On February 11, 2019 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer reported an update on the Company’s strategic plans (Press release, Helix BioPharma, FEB 11, 2019, View Source [SID1234533784]).

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Pre-clinical Development

The Company extended its collaboration with the Moffitt Cancer Center as a result of preliminary studies that show L-DOS47 may increase the activity of a PD-1/PD-L1 inhibitor in treating pancreatic cancer. Helix’s plan is to increase the clinical application of L-DOS47 with various combination treatments, including immunotherapies with checkpoint inhibitors.

Clinical Development

As previously announced on November 13, 2018, the Company’s L-DOS47 clinical development program is focused solely on combination therapies in patients with non-small cell lung cancer ("NSCLC").

The Company currently has two L-DOS47 clinical studies underway. The first is a US Phase I program (LDOS001) in combination with pemetrexed and carboplatin which is near completion and has only two more cohorts to complete the study. The second is a European Phase 2b program (LDOS003) in combination with cisplatin and vinorelbine which is ready to enroll patients.

The Company is actively working on an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for an L-DOS47 pancreatic cancer study in combination with doxorubicin ("LDOS006"). The company expects to file the IND application in March.

The Company is also considering a new L-DOS47 combination study with pemetrexed, cisplatin and immunotherapy, such as Keytruda ("LDOS007").

These clinical programs form part of the Company’s overall strategic plan which includes demonstrating L-DOS47’s broad utility as a drug in combination with leading treatments for lung and pancreatic cancer.

Licensing / Partnerships

The Company continues to work with Deloitte Corporate Finance Inc. The Company has engaged in dialogue with several targeted groups of potential qualified partners with the goal of negotiating on a prospective partnership, alliance or licensing transaction.

Divestiture of Polish subsidiary

The Company has been in discussions with a group that includes ACM Alpha Consulting Management AG ("ACMag") to divest a majority stake in the Company’s wholly owned subsidiary Helix Immuno-Oncology S.A. which the Company is working towards putting it to a vote for shareholder approval at its annual general and special meeting which is to take place no later than April 18, 2019.

Corporate Development

The Company has also been in discussions with several U.S. based financial advisory firms. These discussions include the raising of working capital to finance the Company’s drug development programs as well as exploring possible merger and acquisition opportunities and exploring U.S. listing alternatives, such as Nasdaq.

Conference

Dr. Heman Chao, Helix’s Chief Executive Officer will be the attending BIO CEO Conference in New York on February 11th and 12th and has scheduled several meetings with potential licensing partners and U.S. financial advisory firms.

On February 11, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that its collaborator, Takeda Pharmaceutical Company Limited, received approval from the European Commission to extend the marketing authorization for ADCETRIS (brentuximab vedotin) to include ADCETRIS in combination with AVD (Adriamycin, vinblastine and dacarbazine) in adults patients with previously untreated CD30+ stage IV classical Hodgkin lymphoma (HL) (Press release, Seattle Genetics, FEB 11, 2019, View Source [SID1234533215]). The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 13, 2018. As a result, Seattle Genetics will receive a milestone payment from Takeda of $30 million. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL that plays a role in tumor growth and survival.

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"Receipt of this milestone payment reflects continued progress by our partner Takeda to expand ADCETRIS approved indications globally," said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. "We look forward to continuing our work with Takeda to establish ADCETRIS as the global foundation of care for CD30-expressing lymphomas, including Hodgkin lymphoma."

The marketing authorization for ADCETRIS is based on positive results from the ECHELON-1 phase 3 clinical trial that were presented in the Plenary Scientific Session at the 59thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2017 with simultaneous publication in the New England Journal of Medicine.

In September 2018, the Japanese Ministry of Health, Labour and Welfare approved ADCETRIS in combination with AVD as a frontline treatment option for CD30-positive HL patients in Japan. In March 2018, the U.S. Food and Drug Administration (FDA) approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical HL based on the positive results of the ECHELON-1 phase 3 clinical trial.

For more information about the European Commission decision, please visit the European Medicines Agency website: www.ema.europa.eu/ema.

About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS (brentuximab vedotin)

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma. The phase 3 CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma is ongoing.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS for injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, and adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 72 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On February 8, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Guggenheim Healthcare Talks Idea Forum on Thursday, February 14, 2019 (Press release, Eli Lilly, FEB 8, 2019, View Source [SID1234533186]). Anne White, president of Lilly Oncology, and Levi Garraway, M.D., Ph.D., senior vice president, oncology research and development, will participate in a fireside chat at 1:00 p.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On February 8, 2019 Biocept, Inc. (NASDAQ: BIOC) ("Biocept" or the "Company"), a leading commercial provider of liquid biopsy solutions, reported the pricing of an underwritten public offering of 6,250,000 shares of its common stock and warrants to purchase up to 6,250,000 shares of the Company’s common stock (Press release, Biocept, FEB 8, 2019, View Source [SID1234533187]). Each share of common stock is being sold together with one warrant to purchase one share of common stock at a combined price to the public of $1.20 per share and warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $7.5 million.

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The warrants will be immediately exercisable at a price of $1.20 per share of common stock and will expire five years from the date of issuance. The shares of common stock and the accompanying warrants, can only be purchased together in the offering, but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about February 12, 2019, subject to customary closing conditions.

Maxim Group LLC is acting as the book-running manager and Dawson James Securities, Inc. is acting as a co-manager in connection with the offering.

Biocept also has granted to the underwriter a 45-day option to purchase up to an additional 937,500 shares of common stock and/or warrants to purchase up to 937,500 shares of common stock, at the public offering price less discounts and commissions.

The offering is being conducted pursuant to the Company’s registration statement on Form S-1 (File No. 333-228566) previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). A prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.

This press release shall not constitute an offer to sell or the 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 February 8, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it will announce its final results for the year ended December 31, 2018 on Monday, March 11, 2019 at 7:00 am Greenwich Mean Time (GMT) (Press release, Hutchison China MediTech, FEB 8, 2019, https://www.chi-med.com/to-announce-2018-final-results/ [SID1234533190]).

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An analyst presentation will be held at 9:00 am GMT (5:00 pm Hong Kong Time) on the same day at Citigate Dewe Rogerson, 3 London Wall Buildings, London, EC2M 5SY, UK, which will be webcast via the company website at www.chi-med.com/investors/event-information/. The presentation will be available to download before the analyst presentation begins.

For North America based analysts and investors, Chi-Med will also host a conference call with Q&A at 9:00 am Eastern Daylight Time (1:00 pm GMT).

Details of the analyst presentation and conference call dial-in will be provided in the financial results announcement. A replay will also be available on the website shortly after each event