On May 29, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that it has earned a milestone payment from Merck (known as MSD outside the US and Canada) achieved under the companies’ 2014 research and license agreement (Press release, Zymeworks, MAY 29, 2019, View Source [SID1234536659]). Zymeworks will receive US$2.0 million in connection with Merck’s completion of a late-stage preclinical study for a bispecific antibody candidate using Zymeworks’ proprietary Azymetric and EFECT therapeutic platforms.

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"Merck’s completion of this milestone is great news," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "We believe this accomplishment from another one of our long-term partners provides additional evidence of the potential of our bispecific antibody technology. We expect similar advancements from our other partners’ therapeutic programs in the years ahead."

Under the terms of the research and license agreement, Zymeworks has granted Merck a worldwide, royalty-bearing license to research, develop and commercialize certain bispecific therapeutic candidates toward Merck’s therapeutic targets for which Zymeworks is eligible to receive additional development and commercial milestone payments as well as tiered royalties on product sales.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

About the EFECT Platform

The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up- and down-regulation of effector functions. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization of therapeutic responses for different diseases.

On May 29, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), reported that it has commenced an underwritten public offering of its Common Shares (the "Offering") (Press release, Aptose Biosciences, MAY 29, 2019, View Source [SID1234536675]). In addition, Aptose intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the common shares offered in the Offering. The Offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Aptose intends to use the net proceeds of the Offering to accelerate and expand its clinical trial programs, and for working capital and general corporate purposes.

RBC Capital Markets and Canaccord Genuity are acting as joint book-running managers for the Offering.

No Common Shares will be offered or sold in Canada as part of this Offering. The Offering is subject to the approval of the Toronto Stock Exchange ("TSX"). For the purposes of TSX approval, the Company is relying on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ.

The securities described above are being offered by Aptose pursuant to a shelf registration statement on Form S-3 (File. No. 333-230218), including a base prospectus, that was previously filed by Aptose with the Securities and Exchange Commission ("SEC") and declared effective on April 25, 2019. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A copy of the Prospectus Supplement and the accompanying prospectus will be available on EDGAR at www.sec.gov or may be obtained upon request to Aptose’s Investor Relations Department using the contact information set out below. Before you invest, you should read the Prospectus Supplement and the accompanying prospectus and other documents the issuer has filed with the SEC for more complete information about the issuer and this offering. You may get these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov. Copies of the the Prospectus Supplement and the accompanying prospectus may also be obtained, once available, from RBC Capital Markets, LLC, 200 Vesey Street, 8th Floor, New York, NY 10281 Attention: Equity Syndicate or by email at [email protected], or Canaccord Genuity LLC Attention: Syndicate Department, 99 High Street, Suite 1200, Boston, MA 02110, by telephone at (617) 371-3900 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Aptose, and shall not constitute an offer, solicitation or sale of any security 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.

On May 29, 2019 Bayer AG and Foundation Medicine, Inc. reported a global collaboration for the development and commercialization of NGS-based companion diagnostics (Press release, Foundation Medicine, MAY 29, 2019, View Source [SID1234536644]). This agreement allows for collaboration across multiple oncology drug candidates and approved therapies developed by Bayer and covers Foundation Medicine’s full portfolio of tests, including FoundationOneCDx. The first project will be to develop a companion diagnostic for Vitrakvi (larotrectinib), the first and only TRK inhibitor approved in the U.S. for patients with TRK fusion cancer across all solid tumors.

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In the United States, Vitrakvi is approved for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.1 This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

NGS based companion diagnostic tests aim to unlock molecular information from each patient’s tumor genome to guide treatment decisions for cancer therapies. FoundationOneCDx is the first FDA-approved broad companion diagnostic for all solid tumors2.

"We are excited to collaborate with Foundation Medicine to develop new companion diagnostics and provide tools to move to a more personalized treatment approach," said Robert LaCaze, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. "The development of a companion diagnostic for Vitrakvi, and our broader collaboration with Foundation Medicine, is an important step forward toward expanding access to testing and identifying the right treatment options for patients with cancer."

"Foundation Medicine is proud to collaborate with Bayer to develop multiple companion diagnostics including a companion diagnostic for Vitrakvi," stated Cindy Perettie, Foundation Medicine’s Chief Executive Officer. "It is imperative that patients receive broad comprehensive genomic profiling at initial diagnosis of late stage cancer to determine if they are eligible for these medicines."

Financial terms of the agreement were not disclosed.

Important Safety Information for VITRAKVI (larotrectinib)

Neurotoxicity: Among the 176 patients who received VITRAKVI, neurologic adverse reactions of any grade occurred in 53% of patients, including Grade 3 and Grade 4 neurologic adverse reactions in 6% and 0.6% of patients, respectively. The majority (65%) of neurologic adverse reactions occurred within the first three months of treatment (range 1 day to 2.2 years). Grade 3 neurologic adverse reactions included delirium (2%), dysarthria (1%), dizziness (1%), gait disturbance (1%), and paresthesia (1%). Grade 4 encephalopathy (0.6%) occurred in a single patient. Neurologic adverse reactions leading to dose modification included dizziness (3%), gait disturbance (1%), delirium (1%), memory impairment (1%), and tremor (1%).1

Advise patients and caretakers of these risks with VITRAKVI. Advise patients not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dose when resumed.1

Hepatotoxicity: Among the 176 patients who received VITRAKVI, increased transaminases of any grade occurred in 45%, including Grade 3 increased AST or ALT in 6% of patients. One patient (0.6%) experienced Grade 4 increased ALT. The median time to onset of increased AST was 2 months (range: 1 month to 2.6 years). The median time to onset of increased ALT was 2 months (range: 1 month to 1.1 years). Increased AST and ALT leading to dose modifications occurred in 4% and 6% of patients, respectively. Increased AST or ALT led to permanent discontinuation in 2% of patients.1

Monitor liver tests, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter, and as clinically indicated. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dosage when resumed.1

Embryo-Fetal Toxicity: VITRAKVI can cause fetal harm when administered to a pregnant woman. Larotrectinib resulted in malformations in rats and rabbits at maternal exposures that were approximately 11- and 0.7-times, respectively, those observed at the clinical dose of 100 mg twice daily.1

Advise women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 1 week after the final dose of VITRAKVI.1

Most Common Adverse Reactions (≥20%): The most common adverse reactions (≥20%) were: increased ALT (45%), increased AST (45%), anemia (42%), fatigue (37%), nausea (29%), dizziness (28%), cough (26%), vomiting (26%), constipation (23%), and diarrhea (22%).1

Drug Interactions: Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors (including grapefruit or grapefruit juice), strong CYP3A4 inducers (including St. John’s wort), or sensitive CYP3A4 substrates. If coadministration of strong CYP3A4 inhibitors or inducers cannot be avoided, modify the VITRAKVI dose as recommended. If coadministration of sensitive CYP3A4 substrates cannot be avoided, monitor patients for increased adverse reactions of these drugs.1

Lactation: Advise women not to breastfeed during treatment with VITRAKVI and for 1 week after the final dose.5

On May 29, 2019 AVEO Oncology (NASDAQ: AVEO) reported that Mike Ferraresso, Senior Vice President, Business Analytics and Commercial Operations, will present at the 2019 BIO International Convention in Philadelphia on Wednesday, June 5, 2019 at 4:30 p.m. EDT (Press release, AVEO, MAY 29, 2019, View Source [SID1234536660]).

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A live webcast of the presentation can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

On May 29, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported that Chief Executive Officer William Annett will present a company overview at the 2019 BIO International Convention, which is being held June 3 – 6, 2019 at the Pennsylvania Convention Center in Philadelphia (Press release, BioTime, MAY 29, 2019, View Source;p=RssLanding&cat=news&id=2400014 [SID1234536676]).

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Presentation details:
Date: Wednesday, June 5
Time: 10:45am EDT
Location: Theatre 2
A live webcast of the presentation can be access using the following link: http://www.veracast.com/webcasts/bio/internationalconvention2019/81201224287.cfm

A replay of the webcast will be available through September 3, 2019.

About the BIO International Convention

The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.

The Convention allows for public and private companies to provide company presentations, request meetings with biotech investors and executives, attend educational sessions and engage in networking opportunities.

For more information, please visit: View Source

About DetermaVu

DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $2 billion to $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on the scope of physician utilization, market penetration and reimbursable pricing.

DetermaVu has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a study of Medicare data by an independent health economics firm, cost on average $14,634 each. In addition, DetermaVu can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.

DetermaVu is a trademark of OncoCyte Corporation