On October 29, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported initial safety data in ovarian cancer patients from its ongoing Phase I study of STRO-002, a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC) and potent anti-tumor activity in preclinical endometrial cancer patient-derived xenograft (PDX) models (Press release, Sutro Biopharma, OCT 29, 2019, View Source [SID1234549956]).

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To date, 13 patients have been treated in the Phase I study of STRO-002 and the maximum tolerated dose (MTD) has not been reached. Dose escalation continues with two patients currently being treated at the 6 mg/kg dose level and having completed the dose limiting toxicity (DLT) observation period. There have been no DLTs and no infusion reactions to date in these heavily pre-treated patients. Preliminary evidence of anti-tumor activity was observed in a patient who achieved a confirmed partial response by RECIST 1.1 criteria. This patient also achieved and confirmed a CA-125 response for at least 28 days. Stable disease by RECIST 1.1 has been confirmed in two ongoing patients at cycles 5 and 10 of study treatment. Three ongoing patients at the 4.3 mg/kg dose level have unconfirmed stable disease per RECIST 1.1 at cycle 3. Patients are not receiving prophylactic corticosteroid eye drops. Ninety-five percent (95%) of adverse events were grade 1 or grade 2. The preliminary pharmacokinetic (PK) profile reveals an estimated half-life for the total antibody of 22-76 hours with increasing exposure in an apparent dose dependent manner.

Anti-tumor activity of STRO-002 was assessed in preclinical PDX models of endometrial cancer that expressed varying levels of FolRα. High FolRα-expressing models showed the highest tumor growth inhibition. Some models with low and medium FolRα expression also exhibited good tumor growth inhibition.

"The emerging safety profile of STRO-002 is very promising," said Arturo Molina, M.D., Chief Medical Officer at Sutro Biopharma. "Antibody-drug conjugates offer the ability to preferentially kill tumor cells while avoiding healthy cells. Early signs of clinical benefit are encouraging, and we believe STRO-002 has potential in this heavily pre-treated population of patients with advanced, relapsed and refractory ovarian cancer."

Bill Newell, Sutro’s Chief Executive Officer added, "STRO-002 is our second proprietary ADC in clinical trials, and one of our four ADC clinical product candidates from our platform in the past three years, including those of our collaborators. Our goal is to continue to develop targeted therapies for cancer patients. The STRO-002 data add to the growing body of evidence that our ADC development platform and pipeline of products has the potential to help patients with life-threatening cancers."

The ongoing Phase I, open-label, multicenter, dose escalation study with dose expansion of STRO-002 is designed to identify the MTD, the recommended Phase II dose and to evaluate the safety, tolerability, and preliminary anti-tumor activity of STRO-002 in adults with advanced epithelial ovarian cancer, including fallopian or primary peritoneal cancer, and endometrial cancer. This trial is registered with clinicaltrials.gov identifier NCT03748186.

Additional multimedia content from Sutro regarding STRO-001 and STRO-002 can be found here and here.

The poster will be accessible through the Clinical/Scientific Presentation and Publication Highlights page of the News section of the company’s website at www.sutrobio.com.

On October 29, 2019 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that it will hold a conference call and webcast on Friday, November 8, 2019 at 8:00 a.m. ET to discuss the company’s third quarter 2019 financial and operational results (Press release, IMV, OCT 29, 2019, View Source [SID1234549974]).

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Financial analysts are invited to join the conference call by dialing (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID# 6590953 Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and available on the IMV website for 30 days following the call.

On October 29, 2019 Boehringer Ingelheim reported promising preclinical data from its pan-KRAS program including the novel, oral inhibitor BI 1701963 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, USA1 (Press release, Boehringer Ingelheim, OCT 29, 2019, View Source [SID1234549990]). Based on these results the compound has been advanced to Phase I clinical testing alone and in combination with trametinib in patients with different types of advanced solid tumors with KRAS mutations.

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KRAS mutations occur in one in seven of all human metastatic cancers making it the most frequently mutated cancer-causing oncogene, with mutation rates of more than 90 percent in pancreatic cancers, more than 40 percent in colorectal cancers and more than 30 percent in lung adenocarcinomas. It has evaded attempts to develop inhibitors for almost 40 years. Only recently have promising compounds targeting the specific KRAS mutation G12C entered the clinic. There are however many KRAS gene mutations beyond G12C that drive tumor growth and have previously been ‘undrugged,’ such as KRAS-G12D and KRAS-G12V, which make up half of all KRAS driven cancers.

"Our pan-KRAS inhibitor has been designed to target a broad range of oncogenic KRAS variants, including all major G12 and G13 oncoproteins. Effective targeting of the most prevalent KRAS mutant alleles that have so far proved elusive could enable us to develop much needed new therapy regimens for patients with gastrointestinal and lung cancers who have limited treatment options available," said Norbert Kraut, Ph.D., Head of Global Cancer Research at Boehringer Ingelheim.

"We have a comprehensive KRAS R&D program beyond BI 1701963 and aim to develop therapies for all patients with mutant KRAS driven cancer," said Clive R. Wood, Ph.D., Corporate Senior Vice President and global head of Discovery Research at Boehringer Ingelheim. "This program is part of our strategy to defeat cancer with optimal combinations of cancer cell-directed and immune cell-directed therapies," added Wood.

BI 1701963 inhibits KRAS by binding to SOS1, which plays an essential role in activating KRAS through the exchange of RAS-bound GDP for GTP. The selective inhibition of SOS1 is a therapeutic concept that could allow KRAS blockade irrespective of KRAS mutation type. Preclinical data have shown that the pan-KRAS inhibitor blocks tumor growth for many tested G12 and G13 KRAS gene mutations, the most frequently affected residues of the protein. Further, the compound is selective for cancer cell lines with mutations in the KRAS gene.

In non-clinical studies, the combination of BI 1701963 with a MEK inhibitor demonstrated a strong impact on KRAS signaling and resulted in increased anti-tumor activity based on dual pathway blockade and complementary mechanism of action in keeping KRAS-driven cancers in check. BI 1701963 will be further developed in combination with LNP3794 a MEK inhibitor compound in-licensed from Lupin.

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This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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On October 24, 2019, OPKO Health, Inc., a Delaware corporation (the "Company"), reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, Piper Jaffray & Co. and Guggenheim Securities, LLC, as representatives of the several underwriters identified therein (the "Underwriters"), pursuant to which the Company agreed to issue and sell to the Underwriters, and the Underwriters agreed to purchase from the Company, 50,000,000 shares (the "Firm Shares") of the Company’s common stock, par value $0.01 per share ( "Common Stock"), in a registered public offering under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-229400) and a related prospectus, together with the related prospectus supplements for the underwritten public offering of the Common Stock, filed with the Securities and Exchange Commission (Filing, 8-K, Opko Health, OCT 29, 2019, View Source [SID1234550012]).

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In addition, the Company granted the Underwriters a 30-day option to purchase up to an additional 7,500,000 shares of Common Stock.

The Company intends to use the net proceeds received from the offering of the Common Stock to fund research and development, to further develop and commercialize its portfolio of proprietary pharmaceutical and diagnostic products and for working capital, capital expenditures, acquisitions and other general corporate purposes.

The Underwriting Agreement includes customary representations, warranties and covenants by the Company and customary closing conditions. Under the terms of the Underwriting Agreement, the Company has agreed to indemnify the Underwriters against certain liabilities.

The closing of the issuance of the Firm Shares occurred on October 29, 2019.

The foregoing description of the Underwriting Agreement is qualified in its entirety by reference to the complete text of the Underwriting Agreement attached as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated by reference herein. A copy of the opinion of Greenberg Traurig, LLP regarding the validity of the Common Stock issued in this offering is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On October 29, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the commencement of a registered underwritten public offering of up to $125 million in shares of its common stock (Press release, Y-mAbs Therapeutics, OCT 29, 2019, View Source [SID1234550051]). All shares in the offering are expected to be offered by the Company. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to $18.75 million in shares of its common stock.

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Morgan Stanley, J.P. Morgan and BofA Securities, are acting as the joint book-running managers for the proposed offering. The offering is subject to market and other customary closing conditions, and there can be no assurance as to whether or when the offering may be completed.

A shelf registration statement relating to the shares of common stock being offered in the public offering described above was filed on Form S-3 (Reg. No. 333-234034) which was declared effective by the Securities and Exchange Commission (SEC) on October 15, 2019. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014; J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, or by telephone at (866) 803-9204; or BofA Securities, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by emailing [email protected].

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