On October 1, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that two abstracts were accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting being held November 7-11, 2018 in Washington, D.C (Press release, NewLink Genetics, OCT 1, 2018, View Source [SID1234529909]). These poster presentations will feature pharmacokinetic (PK) data from the Company’s Phase 1a study of NLG802, a prodrug of indoximod, in patients with advanced solid tumors and biomarker data from its Phase 2 study of indoximod in combination with checkpoint inhibition for patients with advanced melanoma. These data will be available during poster sessions on November 9 and 10, 2018.

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Abstracts to be Presented at SITC (Free SITC Whitepaper) 2018:

Abstract 11213: A phase 1a clinical trial of NLG802, a prodrug of indoximod with enhanced pharmacokinetic properties, Rixe, O., et al.

Abstract 10294: The immunogenomic impact of indoximod on the tumor microenvironment of melanoma patients, Yu, J., et al.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as acute myeloid leukemia (AML), diffuse intrinsic pontine glioma (DIPG) and melanoma.

About NLG802

NLG802 is a prodrug of indoximod. NLG802 has been shown in preclinical trials to increase bioavailability and exposure to indoximod above the levels achievable by direct administration of indoximod. NLG802 is currently being evaluated in clinical trials.

On October 1, 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 pricing of an underwritten public offering of 21,428,572 units at a price to the public of $0.70 per unit (Press release, RXi Pharmaceuticals, OCT 1, 2018, View Source [SID1234529890]). Each unit contains one share of common stock (or common stock equivalent) and one warrant to purchase one share of common stock. This offering is expected to close on or about October 3, 2018, subject to customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

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 common stock equivalents) and the accompanying warrants included in the units can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance.

RXi expects to receive aggregate gross proceeds of approximately $15 million from the offering, prior to deducting underwriting discounts and commissions and estimated offering expenses. RXi intends to use the net proceeds of this offering towards the development of the Company’s immuno-oncology program, for other research and development activities and for general working capital.

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), which became automatically effective on October 1, 2018. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and a final prospectus relating to the offering will be filed with the SEC, and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus, when available, 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 1, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it earned a $22 million payment from Verastem Oncology under the license agreement between the Company and Verastem for COPIKTRA (duvelisib) (Press release, Infinity Pharmaceuticals, OCT 1, 2018, View Source [SID1234529882]). The payment was earned upon the approval by the U.S. Food and Drug Administration (FDA) on September 24, 2018 of duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies, as well as accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies.

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"We are really pleased that duvelisib is now available for patients with CLL/SLL and follicular lymphoma and are proud of the role Infinity played in its development," said Adelene Perkins, Chief Executive Officer and Chair of Infinity. "This $22 millionFDA approval payment from Verastem supports Infinity’s continued expansion of the development of IPI-549, our first-in-class, oral, immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase-gamma (PI3K-gamma), including in doublet and triplet combination trials to identify the best combination regimens to treat patients with specific types of cancer."

In 2016, Infinity entered into a license agreement granting Verastem an exclusive worldwide license for the research, development, commercialization, and manufacture of duvelisib and products containing duvelisib in oncology. Pursuant to the terms of the license agreement, Verastem has notified Infinity of its election to make the $22 million payment in cash, which Infinity expects to receive later this year. Infinity also is eligible for royalties on worldwide net sales of duvelisib ranging from the mid-to-high single digits, shared equally with Takeda.

Infinity’s updated 2018 financial guidance is:

Net Loss: Infinity expects net loss for 2018 to range from $10 million to $20 million.
Cash and Investments: Infinity expects to end 2018 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $50 million to $60 million.
Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company’s capital needs into 2020. Infinity’s financial guidance excludes additional funding or business development activities and does not include a potential $2 million payment from PellePharm, a private company, upon initiation of a Phase 3 study for the hedgehog inhibitor program, which Infinity licensed to PellePharm in 2013.

On October 1, 2018 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, reported two additions to its leadership team: Thomas Davis, M.D. as Chief Medical Officer and Derek Meisner, J.D. as General Counsel (Press release, Genocea Biosciences, OCT 1, 2018, View Source [SID1234529854]).

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"We continue to advance our lead cancer vaccine, GEN-009 and expand the applications for our novel and proprietary ATLAS platform to demonstrate what we believe are critical advantages in neoantigen identification," said Chip Clark, President & CEO of Genocea. "We believe our emerging pipeline of novel neoantigen vaccine and cell therapy programs holds significant promise, and we believe this promise is the reason we’ve been able to attract such talent to Genocea. Tom and Derek bring a depth of industry expertise and quality of insight that will be invaluable."

Dr. Davis joins Genocea with 20+ years of academic and industry experience in immuno-oncology and cancer drug development. Dr. Davis previously served as Chief Medical Officer of Gadeta B.V., a Dutch cell therapy company pursuing novel cancer targets, where he steered a novel cell therapy technology into first-in human clinical studies. He also previously served as Chief Medical Officer of Celldex, a cancer vaccine company, where he led all aspects of clinical and regulatory development.

Mr. Meisner brings broad legal expertise to Genocea as its first in-house General Counsel. He has extensive experience as a corporate attorney, previously serving as the General Counsel to multiple Boston-based financial services firms, including life science investor RA Capital, as well as serving as Partner at the international law firm K&L Gates and as Branch Chief in the Division of Enforcement of the U.S. Securities and Exchange Commission.

On October 1, 2018 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) reported that Alexis Peyroles, chief executive officer, will present an overview of the Company’s business and will be available to participate in one-on-one meetings with investors at the 18th Annual Biotech in Europe Investor Forum to be held Oct. 4-5, 2018, in Basel, Switzerland (Press release, OSE Immunotherapeutics, OCT 1, 2018, View Source [SID1234529791]).

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The details of OSE Immunotherapeutics’ presentation are as follows:

Date: Friday, Oct. 5, 2018

Time: 10:30 a.m. CET

Location: Track 1, Room Darwin, Congress Center Basel, Switzerland

The presentation will be webcast live and remain available for three months thereafter on: View Source