On October 12, 2018 Sutro Biopharma, Inc. (NASDAQ: STRO), reported that it has been granted Orphan Drug Designation by the United States Food and Drug Administration (FDA) for STRO-001 for the treatment of multiple myeloma (Press release, Sutro Biopharma, OCT 12, 2018, View Source [SID1234529894]). STRO-001 is a potential first-in-class antibody drug conjugate (ADC) targeting CD74, a protein highly expressed in B-cell malignancies such as multiple myeloma.

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"There is a growing need for new treatment options for patients with multiple myeloma," commented Bill Newell, Sutro’s Chief Executive Officer. "This Orphan Drug Designation is a great step towards advancing our uniquely designed STRO-001 that could bring new treatment options to patients in need."

STRO-001 was developed with Sutro’s proprietary cell-free protein synthesis and site-specific conjugation platform, XpressCF+, which facilitate precision design and rapid empirical optimization of ADCs. Sutro’s technology enables design and manufacture of a highly optimized single molecular species within the product, rather than the usual mixture of imprecisely conjugated antibodies that comprise an ADC development product made by conventional cell-based manufacturing platforms.

"STRO-001 was designed to directly target cancer cells to deliver a cytotoxic payload. Building upon our XpressCF+ platform we plan to develop better options to treat tumors with greater precision," Bill Newell added.

STRO-001 is currently being studied in a Phase 1 clinical trial enrolling separate dose escalation cohorts for myeloma and B-cell lymphoma.

About Orphan Drug Designation

The Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

On October 10, 2018, the Company delivered notice to Cantor Fitzgerald & Co. ("Cantor") terminating the Controlled Equity OfferingSM Sales Agreement, dated February 1, 2013 (the "Sales Agreement"), with Cantor effective as of October 20, 2018 (Filing, 8-K, Celsion, OCT 12, 2018, View Source [SID1234530287]). The Sales Agreement permitted the Company to sell additional shares of our Common Stock having an aggregate offering price of up to $25 million through "at the market" equity offerings from time to time. From February 2013 through the date of termination, the Company sold 1,784,396 shares of Common Stock under the Sales Agreement generating gross proceeds of $12.8 million. The Company has no further obligations under the Sales Agreement.

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On October 11, 2018 Johnson & Johnson Janssen pharmaceutical companies reported that it will present updates of their entire oncology portfolio at the 2018 annual congress of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), which will be held from 19 to 23 October in Munich, Germany (Press release, Johnson & Johnson, OCT 11, 2018, View Source [SID1234529866]).

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The statement in the original language is the official and authorized version thereof. The translation is only a means of help and should be compared with the text in the original language, which is the only version of the text that will have legal validity

On October 11, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will be presenting at the BIO Investor Forum on Wednesday, October 17, 2018, at 11:15 a.m. PT (2:15 p.m. ET) in San Francisco, CA (Press release, Infinity Pharmaceuticals, OCT 11, 2018, View Source [SID1234529881]). A live webcast of the presentation will be available on the Investors/Media section of Infinity’s website at www.infi.com, and will be available for 30 days following the event.

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On October 11, 2018 Iovance Biotherapeutics, Inc. (Nasdaq:IOVA) ("Iovance" or "Company"), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering (Press release, Iovance Biotherapeutics, OCT 11, 2018, View Source [SID1234530235]). All of the shares in the offering are to be sold by Iovance. Iovance intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares of common stock 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, to fund its commercial manufacturing capabilities and facilities, to fund its ongoing clinical trials for its current product candidates, including its on-going Phase 2 clinical trials of LN-144, TIL for the treatment of metastatic melanoma, and LN-145, TIL for the treatment of cervical and head and neck cancers, to fund its planned clinical trials for its current product candidates, including its ongoing Phase 2 clinical trial of LN-145 for the treatment of non-small cell lung cancer, or NSCLC, in collaboration with MedImmune, and its ongoing Phase 2 clinical trials of LN-145 as an early-line therapy alone or in combination with pembrolizumab in melanoma, head and neck cancer, and NSCLC, and for other general corporate purposes. Additional indications may be explored with the use of proceeds.

Jefferies LLC is acting as sole book-running manager for the offering.

The shares of common stock described above are being offered by Iovance pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). The offering may be made only by means of a prospectus supplement and accompanying prospectus, 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) 821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell or a 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.