On November 17, 2020 PierianDx, the leading clinical genomics informatics company, and Bench International, a leading global executive search firm, reported the appointment of Mark McDonough as Chief Executive Officer (CEO) and member of the Board of Directors of PierianDx, effective immediately (Press release, PierianDx, NOV 17, 2020, View Source [SID1234571286]). In his new role, McDonough will help fulfill the company’s unique value proposition of enabling precision medicine through its best-in-class variant interpretation knowledgebase, integrated infrastructure, and clinical genomics reporting for both cancer and inherited disease. McDonough succeeds Chairman of the Board and Interim CEO, Joe Boorady, who remains as Chairman of the PierianDx Board of Directors.

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"Mark commands a deep understanding of the diagnostics market, and we are delighted to welcome him to the PierianDx family during this exciting time in the company’s development," said Joe Boorady. "Mark will drive company execution on its IVD strategy and solidify its leadership position in the global cancer and hereditary disease diagnostics market."

Mark McDonough is a global technology business executive with nearly 30 years of experience. His personal mission is to impact change in the field of healthcare in a compassionate yet resolute manner, leading by example. He most recently served as CEO and board member for Immunis.AI, where he secured funding and developed a top flight team within six months to launch a novel noninvasive liquid biopsy immunogenomics assay for prostate cancer patients on ‘active surveillance.’ Prior to this, McDonough served as President, CEO and board member of CombiMatrix from 2012 through 2018, orchestrating its sale to Invitae in November 2017. Under his leadership, CombiMatrix experienced 14 consecutive quarters of record growth. Earlier in his career, he served in various sales leadership roles within the clinical laboratory industry and developed his leadership skills as a Navigator and Communications Officer in the US Navy.

"An established, respected and trusted leader in the genomics industry, Mark is the perfect CEO for PierianDx," said DeeDee DeMan, Chairman and CEO of Bench International. "He has a remarkable track record of developing teams, fundraising, and directing corporate strategy and growth."

"I am excited to join PierianDx and lead this talented team committed to delivering tools to our partners and customers that enable precision medicine adoption at scale," said Mark McDonough. "We believe advanced genomic testing should be democratized and available to all at the highest quality and lowest cost. I look forward to helping propel the company as we expand our market leadership and serve more patients through our partners and customers."

On November 17, 2020 OncoSynergy, a patient-focused biotech startup founded by physicians trained in neurosurgery reported that it has opened enrollment in their phase 1 trial which will study OS2966, a novel therapeutic antibody, for treatment of glioblastoma (Press release, OncoSynergy, NOV 17, 2020, View Source [SID1234571311]). The trial will take place at Moffitt Cancer Center in Tampa, Florida under the leadership of Michael Vogelbaum, MD, PhD.

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OS2966 inhibits Beta1 integrin (CD29), a critical receptor responsible for integrating cancer promoting signals and driving cancer growth and spread. Studies have demonstrated that resistance to anti-angiogenic therapy (i.e., bevacizumab) is associated with increased expression of Beta1 integrin. OncoSynergy studied OS2966 in animal models implanted with patient tumor samples that had become resistant to treatment with bevacizumab. These studies revealed that OS2966 prevented the ability of bevacizumab-resistant tumor cells to invade the surrounding brain and resulted in significant tumor cell death (Carbonell et al, 2013).

Despite advancement of several new promising cancer treatments, successful treatment of glioblastoma has been limited by the presence of the brain’s protective blood brain barrier and the invasive nature of glioblastoma. To combat these obstacles, a technique called convection-enhanced delivery (CED) will be utilized to deliver OS2966 directly to the brain tumor and surrounding tumor-infiltrated brain.

The primary goal of this phase 1 study is to determine the safety and tolerability of OS2966 when delivered directly to the brain. That said, given pre-clinical data demonstrating OS2966’s ability to address therapy resistant tumors and a delivery technique designed to overcome obstacles specific to glioblastoma, the ultimate hope is to improve outcomes for patients suffering from this formidable disease.

On November 17, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 6,451,613 shares of common stock of the Company, at a price to the public of $3.10 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, NOV 17, 2020, View Source [SID1234571347]). The closing of the offering is expected to occur on or about November 20, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 967,741 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $20.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On November 17, 2020 Cambrex reported that it is expanding its mid-scale and large-scale API manufacturing capacity in Charles City, Iowa. The $50+ million investment is designed to meet the continually growing demand for small molecule drug substance development and manufacturing (Press release, Cambrex, NOV 17, 2020, View Source [SID1234571206]). It will be the sixth major investment that Cambrex has made at the site in the past eight years to support customers in mid-scale, large-scale and highly potent small molecule API manufacturing.

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The expansion, which will be operational in early 2022, will add 3 large-scale manufacturing work centers and 1 mid-scale work center to the facility in Iowa, increasing the site’s capacity by 30 percent. When completed, the Charles City site will employ more than 400 people.

"Small molecule manufacturing demand has been growing consistently over recent years, and this investment will enable Cambrex to continue to capitalize on this growth, further strengthening our position as a market-leading CDMO," commented Joe Nettleton, President of Cambrex’s Drug Substance Business Unit. He added, "This expansion in the U.S. for API manufacturing capacity comes at a time when our customers increasingly require high-quality partners to ensure reliable supply chains within the pharmaceutical sector."

Cambrex’s Charles City facility is located on a 45-acre site, and as part of the company’s Drug Substance business unit, manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.

In 2019, Cambrex was acquired by funds advised by Permira, a global investment firm, to continue to build upon Cambrex’s market leading position in API development and manufacturing and support the growth of its integrated service offering across the pharmaceutical value chain.

On November 17, 2020 Five Prime Therapeutics, Inc. (Nasdaq: FPRX) reported the closing of its upsized underwritten public offering of 8,280,000 shares of its common stock, which includes 1,080,000 shares sold upon the underwriters’ full exercise of their option to purchase additional shares, resulting in aggregate gross proceeds of approximately $173.9 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Five Prime (Press release, Five Prime Therapeutics, NOV 17, 2020, View Source [SID1234571259]).

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Cowen and SVB Leerink acted as joint book-running managers for the offering. Wedbush PacGrow acted as co-manager for the offering.

The shares of common stock were offering pursuant to a "shelf" registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected], or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at [email protected].