On July 24, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CYAD-101, the first non-gene edited allogeneic clinical program (Press release, Celyad, JUL 24, 2018, View Source [SID1234532513]). The FDA has indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.

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Dr. Christian Homsy, CEO of Celyad: "We are pleased to have achieved this important milestone. Celyad is the first company clinically evaluating a non-gene edited CAR-T candidate, which, we believe, offers significant advantages over gene edited approaches. Our non-gene edited program consists of a family of technologies aimed at reducing or eliminating T cell receptor (TCR) signaling without requiring genetic manipulation. CYAD-101 is part of a robust clinical development plan, establishing the foundations of next generation CAR-T products."

CYAD-101, Celyad’s first allogeneic CAR-T cell product, encodes both the company’s auto-logous CYAD-01 CAR-T and a novel peptide, TIM (TCR Inhibiting Molecule), an inhibitor of TCR signaling. TCR signaling is responsible for the Graft versus Host Disease (GvHD), and tampering or eliminating its signaling could therefore reduce or eliminate GvHD. In CYAD-101, the TIM peptide is encoded alongside the CAR construct allowing allogeneic T cell production through a single transduction step. CYAD-101 benefits from using a manufac-turing process that is highly similar to Celyad’s well established process for its clinical au-tologous CAR-T cell products.

While autologous CAR-T therapies now have well established efficacy in B cell malignancies, the approach can be more challenging for some patients, especially those where the quality of the apheresis is poor. Allogeneic CAR-T cell therapy may provide an alternative approach for this patient population, utilizing cells manufactured from a healthy donor which could allow greater reproducibility and reduced manufacturing costs.

On October 24, 2018 Provectus (OTCQB: PVCT) reported that data from the Company’s ongoing clinical trial of PV-10 for the treatment of symptomatic metastatic neuroendocrine tumors of the liver (NCT02693067) will be presented in a poster presentation at the ESMO (Free ESMO Whitepaper) 2018 Congress (the European Society for Medical Oncology annual meeting), held in Munich, Germany from October 19-23, 2018 (Press release, Provectus Biopharmaceuticals, OCT 24, 2018, View Source [SID1234530056]).

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The presentation is entitled "A Phase 1 Study of Oncolytic Immunotherapy of Metastatic Neuroendocrine Tumours using Intralesional Rose Bengal Disodium."

Details regarding the presentation will be announced closer to the ESMO (Free ESMO Whitepaper) 2018 Congress.

About Neuroendocrine Tumors

Neuroendocrine tumors (NETs) associated with the gastrointestinal tract have endocrine secretory properties and a propensity for metastasis to the lungs, bronchi, and liver. Metastatic neuroendocrine tumors located in the midgut and liver often secrete vasoactive products, giving rise to symptoms such as flushing and diarrhea, wheezing, abdominal cramps, and peripheral oedema.

About PV-10

Provectus’ lead investigational oncology drug product, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

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.

On July 24, 2018 Sutro Biopharma, Inc., reported that it has signed a collaboration and licensing agreement with Merck, known as MSD outside the United States and Canada, to discover and develop novel immune-modulating therapies for cancer and autoimmune disorders (Press release, Sutro Biopharma, JUL 24, 2018, View Source [SID1234529410]).

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The research and development activities will leverage Sutro’s proprietary cell-free protein synthesis andsite-specific conjugation platforms, which facilitate precision design and rapid empirical optimization of protein conjugates, to discover and develop best-in-class immune-modulating cytokine derivativesfor both oncology and autoimmune indications.

Under the agreement, Sutro will be primarily responsible for preclinical research and Merck will gain exclusive worldwide rights to therapeutic candidates derived from the collaboration.

Sutro will receive an upfront payment of $60 million and is eligible for milestone payments totaling up to $1.6 billion associated with the development and sale of all therapeutic candidates and all possible indicationsidentified under the collaboration, as well as tiered royalties on the sale of products.

"There’s an urgent need for novel, targeted and well-tolerated therapies with improved therapeutic profiles for cancer and autoimmune disease," Sutro CEO Bill Newell said. Dr. Joe Miletich, Senior Vice President, Discovery, Preclinical and Early Development, Merck Research Laboratories, said: "Sutro has an impressive suite of technologies that make possible the discovery, characterization and manufacture of novel therapeutic proteins in a timely manner. We look forward to collaborating with Sutro to further expand our pipeline of promising candidates targeting oncology and autoimmune diseases."

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.