On January 30, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported its plans to host a Research and Development Day on February 26, 2019 from 8:00 a.m. – 11:30 a.m. ET in New York City (Press release, CytomX Therapeutics, JAN 30, 2019, View Source [SID1234532972]).

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Members of CytomX’s senior executive team will be joined by:

Alex Spira, M.D., Ph.D., FACP, Director, Virginia Cancer Specialists Research Institute, Assistant Professor, Johns Hopkins School of Medicine and Medical Director, US Oncology Lung Program
The event will be webcast live under the "Investors & News" section of CytomX’s website at View Source Please connect to the webcast several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. An archived webcast replay will be available on the Company’s website for 90 days following the event.

Institutional investors and equity analysts seeking information on or registration for the live event in New York City please contact Chris Keenan at [email protected].

On January 30, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology-focused biopharmaceutical company developing novel therapeutics for global markets, reported a strategic corporate restructuring to focus its resources on its lead clinical programs: varlitinib in biliary tract cancer (BTC), ASLAN003 in acute myeloid leukaemia (AML) and ASLAN004 in atopic dermatitis (Press release, ASLAN Pharmaceuticals, JAN 30, 2019, View Source [SID1234532971]).

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ASLAN will focus its resources on the late-stage development of varlitinib as a potential novel treatment for first- and second-line BTC. Enrolment in a global pivotal study of varlitinib in second-line BTC, the TreeTopp (TREatmEnT OPPortunity) study, was completed ahead of schedule in December 2018 and topline data is expected in the second half of 2019. ASLAN will be closing the ongoing single-arm second-line BTC study in China as it is now expected to read out after the TreeTopp study. If positive, data from the TreeTopp study will be used to submit a New Drug Application (NDA) in China, the US and other major geographies.

ASLAN recently reported positive phase 1b results from an ongoing study of varlitinib as a first-line treatment for BTC which demonstrated that varlitinib increased objective response rate compared to standard of care and this study will continue to recruit patients to strengthen this dataset.

The clinical development of ASLAN003 in AML and ASLAN004 in atopic dermatitis remains on track. ASLAN expects to complete the first part of the phase 2 study of ASLAN003 in AML and the phase 1 SAD study of ASLAN004 in the first half of 2019.

Following this strategic review, ASLAN will reduce its cost base, including a reduction in headcount by 30%. In total, the planned changes will lower operational costs by 50%. ASLAN does not expect to incur any material restructuring charges.

In addition to the reduction in headcount, Dr Bertil Lindmark, currently Chief Medical Officer, has announced he will retire and return to Europe. Dr Chih-Yi Hsieh, currently VP Medical and GM Taiwan, will assume the role of acting Chief Medical Officer. Dr Mark McHale, Chief Operating Officer, will transition to the role of Chief Development Officer and Head of R&D with immediate effect.

Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "We remain committed to ensuring the most effective use of capital to support the development of our three key assets, varlitinib, ASLAN003 and ASLAN004, each of which have the potential to be critical value-drivers. We are approaching several significant milestones in 2019 and beyond, so it is important we complete key studies over the next two years. Restructuring the organisation has involved some tough decisions. It is difficult to lose outstanding members of the team who have contributed to ASLAN over the years and have tackled some of the most challenging obstacles to advancing new treatments for cancer."

On January 30, 2019 Cullinan Oncology, LLC and The Wistar Institute reported an agreement to accelerate the development of VK-2019, a novel EBNA1 (Epstein-Barr Nuclear Antigen 1) inhibitor discovered by The Wistar Institute (Press release, Cullinan Oncology, JAN 30, 2019, View Source [SID1234532970]).

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VK-2019 will be developed by Cullinan Apollo, a company formed and managed by Cullinan Oncology, LLC. Under the terms of the agreement, The Wistar Institute has granted an exclusive worldwide license for the development and commercialization of the EBNA1 inhibitor to Cullinan Apollo. Wistar has received an up-front license fee and an equity interest in Cullinan Apollo, with the potential to receive additional downstream milestones and royalty payments as the asset progresses.

"We look forward to advancing this highly novel, first-in-class asset into the clinic over the coming weeks," said Leigh Zawel, CSO, Small Molecules at Cullinan Oncology, LLC. "The Wistar scientists have spent nearly a decade developing this molecule, and we appreciate their confidence in our ability to successfully develop this EBNA1 inhibitor."

EBV (Epstein-Barr Virus), a well-established driver of various cancers, is critically reliant on the viral DNA-binding factor EBNA1 for viral genome maintenance. This new compound potently inhibits EBNA1 function. In preclinical models of EBV-associated cancer, it eliminated EBV, resulting in tumor growth inhibition. Development of this compound was largely supported by an investment of over U.S. $10 million from Wellcome, a biomedical research charity based in the United Kingdom.

"We are excited to work with the Cullinan Apollo team to embark on the next phase of clinical development of our lead therapeutic candidate for EBV-associated cancers," said Paul M. Lieberman, Ph.D., Hilary Koprowski, M.D., Endowed Professor, professor and leader of the Gene Expression and Regulation Program, and director of the Center for Chemical Biology and Translational Medicine at The Wistar Institute. "This drug is exemplary of the results of the hard work of my lab – most notably Dr. Troy Messick – together with our committed collaborators at Fox Chase Chemical Diversity Center, Inc. and invaluable input from Wellcome and its advisors. We need exceptional partners to work with us to move our discoveries forward, and this is one example of that."

On January 30, 2019 Gossamer Bio, Inc., a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it has filed an amended registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") in connection with its proposed initial public offering of its common stock (Press release, Gossamer Bio, JAN 30, 2019, View Source [SID1234532968]). The amended registration statement restores the delaying amendment language contemplated by Rule 473(a) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), such that the registration statement Gossamer Bio filed on January 23, 2019 will no longer become automatically effective pursuant to Section 8(a) of the Securities Act 20 calendar days after its filing date. With today’s filing, Gossamer Bio intends to request from the SEC acceleration of the effective date of the registration statement prior to the date that it would have otherwise become automatically effective.

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Gossamer Bio previously announced that it had filed a registration statement on January 23, 2019 offering 14,375,000 shares of its common stock at an initial public offering price of $16.00 per share. The proposed offering terms have not changed. Gossamer Bio’s common stock has been approved for listing on the Nasdaq Global Select Market under the symbol "GOSS." Gossamer Bio expects to grant the underwriters a 30-day option to purchase up to an additional 2,156,250 shares of common stock in connection with the offering. All of the shares are being sold by Gossamer Bio.

BofA Merrill Lynch, SVB Leerink, Barclays and Evercore ISI are acting as joint book-running managers for the proposed offering.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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 such state or jurisdiction.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering may be obtained, when available, from: BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or from SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by email at [email protected], or by telephone at (800) 808-7525, ext. 6132; or from Barclays, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at [email protected]; or from Evercore ISI, Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

On January 30, 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 the publication of pre-clinical data that shows the therapeutic potential of mRNA-2752, an investigational mRNA immuno-oncology therapy that encodes a novel combination of three immunomodulators designed to activate the immune system to recognize and eradicate tumors that are resistant to checkpoint inhibitors (Press release, Moderna Therapeutics, JAN 30, 2019, View Source [SID1234532967]).

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The study, published in the scientific journal Science Translational Medicine, found that the local delivery of mRNA encoding the secreted cytokines IL23 and IL36γ and the membrane-bound T-cell co-stimulator OX40L, induced a broad immune response promoting tumor regression in both injected lesions and distant un-injected tumors in mice. When combined with checkpoint inhibitors, mRNA-2752 boosted complete response rates in immunosuppressive and in immunologically barren tumor models that are otherwise unresponsive to checkpoint inhibitors.

"These pre-clinical data are important because they show how we can utilize multiple mRNAs encoding for immune modulators in a single therapy to activate a robust, systemic immune response against cancer in immunosuppressive and in so-called ‘cold’ tumors that are resistant to checkpoint inhibitors," said Joshua Frederick, Ph.D., Moderna’s head of oncology research. "We were pleased to discover the cooperation of the components encoded by this mRNA mixture in engaging innate immune cells, innate-like lymphocytes and effector T cells, ultimately resulting in complete tumor regressions and protective immunity in our mouse models of cancer."

"Unlike conventional biologics, we believe mRNA therapies can uniquely alter the tumor microenvironment to make cancers more susceptible to checkpoint inhibitors via a paracrine effect by producing high, local therapeutic concentrations of membrane-bound and secreted immunomodulators, both of which are believed to play a critical role in the immune response against cancer," said Tal Zaks, M.D., Ph.D., chief medical officer at Moderna. "This important study highlights why we are excited to have started our Phase 1 clinical study for mRNA-2752, as we believe the combination of these immune signals has the potential to help patients for whom checkpoint inhibitors alone have been insufficient."

The study showed that in a MC38-R mouse cancer model that is considered immunosuppressive and found to be unresponsive to checkpoint inhibitor immunotherapy, a single dose of the Triplet administered intratumorally led to complete responses (defined as the absence of all detectable cancer). After multiple injections in the immunosuppressive tumor model, complete response rates increased to a majority of the treated animals. In addition, a single dose of the Triplet led to near-complete control of both injected tumors and distal untreated tumors. The addition of anti-PD-L1, anti-PD-1 or anti-CTLA-4 checkpoint inhibitors to a single dose of the Triplet improved complete response rates over either mRNA or antibody treatment alone.

Moderna has advanced mRNA-2752 into a Phase 1 study (ClinicalTrials.gov Identifier: NCT03739931) and has started dosing patients with advanced or metastatic solid tumor malignancies or lymphoma. The open label, multi-center study is evaluating the safety and tolerability of mRNA-2752 as a monotherapy or in combination with either AstraZeneca’s durvalumab (anti-PD-L1 antibody) or tremelimumab (anti-CTLA-4 antibody) and will assess anti-tumor activity, protein expression in tumors and pharmacokinetics and exploratory endpoints that include assessment of immunological response.

A link to the publication, Durable anti-cancer immunity from intratumoral administration of IL-23, IL-36γ and OX40L mRNAs (S. L. Hewitt, et. al.), can be found here.