On May 2, 2018 Triumvira Immunologics, a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack multiple cancers, reported a strategic relationship with the Centre for Commercialisation of Cancer Immunotherapy (C3i), a catalyst for accelerating market access of breakthrough innovations to fight cancer (Press release, Triumvira Immunologics, MAY 2, 2018, View Source [SID1234525978]). Under the terms of the agreement, C3i will deliver cell therapy products for Triumvira’s global Phase 1 and 2 clinical trials and has committed to underwrite an investment in the company.

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"As we work toward our goal of entering clinical development in 2019, we understand the importance of securing sufficient product from a state-of-the-art facility."

"We are very pleased to be working with C3i for the manufacturing at the Centre of Excellence in Cellular Therapy (CETC) GMP manufacturing facility. It is critical for us to have a supplier with specific expertise in cellular therapies, including cancer immunotherapies," said Paul Lammers, MD, MSc, President & CEO, Triumvira. "As we work toward our goal of entering clinical development in 2019, we understand the importance of securing sufficient product from a state-of-the-art facility."

Francois Bettez, President & CEO of C3i, commented, "We are honored to be supporting Triumvira Immunologics in their drug development program. Their selective and targeted approach to treat cancer aligns well with our manufacturing expertise as well as our commitment to bringing new treatment options to patients with cancer."

As part of the deal, C3i also obtained a license to commercialize Triumvira’s lead product candidate, CD19 TAC, in Canada. "As part of the C3i mission, we not only build long-term partnerships but also ensure that the Canadians will have access to innovative technologies" commented Louisa Petropoulos, Director of Business Development at C3i.

The Centre of Excellence for Cellular Therapy (CETC), located at Hôpital Maisonneuve-Rosemont in Montreal, is a fully operational state-of-the art cGMP manufacturing facility for cellular therapies, including cancer immunotherapies and regenerative medicine. It is the only operational GMP validated center in Canada with commercial capacity, and is compliant with EMA, FDA and Health Canada regulatory requirements

About the Centre for Commercialisation of Cancer Immunotherapy
Established in 2016, the Centre for Commercialisation of Cancer Immunotherapy (C3i) is a Centre of Excellence for Commercialisation and Research from the Networks of Centres of Excellence. The mission is to accelerate access to innovative cancer immunotherapies for patients and offers an integrated structure for the development, translation and commercialization of groundbreaking therapies. C3i, which operates out of the Hôpital Maisonneuve- Rosemont in Montreal, Canada, combines four interacting units: GMP Manufacturing Unit for Regenerative Medicine and Cancer Immunotherapy; Biomarker-Diagnostic Unit; Clinical Research Unit; and Innovation and Commercialization Unit. For more information, visit: www.centrec3i.com

About Maisonneuve Rosemont Hospital (CIUSSS-EMTL)
Affiliated to the Université de Montréal, Hôpital Maisonneuve-Rosemont (HMR) is part of CIUSSS-EMTL. The HMR has a major research center of close to sixty researchers. There are four distinct sectors at the national and international levels: immuno-oncology, vision health, nephrology and cell therapy. Each year, the HMR receives more than 4,000 students, future physicians, nurses and health care professionals. HMR’s cancer program supports one of the largest bone marrow transplantation unit in Canada and is recognized a Canadian leader in cell therapy.

On May 2, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age-related macular degeneration, reported that it will report its first quarter 2018 financial and operating results after the close of U.S. financial markets on Wednesday, May 9, 2018 (Press release, Tracon Pharmaceuticals, MAY 2, 2018, View Source [SID1234525977]). In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly financial results.

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Conference call and webcast:
Date: May 9, 2018
Time: 4:30 pm Eastern Time (1:30 pm Pacific Time)
Dial-in: (855) 779-9066 (Domestic) or (631) 485-4859 (International)
Passcode: 3189378
Via web: www.traconpharma.com; "Events and Presentations" section within the "Investors" section

A replay of the webcast will be available for 60 days on the website.

On May 2, 2018 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that management will present at the Bank of America Merrill Lynch Health Care Conference 2018 on Tuesday, May 15, 2018 at 5:00 p.m. Pacific Time (Press release, Seattle Genetics, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346286 [SID1234525976]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section

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On May 2, 2018 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that there will be a Symposium on the Company’s lead drug Fexapotide held at the Annual Meeting of the American Urological Association on May 20 in San Francisco (Press release, Nymox, MAY 2, 2018, View Source [SID1234525975]). The Symposium is entitled:

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"Phase 3 Clinical Studies and Biology of Fexapotide Triflutate Office Injectable for BPH"

and will feature a presentation reviewing therapeutic highlights from the Company’s extensive Phase III trials involving more than 970 patients in the United States. The presentation is chaired by Dr. Ronald Tutrone of Chesapeake Urology Research Associates, Baltimore MD and a panel discussion with panel members including Dr. Mohamed Bidair, San Diego CA; Dr. Ivan Grunberger, New York NY; Dr. Alan Hay, Salem OR; Dr. Susan Kalota, Tucson AZ and Dr. Jeffrey Snyder, Denver CO.

The Annual Meeting of the AUA is the largest urology meeting held annually in the US and brings together over a 4 day period urologists and health care providers, industry and interested parties from across the world with an expected attendance of over 16,000 visitors.

Nymox’s fexapotide has been shown to produce long-term improvements in lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), a problem that afflicts an estimated 100 million or more men in the world. Fexapotide does not cause the annoying side effects and risks found with available treatments for BPH and has also been shown to lower the occurrence of surgery for BPH. Fexapotide is also in development for low grade prostate cancer.

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, 2017, and its Quarterly Reports

On May 2, 2018 Sandoz, a Novartis division, reported that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab (Press release, Novartis, MAY 2, 2018, View Source [SID1234525974]).

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Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.

There is a substantial unmet need for access to safe and effective therapies. Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilar medicines. As the pioneer and global leader in biosimilar medicines, Sandoz has five biosimilar medicines currently marketed in various countries worldwide, as well as a leading global pipeline.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," "evaluating," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labelling for biosimilar rituximab, or any of the other investigational or approved biosimilar products described in this press release, or regarding potential future revenues from biosimilar rituximab and such other investigational and approved biosimilar products. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that biosimilar rituximab or any of the other investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time. Neither can there be any guarantee that if approved, biosimilar rituximab or such other biosimilar products will be approved for any or all of the indications in the respective reference product’s label. Nor can there be any guarantee that biosimilar rituximab, the other marketed products in the Sandoz biosimilar portfolio, or the potential products in the Sandoz biosimilar pipeline will be commercially successful in the future. In particular, management’s expectations regarding biosimilar rituximab and such other biosimilar products could be affected by, among other things, regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; competition in general, including potential approval of additional versions of biosimilar rituximab or such other biosimilar products; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its biosimilar products; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.