On June 10, 2019 Oncternal Therapeutics, Inc., (Nasdaq: ONCT) a clinical-stage biotechnology company developing potential first-in-class product candidates for cancers with critical unmet medical need, reported that the reverse merger with GTx, Inc., closed on June 7, 2019 (Press release, GTx, JUN 10, 2019, View Source [SID1234536962]). The combined company will operate under the name Oncternal Therapeutics, Inc., and its shares will commence trading on the Nasdaq stock exchange on June 10, 2019, under the ticker symbol "ONCT."

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"We believe that the closing of the merger signifies a transformative event that will provide Oncternal with the opportunity to achieve its next level of corporate growth as we continue to advance our promising oncology drug candidates through development," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We recently presented updated interim data from an ongoing clinical study of our investigational monoclonal antibody, cirmtuzumab, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, and we look forward to achieving a number of exciting milestones in our development programs in the future."

Pursuant to the merger, all of Oncternal’s outstanding shares of common stock and securities convertible into or exercisable for Oncternal’s common stock were converted into GTx common stock and securities convertible into or exercisable for GTx common stock. Immediately following the completion of the merger, the former stockholders of Oncternal held approximately 77.5% of the outstanding shares of common stock of the combined company. In addition to retaining an ownership interest representing approximately 22.5% of the outstanding shares of common stock of the combined company, the GTx stockholders of record as of immediately prior to the effective time of the merger received contingent value rights (CVR) entitling the holders to receive, in the aggregate, 75% of any net proceeds derived from the grant, sale or transfer of rights to GTx’s selective androgen receptor degrader (SARD) and selective androgen receptor modulator (SARM) technology during the term of the CVR and, if applicable, to receive royalties on the sale of any SARD products by the combined company during the term of the CVR.

Oncternal’s development pipeline consists of the following programs:

Oncternal’s lead program, cirmtuzumab, is an investigational, potential first-in-class anti-receptor tyrosine kinase-like orphan receptor 1 (ROR1) monoclonal antibody. Cirmtuzumab is currently in a Phase 1/ 2 clinical trial in combination with ibrutinib for the treatment of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Last week, the company presented interim data from the study at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women

with metastatic breast cancer is being conducted at the University of California San Diego (UC San Diego) School of Medicine. The California Institute for Regenerative Medicine (CIRM) has provided funding to support the cirmtuzumab development program.

TK216, an investigational, potential first-in-class small molecule designed to inhibit the biological activity of E26 transformation-specific (ETS) oncoproteins, is being evaluated alone and in combination with vincristine in a Phase 1 clinical trial in patients with relapsed or refractory Ewing sarcoma, a rare pediatric cancer. Oncternal is also planning a Phase 1 clinical trial in patients with relapsed acute myeloid leukemia (AML).

A ROR-1 targeted chimeric antigen receptor T-cell (CAR-T) program is in preclinical development in collaboration with UC San Diego for hematologic cancers and solid tumors.

On June 9, 2019 CStone Pharmaceuticals ("CStone"; HKEX: 2616) reported that the company has entered into a global clinical collaboration with China focus with Bayer HealthCare LLC to evaluate the safety, tolerability, pharmacokinetics (PK) and antitumor activity of its PD-L1 monoclonal antibody CS1001 in combination with Bayer’s regorafenib, an oral multi-kinase inhibitor (targeting VEGFR, FGFR, CSF1R, etc.), as a treatment for multiple cancers including gastric cancer (Press release, CStone Pharmaceauticals, JUN 9, 2019, View Source [SID1234536959]). This is the first global proof of concept study carried out as a collaboration between the two companies. CStone will be the study sponsor and Bayer will provide regorafenib throughout the clinical trial program.

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Professor Lin Shen, Vice President at the Peking University Cancer Hospital, commented: "At present, patients with advanced gastric cancer lack safe and effective therapies. Preclinical and clinical evidence suggest that the combination of PD-1/PD-L1 antibodies with multi-kinase inhibitors that target VEGFR can induce significant synergistic anti-tumor effects. We hope this combination therapy can provide a new treatment option for patients suffering from gastric cancer and other serious malignancies."

CS1001 is one of CStone’s backbone immuno-oncology pipeline candidates, having demonstrated that it is well-tolerated and has promising anti-tumor activities across a variety of tumor types in clinical studies. Currently, CS1001 is being evaluated in 7 clinical trials, including 5 pivotal trials. Regorafenib is approved in over 90 countries for the treatment of metastatic colorectal cancer (mCRC) and metastatic gastrointestinal stromal tumors (GIST) and in more than 80 countries for the second-line treatment of advanced hepatocellular (HCC).

Dr. Frank Jiang, CStone Chairman and CEO, commented: "We are very pleased that Bayer has chosen CStone as its partner and recognizes CS1001’s potential. We hope, by complementing our two companies’ pipelines via this combination therapy, that we can develop better cancer treatments for patients. In addition, this collaboration will be a big step forward for CStone’s global strategy when we generate positive data."

Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division said: "Combining multi-kinase inhibitors, such as regorafenib, with checkpoint inhibitors is a rising trend in cancer therapy in order to find new solutions for the many treatment gaps that still remain for patients. We look forward to collaborating with CStone, an innovative biopharmaceutical company, and exploring regorafenib’s potential."

About CS1001

CS1001 is an investigational anti-PD-L1 monoclonal antibody being developed by CStone. Authorized by the U.S.-based Ligand Corporation, CS1001 was generated by the OMT transgenic animal platform, which can produce fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can potentially reduce the risk of immunogenicity and toxicities in patients, a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China and has demonstrated promising anticancer activity and good tolerance. CS1001 is currently being evaluated in multiple clinical trials including a bridging phase I trial in the USA, a multi-arm phase Ib study, two pivotal Phase II studies and three Phase III studies in China in various cancer types, respectively. It has not been approved by any health authority for marketing.

About Regorafenib (Stivarga)

Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R).

Regorafenib is approved under the brand name Stivarga in more than 90 countries worldwide, including the U.S., countries of the EU, China and Japan for the treatment of metastatic colorectal cancer (mCRC) and metastatic gastrointestinal stromal tumors (GIST). The product is also approved in more than 80 countries including the U.S., Japan, countries of the EU as well as China for the second-line treatment of advanced hepatocellular (HCC).

Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

On June 9, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics reported that Aron Knickerbocker, Chief Executive Officer, is scheduled to present at the following two investor conferences (Press release, Five Prime Therapeutics, JUN 9, 2019, View Source [SID1234536958]):

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The Raymond James Life Sciences and MedTech Conference, on Wednesday, June 19th at 1:15pm ET / 10:15am PT
The 2019 Bank of Montreal Prescriptions for Success Healthcare Conference on Tuesday, June 25th at 3:00pm ET / 12:00pm PT
The presentations will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at: View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.

On June 7, 2019 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that Stephane Bancel, Chief Executive Officer, and Lorence Kim, M.D., Chief Financial Officer, will present at the Goldman Sachs 40th Annual Global Healthcare Conference on Wednesday, June 12, 2019 at 2:00 p.m. PT (5:00 p.m. ET) (Press release, Moderna Therapeutics, JUN 7, 2019, View Source [SID1234536957]).

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A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at View Source A replay of the webcast will be archived on Moderna’s website for 30 days following the presentation.

On June 7, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that Dr. Thomas Cannell, President and CEO will host a conference call on Monday, June 10, 2019 at 8:00 a.m. ET to provide an update on the Company’s meeting with the FDA on June 6, 2019 (Press release, Eleven Biotherapeutics, JUN 7, 2019, http://ir.elevenbio.com/news-releases/news-release-details/dr-thomas-cannell-president-and-ceo-sesen-bio-host-conference [SID1234536956]).

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To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2958515. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.

About Vicinium

Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.