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.

On May 2, 2018 MannKind Corporation(Nasdaq:MNKD) reported that it will release its 2018 first quarter financial results on Wednesday, May 9, 2018 and its management will host a conference call to discuss the financial results and other Company developments at 5:00 PM (Eastern Time) on May 9, 2018 (Press release, Mannkind, MAY 2, 2018, View Source [SID1234525992]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna, Chief Financial Officer, Steven Binder, Chief Commercial Officer, Pat McCauley and Chief Medical Officer, David Kendall.

To view and listen to the earnings call webcast live via the Internet, visit the Company’s website at www.mannkindcorp.com and click on the "Q1 2018 MannKind Earnings Conference Call" link in the Webcasts section of News & Events. To participate in the live call by telephone, please dial (800) 289-0438 toll-free or (323) 794-2423 toll/international and use the conference passcode: 3321662.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 toll-free or (412) 317-6671 toll/international and use the replay passcode: 3321662. A replay will also be available on MannKind’s website for 14 days.

On May 2, 2018 OnKure, Inc., the epigenetics–focused drug discovery and development company that is advancing the first Largazole-derived, histone deacetylase inhibitor into Phase 1 clinical trials, reported it has completed a $7M Series A financing (Press release, OnKure, MAY 2, 2018, View Source [SID1234535520]). Delian Capital led the investment round with participation from existing and new investors including OnKure management. The investment will help the company aggressively accelerate its research and development activities.

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Delian Capital invests in early stage biopharmaceutical startups that redefine or create large new markets, with notable investments such as Chance Pharma, MicuRx and Bioceutiq. The Series A financing builds on an exceptional year for OnKure, which made significant progress towards advancing its first clinical candidate, OKI-179, towards Phase 1.

OnKure’s platform transforms naturally occurring, biologically active lead compounds into commercial drugs that address a variety of diseases with an emphasis on oncology. At the heart of OnKure’s solution to Class 1 histone deacetylase inhibition is a molecule (OKI-179) that parallels the potency and selectivity of Romidepsin (Istodax), the most potent Class 1 biased histone deacetylase inhibitor currently approved by the FDA. While Romidepsin is administered by continuous infusion, OKI-179 was designed as an orally active drug and has demonstrated a superior safety profile in preclinical studies. As an orally administered therapy, it is also more suitable for combination dosing with a variety of targeted anti-cancer agents.

"We are delighted that Delian Capital chose to lead our Series A round and I look forward to working with Mr. Guobao Zhao, Vice President of Delian Capital’s Healthcare Division and OnKure’s newest addition to the board," said Tony Piscopio, co-founder, President & CEO of OnKure. "OnKure will use these funds to accelerate the clinical development of OKI-179 and expand its pipeline through in-licensing first–in–class or best–in–class compounds that synergize with OKI-179."

Mr. Guobao Zhao, Vice President of Delian Capital, commented, "Delian invests in pharmaceutical companies with a deep understanding of disease mechanisms and extensive clinical expertise." Mr. Zhao added, "OnKure has a very experienced management team, and thus we look forward to supporting the parallel development of OKI-179 in the United States and China, as this novel HDAC inhibitor has the potential to offer an attractive option for addressing cancer’s growing unmet medical needs."

On May 2, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the 2018 Bank of America Merrill Lynch Health Care Conference on Wednesday, May 16, 2018 (Press release, Incyte, MAY 2, 2018, View Source [SID1234525938]). Richard A. Gonzalez, chairman and chief executive officer, will present at 6:20 p.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On May 2, 2018 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to initiate a Phase 1 clinical trial for UCART22, Cellectis’ second wholly controlled TALEN gene-edited product candidate, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL) in adult patients (Press release, Cellectis, MAY 2, 2018, View Source;utm_medium=feed&utm_campaign=Feed%3A+cellectis+%28Cellectis+RSS+Feed%29#When:20:30:00Z [SID1234525958]).

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Pending regulatory clearance, Cellectis plans to initiate a Phase I clinical trial in the third quarter of 2018. The clinical research will be led by Dr. Nitin Jain, Assistant Professor, and Prof. Hagop Kantarjian, Chairman in the Department of Leukemia and University Chair in Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston.

"This IND application for UCART22 is an important regulatory milestone for the Company," said Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis. "The first ever FDA approval for a CAR T-cell therapy, directed against CD19, for pediatric and young patients with R/R B-ALL occurred in 2017. However, further CART approaches are needed, as some limitations of the CD19-CART treatment appear to be due to the expansion of CD19-negative leukemia clones.[1] The UCART22 product candidate will be evaluated in relapsed or refractory CD22 B-ALL, including relapses after CD19 CAR-T administration."

Acute lymphoblastic leukemia (ALL) is a rapidly progressing form of leukemia that is characterized by the presence of a large number of immature white blood cells in the blood and bone marrow. In 2016, an estimated 6,590 new cases were diagnosed in the U.S., with over 1,400 deaths due to ALL.[2] Approximately 85 percent of ALL cases involve precursor B-cells (B-ALL).

UCART22 is an allogeneic, off-the-shelf gene-edited T-cell product candidate designed for the treatment of B-ALL. Like CD19, CD22 is a cell surface antigen expressed from the pre B-cell stage of development through mature B-cells and CD22 expression occurs in more than 90 percent of patients with B-ALL.[3]

"Given the high unmet medical need for patients who suffer from B-ALL, filing the IND is the first vital step to potentially creating a treatment to be manufactured on an industrial scale, allowing these patients to get the help that they need much faster," added Prof. Stéphane Depil, Senior Vice President Research & Development and Chief Medical Officer. "We are dedicated to making this a reality as soon as possible and look forward to hitting the ground running with the clinical trial once we obtain regulatory clearance."

The manufacturing process of Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, non-alloreactive engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production is industrialized with defined pharmaceutical release criteria.