Onconova Therapeutics to Present at the Disruptive Growth and Healthcare Conference on May 8th, 2018

On May 3, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported that the Company will present and meet investors at the 2018 Disruptive Growth and Healthcare Conference in New York City (Press release, Onconova, MAY 3, 2018, View Source [SID1234526084]). Dr. Ramesh Kumar, President & CEO, will present at the event.

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Details of the Presentation:

2018 Disruptive Growth and Healthcare Conference

Reed Smith
599 Lexington Avenue, 22nd Floor
New York, NY 10022

Presentation time: 5:05-5:25 PM EDT (breakout 5:30-05:50 PM)

Presentation room: A/B

The Company is available for investor and partnering meetings

NEOMED Institute partners with McGill University to identify small molecule inhibitors of a novel oncology target: Cut-Like Homeobox 1 (CUX1)

On May 3, 2018 The NEOMED Institute reported that it has entered into a development collaboration with McGill University (Press release, NEOMED, MAY 3, 2018, View Source [SID1234527387]). Kemal Payza, Senior Project Director at NEOMED Institute will collaborate with Professor Alain Nepveu, Professor at the Goodman Cancer Research Centre and Departments of Oncology, Biochemistry and Medicine at McGill University, to discover new therapeutic small molecules to inhibit the protein target, Cut-Like Homeobox 1 (CUX1).

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"I am delighted that we have added this new drug discovery project into NEOMED’s pipeline and I look forward to working with Dr. Nepveu on this very exciting target. Dr. Nepveu is a renowned expert on the DNA repair function of CUX1, a mechanism upon which RAS-driven cancer cells are acutely dependent for their survival. This is very important, because currently there is no treatment that targets RAS-driven tumours," explains Payza.

"This academic/industrial collaboration that we have entered into with the NEOMED Institute will permit us to rapidly leverage our biological understanding of this important target to develop small molecule drug candidates. A drug capable of interfering with the ability of CUX1 to participate in DNA repair would target many types of cancers in which reactive oxygen species are produced as a consequence of mutation in a RAS gene or any oncogene that activates the RAS pathway; such activation is seen in 59% of pancreatic cancers and some 30% of human cancers overall," adds Professor Nepveu.

"This collaboration exemplifies, once again, the ability of NEOMED to deliver on its mission to help advance academic innovation and excellence by leveraging our industrial drug development experience and expertise. We look forward to collaborating with world-leading experts, like Professor Nepveu and Zubaidah Ramdzan, to translate their science into therapeutic options for patients within the Canadian ecosystem," concludes Donald Olds, President & CEO of NEOMED Institute.

About CUX1
Activation of the RAS pathway in cancer cells leads to higher production of reactive oxygen species, which cause DNA damage by oxidation. In turn, sustained DNA damage triggers cellular senescence. Cancer cells can adapt to such oxidative DNA damage by increasing their expression of CUX1, which stimulates the activities of two enzymes that repair oxidized bases in DNA. Knocking down the CUX1 protein has been found to kill all cancer cells that have high levels of reactive oxygen species (ROS). Thus, small molecules that inhibit the ability of CUX1 to stimulate those critical DNA repair enzymes would be expected to provide therapeutic benefit to patients with RAS-driven cancers. While therapeutic approaches targeting various aspects of the DNA damage response are strategically important in cancer, direct inhibition of base excision repair enzymes can cause severe adverse effects on normal cells. In contrast, CUX1 is not essential to normal cells, but is absolutely required for survival in situations of severe genotoxic stress such as that caused by reactive oxygen species in RAS-driven cancer cells or by DNA-damaging cancer treatments. Thus, small molecules that inhibit the ability of CUX1 to stimulate base excision repair enzymes are expected to treat RAS-driven cancers with an improved therapeutic window.

Alligator Bioscience: ATOR-1017 pre-clinical data support a best-in-class 4-1BB antibody profile

On May 3, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that it will present pre-clinical data for the drug candidate ATOR-1017 at the Protein Engineering Summit (PEGS) 14th Annual Meeting in Boston, US (Press release, Alligator Bioscience, MAY 3, 2018, View Source [SID1234538678]). ATOR-1017 is a monoclonal antibody that activates the costimulatory receptor 4-1BB expressed on T cells in the tumor area and is being developed for the treatment of metastasizing cancer.

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The data support a best-in-class profile for ATOR-1017, with a strong potential for high efficacy and tumor-directed immune activation.

ATOR-1017 is dependent on cross-linking with Fc-gamma receptors. This means that it has to bind both 4-1BB and Fc receptors for full activity. Both 4-1BB and Fc-gamma receptors are highly expressed in certain tumors and these receptors could be used as predictive efficacy biomarkers. Patients that overexpress these receptors should demonstrate a higher efficacy response to ATOR-1017, resulting in an increased immune activation in the tumors compared to the rest of the body. This supports that ATOR-1017 has the potential for a superior benefit/risk profile.

"I am very encouraged by these pre-clinical data. ATOR-1017 has the ideal profile to become a best-in-class 4-1BB antibody, with strong efficacy and minimal side-effects. This is perfectly in line with Alligator’s strategy to build a pipeline of tumor-directed immunotherapies" said Christina Furebring, SVP Research at Alligator Bioscience.

Today at 4:20 p.m. local EDT (10:20 pm CEST) Dr Peter Ellmark, VP Discovery at Alligator, will give an oral presentation with the title: "Tumor-directed targeting of Effector T cells and Regulatory T cells". Dr Ellmark is chairing the session on "Agonist Immunotherapy Targets" at PEGS.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 3:00 p.m. CEST on 3 May 2018.

About ATOR-1017
ATOR-1017 is an immunostimulatory antibody (IgG4) that binds to the costimulatory receptor 4-1BB (also known as CD137) expressed on tumor-specific T cells and NK cells. 4-1BB has the capacity to support the immune cells involved in tumor control, making 4-1BB a particularly attractive target for cancer immunotherapy.

ATOR-1017 is differentiated from other 4-1BB antibodies, partly because of its unique binding profile, but also because its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells. The aim is to achieve effective tumor-targeted immune stimulation with minimum side effects.

Curis Reports First Quarter 2018 Financial Results

On May 3, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2018 (Press release, Curis, MAY 3, 2018, View Source [SID1234526008]).

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"Curis continues to advance our clinical pipeline, developing therapeutics in precision oncology and applying a small-molecule approach for immune checkpoint inhibition," said Ali Fattaey, Ph.D., Chief Executive Officer of Curis. "We continue to prepare for a pivotal study of fimepinostat, formerly CUDC-907, to bring a much-needed treatment option to patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) with MYC alterations. Our Phase 1 study of CA-4948, currently the only IRAK4 kinase inhibitor in clinical development for cancer, continues to enroll patients with lymphoma. We are also continuing to enroll patients in escalating doses in the Phase 1 clinical study of CA-170, a small-molecule dual inhibitor of PDL1 and VISTA immune checkpoints. Our collaborator, Aurigene, is also enrolling patients at sites in India in a Phase 2 trial of CA-170. We are proud of the depth of our pipeline and encouraged by the potential for the novel treatment mechanisms of our candidate therapeutics to make an impact on patient care in oncology."

First Quarter 2018 Financial Results

Curis reported a net loss of $10.7 million, or $0.07 per share on both a basic and diluted basis for the first quarter of 2018, as compared to a net loss of $15.7 million, or $0.11 per share on both a basic and diluted basis for the same period in 2017.

Revenues for the first quarter of 2018 were $2.5 million, as compared to $2.1 million for the same period in 2017. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $12.4 million for the first quarter of 2018, as compared to $17.2 million for the same period in 2017, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for both the first quarter of 2018 and 2017.

Research and Development Expenses. Research and development expenses were $8.3 million for the first quarter of 2018, as compared to $13.5 million for the same period in 2017. The decrease was primarily due to a payment to Aurigene of $3.8 million for an exclusivity option in January 2017, as well as decreased costs related to ongoing clinical activities for CUDC-907 and CA-170.

General and Administrative Expenses. General and administrative expenses were $4.0 million for the first quarter of 2018 as compared to $3.5 million for the same period in 2017. The increase in general and administrative expenses was driven primarily by higher legal, professional and consulting services for the period.

Other expense, net was $0.8 million for the first quarter of 2018, as compared to $0.7 million for the same period in 2017. Other expense, net primarily consisted of interest expense related to Curis Royalty’s (a wholly owned subsidiary of Curis) debt obligations.

As of March 31, 2018, Curis’s cash, cash equivalents, marketable securities and investments totaled $48.5 million and there were approximately 165.6 million shares of common stock outstanding.

Recent Operational Highlights

Precision oncology, fimepinostat (formerly CUDC-907):

Engaged with a companion diagnostic partner to enable selection of DLBCL patients with MYC-alterations
Engaged with commercial API and product manufacturers
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene collaboration):

Initiated enrollment in a Phase 1 trial of CA-4948 for treatment of patients with lymphoma
Immuno-oncology, CA-170 (PDL1 / VISTA antagonist; Aurigene collaboration):

Initiated twice-daily dosing at increasing doses in the Phase 1 trial of CA-170 in patients with advanced solid tumors or lymphomas
Curis collaborator Aurigene continued enrollment of patients in a Phase 2 clinical study of CA-170 at trial sites in India
Immuno-oncology, CA-327 (PDL1 / TIM3 antagonist; Aurigene collaboration):

Completing IND-enabling studies in preparation for a regulatory filing
Conference Call Information

Curis management will host a conference call today, May 3, 2018, at 8:30 a.m. EDT, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial (877) 870-4263 from the United States or (412) 317-0790 from other locations, shortly before 8:30 a.m. EDT. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

West Announces Third-Quarter Dividend, Increase to Fourth-Quarter Dividend and Participation in Upcoming Investor Conferences

On May 3, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported that the Company’s Board of Directors has approved a third-quarter 2018 dividend of $0.14 per share (Press release, West Pharmaceutical Services, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346642 [SID1234526028]). The dividend will be paid on August 1, 2018, to shareholders of record as of July 18, 2018.

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In addition, the Board of Directors has approved a fourth-quarter dividend of $0.15 per share, a 7.1% increase over the $0.14 per share declared for each of the four preceding quarters. This is the twenty-sixth consecutive annual increase in the Company’s dividend. The fourth-quarter dividend will be paid on November 7, 2018, to shareholders of record as of October 24, 2018.

The Company also announced that management will present an overview of the business at two investor conferences in May. Management will present at the Bank of America Merrill Lynch Healthcare Conference in Las Vegas, Nevada, at 4:20 p.m. PDT on Tuesday, May 15, 2018; and at the UBS Global Healthcare Conference in New York, New York, at 1:00 p.m. EDT on Monday, May 21, 2018. A live audio webcast of the presentation and a copy of the presentation will be accessible from the Company’s website at www.westpharma.com/en/investors.