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 [SID1234530645]). 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 million FDA 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 September 30, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today is presenting data describing the tumor microenvironment and immunogenicity of Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine, extended-release) in patients with solid tumor malignancies at the International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) hosted by The Cancer Research Institute (CRI), the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper), the European Academy of Tumor Immunology (EATI), and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in New York City (Press release, Tocagen, SEP 30, 2018, View Source;p=RssLanding&cat=news&id=2369481 [SID1234529699]). The lead author is Jaime Merchan, M.D., director, Phase 1 clinical trials program at Sylvester Comprehensive Cancer Center; associate professor of medicine at the University of Miami Miller School of Medicine.

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The poster describes data available as of August 31st for 20 patients with advanced solid tumors, including colorectal, sarcoma, pancreas and non-small cell lung cancer, treated with intravenous Toca 511 followed by oral Toca FC in the Phase 1b Toca 6 clinical trial. Among these patients, 15 also received Toca 511 via intratumoral administration.

In this preliminary analysis of immune activation in patients with advanced solid tumors, analysis of peripheral blood shows immune cell modulation that is consistent with what has been observed in preclinical studies and in patients with recurrent high grade glioma treated with Toca 511 & Toca FC in previous clinical trials. In addition, available tumor samples from three patients show Toca 511 infected both "hot" (T cells present) and "cold" (T cells low or absent) areas of metastatic tumor, suggesting Toca 511 can penetrate multiple tumor microenvironments. Toca 511 & Toca FC treatment was well tolerated.

"The encouraging preliminary immune activity data from the Toca 6 trial continue to support the proposed mechanism of action for Toca 511 & Toca FC and its potentbiial in the treatment of multiple cancers," said Asha Das, M.D., chief medical officer of Tocagen. "We look forward to advancing expansion opportunities for our lead product in patients with solid tumors."

CRI-CIMT-EATI-AACR Abstract/Poster Number: A018
Abstract Title: Effects of Toca 511 & Toca FC on tumor microenvironment and peripheral blood populations in patients with advanced malignancies
Date: Sunday, September 30, 2018
Time: 11:45 a.m. – 2:15 p.m. ET
The poster is available on Tocagen’s website.

About Toca 6
Toca 6 is a multi-center, open-label Phase 1b study evaluating Toca 511 & Toca FC in patients with advanced solid tumors. The study will evaluate the safety and presence of Toca 511 genes in tumors of patients with widely disseminated disease, immunologic activity in blood and tumor, and clinical activity such as tumor response and clinical benefit. More information can be found at www.tocagen.com/toca6 or by searching clinicaltrials.gov using the clinical trial identifier NCT02576665.

About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

On October 29, 2018 Euronext Paris: FR0010331421 – IPH), reported new data from the Phase I clinical trial of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (CTCL) (Press release, Innate Pharma, SEP 29, 2018, View Source [SID1234530303]). The data, including longer follow up for patients treated in the dose-escalation and observations from an additional patient cohort, will be presented today at the EORTC Cutaneous Lymphoma Group meeting in St. Gallen, Switzerland, by Pr Martine Bagot, Principal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris. IPH4102 is Innate Pharma’s wholly-owned first-in-class anti-KIR3DL2 antibody, designed for treatment of T-cell lymphoma.

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"These data support the positive trends observed in the dose-escalation part of the trial and demonstrated a high response rate and long progression-free survival for these heavily pretreated CTCL patients, a majority being Sézary syndrome," commented Pierre Dodion, Chief Medical Officer of Innate Pharma. "Additionally, these data will serve as a basis for the initiation of a broader Phase II clinical program in Sézary syndrome and other subtypes of T-cell lymphomas. We look forward to providing more insight into the data and subsequent clinical development plans in the near future."

As of June 28, 2018, a total of 44 patients with relapsed/refractory CTCL were evaluable for safety and clinical activity. The study consisted of two parts: a dose-escalation (n=25) and a cohort expansion (n=19). Patients received a median of 3 prior systemic therapies. IPH4102 demonstrated a favorable safety profile and was well-tolerated. The study showed clinical activity that was demonstrated by a high response rate and long progression free survival.

In the total study population, the objective response rate (ORR) was 36% and median duration of response (DOR) and progression free survival (PFS) were 13.8 and 8.2 months, respectively. Sézary syndrome (SS) subset patients treated in the dose-escalation part (n=20) now show median PFS of close to 1 year. At the cut-off date of June 28, 2018, median follow-up was 12.7 months and nine patients were still ongoing treatment.

Better outcomes were observed in patients without evidence of histologic large cell transformation (LCT) (n=29); these patients achieved an ORR of 51.7% and PFS of 12.8 months. LCT is present in approximatively 10% of all Mycosis fungoides/Sézary syndrome patients* and is associated with poorer prognosis and shorter survival using currently available therapies.

"This patient population remains a high unmet medical need as they continue to progress through several lines of treatments," commented Pr Martine Bagot, Principal Investigator. "The patients with complete response, partial response and even those with stable disease showed an improvement in quality of life parameters overtime including pruritus. IPH4102’s encouraging clinical activity provides substantial support to explore its potential therapeutic benefits not only in SS patients but also in other T cell lymphoma patient populations. Together with a favorable safety profile, IPH4102 could emerge as a key therapeutic option in aggressive T-cell lymphomas."

On September 28, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY), (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported the execution of a Common Stock Purchase Agreement ("Agreement") for up to US$26.0 million with Lincoln Park Capital Fund, LLC ("LPC"), an institutional investor (Press release, Oncolytics Biotech, SEP 28, 2018, View Source [SID1234532280]).

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Upon signing of the Agreement, dated September 27, 2018, LPC initially purchased 248,762 shares for $1,000,000, representing a purchase price of approximately $4.02 per share. Thereafter and subject to the terms and conditions of the Agreement, Oncolytics has the right to sell and LPC is obligated to purchase, up to $25 million worth of common stock over a 30-month period at prices that are based on the market price at the time of each sale to LPC. Oncolytics, in its sole discretion, controls the timing and amount of all sales of common stock and there are no warrants, derivatives, or other share classes associated with this Agreement.

"We are pleased to enter this agreement with Lincoln Park Capital, an existing investor, which provides Oncolytics with additional access to capital and financial flexibility, if needed, as we conduct our clinical programs and approach multiple milestones over the next twelve to eighteen months," said Kirk Look, CFO at Oncolytics Biotech. "Importantly, this facility is completely at our discretion and supports our strategy in negotiating future collaborations and, or, a potential partnership."

Oncolytics has the right to terminate the Agreement at any time, at no cost or penalty. Additionally, LPC has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company’s common stock. As consideration for LPC’s obligation under this Agreement, Oncolytics has and may issue additional shares as a commitment fee. Proceeds are intended to be used for general corporate purposes and working capital requirements.

The Company has filed a prospectus supplement, dated September 28, 2018, with respect to its U.S. registration statement on Form F-10 (333-224432) (the "Registration Statement") and Canadian final base shelf prospectus (the "Base Shelf Prospectus"), each dated May 4, 2018, pursuant to which the Company may issue up to US$26,910,000 of common shares pursuant to the terms of the Agreement (representing an aggregate market value of not more than 10% of the market value of the Company’s outstanding common shares based on the determination date under applicable securities laws). Pursuant to the Agreement, the Company may file additional prospectus supplements in the United States and in Canada in the future to qualify the sale of additional common shares to LPC that would result in aggregate gross proceeds to the Company of up to US$26,000,000. No offers or sales of any common shares will be made in Canada or on the Toronto Stock Exchange pursuant to the Agreement or the prospectus supplement. Electronic copies of the prospectus supplement and accompanying prospectus are available on the SEC’s website at View Source or by contacting the Company’s Investor Relations Department at (403) 670-7377.

The common shares to be issued in the Financing have been approved for listing on the NASDAQ and on the Toronto Stock Exchange.

This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these common shares in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On September 28, 2018 Tusk Therapeutics Ltd ("Tusk") reported that acquired by Roche (Press release, Tusk Therapeutics, SEP 28, 2018, View Source [SID1234533243]). Tusk has developed an antibody with a novel mode of action aimed at depleting regulatory T-cells (Tregs). Tregs suppress immune responses, including those against cancer cells. Preclinical data has shown that depleting Tregs from the tumor microenvironment can enhance and/or restore anti-tumor immunity. Tusk’s antibody has been designed to deplete these harmful Tregs, while not interfering with other immune cells acting against the tumor. Tusk’s program is expected to start clinical trials in cancer patients towards the end of 2019.

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Tusk was founded in 2014 by Droia Oncology Ventures, Tusk’s majority shareholder. Under the terms of the agreement, Tusk’s shareholders will receive an upfront cash payment of Euro 70 million, plus additional contingent payments of up to Euro 585 million based on achievements of certain predetermined milestones.

Luc Dochez, Chief Executive Officer of Tusk Therapeutics, said: "We are delighted that Roche will further develop this novel antibody and drive the development ahead. The remaining portfolio of our immune-oncology targets will be further developed by Black Belt Therapeutics, a newly formed company spun out of Tusk Therapeutics."