On October 3, 2018 Harpoon Therapeutics, Inc., a clinical-stage immunotherapy company developing a new class of T cell engaging therapeutics, reported that it has appointed Natalie R. Sacks, M.D., as Chief Medical Officer (Press release, Harpoon Therapeutics, OCT 3, 2018, View Source [SID1234529726]).

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"We are thrilled to welcome Dr. Sacks as our new Chief Medical Offer. Natalie brings a strong record of accomplishment in the development and commercialization of oncology therapeutics, which will be instrumental as we advance our pipeline in the clinic," said Jerry McMahon, Ph.D., President and Chief Executive Officer, Harpoon.

"As an oncologist, I look forward to joining a company that is pioneering new ways to treat cancer and impact the lives of patients in need," says Dr. Sacks. "I am excited about the potential of Harpoon’s clinical programs and its novel TriTAC platform to redirect a patient’s own T cells to attack tumor cells."

Dr. Sacks most recently served as Chief Medical Officer of Aduro Biotech, a company focused on the advancement of novel immuno-oncology technologies. Previously, she was Vice President of Clinical Development at Onyx Pharmaceuticals (acquired by Amgen) where she played a key role in the development and approval of Kyprolis, an FDA-approved therapy for the treatment of multiple myeloma, and in business development strategy. Prior to that, she served as Vice President of Clinical Research for Exelixis where she directed the development of a portfolio of small molecules, with responsibilities ranging from IND filings to late-stage development, including development of Cometriq. Earlier in her career, Dr. Sacks served as Vice President of Clinical Development at Cell Genesys, a company focused on the development of cancer vaccines and engineered chimeric antigen receptor (CAR)-T cells. She received her M.D. from the University of Pennsylvania School of Medicine, her M.S. in Biostatistics from the Harvard University T.H. Chan School of Public Health and her B.A. in Mathematics from Bryn Mawr College. Dr. Sacks was an Assistant Clinical Professor at the University of California, San Francisco, and served as volunteer Attending Physician in Hematology-Oncology at San Francisco General Hospital for more than a decade. She serves as a board member for Zymeworks Inc. and Caribou Biosciences.

On October 3, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will announce its financial results for the third quarter of 2018 on Tuesday, November 6, 2018 (Press release, Eli Lilly, OCT 3, 2018, View Source [SID1234529747]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On October 3, 2018 ArcherDX, a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine and Merck KGaA, Darmstadt, Germany, the vibrant science and technology company which operates its biopharmaceuticals business in the U.S. and Canada as EMD Serono, reported that they have entered into an agreement to develop and commercialize a next generation sequencing (NGS)-based companion diagnostic (CDx) assay (Press release, ArcherDX, OCT 3, 2018, View Source,-darmstadt,-germany-selects-archerdx-for-strategic-global-companion-diagnostic-assay-development-collaboration [SID1234529767]).

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Under the terms of the agreement, ArcherDX will develop and seek regulatory approval for a CDx assay that will help physicians identify patients who may benefit from treatment with a Merck KGaA, Darmstadt, Germany drug candidate, by focusing on the detection of specific genomic alterations in plasma or formalin-fixed paraffin-embedded (FFPE) tissue samples. ArcherDX will develop the CDx using the Archer diagnostic platform, which combines the patented Anchored Multiplex PCR (AMP) technology with the Illumina MiSeqDx sequencing system and Archer Analysis bioinformatics software. The CDx assay will be designed to detect multiple classes of genomic alterations across a range of genes implicated in solid malignant neoplasms and is compatible with both FFPE tissue and plasma specimen types.

"We are pleased to launch this strategic companion diagnostic initiative," stated Jason Myers, Ph.D., president and chief executive officer for ArcherDX. "The work we’ve engaged in with Merck KGaA, Darmstadt, Germany highlights the importance and potential of utilizing our proprietary profiling approach to make available to physicians an FDA-approved companion diagnostic solution for use with targeted therapies."

On October 3, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported the closing of its previously announced underwritten public offering of 3,725,714 units at a public offering price of $0.70 per unit and 17,702,858 pre-funded units at a public offering price of $0.69 per pre-funded unit, raising gross proceeds of approximately $15 million (Press release, RXi Pharmaceuticals, OCT 3, 2018, View Source [SID1234529729]). The Company intends to use the net proceeds of this offering towards the development of RXi’s immuno-oncology program, for other research and development activities and for general working capital.

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Each unit sold in this offering contained one share of common stock and one warrant to purchase one share of common stock. Each pre-funded unit sold in this offering included one pre-funded warrant to purchase one share of common stock, at an exercise of $0.01 per share, and one warrant to purchase one share of common stock. Each warrant has an exercise price of $0.70 per share, is exercisable immediately and will expire seven years from the date of issuance. The shares of common stock (or the pre-funded warrants, as the case may be) and the accompanying warrants included in the units or pre-funded units were purchased together in this offering but were issued separately.

A registration statement on Form S-1 relating to the public offering of the securities described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on September 28, 2018, and an additional registration statement on Form S-1 filed pursuant to Rule 462(b) became automatically effective on October 1, 2018. The offering was made only by means of a prospectus forming part of the effective registration statements. Copies of the final prospectus relating to the offering is available on the SEC’s website at www.sec.gov and may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing [email protected].

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 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 October 3, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported the publication of results of preclinical studies of CPI-444 demonstrating that it induces dose dependent anti-tumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies (Press release, Corvus Pharmaceuticals, OCT 3, 2018, View Source [SID1234529768]). The article, which is titled "A2AR Antagonism with CPI-444 Induces Antitumor Responses and Augments Efficacy to Anti–PD-(L)1 and Anti–CTLA-4 in Preclinical Models," is featured on the cover of and in the October issue of the journal Cancer Immunology Research, which is an official journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The article can be accessed here.

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CPI-444, Corvus’ lead product candidate, is a selective and potent inhibitor of the adenosine A2A receptor. It is currently being evaluated in clinical trials in patients with various solid tumors as a single agent and in combination with Genentech’s atezolizumab, an anti-PD-L1 antibody.

"Our carefully conducted pre-clinical studies of CPI-444 demonstrated robust, dose-dependent inhibition of cancer growth as monotherapy, and synergistic efficacy with checkpoint inhibitors, in multiple tumor models," said Stephen Willingham Ph.D., a senior scientist at Corvus and lead author of the article. "These studies indicate that CPI-444 is associated with T-cell activation, which is believed to be its main mechanism of increased cancer killing activity."

Dr. Willingham added, "In these studies we used two different models to characterize the intratumor levels of adenosine, confirming they should be easily blocked by CPI-444. We believe this is the first publication to accurately measure intratumor levels of extracellular adenosine, which is important for evaluating the potential efficacy of therapeutics aimed at this pathway."

Key takeaways from the pre-clinical studies covered in the article include:

CPI-444 is a selective and potent inhibitor of the adenosine A2A receptor and provides dose dependent inhibition of tumor growth as a monotherapy in multiple tumor models
CPI-444 is synergistic with checkpoint inhibitors (anti-PD-1, anti-PD-L1 and anti-CTLA-4), demonstrating the elimination of tumors in up to 90% of treated mice and the restoration of immune responses in mice with tumors that are resistant to anti-PD-L1 or anti-CTLA-4 monotherapy
In monotherapy and combination-therapy, CPI-444 inhibited tumor growth and enabled long-term anti-tumor immune memory
CD8+ T-cells were shown to be required for a response with CPI-444 , demonstrating a role for CD8+ T-cells in mediating primary and secondary immune responses
Intratumor adenosine levels as measured in two models were shown to be approximately 100-150 nanomolar, which is a level that is completely blocked by CPI-444
"These extensive pre-clinical studies formed the basis for our ongoing Phase 1/1b trial in renal cell cancer and Phase 1b/2 trial in non-small cell lung cancer, in each case, with CPI-444, which has now been investigated in over 250 cancer patients," said Richard A, Miller M.D., an oncologist; co-founder, president and chief executive officer of Corvus; and a senior author of the article. "We are delighted that the quality of this research led to this article being featured on the cover of the journal. We will provide an update on our ongoing human clinical studies at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November."

ABOUT CPI-444
CPI-444 is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.