On June 2, 2020 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel therapeutics for highly aggressive cancers, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate its third therapeutic candidate, CFI-402411, an oral, first-in-class inhibitor of hematopoietic progenitor kinase 1 (HPK1) in patients with solid tumors as a monotherapy or in combination with PD1 pathway blockade (Press release, Treadwell Therapeutics, JUN 2, 2020, View Source [SID1234560766]). In addition, Treadwell also announced the receipt of a No Objection Letter (NOL) to a Clinical Trial Application (CTA) for CFI-402411 in solid tumors from Health Canada.

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"HPK1 represents a novel, orally targettable node of therapeutic intervention in the immune-oncology space. As a pleiotropic negative regulator of immune cell activation, inhibiting HPK1 may result in more potent anti-tumor responses in the treatment of cancer, simultaneously acting on multiple immune cell subsets to prevent tumor evasion. Therefore, we are excited to have received the FDA’s IND clearance to begin clinical trials for our first-in-class, highly-potent, oral HPK1 inhibitor," said Dr. Shane Burgess, Treadwell Co-Chief Executive Officer. "Our inhibitor program is the culmination of over two decades of pioneering work by Treadwell Founders and collaborators in HPK1 biology and immune regulation. Preclinical studies have demonstrated CFI-402411’s promise as a potential monotherapy and in combination with existing checkpoint inhibitors across both solid and hematological cancers, and we look forward to our Phase 1/2 trial later this year," added Dr. Mark Bray, Treadwell Chief Scientific Officer and Co-Founder.

Under this IND, Treadwell intends to initiate a Phase 1/2 clinical trial of CFI-402411, an oral immunomodulatory kinase inhibitor with activity toward HPK1, in the third quarter of 2020. This clinical trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CFI-402411, as well as to determine optimal dosing as a monotherapy and in combination with PD1 pathway inhibitors. Start-up activities are currently underway including clinical study site preparation and subject screening.

CFI-402411 is a highly potent inhibitor of HPK1, which in preclinical studies has been shown to have an immune-activing effect including the alleviation of inhibition of T cell receptors (TCR), disruption of abnormal cytokine expression, alteration of the tumor immunosuppressive environment through effector cells (i.e. Regulatory T cells or Treg), and cytotoxic effects on specific subtypes of AML mouse models.

On June 2, 2020 Pfizer Inc. (NYSE: PFE) reported the establishment of the Pfizer Breakthrough Growth Initiative, through which Pfizer will invest up to $500 million in biotechnology companies to help provide funding and access to Pfizer’s scientific expertise to ensure continuity of the biotechnology companies’ most promising clinical development programs (Press release, Pfizer, JUN 2, 2020, View Source [SID1234560764]).

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"There has never been a more important moment to pursue new collaborations in our industry," said John Young, Pfizer’s Chief Business Officer. "The Pfizer Breakthrough Growth Initiative seeks to do just this by injecting crucial capital into biotechnology companies that share our commitment to delivering transformative therapies for patients."

The Pfizer Breakthrough Growth Initiative will focus on making non-controlling equity investments in clinical-stage public companies, with a primary focus on companies with small- to medium-sized market capitalizations across a range of therapeutic categories that are consistent with Pfizer’s core areas of focus: Internal Medicine, Inflammation & Immunology, Oncology, Rare Disease, Vaccines and Hospital. Partner companies may also have the opportunity to access Pfizer’s significant expertise and resources in research, clinical development and manufacturing.

Today’s announcement builds on Pfizer’s long history of successfully collaborating across the healthcare innovation ecosystem, through a wide range of flexible partnering and funding models, with the shared goal of turning great science into innovative new medicines.

On June 2, 2020 Orion Corporation, reported that 520,144 A shares have been converted into 520,144 B shares (Press release, Orion , JUN 2, 2020, View Source [SID1234560763]). The conversion has been entered into the Trade Register on 2 June 2020.

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The total number of shares in Orion Corporation is 141,257,828 which, after the conversion, consists of 35,507,125 A shares and 105,750,703 B shares. The number of votes of the company’s shares is after the conversion 815,893,203.

On June 2, 2020 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA) ("Iovance" or "Company"), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported the closing of an underwritten public offering of 19,475,806 shares of its common stock at a public offering price of $31.00 per share (Press release, Iovance Biotherapeutics, JUN 2, 2020, View Source [SID1234560759]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are $603.7 million. The shares of common stock issued and sold in the offering include 2,540,322 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less the underwriting discounts and commissions.

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Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel for advanced melanoma and LN-145 for advanced cervical cancer, to initiate a program directed at registration of Iovance’s tumor infiltrating lymphocyte therapies in non-small cell lung cancer, to continue support of ongoing commercial manufacturing activities, and for the development of Iovance’s IL-2 analog, IOV-3001, and for other general corporate purposes. Additional indications or TIL products may be explored with the use of proceeds.

Jefferies LLC and Goldman Sachs & Co. LLC acted as joint lead book-running managers for the offering. Wells Fargo Securities, LLC also acted as book-running manager for the offering. Oppenheimer & Co. Inc. acted as lead co-manager for the offering. Robert W. Baird & Co. Incorporated and H.C. Wainwright & Co., LLC acted as co-managers for the offering.

The shares of common stock described above were offered by Iovance pursuant to its shelf registration statement on Form S-3 that became automatically effective upon filing with the Securities and Exchange Commission (the "SEC") on May 27, 2020. The offering has been made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and is available on the SEC’s website at View Source A final prospectus supplement and accompanying prospectus was filed with the SEC, copies of which may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor New York, New York, 10022, by telephone at (877) 547-6340, or by email at [email protected] or Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected] or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York, 10001, at (800) 326-5897 or email a request to [email protected].

On June 2, 2020 Adaptimmune Therapeutics plc ("Adaptimmune")(Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported that it intends to offer and sell 12,500,000 American Depositary Shares ("ADSs") in an underwritten public offering (Press release, Adaptimmune, JUN 2, 2020, View Source [SID1234560758]). The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Adaptimmune also expects to grant the underwriters a 30-day option to purchase additional ADSs at the public offering price. All of the ADSs in the offering are to be sold by Adaptimmune, with net proceeds to be used to advance the development of Adaptimmune’s immunotherapies into and through clinical trials as well as for other general corporate purposes.

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Cowen and SVB Leerink are acting as joint book-running managers for the offering and Roth Capital Partners is acting as lead manager for the offering.

A shelf registration statement on Form S-3 relating to the public offering of the ADSs described above was declared effective by the Securities and Exchange Commission ("SEC") on September 10, 2019. The offering is being made only by means of a written 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 will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to these securities may also be obtained by sending a request to: 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; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by emailing [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 is not permitted.

For readers in the European Economic Area and the United Kingdom

In any EEA Member State and the United Kingdom (each, a "Relevant State"), this communication is only addressed to and directed at qualified investors in that Relevant State within the meaning of the Prospectus Regulation. The term "Prospectus Regulation" means Regulation (EU) 2017/1129.

For readers in the United Kingdom

This communication, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of s21 Financial Services and Markets Act 2000 as amended) in connection with the securities which are the subject of the offering described in this press release or otherwise, is being directed only at (i) persons who are outside the United Kingdom or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) (Investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) (High net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as "relevant persons"). The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this communication or any of its contents.