On April 14,2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it will present data from across its broad cancer immunotherapy development programme, including approved and investigational medicines, during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from 14 April to 18 April in Chicago, IL, United States (Press release, Hoffmann-La Roche, APR 14, 2018, View Source [SID1234525313]). More than 42 abstracts have been accepted, including five "late breakers" and seven oral presentations.

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"Through our extensive research in the areas of tumour characterisation we are developing therapies that help the immune system to mount a deep and long lasting anti-cancer response," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "A personalised combination approach of cancer immunotherapies like TECENTRIQ with various chemotherapies, targeted medicines and other immunotherapies is central to our goal of providing transformative outcomes for people living with cancer."

Key highlights from the Roche cancer immunotherapy portfolio include an updated analysis from the Phase III IMpower150 study of TECENTRIQ and Avastin plus paclitaxel and carboplatin chemotherapy in people with advanced non-squamous non-small cell lung cancer (NSCLC). The study demonstrated significantly improved progression free survival (PFS) across all PD-L1 subgroups (ITT-WT, hazard ratio [HR]=0.61; p<0.0001%; CI: 0.51-0.72), including in people whose tumours are considered PD-L1-negative regardless of the PD-L1 IHC assay used, compared to Avastin plus paclitaxel and carboplatin chemotherapy. A clinically meaningful progression free survival (PFS) advantage was also seen in people with sensitising EGFR mutations, ALK genomic rearrangements, and in people with liver metastases. Importantly, IMpower150 recently met it’s co-primary endpoint of overall survival (OS) and showed that the combination of TECENTRIQ and Avastin plus paclitaxel and carboplatin chemotherapy helped people with advanced lung cancer live longer compared to Avastin plus carboplatin and paclitaxel as an initial treatment for people with advanced NSCLC. These data will be presented at an upcoming oncology meeting in 2018.

There is a scientific rationale for combining TECENTRIQ and abraxane which suggests that the mechanisms of action of each of the medicines may be complementary in the treatment of mTNBC, as they each target different steps in the cancer immunity cycle.

Results from this single arm cohort (N=33) of the Phase 1b study of TECENTRIQ plus nab-paclitaxel chemotherapy in people with metastatic triple negative breast cancer (mTNBC) show encouraging efficacy signals, and the safety of TECENTRIQ plus nab-paclitaxel in this combination is, so far, consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination.
A trend toward higher response rates and longer PFS and OS was seen for patients treated in the 1L setting compared to later lines. The ongoing randomised Phase III trial, IMpassion130, is investigating the same regimen as the Phase 1b study, with topline data expected later in 2018.

A retrospective analysis of the biology underlying primary immune escape and responsiveness to TECENTRIQ in tumour samples of people from the phase II IMvigor210 study for people with metastatic urothelial cancer showed that response to TECENTRIQ was highly associated with tumour mutational burden (TMB) and pre-existing T cell immunity. Additionally, another signalling protein known as transforming growth factor-beta (TGF-β) appears to be a negative indicator of response to TECENTRIQ, especially in the immune-excluded tumour phenotype that is common in mUC. Integration of these three independent biological features provides a foundation for understanding outcomes for people living with mUC.
Overview of key Cancer Immunotherapy data AACR (Free AACR Whitepaper) 2018

About TECENTRIQ (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

TECENTRIQ is already approved in the European Union, United States and more than 50 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.

About the TECENTRIQ (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support combining TECENTRIQ and Avastin. The TECENTRIQ and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers, including first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.
About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.
To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source

On April 13, 2018 Hanmi Pharmaceutical reported thst it’s long and turbulent development of lung cancer drug olmutinib came to an end this week after the company abandoned the program (Press release, FierceBiotech, APR 13, 2018, View Source [SID1234573812]).

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The South Korean drugmaker took the decision after struggling to recruit patients into clinical trials and concluding that the third-generation EGFR inhibitor was too far behind Tagrisso (osimertinib), AstraZeneca’s fast-growing rival, to make a commercial success of the drug, according to a Korea Biomedical Review report.

Back in 2015, the olmutinib program was riding high on the back of a promising midstage data in T790M-mutated non-small cell lung cancer (NSCLC) and a $730 million licensing deal with Boehringer Ingelheim. The German company described the drug as a possible best-in-class candidate that it was hoping to pair with Merck & Co’s immuno-oncology blockbuster Keytruda in a combination trial.

Just over a year later, Boehringer backed out of the deal after taking another look at the clinical data for the drug and the increasingly crowded EGFR inhibitor market, even though olmutinib had already picked up its first approval—as Olita—in Hanmi’s home market.

Things went from bad to worse last year when the Korean authorities rapped the company for not acting quickly enough to disclose a fatality in a patient treated with the drug who developed life-threatening skin condition Stevens-Johnson syndrome (SJS). All told, the drug was linked to three cases of SJS, two of which proved fatal.

Yet more controversy ensued after Hanmi employees were accused of insider trading relating to the termination of the Boehringer deal, and the Korean firm also lost another partner for olmutinib when Chinese licensee Zai Lab returned rights to the drug.

Meanwhile, olmutinib isn’t the only Hanmi drug to run into trouble of late. Its Eli Lilly-partnered BTK inhibitor LY3337641 failed to hit its objectives in a phase 2 trial in rheumatoid arthritis, leaving the future of the program in other indications under a cloud, while at the end of 2016 a $4.2 billion, three-drug deal with Sanofi for diabetes therapies was trimmed down to two candidates.

Other partnerships with Spectrum for Rolontis (eflapegrastim) and pan-HER drug poziotinib, Johnson & Johnson for diabetes and obesity candidate HM12525A and Roche/Genentech for RAF-targeted cancer drugs currently remain on track.

On April 13, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or the "Company") reported that its Share Purchase Plan ("SPP") closed as planned on 6 April 2018 (Press release, Immutep, APR 13, 2018, View Source [SID1234525810]). The Company received applications from eligible shareholders for 300,561,089 new ordinary shares ("New Shares") at the purchase price of $0.021 per New Share.

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Accordingly, the Company has raised A$6.31 million before transaction-related expenses through the SPP. This is in addition to A$6.85 million institutional placement announced on 12 March 2018, bringing the total funds raised from the SPP and institutional placement to A$ 13.16 million.

The funds raised from the SPP and Placement will be used to support Immutep’s ongoing and planned immuno-oncology clinical development programs, its pre-clinical program in autoimmune disease and for general working capital purposes.

"It is great to see so many of our shareholders participate in the Share Purchase Plan, on the same terms as the Placement to Platinum, Australian Ethical and other investors," said Immutep CEO, Marc Voigt. "I would like to thank our shareholders for their continued support, especially those that have been invested in our Company for some time."

"This funding provides us with cash reach well into Q4 of calendar year 2019, including funding our new Phase II TACTI-002 clinical trial in different cancer indications in collaboration with MSD. Importantly, by that stage we will have Progression Free Survival data from our Phase IIb AIPAC breast cancer trial, data from all four patient cohorts in our Phase I TACTI-mel trial and potentially also the first data from TACTI-002."

The Company will issue the New Shares today and holding statements will also be sent today to shareholders advising them of the number of New Shares they have been allotted. The New Shares are expected to commence trading on the Australian Securities Exchange on 16 April 2018 and will rank pari passu with the Company’s existing fully paid ordinary shares on issue.

On April 13, 2018 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product candidate designed to reduce Graft versus Host Disease (GVHD) and relapse after hematopoietic stem cell transplantations (HSCT), reported its audited 2017 Annual Results for the year ended December 31, 2017, which have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union (Press release, Kiadis, APR 13, 2018, View Source [SID1234525293]).

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Operating highlights (including post reporting period)

In April 2017, based on the positive results from the Phase 2 ‘007’ trial, filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for approval of lead program ATIR101 as an adjunctive treatment in haploidentical (genetically half-matched) hematological stem-cell transplantations for adult patients with malignant disease.
In September 2017, received the Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA for ATIR101. The RMAT pathway is equivalent to the Breakthrough Therapy designation that allows companies, such as Kiadis Pharma, that are developing regenerative medicine therapies to interact with the US FDA more frequently. During 2017 only 12 companies obtained an RMAT designation.
In December 2017, enrolled first patient in a Phase 3 trial of ATIR101 with participating sites in the US, Canada and Europe.
In December 2017, secured access to build in-house manufacturing capabilities with an agreement to lease an existing state of the art commercial manufacturing facility. This includes process development and quality control laboratories, as well as office space.
Strengthened Kiadis organization and Supervisory Board with key people who have a successful track record in developing and commercializing innovative products, including Mr. Arthur Lahr as CEO, Mr. Jan Feijen as COO, Dr. Andrew Sandler as CMO and Dr. Karl Hård as Head of Investor Relations. Dr. Otto Schwarz, former COO of Actelion and Mr. Subhanu Saxena, former Head of Global Product Strategy at Novartis and CEO of Cipla, are proposed as new Supervisory Board members.
In March 2018, submitted responses to the EMA’s list of questions, potentially allowing to obtain an opinion from the EMA as early as the fourth quarter of 2018. If positive, this would enable a conditional marketing approval from the European Commission in the first quarter of 2019, with potential launch in selected countries in Europe starting in the second half of 2019.
Financial highlights (including post reporting period)

Significantly strengthened cash position, raised more than EUR 60 million in equity and debt since June 2017.
The cash position increased to EUR 29.6 million at year-end 2017 compared to EUR 14.6 million at the end of 2016. This is mainly due to cash received from share offerings less the cash used in operating activities in 2017. Cash position was EUR 47.7 million at end of March 2018.
Operating loss increased to EUR 16.1 million in 2017 from a loss of EUR 11.4 million in 2016.
Operating expenses increased by EUR 4.7 million compared to last year as the number of employees increased from

Commenting on the financial results, Arthur Lahr, CEO of Kiadis Pharma, said: "We can look back at 2017 as a truly transformational year and are well on our way turning Kiadis Pharma into a Phase 3 clinical and commercial stage company. I am very proud of what the entire Kiadis Pharma team achieved. We are on track to obtain a CHMP opinion in the fourth quarter of 2018 for our lead program ATIR101. If positive, this would enable an approval from the European Commission in the first quarter of 2019, with potential launch in selected countries in Europe starting in the second half of 2019.

"I wish to thank our employees, partners and shareholders for their support and confidence. ATIR101 has the potential to address a very significant unmet need in transplantation, reducing relapse and Graft versus Host Disease. We look forward to continue this journey together to achieve our vision to become a fully integrated biopharmaceutical company and improve the lives of patients suffering from
serious diseases."

Conference call and presentation
The Kiadis management will host a conference call for analysts and investors today, Friday April 13, 2018 at 2:00pm CEST / 1:00pm BST / 8:00am EDT. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement of the call:

A question and answer session will follow the presentation of the results. The presentation may be accessed by visiting View Source

For more information, please contact:

Kiadis Pharma:
Karl Hård, Head of IR & Communications
Tel. +31 (0) 611 096 298
[email protected]

Optimum Strategic Communications:
London: Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (0) 203 714 1789
Amsterdam: David Brilleslijper
Tel: +31 (0) 610 942 514
[email protected]

On April 13, 2018 VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, reported that the Company will participate in several upcoming events in the second quarter of 2018 (Press release, Vaximm, APR 13, 2018, View Source [SID1234525295]).

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AACR (American Association for Cancer Research) Annual Meeting 2018 April 14 – 18, 2018 Chicago, IL, USA

Poster #733 / 18: "Modulating T cell immunity in tumors by targeting PD‑L1 and neoantigens using a live attenuated oral Salmonella platform"
Poster Session: Vaccines 1
Sunday, April 15th, 1:00 PM – 5:00 PM

The poster summarizes the immunogenicity and anti-leukemia efficacy of VAXIMM’s oral T‑cell immunotherapy candidate VXM10 encoding variants of the murine PD-L1 protein. The animal study also describes the systemic immunogenicity of Salmonella-based polyepitope oral vaccines, supporting the design of Salmonella-based neoantigen vaccines.

The abstract is available here.

European Neoantigen Summit 2018
April 24 – 26, 2018
Amsterdam, The Netherlands

Presentation: "Fast and Cost-Effective Oral Delivery Technology of Personalized T-Cell Vaccines Based on a Live Attenuated Bacteria Platform"
Thursday, April 26th, 11:15 AM CEST

Dr. Heinz Lubenau, Chief Operating Officer of VAXIMM, will present the Company’s platform technology based on first-in-class oral T-cell activators using modified attenuated bacteria that can be readily adapted to target a wide range of cancer-related antigens.

Dr. Lubenau also will participate in the panel, "Advancing Manufacturing Practices for Personalized Cancer Vaccines" taking place on Thursday, April 26th at 2:45 PM CEST.

Bio€quity Europe
May 14 – 16, 2018
Ghent, Belgium

Dr. Lubenau will give a corporate presentation on Tuesday, May 15th at 11:40 AM CEST.