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

For further information, please contact:

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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.

On November 2, 2018 CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the quarter ended September 30, 2018, and provided an overview of recent accomplishments and plans for its research and development programs (Press release, CytRx, NOV 2, 2018, View Source [SID1234530692]).

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"The third quarter of 2018 was highlighted by the filing of a provisional patent by Centurion BioPharma for the breakthrough albumin companion diagnostic (ACDx) for use alongside our innovative LADR (Linker Activated Drug Release) assets," said Eric Curtis, CytRx’s President and Chief Operating Officer. "This new intellectual property is an important component of the overall LADR value proposition and will enhance our efforts to secure a strategic partnership to further advance these unique, promising assets, with the overarching goal of bringing these albumin binding ultra-high potency drug candidates to the physicians and patients who need them."

"Also during the quarter, we were pleased to make the final payment under our long-term loan agreement, and thereby extinguishing all of our outstanding debt. We also saw the expiration of approximately 3.2 million outstanding warrants for shares of our common stock, improving our overall capital structure."

Third Quarter 2018 and Recent Highlights

Centurion BioPharma Corporation

Breakthrough Personalized Medicine Companion Diagnostic Filed for Albumin-Binding LADR Drug Candidates. In July 2018, Centurion filed a provisional patent application with the U.S. Patent and Trademark Office covering its unique albumin companion diagnostic (ACDx) for use alongside its albumin binding ultra-high potency LADR drug candidates. The goal of ACDx is to identify patients with cancer who are most likely to benefit from the treatment with the Company’s lead assets, LADR-7, LADR-8, LADR-9 and LADR-10 and any albumin-binding drugs the Company may generate in the future.
CytRx Corporation

Receipt of Milestone Payment from Orphazyme A/S. In September 2018, CytRx announced receipt of a milestone payment totaling $250,000 (USD) from Orphazyme A/S (CPH: ORPHA). The payment was a result of Orphazyme dosing the first patient in their Phase 3 clinical trial evaluating arimoclomol in patients with amyotrophic lateral sclerosis. Orphazyme, a public company trading on the Nasdaq Copenhagen exchange, is testing arimoclomol in three additional indications beyond ALS, including Niemann-Pick disease Type C, Gaucher disease and sporadic Inclusion Body Myositis. Should arimoclomol be approved for NPC in Europe, CytRx will receive a $4 million milestone payment, plus royalties. Additional arimoclomol milestones include $6 million upon approval in the U.S. and $2 million upon approval in Japan, plus royalties on net sales in all territories.
Paid Off Long-Term Loan. In August 2018, CytRx announced that it made the final payment under a long-term loan agreement. As of August 1, 2018, the loan was paid in full, which extinguished all of CytRx’s outstanding debt.
Expiration of the Majority of Outstanding Warrants. In July 2018, CytRx announced the expiration of warrants for approximately 3.2 million shares of its common stock. CytRx believes the expiration of these warrants, the majority of which were associated with a public offering in December 2016, eliminates overhang and provides additional common share float stability.
Participated in Three Institutional Investor Conferences. During the third quarter, CytRx participated in three institutional investor conferences in New York City, including the H.C. Wainwright & Co. 20th Annual Global Investment Conference, the 2018 MicroCap Conference and the Singular Research Summer Solstice 2018 Conference. At each conference, CytRx executive management made a formal presentation and had one-on-one meetings with institutional investors.
Third Quarter 2018 Financial Results

CytRx reported cash and cash equivalents of $24.7 million as of September 30, 2018.

Net loss for the quarter ended September 30, 2018, was $3.3 million, or $(0.10) per share, compared with a net loss of $5.1 million, or $(0.19) per share, for the comparative 2017 period, a reduction of $1.8 million, or approximately 36 percent. The comparative 2017 quarter included a non-cash gain of $3.8 million on the fair value adjustment of warrant derivative liabilities related to warrants issued in 2016, compared to no gain during the current third quarter related to these now expired warrants.

Research and development (R&D) expenses were $0.9 million for the third quarter of 2018, which represents primarily expenses for the development of the albumin companion diagnostic (ACDx). In the third quarter of 2017, R&D expenses of $4.8 million included $3.7 million related to our aldoxorubicin program and its clinical support and $1.0 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs.

General and administrative (G&A) expenses were $2.4 million for the third quarter of 2018, compared with $3.4 million for the third quarter of 2017. G&A expenses decreased by approximately 31 percent primarily due to a decrease in professional fees.

Based on our currently projected expenditures for the next 13 months our monthly burn rate is estimated at approximately $700,000 per month.

Conference Call and Webcast

CytRx will be hosting a conference call and webcast today beginning at 11:00 am Eastern Time (8:00 am Pacific Time). To access the conference call, dial (+1) 844-358-6753 (U.S. and Canada) or (+1) 216-562-0397 (international callers) and enter the conference ID number: 4382473. A live and archived webcast will be available in the News and Events/Events Calendar section of the Company’s website, www.cytrx.com. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial (+1) 855-859-2056 (U.S. and Canada) or (+1) 404-537-3406 (international callers) and enter the conference ID number: 4382473.