On November 10, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it is presenting two trials in progress posters summarizing study designs for ongoing clinical trials with MAGE-A4 and NY-ESO SPEAR T-cells at the 2017 SITC (Free SITC Whitepaper) annual meeting at the Gaylord National Hotel & Convention Center in National Harbor, Maryland, United States (Press release, Adaptimmune, NOV 10, 2017, View Source;p=RssLanding&cat=news&id=2316203 [SID1234521929]).

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Overview of Study Designs:

MAGE-A4 SPEAR T-cells targeting multiple solid tumors1:
– Open-label, non-randomized pilot study evaluating the safety, tolerability, and antitumor activity of MAGE-A4 SPEAR T-cells in patients with HLA-A*02 and MAGE-A4 positive inoperable locally advanced or metastatic tumor(s)
– This dose escalation study utilizes a modified 3+3 design:
• Group 1: to enroll 3-6 patients; dose of 100 million transduced SPEAR T-cells, 21-day interval for safety review
• Group 2: to enroll 3-6 patients; dose of 1 billion transduced SPEAR T-cells, 7-day interval for safety review2
• Group 3: to enroll 3-6 patients; dose of 1-5 billion transduced SPEAR T-cells, 7-day interval for safety review2
• Study allows for expansion at optimal dose range up to 20 patients across tumors
– Patients must be: ≥ 18 yrs old; HLA-A*02 positive; have MAGE-A4 positive inoperable locally advanced or metastatic tumor(s) at ≥1+ intensity in ≥ 10% of tumor cells MAGE-A4 expression by immunohistochemistry (IHC); have ECOG status 0 or 1; and adequate organ function
– Lymphodepletion regimen: fludarabine (30 mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days
– Efficacy assessed by overall response rate, time to response, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months until confirmation of disease progression
– The study is open and enrolling

NY‑ESO SPEAR T-cells with or without KEYTRUDA (pembrolizumab) in multiple myeloma:
– Open-label, randomized pilot study evaluating the safety, tolerability, and antitumor activity of NY-ESO SPEAR T-cells with or without KEYTRUDA in patients with multiple myeloma
– Eligible patients will be randomly assigned to a treatment arm: NY-ESO SPEAR T-cells alone (Arm 1) or NY-ESO-1 SPEAR T-cells in combination with KEYTRUDA (Arm 2)
– Target enrollment is 20 patients with 10 in each arm; eligible patients who do not receive the T‑cell infusion may be replaced.
– Patients must be: ≥ 18 yrs old; HLA-A*02:01, *02:05, or *02:06 positive; have histologically confirmed diagnosis of multiple myeloma with either primary refractory or relapsed/refractory disease expressing NY-ESO-1 and/or LAGE-1a; have received prior therapies including IMiD and a proteasome inhibitor as separate lines or a combined line of therapy; have ECOG status 0 or 1; and adequate organ function
– Lymphodepletion regimen: fludarabine (30 mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days, followed by granulocyte-colony stimulating factor
– For patients in Arm 2, KEYTRUDA will be administered every 3 weeks, starting at week 3 following T-cell infusion until week 108
– Target dose of 1 – 8 × 109 transduced SPEAR T-cells
– Efficacy will be assessed by the International Myeloma Working Group (IMWG) Uniform Response Criteria. Overall response rate, time to response, duration of response, progression-free survival, and overall survival will be determined.
– The study is open and enrolling

On November 10, 2017 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported that five posters based on the Company’s PD-1-directed franchise will be presented at the 2017 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD (Press release, MacroGenics, NOV 10, 2017, View Source [SID1234521925]).

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Posters will be displayed in the poster hall both Friday, November 10 and Saturday, November 11. Presentation details are provided below:

MGA012 (anti-PD-1 monoclonal antibody):

P249: "A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics (PK) of MGA012 (anti‐PD‐1 Antibody) in Patients with Advanced Solid Tumors"

P336: "Preclinical Characterization of MGA012, a Novel Clinical‐stage PD‐1 Monoclonal Antibody"

MGD013 (PD-1 x LAG-3 bispecific DART molecule):

P244: "A Phase 1, First‐in‐Human, Open‐label, Dose Escalation Study of MGD013, a Bispecific DART Protein Binding PD‐1 and LAG‐3 in Patients with Unresectable or Metastatic Neoplasms"

P337: "Preclinical Characterization of MGD013, a PD‐1 x LAG‐3 Bispecific DART Molecule"

MGD019 (PD-1 x CTLA-4 bispecific DART molecule):

P308: "A PD‐1 x CTLA‐4 Bispecific DART Protein with Optimal Dual Checkpoint Blockade and Favorable Tolerability in Non-human Primates"

The above posters are available for download from the Events & Presentations page on MacroGenics’ website at View Source

On November 10, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported data from preclinical studies with ADU-1604, the company’s humanized anti-CTLA-4 monoclonal antibody. Data from these in vitro and in vivo studies demonstrate the potency of ADU-1604 and its ability to inhibit tumor growth and enhance T cell-dependent antibody responses (Press release, Sangamo Therapeutics, NOV 10, 2017, View Source;p=RssLanding&cat=news&id=2316178 [SID1234521919]). These data, which will be highlighted later today in a poster presentation (Poster #335) at the 32ND Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), underscore the potential application of ADU-1604 for the treatment of multiple cancer types, either as monotherapy or in combination with other therapies.

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"These data from preclinical studies of ADU-1604, a novel anti-CTLA-4 product candidate derived from our proprietary B-select antibody platform, are encouraging and provide support to file an Investigational New Drug Application to advance ADU-1604 into clinical studies," stated Andrea van Elsas, Ph.D., chief scientific officer of Aduro Biotech. "As a company with multiple programs and proprietary technology platforms, we are well positioned to leverage our product candidates, as monotherapies and in rational combinations, to develop new treatment options for patients in need."

Presentation Title: Characterization of a novel differentiated anti-CTLA-4 antibody (ADU-1604) in vitro and in vivo
Researchers conducted in vitro and in vivo studies comparing ADU-1604 to benchmark anti-CTLA-4 antibodies 10D1 (‘ipilimumab’) and CP-675,206 (‘tremelimumab’). Data from these studies demonstrate that ADU-1604 binds to a unique epitope on a human CTLA-4 (hCTLA-4) and is at least comparable to benchmarks in functionality. Data from in vivo studies using a well-established humanized mouse model of non-small cell lung cancer and a non-human primate model, demonstrate that ADU-1604 inhibits tumor growth and enhances T cell responses, respectively. Further, proof of concept studies in syngeneic mouse models demonstrate that anti-CTLA-4 further enhances anti-tumor activity when used in combination with ADU-S100 (also known as MIW815), Aduro’s lead investigational STING agonist, and in combination with Aduro’s proprietary immunotherapy platform of live-attenuated double-deleted Listeria monocytogenes strains (LADD).

About CTLA-4
Cytotoxic T‐lymphocyte‐associated protein 4 (CTLA‐4) is a negative regulator of T‐cell responses and is an immune checkpoint. Blocking CTLA-4 using antibodies may produce an anti-tumor response by enhancing T cell activation and their cancer cell killing activity in the tumor. This therapeutic target has been clinically validated by others in advanced melanoma. Aduro is developing a proprietary humanized anti-CTLA-4 antibody (ADU-1604) that binds to a unique epitope and its potency has been demonstrated in vitro and in vivo. Based on preclinical studies, Aduro believes that ADU-1604 when combined with innate and adaptive immune cell stimulators, such as STING agonists and cancer vaccines, can display an amplified anti-tumor effect against poorly immunogenic tumors. Aduro’s CTLA-4 antibody is being advanced through IND-enabling studies.

On November 10, 2017 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that a Symposium on Fexapotide Triflutate studies will be held at the Annual Meeting of the American Urological Association North Central Section, in Scottsdale AZ next week (Press release, Nymox, NOV 10, 2017, View Source;fvtc=4&fvtv=6907 [SID1234521932]). The symposium, "Fexapotide Triflutate: Long-Term BPH Studies 2009-2017" will be chaired by Mohamed Bidair MD of San Diego CA. The other panel members at the Symposium will be Alan Hay MD FACS of Salem OR, Stephen Richardson MD of Salt Lake City UT, and Barton Wachs MD of Long Beach CA.

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Nymox’s lead drug Fexapotide has been in development for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 995 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical program has also shown in a long-term blinded placebo crossover group study an 82-95% reduction in the number of these patients who required surgery after they received crossover Fexapotide in the trial, as compared to patients who did not receive Fexapotide but instead received crossover conventional approved BPH treatments (p<.0001).

The Symposium will present detailed clinical data on the Phase 3 clinical trials that have been completed for Fexapotide and that have shown excellent safety and significant efficacy for the treatment of BPH. In addition, scientific data supporting the safety and efficacy from non-clinical and laboratory testing and analysis will be demonstrated. The main presentation will be followed by a panel discussion and by an interactive question and answer session with the specialist doctors in attendance.

For more information please contact [email protected] or 800-936-9669.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox’s regulatory filings, Nymox’s substantial dependence on Fexapotide, Nymox’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. Nymox undertakes no obligation to update or revise any forward looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2016, and its Quarterly Reports.

On November 9, 2017, Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that Stephen Hurly, President and Chief Executive Officer, will present a company overview at the Stifel 2017 Healthcare Conference in New York on Wednesday, November 15, 2017 at 3:30 p.m. EST (Press release, Eleven Biotherapeutics, NOV 9, 2017, View Source [SID1234521861])Eleven Biotherapeutics, Inc. (NASDAQ:EBIO).

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A live webcast can be accessed from the Investors & Media section of Eleven’s website, www.elevenbio.com. An archived replay of the webcast will be available on the Company’s website for 90 days after the conference.