On July 2, 2020 Menarini Ricerche, the R&D division of the Menarini Group, reported that it plans to launch in the second half of 2020 a new phase Ib / II trial of MEN1611, a potent and selective phosphatidylinositol 3-kinase inhibitor currently under development for the treatment of breast cancer (Press release, Menarini, JUL 2, 2020, View Source [SID1234561659]). The new study, called C-PRECISE-01, will evaluate MEN1611 in combination with cetuximab in patients with mutated pIK3 metastatic colorectal cancer (CRCm) and native RAS / BRAF who have not responded to treatment with irinotecan, oxaliplatin, 5-FU. and regimens containing anti-EGFR.

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The study design will be presented at the ESMO (Free ESMO Whitepaper) 2020 Virtual World Congress on Gastrointestinal Cancer [1-4 July 2020], with the e-poster entitled "C-PRECISE-01 Study: a phase Ib / II trial of MEN1611, a PI3K inhibitor, and cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens. "

MEN1611 is an oral PI3K inhibitor active on p110α, β and γ isoforms, while preserving δ. Preclinical and clinical evidence supports the development of MEN1611 in combination with other agents in the context of solid tumors. the presence of PIK3CA mutations in CRCm has been correlated with a prediction of a negative response to anti-EGFR treatment, making PI3K an attractive therapeutic target. The primary objective of Study C-PRECISE-01 is to determine the recommended phase 2 dose (RP2D) of MEN1611 in combination with cetuximab, and to assess the antitumor activity of MEN1611. Secondary objectives will include evaluation of the safety, tolerability and pharmacokinetic profile of MEN1611 in combination with cetuximab.

Speaking by Andrea Pellacani , CEO of Menarini Ricerche: "Colorectal cancer is among the most prevalent malignancies in the world and there is an urgent need to discover new therapeutic options to help CRC patients, especially those with metastatic lesions. The start of the C-PRECISE-01 trial will give us the possibility to investigate the potential of MEN1611 in a disease with a high medical need, where PIK3CA represents an adequate therapeutic target. This confirms our commitment to advance in precision oncology and develop effective therapeutic alternatives that mean before and after for cancer patients. "

On July 2, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), reported that the underwriters of its recently closed underwritten public offering of 2,000,000 shares of its common stock have exercised in full their option to purchase an additional 300,000 shares of common stock at the public offering price of $37.00 per share, less underwriting discounts and commissions (Press release, Castle Biosciences, JUL 2, 2020, View Source [SID1234561657]). The gross proceeds to Castle Biosciences from the offering, including the shares sold pursuant to the underwriters’ option, before deducting the underwriting discounts and commissions and offering expenses, were $85.1 million.

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SVB Leerink and Baird were joint book-running managers for the offering and representatives of the underwriters. Canaccord Genuity was passive book-runner and BTIG was co-manager for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission ("SEC") and became effective on June 24, 2020. The offering was made only by means of a prospectus. A copy of the final prospectus related to the offering may be obtained for free by visiting the SEC’s website located at View Source; from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone: (800) 808‐7525, ext. 6218, or by email: [email protected]; or from Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, WI 53202, by telephone: (800) 792-2473, or by email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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 such state or jurisdiction.

On July 2, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported an update on its clinical development plan for Annamycin (Press release, Moleculin, JUL 2, 2020, View Source [SID1234561656]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

After consultation with both US and European regulatory agencies, Moleculin has mapped out a course for development of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML"). In its End of Phase 1 meeting with the US Food and Drug Administration ("FDA") the Company agreed to expand its protocol-mandated testing for cardiotoxicity throughout the remainder of its European Phase 1 trial. The expansion of testing will provide additional safety data, investigating the continued evidence of little to no cardiotoxicity, and efficacy data that both US and European regulators may consider as the Company prepares to transition to a Phase 2 clinical trial, which management believes will focus on Europe.

Moleculin has now received approval from European authorities to increase the increment for dose-escalation from 30 mg/m2 per cohort to 60 mg/m2 per cohort, as treatment to date in its clinical trials has been at what the Company considers to be subtherapeutic levels. The first patient in the European trial has now been treated at 240 mg/m2 with no evidence of cardiotoxicity or other dose limiting toxicities. Once 2 more patients are successfully treated at this level, the next cohort will be treated with 300 mg/m2. With these timing and dosing expectations, the Company believes that European dosing will increase in 2020, allowing a recommended Phase 2 Dose to be established in 2021.

"Based on what we know from prior clinical trials, we think it may require a dose level of 300 to 360 mg/m2, or possibly higher, before we begin to see a solid therapeutic window for Annamycin in AML," commented Walter Klemp, Chairman and CEO of Moleculin. "Now, with 5 clinical sites open in Poland, the European trial is in the best position to complete the safety portion of our development. That also allows us to close out the US trial, which has already reached its primary safety endpoint."

The Company intends to use what it learns from the Phase 1 clinical trials in AML to inform the starting dosage in clinical testing of Annamycin for the treatment of lung metastases, for which it hopes to file an Investigational New Drug application or its European equivalent by the end of this year.

Mr. Klemp concluded: "With the confirmation of animal model activity in lung metastases we just announced last week, we are pushing hard to prepare to seek regulatory approval to begin a Phase 1 clinical trial in sarcomas that have metastasized to the lungs, a condition for which there is a significant unmet need."

On July 2, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that it will host an investor conference call and webcast on Thursday, July 9, 2020 at 9:00 a.m. ET to discuss the Company’s early development pipeline and research (Press release, BeiGene, JUL 2, 2020, View Source/news-releases/news-release-details/beigene-host-investor-conference-call-and-webcast-discuss-0" target="_blank" title="View Source/news-releases/news-release-details/beigene-host-investor-conference-call-and-webcast-discuss-0" rel="nofollow">View Source [SID1234561655]).

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A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available for 90 days following the event.

On July 2, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that it has strategically realigned its business focus and redirected resources to exclusively focus on the development of therapeutics and vaccines in high-need patient populations (Press release, Anixa Biosciences, JUL 2, 2020, View Source [SID1234561652]). As part of this realignment, the company has suspended development of the Cchek liquid biopsy technology.

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Going forward, Anixa’s operations will center entirely on the development and expansion of its therapeutics and vaccine portfolio, which includes a cancer immunotherapy program being developed in partnership with the Moffitt Cancer Center, that uses chimeric endocrine receptor T-cell (CER-T) technology, a novel type of CAR-T. Anixa is also developing a cancer vaccine technology addressing breast cancer with a specific focus on triple negative breast cancer (TNBC), the most lethal form of the disease, in partnership with the Cleveland Clinic. Anixa will continue drug discovery and development of Covid-19 therapies, in partnership with OntoChem, GmbH. In addition, Anixa will continue to examine emerging therapeutic technologies for further development.

"Due to the evolving dynamics of the diagnostics market during this pandemic and projected disruptions in this industry, we see greater opportunity to benefit patients and our shareholders as a therapeutics-directed company," said Amit Kumar, Ph.D., Chief Executive Officer of Anixa. "The pandemic and market forces have made it clear that we need to pivot. Our confidence in the Cchek technology remains undiminished, but we feel the prudent decision is to suspend work on diagnostics at this time."

Dr. Kumar continued, "Anixa is a company built on the efficient use of capital. Capital allocation decisions are made based on the potential to provide the highest return to shareholders. We are all aware of the challenges to various industries caused by the coronavirus pandemic. The diagnostics industry is not immune, and considering this, as well as certain characteristics of our program, we have chosen this course of action. This decision will free up capital that we can devote to advance our existing therapeutic programs and to in-license and initiate innovative new assets that will help drive the greatest value for our shareholders."