Sutro’s STRO-001 Receives U.S. FDA Orphan Drug Designation for Treatment of Multiple Myeloma

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.

Termination of a Material Definitive Agreement

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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Nordic Nanovector Presentations at the Annual Congress of the European Association of Nuclear Medicine (EANM)

On October 12, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the Company and its collaborators will present data and analyses from its non-clinical and clinical studies with Betalutin (177Lu-lilotomab satetraxetan) at the 32nd Annual Congress of the European Association of Nuclear Medicine (13-17 October 2018, Düsseldorf, Germany) (Press release, Nordic Nanovector, OCT 12, 2018, View Source [SID1234553493]).

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The presentations are:

Therapeutic efficacy of 177Lu-lilotomab satetraxetan in non-Hodgkin B-cell Lymphoma is controlled by G2/M cell cycle progression

Authors: A. Pichard et al.

Session: 305 – M2M: Therapy Effects, Preclinical

Abstract No. OP-069

Format: Oral presentation

Date/time: Sunday 14 October, 11:30-12:45 CEST

Tumor Absorbed Dose and Changes in FDG PET Parameters in Non-Hodgkin Lymphoma Patients Treated with 177Lu-lilotomab satetraxetan

Authors: A. Løndalen et al.

Session: 608 – Clinical Oncology – Rapid Fire Session: It’s in the Blood!

Abstract No. OP-252

Format: Oral presentation

Date/time: Monday 15 October, 08:00-09:30 CEST

Oncopeptides to present at the Jefferies London Healthcare Conference on November 14th

On October 12, 2018 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that they will present at Jefferies London Healthcare Conference on November 14th at 3.20 PM local time (GMT), the presentation will be webcasted (Press release, Oncopeptides, OCT 12, 2018, View Source [SID1234530258]).

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Oncopeptides is a research and development stage pharmaceutical company developing drugs for the treatment of cancer. Since the founding of the company, the focus has primarily been on the development of the lead product candidate melflufen (Ygalo), an alkylating peptide, belongs to a novel class of peptidase-enhanced compounds (PEnCs), intended for effective and focused treatment of hematological cancers, and in particular multiple myeloma.

Melflufen (Ygalo) has been used to treat late-stage RRMM patients in the phase II clinical study called O-12-M1 that is completed with favorable results which have been reported previously. Currently, Oncopeptides conduct four clinical trials with melflufen for the treatment of multiple myeloma. These are HORIZON, OCEAN, ANCHOR and BRIDGE.

The current clinical study program is intended to demonstrate better results from treatment with melflufen (Ygalo) compared to established alternative drugs for patients with late-stage multiple myeloma. This could potentially provide physicians with a new treatment option for patients suffering from this serious disease.

For further information, please contact:

Rein Piir, Head of Investor Relations at Oncopeptides AB
E-mail: [email protected]

This information was submitted for publication at 09.00 CET October 12, 2018

Verastem Oncology Announces Pricing of Registered Direct Offering of $150 Million of Convertible Notes

On October 11, 2018 Verastem, Inc., (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported the pricing of an offering of 5.00% Convertible Senior Notes due 2048 (the Convertible Notes) through a registered direct offering (Press release, Verastem, OCT 11, 2018, View Source [SID1234529869]). The aggregate principal amount of Convertible Notes to be sold in the offering is $150 million. The Convertible Notes will be unsecured, will bear interest at a rate of 5.00% per annum, paid semi-annually in arrears, and will mature on November 1, 2048, unless earlier converted, redeemed or repurchased in accordance with their terms prior to such date.

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The net proceeds to Verastem Oncology from the offering of the Convertible Notes are expected to be approximately $145.4 million, after transaction fees and expenses. The net proceeds will be used by Verastem Oncology for the continued clinical development of COPIKTRA (duvelisib) and its other lead product candidates, and the balance to fund working capital, capital expenditures and other general corporate purposes, which may include the acquisition or in-license of additional compounds, product candidates or technology.

Lazard Frères & Co. LLC acted as placement agent in connection with the offering of the Convertible Notes.

Noteholders may convert their Convertible Notes into shares of the Company’s common stock, together, if applicable, with cash in lieu of any fractional share, based on an initial conversion rate of 139.5771 shares per $1,000 principal amount of Convertible Notes, which represents an initial conversion price of approximately $7.16 per share, an approximately 15% premium to the last reported sale price of the Company’s common stock on Thursday, October 11, 2018. To the extent the Company has insufficient authorized but unissued shares to settle conversions in shares of its common stock, the Company will settle the deficiency in cash.

The Company will have the right, exercisable at its option, to cause all Convertible Notes then outstanding to be converted automatically if the volume-weighted average price per share of the Company’s common stock equals or exceeds 130% of the conversion price for a specified period of time and certain other conditions are satisfied.

Prior to November 1, 2022, the Company will not have the right to redeem the Convertible Notes. On or after November 1, 2022, the Company may elect to redeem the Convertible Notes, in whole or in part, at a cash redemption price equal to the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest, if any.

Unless the Company has previously called all outstanding Convertible Notes for redemption, the Convertible Notes will be subject to repurchase by the Company at the noteholders’ option on each of November 1, 2023, November 1, 2028, November 1, 2033, November 1, 2038 and November 1, 2043 (or, if any such date is not a business day, on the next business day) at a cash repurchase price equal to the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest, if any. Upon the occurrence of certain events, noteholders will have the right to require the Company to repurchase their Convertible Notes at a cash repurchase price equal to the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest, if any. In certain circumstances that constitute a "make-whole fundamental change" occurring prior to November 1, 2022, the Company may be required to increase the conversion price for noteholders who convert their Convertible Notes in connection with the make-whole fundamental change.

The offering is expected to close on or about October 17, 2018, subject to customary closing conditions.

The Convertible Notes are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-226322), which was declared effective by the U.S. Securities and Exchange Commission (SEC) as of August 3, 2018. A prospectus supplement and accompanying base prospectus relating to the offering may be obtained at the SEC’s website, View Source or by calling Lazard Frères & Co. LLC toll free at (800) 445-9522.

This news release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale in any jurisdiction in which, or to any person to whom, such offer, solicitation or sale is unlawful. The Convertible Notes and the shares of the Company’s common stock issuable upon conversion of the Convertible Notes may only be offered by means of a prospectus.