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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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.

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 A-Alpha Bio reported that it has been awarded a National Science Foundation Phase I Small Business Innovation Research (SBIR) grant for $225,000 to develop AlphaSeq: a cell-based platform that will accelerate cancer drug development by enabling high-throughput and quantitative characterization of protein-protein interactions (Press release, A-Alpha Bio, JUL 24, 2018, View Source [SID1234636894]).

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Proteins bind to one another, like Lego pieces, to form complex biological machines. In cancer cells, these machines are dysregulated, causing cell-survival and uncontrolled growth. Pharmaceutical companies are developing drugs that kill cancer cells by blocking key protein-protein interactions. However, blocking any of the millions of protein-protein interactions that occur in healthy cells could cause serious side-effects, making specificity a major concern.

"A-Alpha Bio’s AlphaSeq technology is a game-changer for preclinical drug screening," said Randolph Lopez, CTO and Co-founder of A-Alpha Bio. "It lets us measure the effect of a drug on thousands of protein-protein interactions simultaneously, instead of having to measure each one individually. Pharmaceutical companies will not have to limit their preclinical testing to a small number of likely off-target effects. With AlphaSeq, they can avoid costly and potentially life-threatening surprises during clinical trials by screening their drugs against whole protein networks"

Protein interactions are already widely recognized as being critically important for the development of many different types of drugs. AlphaSeq provides a unique advantage over existing approaches by combining high accuracy and throughput, which is enabled by advances in the fields of synthetic biology and DNA sequencing. This SBIR grant is aimed at expanding the capabilities of AlphaSeq for screening interactions with challenging proteins and insoluble small molecule drugs. Once completed, A-Alpha Bio will be eligible to apply for a Phase II grant (up to $750,000) for pilot testing and scale-up.

On July 24, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was dosed in a global Phase 3 clinical trial of pamiparib, an investigational PARP inhibitor, as maintenance therapy in patients with inoperable locally advanced or metastatic gastric cancer who responded to platinum-based first-line chemotherapy (Press release, BeiGene, JUL 24, 2018, View Source;p=RssLanding&cat=news&id=2359579 [SID1234527826]).

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"We are pleased to announce the initiation of the first global Phase 3 trial of pamiparib, an important compound in our clinical pipeline. With our recently announced Phase 3 clinical trial of pamiparib in China for patients with platinum-sensitive recurrent ovarian cancer and now with this global Phase 3 trial in gastric cancer, we are striving to maximize opportunities for patients with a broad range of cancer diagnoses to be treated with and potentially benefit from pamiparib," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"Our focus at BeiGene is on developing treatments for patients who often have limited options. We are excited about this opportunity to evaluate our PARP inhibitor as maintenance therapy for patients with platinum-sensitive gastric cancer, especially considering more than 50 percent of these patients worldwide live in Eastern Asia, mainly China1," commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology at BeiGene.

The global Phase 3, randomized, double-blind, placebo-controlled trial in China, the U.S., Europe, Japan, Australia, and Singapore, is designed to compare the efficacy and safety of pamiparib to placebo as maintenance therapy in approximately 540 patients with advanced gastric cancer who have responded to first-line platinum-based chemotherapy. The primary endpoint of the trial is progression-free survival (PFS) by blinded independent review committee assessment. Overall survival (OS) is a key secondary endpoint as are progression after the next line of therapy (PFS2) and safety and tolerability.

"Inoperable, locally advanced and metastatic gastric cancer has limited treatment options. While first-line platinum-based therapy can result in initial responses, platinum-based chemotherapies are associated with significant toxicities. We are currently studying pamiparib, a PARP inhibitor, as a maintenance therapy to understand if a response to chemotherapy can be maintained without the associated toxicities," said Johanna Bendell, M.D., Chief Development Officer at Sarah Cannon, Nashville, Tenn., and co-chair of the steering committee for this trial.

About Pamiparib
Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Pamiparib is currently in global clinical development as a monotherapy and in combination with other agents for a variety of solid tumor malignancies