On March 28, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it will share further data on the savolitinib development programs in lung cancer at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, Georgia, USA, March 31 to April 3, 2019 (Press release, Hutchison China MediTech, MAR 28, 2019, http://www.chi-med.com/pres-on-savo-at-aacr19/ [SID1234534753]).

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Preliminary efficacy and safety results will be presented from the China Phase II study of savolitinib monotherapy in non-small cell lung cancer ("NSCLC") patients with MET Exon 14 skipping mutations who have failed prior systemic therapy, or are unable to receive chemotherapy (abstract #CT031, clinicaltrials.gov identifier NCT02897479).

In addition, several abstracts will be presented from the TATTON Phase Ib/II trial of savolitinib in combination with Tagrisso (osimertinib) in patients with epidermal growth factor receptor ("EGFR") mutation-positive NSCLC and MET-amplification who have progressed following treatment with an EGFR tyrosine kinase inhibitor ("EGFR-TKI") (clinicaltrials.gov identifier NCT02143466). One presentation will focus on patients who had progressed on a first- or second-generation EGFR-TKI and had not previously received a third-generation EGFR-TKI (abstract #CT032). Another presentation will focus on patients whose disease further progressed despite prior treatment with a third-generation EGFR-TKI (abstract #CT033). These presentations are complemented by a poster presentation on detection methods for identifying MET-driven EGFR-TKI resistance in the TATTON trial (abstract #4897/20).

TATTON preliminary results were presented at the World Conference on Lung Cancer (WCLC) in Yokohama, Japan, in October 2017.[1] The TATTON trial supports SAVANNAH, an ongoing Phase II clinical trial exploring the combination of savolitinib and Tagrisso to overcome MET-driven EGFR-TKI resistance following treatment with Tagrisso (clinicaltrials.gov identifier NCT03778229).

Further details of the presentations are as follows:

Session: Can the Challenge of NSCLC Resistance Be MET or Will We Not MEK It?
Session Type: Clinical Trials Plenary Session
Session # & Link: CTPL02
Date & Time: Sunday, March 31: 3:00 PM-5:15 PM
Location: Marcus Auditorium, Building A, Georgia World Congress Center
1st Presentation Title: Preliminary efficacy and safety results of savolitinib treating patients with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations
Lead Author: Shun Lu, Professor at Shanghai Chest Hospital, Jiao Tong University
Abstract # & Link: CT031 – abstract available after 3:00 PM EST on Friday, March 29, 2019
Time: 3:05 PM-3:30 PM
2nd Presentation Title: TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior first/second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
Lead Author: Helena A. Yu, Medical Oncologist at Memorial Sloan Kettering Cancer Center
Abstract # & Link: CT032 – abstract only available at time of presentation
Time: 3:40 PM-3:55 PM
3rd Presentation Title: TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
Lead Author: Lecia V. Sequist, Associate Professor of Medicine at Harvard Medical School and the Director of the Center for Innovation in Early Cancer Detection at Massachusetts General Hospital
Abstract # & Link: CT033 – abstract only available at time of presentation
Time: 3:55 PM-4:15 PM

Session: Novel Strategies for Biomarker Identification and Use in Cancer 3
Poster Title: Detection of MET-mediated EGFR tyrosine kinase inhibitor (TKI) resistance in advanced non-small cell lung cancer (NSCLC): biomarker analysis of the TATTON study
Lead Author: Ryan J. Hartmaier, AstraZeneca
Abstract # & Link: 4897 / 20 – abstract now available
Date & Time: April 3, 2019, 8:00 AM – 12:00 PM
Location: Section 19, Building B, Georgia World Congress Center

About Savolitinib
Savolitinib is a potential first-in-class inhibitor of c-MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective c-MET inhibitors. In clinical studies to date, involving over 900 patients, savolitinib has shown promising signs of clinical efficacy in patients with c-MET gene alterations in multiple tumor types with an acceptable safety profile. Chi-Med is currently testing savolitinib in partnership with AstraZeneca in Phase Ib/II studies, in multiple solid tumor indications, both as a monotherapy and in combinations.

On March 28, 2019 ESSA Pharma Inc. (TSX-V: EPI;Nasdaq: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the nomination of EPI-7386 as the lead clinical candidate for the treatment of metastatic castration-resistant prostate cancer ("mCRPC") (Press release, ESSA, MAR 28, 2019, View Source [SID1234539332]). EPI-7386 is a novel drug candidate that inhibits the N-terminal domain of the androgen receptor. Through this novel mechanism of action, EPI-7386 displays activity in vitro in numerous prostate cancer models including models where current antiandrogens are inactive. Compared to ESSA’s first generation compound, ralaniten acetate, EPI-7386 is significantly more potent, metabolically stable and more effective in preclinical studies. In addition, EPI-7386 has demonstrated a favorable tolerability profile in all animal studies of the compound conducted to date. IND-enabling studies are currently underway, and ESSA expects to enter clinical studies with EPI-7386 in the first quarter of 2020.

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As recently presented at the 2019 Genitourinary Cancers Symposium, EPI-7386 demonstrates in vitro cellular potency against the androgen receptor in a similar range to the leading antiandrogens, bicalutamide and enzalutamide. Importantly, EPI-7386 shows activity in numerous in vitro models of antiandrogen resistance driven by the AR-V7 splice variant of the androgen receptor while enzalutamide is inactive. In addition, EPI-7386 is metabolically stable in liver microsome and hepatocyte preparations and shows a favorable pharmacokinetic profile in mice, exhibiting significant exposure and a long half-life. Lastly, EPI-7386 (60 mg/kg) displayed comparable activity to enzalutamide (30 mg/kg) in a prostate cancer LNCaP xenograft mouse model in which enzalutamide mouse exposure was estimated to be twice the clinical exposure of enzalutamide in humans.

"We are excited to announce the nomination of EPI-7386 as our lead clinical candidate for the treatment of mCRPC," said David Parkinson, President and Chief Executive Officer of ESSA. "EPI-7386 represents a novel approach to targeting the androgen receptor, one of the most validated targets in oncology. We look forward to bringing this novel drug candidate to patients with mCRPC who have no other treatment options."

On March 28, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported publication of abstracts on neratinib for the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 (Press release, Puma Biotechnology, MAR 28, 2019, View Source [SID1234534707]). The AACR (Free AACR Whitepaper) Annual Meeting will be held at the Georgia World Congress Center in Atlanta, Georgia from March 29 to April 3. Posters will be available on Puma’s website following presentation.

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Full abstracts of the following presentations are available online at www.aacr.org :

March 31, 2019, 3:35 – 3:50 p.m. EDT – Abstract 1724 (Oral): Natural history and clinical characteristics of ERBB2 mutant hormone receptor-positive breast cancers: Results from the AACR (Free AACR Whitepaper) Project GENIE Registry.
Michele LeNoue-Newton et al, Vanderbilt-Ingram Cancer Center, TN.

March 31, 2019, 3:50 – 4:05 p.m. EDT – Abstract 929 (Oral): Paired tumor and cfDNA in patients with HER2-mutant solid tumors treated with neratinib reveals convergence of multiple ontarget resistance mechanisms: Results from the SUMMIT ‘Basket’ Trial.
Helen H. Won et al, Memorial Sloan Kettering Cancer Center, New York.

April 2, 2019, 3:20 – 3:35 p.m. EDT – Abstract 4459 (Oral): Morphologic and genomic characterization of circulating tumor cells in patients with ERBB2 mutant HER2 non-amplified metastatic breast cancer treated with neratinib.
Stephanie Nicole Shishido et al, USC, Los Angeles.

April 2, 2019, 4:35 – 4:50 p.m. EDT – Abstract 4527 (Oral): Patient-derived organoids and xenografts identify neratinib plus HER2 antibody drug conjugate as a synergistic drug combination for HER2 mutated, non-amplified metastatic breast cancer.
Shunqiang Li et al, Washington University School of Medicine, Saint Louis, MO.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 328 (Poster): ADAM17-induced activation of HER receptors mediate resistance to trastuzumab in a subset of moderate HER2-expressing breast cancer cells.
Katharina Feldinger et al, University of Birmingham, UK.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 329 (Poster): Hyperactivation of mTORC1 drives acquired resistance to the pan-HER tyrosine kinase inhibitor neratinib in HER2-mutant cancers.
Dhivya R. Sudhan et al, UT Southwestern Medical Center, Dallas, TX.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 389 (Poster): Role of HER3 signaling pathways in ER+ and HER2+ breast cancers.
Rosalin Mishra et al, University of Cincinnati College of Pharmacy, Cincinnati, OH.

March 31, 2019, 1:00 – 5:00 p.m. EDT – Abstract 395 (Poster): Aberrant HER2 signaling is a therapeutic target in a subset of castration-resistant prostate cancer.
Joshua W. Russo et al, Beth Israel Deaconess Medical Center, Boston, MA.

April 1, 2019, 1:00 – 5:00 p.m. EDT – Abstract 1923 (Poster): KRAS-mutant (mt) colorectal cancer (CRC) organoid models generated from patient-derived xenografts (PDX) show response to combination of trametinib (Tm), neratinib (N), and trastuzumab (Tz).
Rekha Pal et al, NSABP Foundation, Inc., Pittsburgh, PA.

April 2, 2019, 1:00 – 5:00 p.m. EDT – Abstract 3705 (Poster): Identification of frequent HER2 activating mutations in canine primary pulmonary adenocarcinoma.
Gwendolen Lorch et al, Ohio State University College of Veterinary Med., Columbus, OH.

April 3, 2019, 8:00 a.m. – 12:00 p.m. EDT – Abstract 4827 (Poster): The therapeutic superiority of neratinib in combination with trastuzumab compared to pertuzumab plus trastuzumab in HER2-positive in vivo breast cancer models.
Jamunarani Veeraraghavan et al, Baylor College of Medicine, Houston, TX.

April 3, 2019, 8:00 a.m. – 12:00 p.m. EDT – Abstract 4832 (Poster): Preclinical evaluation of neratinib plus T-DM1 in orthotopic PDX models of HER2-positive breast cancer brain metastases.
Jing Ni et al, Dana Farber Cancer Institute, Boston, MA.

On March 28, 2019 Cytonus Therapeutics Inc., a biotechnology company developing new platforms for delivering biologics, reported that it will be presenting preclinical data for its Cargocyte technology platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting March 29 – April 3, at the Georgia World Congress Center in Atlanta (Press release, Cytonus Therapeutics, MAR 28, 2019, View Source [SID1234534723]).

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Cargocytes are engineered allogenic cell lines that can carry a variety of payloads like small molecule compounds, gene editing therapies, therapeutic RNAs, and powerful biologics such as immune modulating cytokines, antibodies and oncolytic viruses.

"Cytonus Therapeutics will be presenting preclinical data from our growing oncology pipeline that supports the versatility of our Cargocytes as a groundbreaking allogeneic, off-the-shelf, immune-therapy platform," said Remo Moomiaie-Qajar, M.D., president and CEO of Cytonus. "Our preclinical results in our Triple Negative Breast Cancer model experiments are impressive and exciting. We are able to demonstrate that 40 percent of our animals being treated with our Cargocyte associated IL-12 are showing no sign of disease more than 260 days post treatment where as our control animals are dying typically 25 to 30 days into the experiments. These experiments are still ongoing and our mice are doing well. We have replicated these studies multiple times and have found the pattern to exist."

Details of the presentation:

Abstract Title: Cargocytes: A novel cell therapy platform to drive anti-tumor immunity

Session Category: Immunology
Session Title: Late-Breaking Research: Immunology 1
Session Date and Time: Monday, April 1, 2019 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 41
Poster Board Number: 12
Permanent Abstract Number: LB-067
Cytonus will also be presenting at:
Association Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), April 29-May 2, 2019 in Washington, D.C.
Bio International Convention, June 3-6, 2019 in Philadelphia

On March 28, 2019 Evotec AG (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the fiscal year ended 31 December 2018 (Press release, Evotec, MAR 28, 2019, View Source;announcements/press-releases/p/evotec-ag-fiscal-year-2018-results-accelerated-growth-and-strong-long-term-outlook-5795 [SID1234534685]).

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STRONG FINANCIAL PERFORMANCE
Group revenues up 42% to € 375.4 m (2017: € 263.8 m); € 364.0 m Revenues from customer contracts, excluding revenues from recharges according to IFRS 15
Adjusted Group EBITDA up 67% to € 95.5 m (2017: € 57.2 m); € 92.0 m excluding one-off effects from tax credits and receivables
Total R&D expenses of € 35.6 m (2017: € 17.6 m) including € 12.7 m of infectious diseases-related expenses fully reimbursed by Sanofi ("partnered R&D")
Strong strategic liquidity position of € 149.4 m
OPERATIONAL AND SCIENTIFIC EXCELLENCE – "EXCELLENCE SQUARED"
Multiple new and extended drug discovery and development alliances
INDiGO roll-out and integration of high-end CMC offering
Leading application of Artificial Intelligence ("AI") in drug discovery projects
Continued strong performance of high-throughput ADME-tox testing (Cyprotex)
Significant progress in partnered co-owned pipeline; Clinical Phase I & Phase II starts
Multiple important milestone achievements, also in iPSC-based alliances
Continued expansion of iPSC leadership and focus on patient-centric approaches
Initiation of world-leading protein degradation platform
Global roll-out and expansion of Academic BRIDGE model
CORPORATE
Creating important footprint in infectious disease through acquisition of Evotec ID (Lyon)
Conversion into European Company (SE) expected to become effective by end of March 2019
FINANCIAL GUIDANCE 2019 – CONTINUED STRONG LONG-TERM GROWTH
Group revenues expected to increase by approx. 10% (2018: € 364.0 m excluding revenues from recharges according to IFRS 15)
Adjusted Group EBITDA expected to improve by approx. 10% (2018: € 92.0 m excluding one-off effects from tax credits and receivables)
Unpartnered research and development expenses expected to be approximately € 30-40 m (2018: € 22.9 m)

1. STRONG FINANCIAL PERFORMANCE
In 2018, Evotec’s Group revenues increased by 42% to € 375.4 m (2017: € 263.8 m). This increase was driven primarily by the strong performance in the base business, increased milestone payments and a positive first full-year contribution from the acquired business of Aptuit (€ 117.7 m) while contributing only € 46.0 m in 2017 (mid-August to December 2017). Revenues from milestones, upfronts and licences amounted to € 29.5 m, an increase of 6% in comparison to the previous year (€ 27.8 m). Milestones in 2018 resulted mainly from the collaborations with Bayer in endometriosis/chronic cough and kidney diseases, and from Evotec’s iPSC-based collaborations with Celgene in neurodegeneration as well as Sanofi in diabetes.

In 2018, Evotec focused its R&D expenses of € 35.6 m primarily on its iPSC research, projects in metabolic diseases, oncology and R&D platforms (2017: € 17.6 m). Furthermore, Evotec increased its R&D expenses significantly in infectious disease (ID)-related research following the acquisition of Evotec ID (Lyon) from Sanofi. These additional ID-related R&D expenses (€ 12.7 m) are fully reimbursed by Sanofi in context of the five-year agreement and are recognised under other operating income. Thus, they are not detrimental to the operating result and the adjusted EBITDA.

In 2018, the Group’s selling, general and administrative ("SG&A") expenses increased as expected by 35% to € 57.0 m (2017: € 42.4 m). This increase resulted primarily from first full-year SG&A expenses of Aptuit, additional Evotec ID (Lyon) costs as well as M&A-related and increased business development and administrative expenses in response to overall Company growth. However, this increase remained sub-proportional to revenue and adjusted EBITDA growth rates.

Evotec recorded a significant step-up in the adjusted Group EBITDA for 2018 to € 95.5 m (2017: € 57.2 m), yielding an adjusted EBITDA margin of 25.4% (2017: 21.7%). This adjusted EBITDA contains positive one-off effects from receivables and tax credits relating to prior periods in the amount of € 3.5 m. Without this effect, the adjusted EBITDA would amount to € 92.0 m.

Evotec’s operating result amounted to € 77.5 m in 2018 (2017: operating result of € 36.7 m) being positively impacted by the income from bargain purchase and higher R&D tax credits as well as positive one-off effects from receivables and tax credits. In 2018, an income from bargain purchase of € 15.4 m was recorded for the acquisition of Evotec ID (Lyon) as the purchase price was below the net assets acquired. The Company’s net result in 2018 amounted to € 84.1 m (2017: net result of € 23.2 m), being impacted by most recent acquisitions and the strong performance of the base business.

Evotec ended 2018 with a liquidity of € 149.4 m (2017: € 91.2 m), which was composed of cash and cash equivalents (€ 109.0 m) and investments (€ 40.4 m). The strong increase in liquidity in 2018 resulted mainly from the prepayments received from Celgene and the upfront received from Sanofi for Evotec ID (Lyon) (€ 61 m), off-set by net loan repayments (€ 78.2 m).

2. OPERATIONAL AND SCIENTIFIC EXCELLENCE – "EXCELLENCE SQUARED" IN EVT EXECUTE & EVT INNOVATE
The EVT Execute segment demonstrated strong progress in 2018 with new and extended alliances (e.g. CHDI, C4X, Dermira, Ferring, Forge, LEO Pharma, Novo Nordisk). In 2018, Evotec was involved in more than 700 customer alliances and recorded a repeat business of 92%. Following the launch of its INDiGO services in early 2018, Evotec was able to sign multiple new INDiGO agreements with e.g. Ankar, Astex, Carna Biosciences, Inflazome, and Yumanity. The high-throughput ADME-tox testing business of Cyprotex continued its excellent performance.

In EVT Innovate, 2018 was characterised by important progress in its strategic partnerships (iPSC neurodegeneration alliance with Celgene; iPSC diabetes alliance with Sanofi; kidney disease alliance with Bayer) as well as the signing of new partnerships, e.g. two new partnerships with Celgene in oncology as well as a new partnership with Almirall in dermatological diseases. Furthermore, the Company is blending artificial intelligence ("AI") and machine-learning tools into many of its biology- and chemistry-driven platforms to further accelerate and increase effectiveness in the process and continues to place great emphasis on patient-centric approaches to drug discovery. The partnered clinical projects are progressing to plan.

In 2018, Evotec’s academic BRIDGE model continued to attract significant interest from academia and industry partners.

3. CORPORATE
ACQUISITION OF EVOTEC ID (LYON)

Effective 01 July 2018, Evotec acquired 100% of the shares of Evotec ID (Lyon), the former Sanofi infectious disease unit in Lyon. The collaboration resulted in an upfront payment of € 61 m (€ 43 m in cash plus € 18 m cash of the acquired company) to Evotec. Evotec is eligible for significant further long-term funding from Sanofi in order to ensure the support and progression of a world-leading portfolio in this field.

4. FINANCIAL GUIDANCE 2019 – CONTINUED STRONG LONG-TERM GROWTH
Revenues, research and development expenses and adjusted EBITDA remain the financial key performance indicators of the Evotec Group.

For the financial year 2019, the Management Board expects Evotec to show Group revenue growth from contracts with customers without revenues from recharges of approx. 10%. This revenue growth is based on visibility of the current order book, expected new contracts, contract extensions and milestone opportunities. Projections are based on constant 2018 exchange rates.

Evotec’s adjusted Group EBITDA from 2018 includes one-off effects associated to the business years 2016 and 2017 in the amount of € 3.5 m. Without these one-off effects, the adjusted Group EBITDA in 2018 would amount to € 92.0 m. Against this number, Evotec’s adjusted Group EBITDA is expected to improve by approx. 10% in 2019 compared to 2018.

Evotec will continue to significantly invest in its own "unpartnered" research and development (R&D) efforts to create a long-term pipeline of first-in class assets and platforms. In addition, the Company will also continue to invest in its infectious disease-related efforts. ID-related R&D expenses of approx. € 35 m will be completely cost-covered by its partner Sanofi ("partnered R&D"). For better comparison against previous years, Evotec will focus its guidance and reporting during the course of 2019 on the "unpartnered R&D" part, estimated at approx. € 30-40 m.

WEBCAST/CONFERENCE CALL
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. Furthermore, the Management Board will present an outlook for fiscal year 2019. The conference call will be held in English.

Conference call details

Date: Thursday, 28 March 2019

Time: 02.00 pm CET (09.00 am EDT, 01.00 pm GMT)

From Germany: +49 69 201 744 220

From France: +33 170 709 502

From Italy: +39 02 3600 6663

From the UK: +44 20 3009 2470

From the USA: +1 877 423 0830

Access Code: 75185877#

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 20 17 44 222 (Germany) or +44 20 3364 5150 (UK) and in the USA by dialling +1 844 307 9362. The access code is 315534320#. The on-demand version of the webcast will be available on our website: View Source