On November 2, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that preliminary clinical and immunological data from its ongoing KEYNOTE-695 study, a global, multicenter, registration-directed Phase 2b trial of TAVO in combination with KEYTRUDA for the treatment of metastatic melanoma, were accepted for a late-breaking Poster Presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting to be held at the Walter E. Washington Convention Center in Washington, D.C. on November 7-11, 2018 (Press release, OncoSec Medical, NOV 2, 2018, View Source [SID1234530633]).

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The details of the Poster Presentation are as follows:

Presentation Title: Initial report of intratumoral tavokinogene telseplasmid with pembrolizumab in advanced melanoma: an approach designed to convert PD-1 antibody progressors into responders.
Author: Atkinson, et. al.
Poster Number: P717
Presentation date: Friday, November 9 and Saturday, November 10, 2018

The late-breaking abstract titles can be found on the conference website here.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On November 2, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that it will announce its 2018 third quarter results on Friday, November 9, 2018 (Press release, Bavarian Nordic, NOV 2, 2018, View Source [SID1234530666]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CET (8:00 am EST) on the same day to present the interim results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at http://bit.ly/2Rv5ulo.

To join the Q&A session dial one of the following numbers and state the participant code 8332812: Denmark: +45 35 15 81 21, UK: +44 (0) 330 336 9411, US: +1 323-794-2551.

On November 2, 2018 I-MAB Biopharma Co., Ltd. ("I-Mab"), a Shanghai-based biotech company exclusively focused on innovative biologics in immuno-oncology and autoimmune diseases, and Genexine Inc. (KOSDAQ: 095700), a South Korea-listed clinical stage pharma company developing innovative biologics, jointly reported that China National Medical Products Administration (NMPA) has officially approved the Investigational New Drug (IND) application for TJ107 (HyLeukin), the first and only long-acting recombinant human interleukin-7 (rhIL-7) globally to treat chemotherapy induced lymphopenia and cancer (Press release, I-Mab Biopharma, NOV 2, 2018, View Source [SID1234530691]).

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"We are pleased that the NMPA has given their greenlight to the IND filing, which is another significant development milestone in advancing our China Portfolio," said Joan Shen, M.D., Ph.D., President of R&D at I-Mab. "The clinical potential of TJ107 (HyLeukin) has been recognized and endorsed by the regulatory authorities, since there is no approved treatment globally for lymphopenia, the unmet medical need is substantial."

TJ107 (HyLeukin) is an immuno-oncology agent comprised of an optimally engineered interleukin-7 (IL-7) molecule based on Genexine’s proprietary hybrid Fc (hyFc) technology for half-life extension, with improved stability and developability. I-Mab has development and commercialization rights to TJ107 (HyLeukin) in Greater China through an exclusive licensing agreement with Genexine in December 2017.

"The IND approval in China for Hyleukin-7 clinical trial is a very important progress in its development and the data generated from the study in cancer patients with lymphopenia will significantly contribute to the global development of Hyleukin-7 as an antitumor immunotherapeutic," commented by Kyudon Kim, Ph.D., President at Genexine, Inc..

"Our long term goal is to develop TJ107 into a potential global first-in-class immuno-oncology therapy," Shen added

On November 2, 2018 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary immune cell-activating cancer treatments, reported the completion of a $6.5 million Series B financing (Press release, Intensity Therapeutics, NOV 2, 2018, View Source [SID1234530618]).
Intensity plans to use the proceeds of the financing to advance the clinical development of lead product candidate INT230-6, a direct intratumoral injection that is currently being evaluated in a Phase 1/2 clinical study in patients with various advanced solid tumors. The Company intends to expand the study by adding clinical sites outside the U.S. and Canada, as well as adding combination arms with an anti-PD-1 antibody.

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"The support from our investors in this round, who purchased stock at a 150 percent premium to our Series A financing, underscores the potential of INT230-6 and our proprietary DfuseRxSM technology discovery platform," said Lewis Bender, Founder and Chief Executive Officer of Intensity. "With this funding, we are well positioned to complete the ongoing Phase 1/2 study of INT230-6, including planned combination arms with an anti-PD-1 antibody, and initiate Phase 2a studies in specific tumor types next year. We look forward to further evaluating the safety and efficacy of INT230-6 to ultimately bring a novel, intratumoral, immune response-activating treatment to patients with refractory solid tumor cancers."

As the Company recently reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, preliminary data from the ongoing Phase 1/2 study demonstrated intratumoral injections of INT230-6 were well tolerated with no drug-related serious adverse events or dose-limiting toxicity in patients with advanced solid tumors. In addition, increases in circulating CD8 and CD4 T-cells and evidence of abscopal responses in non-injected tumors were observed. Preliminary data from this study will also be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, which is being held November 7-11 in Washington, DC.

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

On November 2, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the first patient has been dosed in the Archer-1 trial investigating Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, NOV 2, 2018, View Source [SID1234530667]).

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Rituximab is a CD20-targeting monoclonal antibody that is administered to patients with newly-diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to RTX, thus alternative targets are important. In addition, developing novel "chemo-free" regimens for patients as an alternative to chemotherapy is desirable.

Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of combining CD37-targeted Betalutin with CD20-targeted RTX in 20-25 patients with relapsed/refractory FL who have received one or more prior therapies. Starting doses of Betalutin and lilotomab are 10MBq/kg and 40mg, respectively, with the option for dose escalation. Following Betalutin dosing, patients will receive four weekly doses of RTX (375mg/m2). The primary endpoint is safety, and secondary endpoints include overall response rate, duration of response, progression free survival and overall survival.

The rationale for Archer-1 was provided by preclinical data recently published in the European Journal of Haematology in July 2018 (reference below). These data demonstrate that treatment with the combination of Betalutin and RTX significantly prolonged overall survival in a murine model of NHL compared to treatment with either agent alone, possibly by reverting downregulation of CD20 and resistance to RTX.

Eduardo Bravo, Nordic Nanovector CEO, commented: "Archer-1 presents an opportunity to investigate the potential of a novel dual CD37/CD20-targeting combination approach in 2L FL patients. If the preclinical results translate to patients, this may indicate a new way to administer biologic therapy in FL."

Reference

Repetto-Llamazares, A.H.V. et al. Combination of 177Lu-lilotomab with rituximab significantly improves the therapeutic outcome in preclinical models of non-Hodgkin’s lymphoma. Eur J Haematol. 2018 View Source

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About Betalutin

Betalutin is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and safety in the first part of the Phase 1/2 LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL). A global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to anti-CD20 immunotherapy (including rituximab, RTX) is currently on-going. Betalutin is also being investigated in the Phase 1b Archer-1 study in combination with RTX in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma (NHL). Betalutin has been granted Fast Track designation in the US and Promising Innovative Medicine (PIM) Designation in the UK for the treatment of patients with R/R FL. Betalutin also received Orphan Drug designations for FL in both the USA and Europe in 2014. Betalutin is selective for CD37, which is highly expressed on the surface of B-cell non-Hodgkin’s lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin is internalised, causing DNA damage and cell death.