV Technologies Establishes an At-The-Market (ATM) Program on Nasdaq

On May 2, 2022 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Global Select Market: DBVT) (the "Company"), a clinical-stage biotechnological company, reported that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission ("SEC") relating to an At-The-Market offering (the "ATM Program") (Press release, DBV Technologies, MAY 2, 2022, View Source [SID1234613297]). Pursuant to this new financing program, the Company may offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares ("ADS"), each ADS representing one-half of one ordinary share of DBV Technologies, from time to time in sales deemed to be an "at the market offering" pursuant to the terms of a sales agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), acting as sales agent, subject to French regulatory limits. The timing of any sales will depend on a variety of factors. The ATM Program is presently intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM Program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached.

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The Company currently intends to use the net proceeds (after deduction of fees and expenses related to the financing), if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes, at the Company’s discretion.

Jefferies, as sales agent, will use commercially reasonable efforts to arrange on the Company’s behalf for the sale of all ADSs requested to be sold by the Company to eligible investors requesting it, consistent with Jefferies’ normal sales and trading practices. Sales prices may vary based on market prices and other factors. Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM Program.

The ADSs and the underlying ordinary shares will be issued through one or more share capital increases without shareholders’ preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to the 28th resolution adopted by the Annual General Meeting of Shareholders held on May 19, 2021 (the "2021 Annual General Meeting") (or any substitute resolutions, adopted from time to time), within the limit of a maximum number of 16,528,961 ordinary shares (being the maximum authorized by the shareholders for such resolution), representing a maximum potential dilution of approximately 30% based on the existing share capital of the Company, it being specified that the number of underlying ordinary shares to be admitted on the regulated market of Euronext in Paris ("Euronext Paris") shall represent, over a period of 12 months,

less than 20% of the ordinary shares already admitted to trading on said market without a French listing prospectus.

The new ordinary shares to be sold in the form of ADSs would be issued in one or more offerings at market prices of the ADSs at the time of pricing of the considered capital increase.

The ATM Program may only be issued to the categories of investors defined in the 28th resolution adopted by the 2021 Annual General Meeting (or any similar resolutions that may be substituted for it in the future), comprising (i) any natural person(s) or legal entity(ies), including companies, trusts, investment funds or other investment vehicle(s), regardless of their form, under French or foreign law, investing on a regular basis in the pharmaceutical, biotechnological or medical technology sector, and/or (ii) French or foreign companies, institutions or entities of any form, carrying out a significant portion of their business in these sectors or in the cosmetics or chemical sector or in the field of medical devices or research in these areas. The new ordinary shares will be admitted to trading on the regulated market of Euronext in Paris and the issued ADSs will trade on the Nasdaq Global Select Market ("Nasdaq").

On an illustrative basis, assuming the issuance of the full amount of $100 million (or €92.7 million (all convenience translations in this press release are based on the noon buying rate of the Federal Reserve Bank of New York in effect as of April 25, 2022, of €1.00 = $1.08) of ADSs under the ATM Program at an assumed offering price of $1.29 (or €1.20), the last reported sale price of the ADSs on Nasdaq on April 29, 2022, a holder of 1.0% of the outstanding Company’s share capital as of the date of this press release, would hold 0.60% of the outstanding Company’s share capital after the completion of the transaction (calculated on the basis of the number of outstanding shares on the date of publication of this press release), it being specified that, in any event, the
number of underlying ordinary shares shall not exceed the limit set forth in the 28th resolution adopted by the 2021 Annual General Meeting (or any substitute resolutions, adopted from time to time, including the 18th resolution presented to the shareholders vote at the Annual General Meeting to be held on May 12, 2022) and shall represent, over a period of 12 months, less than 20% of the ordinary shares already admitted to trading on said market without a listing prospectus.

During the term of the ATM Program, the Company will include in the publication of its quarterly results information about its use of the program during the preceding quarter and will also provide an update after each capital increase on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM Program from time to time.

A shelf registration statement on Form S-3 (including a prospectus) relating to DBV Technologies’ securities, including the ADSs, was filed with the SEC and has been declared effective. Before purchasing ADSs in the offering, prospective investors should read the prospectus supplement and the

accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at [email protected]. No prospectus will be subject to the approval of the French Financial Markets Authority (the Autorité des Marchés Financiers or the "AMF") pursuant to Regulation (EU) 2017/1129 of the European Parliament and of the Council dated June 14, 2017, as amended (the "Prospectus Regulation") since the contemplated share capital increase(s) (for the issuance of the ordinary shares underlying the ADSs) would be offered to qualified investors (as such term is defined in Article 2(e) of the Prospectus Regulation) and fall under the exemption provided for in Article 1(5)(a) of the Prospectus Regulation which states that the obligation to publish a prospectus shall not apply to admission to trading on a regulated market of securities fungible with securities already admitted to trading on the same regulated market, provided that they represent, over a period of 12 months, less than 20% of the number of securities already admitted to trading on the same regulated market.

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. In particular, no public offering of the ADSs will be made in Europe.

Information available to the public

Detailed information concerning the Company, in particular with regard to its business, results, forecasts and corresponding risk factors, is provided in the Company’s Annual Report on Form 10-K (the "Annual Report"), filed with the U.S. SEC on March 9, 2022, its 2021 universal registration document (the "URD"), filed with the AMF on March 9, 2022 and under number D.22-0081, as well as in the half-yearly financial report (containing an update of the main information on the Company, its development and its projects) (the "Half-Year Report"), and documents filed with the U.S. SEC from time-to-time (the "SEC Filings"). The Annual Report and SEC Filings are available on the SEC’s website (www.sec.gov). The URD as well as other regulated information are available on the AMF website (www.amf-france.org). All of the foregoing documents are available on the Company’s website and are available free of charge on request at the Company’s registered office at 177-181 avenue Pierre-Brossolette, 92120 Montrouge, France.

iBio Announces Presentation Highlighting Superior Glycosylation for Antibodies Produced in Plants

On May 2, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported that it will present a poster at the 18th Annual Protein & Antibody Engineering Summit (PEGS) Boston Conference & Expo, May 2-5 (Press release, iBioPharma, MAY 2, 2022, View Source [SID1234613313]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Rachel Jordan, PhD, a senior product manager at iBio, will present the poster (#P061), titled "Plant-Made Antibodies Show Superior Glycosylation Homogeneity While Retaining Pharmacokinetic Properties," which highlights:

The production of a single uniform G0 glycosylation pattern, lacking fucose and xylose, of NISTmAb and rituximab when compared to Chinese Hamster Ovary (CHO) cell culture produced antibodies, which contain more heterogeneous glycosylation patterns.

Comparability of in vivo rodent pharmacokinetic profiles for NISTmAb and rituximab produced using mammalian cell culture and the FastPharming System.

How rapid, scalable transient expression in plants of high-quality mAbs for in vivo studies can significantly shorten the time to achieve in vivo proof-of-concept.
More information about producing consistent, high-quality antibodies in the FastPharming System may be accessed in a whitepaper here.