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Athenex Announces Key Company Activities at San Antonio Breast Cancer Symposium

On November 19, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that its abstract for the Phase III study of oral paclitaxel and encequidar (Oral Paclitaxel) in metastatic breast cancer has been selected for the press program of the 2019 San Antonio Breast Cancer Symposium (SABCS) (Press release, Athenex, NOV 19, 2019, View Source [SID1234573892]). The Company will deliver an oral presentation at SABCS, taking place in San Antonio, Texas, on Friday, December 13, 2019. After the oral presentation, the Company plans to discuss the results in a Key Opinion Leader (KOL) webcast event for the investment community.

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"We look forward to presenting additional data and analyses at SABCS from the pivotal Phase III study of Oral Paclitaxel in metastatic breast cancer," said Dr. Johnson Lau, Athenex’s Chairman and Chief Executive Officer. "We are excited by the opportunity to share these updates with oncologists, patients and researchers to highlight Oral Paclitaxel’s potential to positively impact outcomes for people living with metastatic breast cancer."

Oral Presentation Details:
Abstract Title: Oral Paclitaxel with Encequidar: The first orally administered paclitaxel shown to be superior to IV paclitaxel on confirmed response and survival with less neuropathy: a Phase III clinical study in metastatic breast cancer.
Session: General Session 6
Date and Time: Friday, December 13, 2019 at 3:15pm CT
Location: Hall 3 / Henry B. Gonzalez Convention Center, San Antonio, Texas
For more information, please visit View Source
Abstracts that have been selected for the press program will only have titles posted to the SABCS website until the embargo lifts on December 13, when the complete abstract will post online.

KOL Webcast Event

On December 13, 2019, after the oral presentation, the Company plans to review the Phase III clinical data presented at SABCS during a webcasted event for the investment community. Further details will be made available in a separate announcement.

Athenex Exhibit Booth

Attendees at SABCS are invited to visit the exhibit booth hosted by Athenex Oncology at the conference (booth #627/629), December 10 to 13, from 10:45am to 5pm CT daily.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

Publication in Nature Communications Confirms DRD2 as Target of ONC201

On November 19, 2019 Oncoceutics, Inc. reported a publication in the journal Nature Communications demonstrating selective antagonism of the G-protein coupled receptor (GPCR) dopamine receptor D2 (DRD2) by Oncoceutics’ lead candidate imipridone, ONC201 (Press release, Oncoceutics, NOV 19, 2019, View Source [SID1234558321]).

ONC201 was found to specifically bind and antagonize DRD2, and its functionally redundant family member DRD3, without affecting other dopamine receptors, other GPCRs, nuclear hormone receptors, kinases, or other drug targets of FDA-approved cancer therapies. Additionally, a biologically inactive isomer of ONC201 did not antagonize DRD2, indicating that antagonism of this receptor may be linked to anti-cancer efficacy as shown in other publications (Clinical Cancer Research and Neoplasia).

The publication also describes the novel approach taken by Oncoceutics collaborators in the laboratory of Olivier Elemento, PhD, Director of the Englander Institute for Precision Medicine at Weill Cornell Medicine. The researchers used a novel machine-learning platform, called BANDIT, created in the Elemento Lab that suggested DRD2 as a target of ONC201. This method used the molecular structure of ONC201, its in vitro efficacy profile, and its publicly available bioactivity assay results as inputs to compare ONC201 against all small molecules with known targets.

"This publication represents years of collaborative work that uncovered DRD2 as the first known binding target of ONC201," said Joshua Allen, PhD and Senior Vice President of R&D of Oncoceutics. "Along with downstream biomarkers, the dopamine pathway has guided tumor type selection and interpretation of activity of ONC201 in clinical trials. So far, we have observed the most robust single agent efficacy in malignancies that exhibit dysregulation of the dopamine pathway and grow in a dopamine-rich microenvironment, such as midline gliomas."

"Our findings have helped uncover imipridone small molecules as a unique chemical scaffold for targeting GPCRs," said Dr. Elemento. "We are pleased to see the clinical translation of our precision medicine efforts in ONC201 clinical trials and hope this information can be used to identify additional indications for this new therapy."

"The unique mechanism of action of ONC201 is now well defined," said Martin Stogniew, PhD and Chief Development Officer of Oncoceutics. "The most conserved downstream effect of ONC201 in tumor cells is activation of the integrated stress response. Several additional downstream effects, such as dual inactivation of Akt/ERK, induction of TRAIL and DR5, and degradation of Myc also occur in many tumor models, along with immunostimulatory effects involving NK cells and cancer stem cell depletion. These effects aggregately explain the broad antitumor activity observed in multiple models and are likely trigged by the interaction ONC201 with DRD2 and/or ClpP, a recently uncovered additional binding target of the molecule."

For further reference, please refer to additional publications on ONC201 and imipridone small molecules.

Conversion Right Triggered for LabCorp’s Zero Coupon Convertible Subordinated Notes Due 2021

On November 19, 2019 LabCorp (NYSE: LH) reported that it has provided notice of its intention to redeem all of its outstanding Zero Coupon Convertible Subordinated Notes due 2021 (Zero Coupon Notes) for cash on Dec. 19, 2019, (Redemption Date) in accordance with the terms of the Indenture, dated as of Oct. 23, 2006, (Indenture), between LabCorp and The Bank of New York Mellon, as trustee (Trustee) and the conversion agent (Press release, LabCorp, NOV 19, 2019, View Source [SID1234552831]). The redemption price will be equal to $966.20 per $1,000 principal amount of Zero Coupon Notes at maturity, plus accrued and unpaid contingent cash interest to the Redemption Date (Redemption Price). The current outstanding aggregate principal amount at maturity of the Zero Coupon Notes is approximately $935,000.

As a result of the issuance of the notice of redemption, the Zero Coupon Notes are convertible into cash and Common Stock of LabCorp, if any, subject to the terms of the Zero Coupon Notes and the Indenture. Zero Coupon Notes may be converted at any time before the close of business on Dec. 17, 2019, at the current conversion rate of 13.4108 shares of Common Stock per $1,000 principal amount of Zero Coupon Notes at maturity.

In order to exercise the option to convert all or a portion of the Zero Coupon Notes, holders must validly surrender their Zero Coupon Notes at any time through the close of business at 5:00 p.m., New York City time, on Dec. 17, 2019. The Trustee has informed LabCorp that, as of this date, all custodians and beneficial holders of the Zero Coupon Notes hold the Zero Coupon Notes through Depository Trust Company (DTC) accounts and that there are no certificated Zero Coupon Notes in non-global form. Accordingly, all Zero Coupon Notes surrendered for conversion must be delivered through the transmittal procedures of DTC.

Should Zero Coupon Notes be converted, LabCorp would be required to pay holders in cash for the accreted principal amount of the securities to be converted, with the remaining amount, if any, to be satisfied with shares of Common Stock. The shares required for settlement of the Zero Coupon Notes are included in LabCorp’s computation of fully diluted earnings per share.

Original issue discount and contingent cash interest on the Zero Coupon Notes will cease to accrue on and after the Redemption Date, and the only remaining right of holders of the Zero Coupon Notes will be to receive payment of the Redemption Price.

CRISPR Therapeutics Announces Proposed Public Offering of Common Shares

On November 19, 2019 CRISPR Therapeutics (Nasdaq:CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, reported that it is commencing an underwritten public offering of 4,250,000 common shares (Press release, CRISPR Therapeutics, NOV 19, 2019, View Source [SID1234551537]). In addition, the underwriters will have a 30-day option to purchase up to 637,500 additional common shares at the public offering price less the underwriting discount.

Goldman Sachs & Co. LLC, Piper Jaffray & Co. and Jefferies LLC are acting as joint book-running managers for 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.

The common shares will be offered and sold pursuant to the Company’s previously filed automatically effective shelf registration statement on Form S-3 (File No. 333-227427) filed with the U.S. Securities and Exchange Commission (the "SEC") on September 19, 2018. This press release shall not constitute an offer to sell or a 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.

The offering will be made only by means of a prospectus. A copy of the prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; from Piper Jaffray & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected]; or from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340, or by email at [email protected].

Moleculin Announces Positive Trial Data with 100% Safe Delivery of p-STAT3 Inhibitor and Efficacy in Majority of Patients

On November 19, 2019 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, reported it now has preliminary data from its clinical trial of WP1220 for the treatment of cutaneous T-cell lymphoma ("CTCL"), which was published in Blood in conjunction with the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held December 7-10, 2019 (Press release, Moleculin, NOV 19, 2019, View Source [SID1234551470]).

"For years, p-STAT3 (the activated form of STAT3) has been considered an ‘undruggable’ target because of the difficulty of reaching and affecting this cell-signaling protein," commented Walter Klemp, Moleculin’s Chairman and CEO. "Some consider it to be a master regulator of cancer-related gene transcription, so we believe the ability to show a therapeutic effect from a p-STAT3 inhibitor could be considered a significant breakthrough in cancer research."

Results: There were 6 patients screened, and 5 patients enrolled between March and July 2019. Three are evaluable for both safety and efficacy after completing 3 months of treatment, with 2 ongoing and evaluable for safety. The only AE reported potentially related to study drug in one of the five patients was a mild contact dermatitis not requiring treatment. CAILS scores on index lesions were significantly decreased in the first 3 patients, who were stages IA, IB, and IIB, respectively, at entry. A composite score was obtained for all treated lesions for each patient, and percent changes were calculated from baseline to Day 84. There was a median reduction of 70.8% (range 62.1%-76.2%) for the 3 patients. Improvement was noted as early as 7 days after initiation of treatment, and maintenance of improvement was also shown at follow up (1 month after discontinuation, as per protocol). The fourth patient has also shown an initial reduction in the composite CAILS score after 56 days (26.7%), and is continuing on treatment. Evaluations of the biopsy samples for histopathology and status of p-STAT3 in treated lesions are in progress.

Conclusions: WP1220, an inhibitor of p-STAT3, has shown demonstrable safety and significant efficacy after at least 3 months of topical treatment in 3 patients with progressive MF, with a continuing trend towards improvement in additional patients currently in treatment. This is the first demonstration that inhibition of the STAT3 activation pathway with topical therapy has impacted the course of this disease. The trial is continuing, and updated and more comprehensive data from this study as well as assessment of STAT3 phosphorylation in treated lesions will be reported.

Dr. Sandra Silberman, Chief Medical Officer for New Projects at Moleculin, added: "this is the first topical delivery of a p-STAT3 inhibitor that we know of for CTCL, where there is a significant unmet need for improved treatment of the lesions associated with this potentially deadly skin cancer. But, we believe the significance

of this data goes well beyond CTCL, as it speaks to the targeting of p-STAT3 as a general strategy. We are excited to share these preliminary results in association with ASH (Free ASH Whitepaper), especially because we believe showing activity here could have exciting implications for the future of STAT3 inhibitors in general. Although this is a relatively small pilot study, we believe the results justify an expansion to a larger patient population in a Phase 2 clinical trial."