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, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that it will present preclinical safety data for the drug candidate ATOR-1017 at the 4th CRI-CIMT-EATI-AACR International Cancer lmmunotherapy Conference in New York, USA (Press release, Alligator Bioscience, SEP 28, 2018, View Source [SID1234538676]). The conference is taking place from September 30 – October 3, 2018.

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ATOR-1017 is a monoclonal antibody in development for the treatment of metastasizing cancer. It activates the costimulatory receptor 4-1BB and its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells.

The new data include preclinical safety studies supporting a good tolerability profile of ATOR-1017. The inclination for inducing cytokine release, a common adverse effect of immunotherapy, was assessed in standardized assays and was found to be low. In accord, ATOR-1017 was found to be well tolerated in a repeated dose toxicology study with no signs of adverse events. Furthermore, the expression of 4-1BB in circulating immune cells of cancer patients was found to be low. Also, co-expression of the two targets needed for effect, 4-1BB and Fc-gamma receptors, was seen in tumors but lacking in healthy liver tissue. Taken together, these data support the potential of ATOR-1017 to induce stronger immune activation in the tumor area compared to other parts of the body, which is believed to minimize the risk of systemic immune-related adverse events.

"ATOR-1017 is designed to have a superior safety and efficacy profile through its tumor-directed properties, and we are delighted that our new preclinical safety data support this. We will now push ahead with CTA-enabling activities which will allow us to begin clinical trials in cancer patients next year," said Christina Furebring, SVP Research, at Alligator Bioscience.

Dr Eva Dahlén, Senior Director Business Development at Alligator, will present a poster (A183) with the title: "ATOR-1017; a 4-1BB antibody designed for superior safety/efficacy profile in cancer immunotherapy" on Sunday, September 30, 11:45 a.m.-2:15 p.m. EDT (17:45-20:15 CEST).

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:30 a.m. CEST on September 28, 2018.

About ATOR-1017
ATOR-1017 is an immunostimulatory antibody (IgG4) that binds to the costimulatory receptor 4-1BB (also known as CD137) expressed on tumor-specific T cells and NK cells. 4-1BB has the capacity to support the immune cells involved in tumor control, making 4-1BB a particularly attractive target for cancer immunotherapy.

ATOR-1017 is differentiated from other 4-1BB antibodies, partly because of its unique binding profile, but also because its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells. The aim is to achieve effective tumor-targeted immune stimulation with minimum side effects. ATOR-1017 is planned to enter clinical studies 2019.

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."

On September 28, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it will be providing updates on its two clinical trials with TTI-621, a dual function SIRPaFc IgG1 decoy receptor that targets CD47, at two upcoming scientific conferences (Press release, Trillium Therapeutics, SEP 28, 2018, View Source [SID1234529681]). As previously announced, the presentations will be made on September 28 at the European Organisation for Research and Treatment of Cancer, Cutaneous Lymphoma Task Force (EORTC CLTF) meeting in St. Gallen, Switzerland and the 16th Annual Discovery on Target conference in Boston, MA. The presentations will be available on the Company’s website after the presentations have been delivered.

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The presentation at the EORTC CLTF meeting will provide an update on the safety and efficacy of the ongoing multicenter, open-label phase 1 intratumoral trial of TTI-621 in 23 patients with relapsed/refractory mycosis fungoides/Sézary syndrome, 20 of whom only received induction therapy consisting of 1-6 injections over 2 weeks. Local delivery of TTI-621 was well tolerated, with no treatment-related > Grade 3 adverse events or dose-limiting toxicity observed. Reductions in CAILS scores, which measure local lesion responses, were observed in 89% of patients, with 42% exhibiting reductions of 50% or greater. These responses occurred rapidly within the 2- week induction period. Similar

CAILS scores changes were seen in adjacent non-injected lesions, suggesting locoregional effects that were not confined to the site of injection. Evidence of a systemic (abscopal) effect was observed in 1 of 2 patients receiving continuation monotherapy beyond the 2-week induction therapy. In addition, data suggest a combination effect with pegylated IFN-alpha-2a.

"These data expand on the observations first presented at ASH (Free ASH Whitepaper) 2017, and highlight the potential value of localized delivery of TTI-621 in heavily pre-treated mycosis fungoides/ Sézary syndrome patients," said Dr. Yaping Shou, Trillium’s Chief Medical Officer. "We are particularly encouraged to see reductions in CAILS scores after such a short course of therapy, and the abscopal effect seen in one of the two patients receiving continuation treatment suggest that a longer duration of dosing may offer further opportunity to induce systemic responses."

"The ability to induce rapid anti-tumor responses through local administration with our potent IgG1-containing Fc fusion protein opens up numerous possibilities, not only in mycosis fungoides but also in many solid tumors. As is the case with other agents targeting the innate immune system, such as STING and TLR agonists, local administration is the route of choice to ensure instant high local drug concentrations at the site of the tumor," said Dr. Niclas Stiernholm, Trillium’s President and Chief Executive Officer. "We intend to expand the intratumoral program both with respect to additional indications and combination therapies with complementary immunostimulatory therapies, especially those acting downstream of CD47."

The presentation at the Discovery on Target conference will provide a high level update of the safety and efficacy of the ongoing multicenter, open-label phase 1a/b intravenous trial of TTI-621 in patients with relapsed/refractory hematologic malignancies. Based on an expanded data set of 163 patients, weekly infusions of TTI-621 were shown to be well tolerated. Thrombocytopenia was the most frequent grade 3 or higher treatment-emergent adverse event, occurring in 20% of patients. Platelet reductions, however, were shown to be transient and pre-dose platelet levels remained steady during the course of the study. Notably, the reversible thrombocytopenia did not lead to an increased risk of bleeding and had no impact on drug delivery, nor was there a significant impact of TTI-621 on hemoglobin levels. Monotherapy efficacy was observed in patients with mycosis fungoides (19% ORR, n=21), peripheral T-cell lymphoma, or PTCL (25% ORR, n=12), and diffuse large B-cell lymphoma, or DLBCL (25% ORR, n=8), and in DLBCL patients when combined with rituximab (25% ORR, n=24). This clinical activity was observed in patients receiving relatively low doses of drug (0.2 mg/kg for monotherapy or 0.1 mg/kg in combination with rituximab). Dose intensification beyond 0.2 mg/kg is currently ongoing, and doses of 0.5 mg/kg have been well tolerated for up to 27 weeks.

"These data reinforce our prior observations that thrombocytopenia, which we believe to be an on-target pharmacodynamic effect, does not appear to be clinically consequential. Based on the data in hand, the transient decrease in platelets is not associated with bleeding events or premature treatment discontinuations, and has not impacted our ability to dose intensify patients beyond 0.2 mg/kg," commented Dr. Shou. "The monotherapy

anti-tumor activity we have observed in multiple disease indications is particularly intriguing given that patients have received relatively low doses of drug. Characterizing the efficacy of TTI-621 at higher doses, which is currently ongoing, remains a top priority in the intravenous trial."

"Having concluded this exploratory phase in a wide variety of hematologic malignancies and having gained increased clarity with respect to potential registration paths, we plan to move forward with three distinct clinical programs: intratumoral mono- and combination-therapy in CTCL, intravenous monotherapy in both CTCL and PTCL, as well as intravenous combination therapy in DLBCL," said Dr. Stiernholm. "While we are gratified to have observed meaningful clinical responses with monotherapy at low doses, we are equally excited about how well tolerated TTI-621 appears to be, allowing us to incorporate dose intensification as a major component of our clinical efforts moving forward."