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Proteros enters into new research collaboration with Johnson & Johnson Innovation on sub-class of epigenetic targets

On July 27, 2017 Proteros biostructures GmbH reported that the company has entered into a collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, on a sub-class of epigenetic targets (Press release, proteros biostructures, JUL 27, 2017, View Source;tx_news_pi1%5Baction%5D=detail&cHash=a38b6bfffb6b6cbdbafc7a8a11ea05f0 [SID1234519912]). The deal was facilitated by Johnson & Johnson Innovation.

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The new collaboration agreement is focused on the discovery of novel lead compounds against several epigenetic targets for various cancer indications. Under the agreement, Janssen gains access to Proteros’ proprietary Nucleosomal Epigenetic Assay Technology (NEATTM) and discovery platform aimed at technically complex targets to identify quality lead compounds. Janssen has the option to license the lead compounds for further development and commercialization or the parties may jointly further develop and partner.

Financial terms of the collaboration were not disclosed.

Dr. Torsten Neuefeind, CEO of Proteros commented: "We are pleased to be working with Janssen to address a set of novel and complex epigenetic targets to create oncology drugs. We believe that the structure of the collaboration will accelerate the discovery of novel therapies and maximize the value generation for both parties."

NewLink Genetics Announces First Patient Dosed in Phase 1 Study of IDO Pathway Inhibitor NLG802

On July 27, 2017 NewLink Genetics Corporation (NASDAQ: NLNK) reported first patient dosed in the Phase 1 study of NLG802, a novel prodrug of indoximod. NLG802 is an investigational agent targeting the IDO pathway and represents an important step in the company’s strategic planning and intellectual property (IP) management (Press release, NewLink Genetics, JUL 27, 2017, View Source [SID1234519909]).
The NLG802 trial is a Phase 1 open-label clinical trial for patients with advanced solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses. The trial will utilize a standard 3+3 dose-escalation design.

"Preclinical data for NLG802 have shown an advantageous pharmacokinetic profile in preclinical models and were presented in April at the AACR (Free AACR Whitepaper) annual meeting," said Charles J. Link, Jr., MD, Chairman, Chief Executive Officer and Chief Scientific Officer. "NLG802 further expands the lifecycle and IP surrounding our evolving immuno-oncological platform."

Trial specific information is available on clinicaltrials.gov

About NLG802
NLG802 is an investigational, orally available prodrug of indoximod, a small molecule targeting the IDO Pathway. The IDO Pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape. NewLink Genetics is currently evaluating NLG802 in a Phase 1 dose-escalation clinical trial in cancer patients to assess the safety and pharmacokinetics of NLG802.

Infinity Amends PI3K-Delta,Gamma Agreement with Takeda Oncology

On July 27, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), reported that it has amended its license agreement with Takeda Oncology for IPI-549, Infinity’s potentially first-in-class immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma) (Press release, Infinity Pharmaceuticals, JUL 27, 2017, View Source;p=RssLanding&cat=news&id=2289511 [SID1234519908]). Under the amended agreement, Infinity will no longer have an obligation to pay Takeda future royalties on worldwide net sales of selective inhibitors of PI3K-gamma, including IPI-549.

In exchange for eliminating the royalty obligation, Infinity issued to Takeda an unsecured $6.0 million convertible note that matures on July 27, 2018, and accrues interest at an annual rate of eight percent. The company is obligated to pay the principal amount together with any accrued interest on or before the maturity date in cash or in shares of Infinity common stock, at the election of Takeda. The share payment price would equal the average closing price of Infinity’s common stock for the 20 days prior to the payment date.

"Our decision to enter this amendment underscores Infinity’s belief in the potential of IPI-549 to be an oral, selective first-in-class inhibitor of PI3K-gamma for the treatment of a broad range of solid tumors, and we are continuing to advance our Phase 1 study evaluating IPI-549 both as a monotherapy and in combination with Opdivo, a PD-1 immune checkpoint inhibitor," stated Adelene Perkins, Infinity’s chief executive officer. "This amendment reduces the total royalty burden on any future net sales of IPI-549 to four percent due to Mundipharma and Purdue from a previous agreement."

Infinity remains obligated to pay development, regulatory and commercial milestones to Takeda for IPI-549. The remaining milestones comprise up to a total of $5 million in development milestones, up to $50 million in success-based regulatory milestones, and up to $115 million in commercial milestones, which are due once certain sales thresholds have been met.

Under a previous agreement, Infinity is obligated to pay Mundipharma International Corporation Limited and Purdue Pharmaceutical Products L.P. a four percent royalty in the aggregate on worldwide net sales of IPI-549, which steps down to one percent in the U.S. after a certain sales threshold is met.

About IPI-549 and the Ongoing Phase 1 Study

IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor to an anti-tumor phenotype and is able to overcome resistance to checkpoint inhibition.1,2 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing to explore the activity, safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with advanced solid tumors.3 The study includes monotherapy and combination dose-escalation phases, in addition to a monotherapy expansion cohort and combination expansion cohorts. The expansion cohorts evaluating IPI-549 plus Opdivo will include patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN). Patients enrolled in these combination expansion cohorts represent a difficult-to-treat population, as they must have demonstrated initial resistance or subsequently develop resistance to a PD-1 or PD-L1 therapy immediately prior to enrolling in the study. Overall, the study is expected to enroll approximately 175 patients.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

Cancer Research UK brings commercialisation arm in-house

On July 27, 2017 Cancer Research UK reported that the charity’s commercialisation arm, Cancer Research Technology, has been brought together with the Charity’s research funding teams to form a new in-house division called Research and Innovation (Press release, Cancer Research Technology, JUL 27, 2017, View Source [SID1234523163]).

The move will increase the ease with which funded research can progress toward the development of new therapeutics, diagnostics and other innovations that ultimately deliver benefits to cancer patients and the wider population.

Dr Iain Foulkes, Cancer Research UK’s executive director of research and innovation, said: "It’s become clear that the more integrated we are as an organisation, the more we can ensure that our incredible network of discovery science, translational research and clinical development activities are brought to bear in the development of new advances that benefit patients.

"Partnership plays an incredibly important role in this – we can’t advance the discoveries our researchers make in isolation – and with this move we can engage partners sooner and bring our network of capability together with their expertise to accelerate progress.

"Our goal is to be the world leading cancer research and innovation organisation. Partners need to understand what we do and how to engage with our funded scientists and our portfolio of research. We have a broad research strategy spanning discovery science, cancer prevention, big data, therapeutic innovation and early detection. This move we are making will help us develop effective strategic partnerships to advance our work in these areas."

All commercialisation activity will be carried out by Cancer Research UK’s Commercial Partnerships team* and the CRT Discovery Laboratories will become the CRUK Therapeutic Discovery Laboratories. With exclusive rights to over £350m of world-class cancer research annually, we are able to offer unique opportunities to commercial partners looking for early involvement in new discoveries.

The move will also benefit researchers, enabling them to progress their projects through cross-disciplinary or industry interactions, while industry partners will benefit from academia’s high-risk research and innovative thinking.

H1 2017 Results

On July 27, 2017 AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience reported financial results for the first half of 2017 ended June 30, 2017 (Press release, AstraZeneca, JUL 27, 2017, View Source [SID1234519936]).

Financial Summary
H1 2017Q2 2017
$m% change$m% change
Actual1CER2ActualCER
Total Revenue10,456(11)(9)5,051(10)(8)
Product Sales9,783(11)(10)4,940(10)(8)
Externalisation Revenue673(2)(1)111(17)(15)

Reported Operating Profit1,8423722925n/mn/m
Core Operating Profit33,215731,548108

Reported Earnings Per Share (EPS)$0.805841$0.38n/mn/m
Core EPS3$1.8651$0.8756
Financial Highlights
● The residual effects of the Crestor and Seroquel XR loss of exclusivity in the US impacted Product Sales
● Cost discipline continued:
o Reported R&D costs declined by 5% (1% at CER) to $2,802m
o Core R&D costs declined by 7% (4% at CER) to $2,617m
o Reported SG&A costs declined by 17% (15% at CER) to $4,658m
o Core SG&A costs declined by 12% (9% at CER) to $3,728m
● Reported Other Operating Income and Expense increased by 97% (101% at CER) to $839m; Core Other Operating Income and Expense increased by 105% (108% at CER) to $958m
● Reported EPS increased by 58% (41% at CER) to $0.80; Core EPS increased by 5% (1% at CER) to $1.86
● An unchanged first interim dividend of $0.90 per share
● Financial guidance for 2017 reiterated
Commercial Highlights
● The Growth Platforms grew by 2% (3% at CER) and represented 70% of Total Revenue:
● Emerging Markets: 3% growth (6% at CER), underpinned by China sales growth of 3% (8% at CER). Economic conditions in Latin America and Saudi Arabia limited overall Emerging Markets growth
● Respiratory: A decline of 6% (4% at CER), reflecting the competitive environment for Symbicort in the US
● New CVMD4: Growth of 3% (4% at CER). Brilinta growth of 26% (28% at CER) and Farxiga growth 22% (22% at CER), offset by other Diabetes
● Japan: Growth of 7% (6% at CER), with an accelerated performance in Q2 2017 reflecting the strong uptake of Tagrisso
● New Oncology5: Sales of $537m (H1 2016: $251m); particularly encouraging growth of Tagrisso. Lynparza’s US performance reflected the current indication
Achieving Scientific Leadership
The table below highlights the development of the late-stage pipeline since the last results announcement:
Regulatory ApprovalsImfinzi (durvalumab) – bladder cancer (US)
Faslodex – breast cancer (1st line) (EU, JP)
Kyntheum (brodalumab) – psoriasis (EU, received by partner)
Regulatory Submission AcceptancesLynparza – ovarian cancer (2nd line) (EU, JP)
Bevespi – chronic obstructive pulmonary disease (COPD) (EU)
Phase III or Major Data ReadoutsImfinzi – lung cancer (PACIFIC)
Bydureon – type-2 diabetes cardiovascular outcomes trial (met primary safety objective, did not meet primary efficacy objective)
tralokinumab – severe, uncontrolled asthma (did not meet primary endpoint)
Pascal Soriot, Chief Executive Officer, commenting on the results said:
“Our performance in the first half was in line with expectations as we experience the loss of exclusivity of Crestor and Seroquel XR in the US. We continued to deliver transformative science across the pipeline, particularly in Oncology. Imfinzi was launched in bladder cancer while we published practice-changing data in breast cancer for Lynparza, our first-in-class PARP inhibitor. In lung cancer, we strengthened our unique portfolio focused on both the genetic drivers of disease and immunotherapy. In the first half, we shared positive results for Imfinzi in the PACIFIC trial and reported more encouraging data for Tagrisso in patients with central nervous system metastases.
“I’m excited about our pipeline-driven transformation as we continue to deliver for shareholders on our strategy to return to sustainable long-term growth. In a pivotal year for AstraZeneca, we remain focused on realising the potential of our pipeline, growing our new launch medicines and bringing our strong science to patients.”
FY 2017 Guidance: Reiterated
The Company provides guidance on Total Revenue and Core EPS only. All commentary in this section is at CER and is unchanged from the prior results announcement:
Total RevenueA low to mid single-digit percentage decline
Core EPSA low to mid teens percentage decline*
*The Core EPS guidance anticipates a normalised effective Core tax rate in FY 2017 of 16-20% (FY 2016: 11%)
Guidance is subject to base-case assumptions of the progression of the pipeline and the extensive level of news flow listed on the following page. Variations in performance between quarters can be expected, with year-on-year comparisons expected to begin to ease in the second half of the year, given the recent annualisation of the impact of the entry of multiple Crestor generic medicines in the US.
The Company presents Core EPS guidance only at CER. It is unable to provide guidance on a Reported/GAAP basis because the Company cannot reliably forecast material elements of the Reported/GAAP result, including the fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the section ‘Cautionary Statements Regarding Forward-Looking Statements’ at the end of this announcement.
In addition to the unchanged guidance above, the Company also provides unchanged indications in other areas of the Income Statement. The sum of Externalisation Revenue and Other Operating Income and Expense in
FY 2017 is anticipated to be ahead of that in FY 2016. Sustainable and ongoing income6 is expected to increase further as a proportion of total Externalisation Revenue in FY 2017 (FY 2016: 21%). Core R&D costs are expected to be broadly in line with those in FY 2016 and the Company anticipates a further reduction in Core SG&A costs in FY 2017, reflecting the evolving shape of the business. A full explanation is listed in the Operating & Financial Review.
FY 2017 Currency Impact
Based only on average exchange rates in H1 2017 and the Company’s published currency sensitivities, the Company continues to expect a low single-digit percentage adverse impact from currency movements on Total Revenue and a minimal impact on Core EPS. Further details on currency sensitivities are contained within the Operating and Financial Review.
Notes
1. All growth rates are shown at actual exchange rates, unless stated otherwise.
2. Constant exchange rates. These are non-GAAP measures because they remove the effects of currency movements from Reported results.
3. Core financial measures. These are non-GAAP measures because, unlike Reported performance, they cannot be derived directly from the information in the Group Financial Statements. See the Operating and Financial Review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
4. New Cardiovascular and Metabolic Diseases, incorporating Brilinta and Diabetes.
5. New Oncology, comprising Lynparza, Tagrisso, Iressa (US) and Imfinzi.
6. Sustainable and ongoing income is defined as Externalisation Revenue, excluding initial revenue.
7. All commentary in this announcement refers to the performance in H1 2017, unless stated otherwise.
Pipeline: Forthcoming Major News Flow
Innovation is critical to addressing unmet patient needs and is at the heart of the Company’s growth strategy. The focus on research and development is designed to yield strong results from the pipeline.
Mid-2017Imfinzi +/- tremelimumab (treme) – lung cancer (MYSTIC): Data readout
H2 2017Faslodex – breast cancer (1st line): Regulatory decision (US)
Lynparza – ovarian cancer (2nd line): Regulatory decision (US)
Lynparza – breast cancer: Regulatory submission
Tagrisso – lung cancer (1st line): Data readout, regulatory submission
Imfinzi – lung cancer (PACIFIC): Regulatory submission
Imfinzi +/- treme – lung cancer (MYSTIC): Regulatory submission
Imfinzi +/- treme – lung cancer (ARCTIC): Data readout, regulatory submission
acalabrutinib – blood cancer: Regulatory submission (US) (Phase II)*
moxetumomab – leukaemia: Data readout
Bydureon – autoinjector: Regulatory decision (US), regulatory submission (EU)
benralizumab – severe, uncontrolled asthma: Regulatory decision (US)
tralokinumab – severe, uncontrolled asthma: Data readout
H1 2018Lynparza – ovarian cancer (2nd line): Regulatory decision (EU, JP)
Lynparza – ovarian cancer (1st line): Data readout, regulatory submission
Imfinzi +/- treme – head& neck cancer (KESTREL): Data readout
Imfinzi +/- treme – head & neck cancer (EAGLE): Data readout
moxetumomab – leukaemia: Regulatory submission
selumetinib – thyroid cancer: Data readout, regulatory submission
Bevespi – COPD: Regulatory submission (JP)
Duaklir – COPD: Regulatory submission (US)
benralizumab – severe, uncontrolled asthma: Regulatory decision (EU, JP)
tralokinumab – severe, uncontrolled asthma: Regulatory submission
PT010 – COPD: Data readout
H2 2018Imfinzi + treme – lung cancer (NEPTUNE): Data readout, regulatory submission
Imfinzi +/- treme – head& neck cancer (KESTREL): Regulatory submission
Imfinzi +/- treme – head & neck cancer (EAGLE): Regulatory submission
Imfinzi +/- treme – bladder cancer (DANUBE): Data readout, regulatory submission
roxadustat – anaemia: Regulatory submission (US)
Bevespi – COPD: Regulatory decision (EU)
benralizumab – COPD: Data readout, regulatory submission
PT010 – COPD: Regulatory submission (JP)
anifrolumab – lupus: Data readout
The term ‘data readout’ in this section refers to Phase III data readouts, unless stated otherwise.
*Potential fast-to-market opportunity ahead of randomised, controlled trials.