F-star Announces the Achievement of a Clinical Milestone in its Immuno-Oncology Collaboration with Merck

On July 24, 2018 F-star, a clinical-stage biopharmaceutical company developing novel bispecific antibodies (mAb²), reported that FS118 has successfully reached the first clinical milestone in its collaboration with Merck, a leading science and technology company (Press release, f-star, JUL 24, 2018, View Source [SID1234527845]).

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FS118 is a first-in-class antagonist mAb² which simultaneously targets the LAG-3 and PD-L1 immuno-suppressive pathways and which has the potential to overcome tumour resistance and restore the natural anti-cancer immune response.

In May 2018, FS118 entered into a Phase I study in patients with advanced malignancies that have progressed on PD-1/PD-L1 therapy.

"Achieving this clinical milestone is a significant step in our alliance with Merck" said John Haurum, CEO of F-star. "FS118 is uniquely positioned as a first-in-class treatment for cancer patients. We are pleased with the progress being made and look forward to advancing our next mAb² molecules into the clinic."

Under the collaboration, which was announced in June 2017, Merck has an exclusive option to acquire FS118 and a further four early stage immuno-oncology bispecific antibody programmes which are under discovery and development by F-star. Further payments are contingent on option exercise and achievement of clinical and commercial milestones with a potential total deal value reaching over €1B.

FS118 was generated using F-star’s proprietary Modular Antibody Technology by incorporating an anti-LAG-3 Fcab (Fc-region with antigen binding) into a PD-L1-specific antibody. Further information about the ongoing Phase I clinical trial is available on clinicaltrials.gov NCT03440437.

Mirati Therapeutics To Present Updated Sitravatinib Clinical Data At The European Society For Medical Oncology (ESMO) 2018 Congress

On July 24, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that two abstracts highlighting data from ongoing clinical studies of sitravatinib will be presented as Proffered Papers in oral presentations at the 2018 Annual Meeting of the European Society for Medical Oncology October 19-23 in Munich, Germany (Press release, Mirati, JUL 24, 2018, View Source [SID1234527849]).

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Title: Stage 2 enrollment complete: Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor Therapy
Presentation Topic: Proffered paper session – Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (ID 159)
Location: Hall A2 – Room 18, ICM München, Munich, Germany
Lecture Date and Time: October 22, 2018 at 12:06 p.m. – 12:18 p.m. CEST
Presentation Number: 1129O
Presenter: Ticiana A. Leal, M.D.

Title: Sitravatinib demonstrates activity in patients with novel genetic alterations that inactivate CBL
Presentation Topic: Proffered paper session – Developmental therapeutics (ID 170)
Location: Hall B3 – Room 22, ICM München, Munich, Germany
Lecture Date and Time: October 21, 2018 at 11:00 a.m. – 11:12 a.m. CEST
Presentation Number: 408O
Presenter: Lyudmila Bazhenova, M.D.

10-Q – Quarterly report [Sections 13 or 15(d)]

Biogen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Biogen, 2018, JUL 24, 2018, View Source [SID1234527837]).

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Minomic announces completion of accrual for clinical study of Miltuximab® in prostate, bladder and pancreatic cancers

On July 24, 2018 Minomic International Ltd (Minomic) is an immuno-oncology company specializing in therapeutics and diagnostics for solid tumors, including prostate, bladder and pancreas (Press release, Minomic, JUL 24, 2018, View Source [SID1234528622]). The Company reported that it has completed enrolment and dosing of all 12 patients in its pioneering clinical trial of Miltuximab, a chimeric version of Minomic’s MIL-38 anti-Glypican 1 antibody conjugated to the radioactive isotope 67Gallium.

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The Miltuximab Trial is a first-in-human study to evaluate the safety and tumor targeting of Miltuximab, in patients with metastatic prostate, bladder, and pancreatic cancer. The primary endpoint of the MILGa trial is safety and tolerability of Miltuximab. Secondary endpoints include tumor targeting, pharmacokinetics and dosimetry to determine relative accumulation of Miltuximab, in different organs.
All patients have now been dosed and we are pleased to report Miltuximab was well tolerated with patients reporting no drug related adverse events. Secondary endpoints will be reported when data analysis is completed – to date these are progressing well.

Minomic’s CEO, Dr Brad Walsh, said, "These results will inform the future development of the drug and most importantly the next step, progression to a Phase 1 trial in Australia. Each phase in this process enhances the attractiveness of the company to potential partners. "

We are grateful to the principal investigator Prof. Howard Gurney and his team at Macquarie University Hospital for their dedication to bringing new therapies to cancer patients.

Cytori Announces $6.7 Million in Expected Gross Proceeds from Recently Expired Rights Offering

On July 24, 2018 Cytori Therapeutics, Inc. (NASDAQ:CYTX) reported that its previously announced rights offering ("the Rights Offering") expired on July 20, 2018 and such rights are no longer exercisable (Press release, Cytori Therapeutics, JUL 24, 2018, View Source [SID1234529750]). Cytori accepted all valid subscriptions that were presented and estimates that the Rights Offering will result in approximately $6.7 million in gross proceeds. The results of the Rights Offering and Cytori’s estimates regarding the aggregate gross proceeds of the Rights Offering to be received by Cytori are subject to finalization and verification by Cytori and its subscription agent.

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Cytori expects the closing of the Rights Offering will occur on or about July 25, 2018 subject to satisfaction or waiver of all conditions to closing. Upon the closing, the subscription agent will distribute, by way of direct registration in book­-entry form or through the facilities of DTC, as applicable, shares of its Series C Convertible Preferred Stock and warrants to holders of rights who have validly exercised their rights and paid the subscription price in full. No physical stock or warrant certificates will be issued to such holders.

Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series C Convertible Preferred Stock with a stated value of $1,000 (and immediately convertible into common stock at a conversion price of $0.7986 per share, which is equal to 85% of the lowest daily volume weighted average price for Cytori’s common stock, as reported at the close of trading by Nasdaq, during the five trading days prior to the expiration of the Rights Offering (including the expiration date)) and 1,050 warrants. Each warrant entitles the holder to purchase one share of common stock at an exercise price of $0.7986, from the date of issuance through its expiration 30 months from the date of issuance.

Cytori engaged Maxim Group LLC as dealer-manager in the Rights Offering. Questions about the Rights Offering or requests for copies of the final prospectus may be directed to Maxim Group LLC at 405 Lexington Avenue, New York, NY 10174, Attention Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other 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.