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, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that preclinical research for its glutaminase inhibitor CB-839 will be shared as poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 in Chicago (Press release, Calithera Biosciences, APR 13, 2018, View Source [SID1234535242]). CB-839 is a potent, selective, orally bioavailable glutaminase inhibitor in Phase 2 trials. The company and its academic collaborators will highlight data of CB-839 in novel therapeutic combinations in preclinical models of selected cancers.

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"Tumor metabolism is a novel therapeutic approach that exploits the way in which cancer cells utilize nutrients to grow and survive," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "CB-839, a novel glutaminase inhibitor, has the potential to be developed in combination with standard of care cancer therapeutics such as CDK4/6 or PARP inhibitors to improve patient outcomes."

Preclinical data will be presented by Ethan Emberley, PhD, in a poster titled, "The glutaminase inhibitor CB-839 synergizes with CDK4/6 and PARP inhibitors in preclinical models," on April 17, 2018 (Abstract #3509/6). Data will be presented demonstrating that CB-839 synergizes with the CDK4/6 inhibitor palbociclib in colorectal carcinoma, triple negative breast cancer (TNBC), and ER+ breast cancer cell lines, and enhances anti-tumor activity in both an ER+ breast cancer and a colorectal cancer (CRC) xenograft tumor model. CB-839 treatment in combination with the PARP inhibitors niraparib and talazoparib has synergistic anti-proliferative activity in TNBC, CRC, non-small cell lung carcinoma, ovarian and prostate cancer cells. In vivo, the combination of CB-839 with PARP inhibitors enhances anti-tumor activity compared to single agent treatment in a CRC tumor xenograft model. Two additional posters will be presented by academic collaborators:

Suppression of clear cell ovarian carcinoma growth by glutaminase-1 inhibitor as single agent and in combination with PARP-1 inhibitor
Abstract # LB-253/20
Presenter: T. Li, Laboratory of Othon Iliopoulos, Massachusetts General Hospital Tuesday April 17, 2018

Combination treatment with CB-839 and romidepsin induces apoptosis and suppresses cell viability in preclinical models of chondrosarcoma
Abstract #1329/7
Presenter: T.N. Sheikh, Laboratory of Gary Schwartz, Columbia University Monday, April 16, 2018

About CB-839

Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents

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 Menarini Ricerche reported that it will present on the latest preclinical studies of its phosphatidylinositol 3-kinase (PI3K) class I inhibitor MEN1611, in development for solid tumors, at the AACR (Free AACR Whitepaper) Annual Meeting 2018, which will take place on April 14-18, 2018, in Chicago, Illinois, USA (Press release, Menarini, APR 13, 2018, View Source [SID1234531254]).

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The results of these preclinical studies will be described in two posters. The first one, entitled "MEN1611, a novel α-selective PI3K inhibitor in solid tumors", demonstrates the in-vitro and in-vivo antitumor activity of MEN1611, showing synergistic effects in combination with a number of targeted therapies in cell lines and patient-derived xenograft models of different tumor types. The second poster, entitled "The role of MEN1611, a class I PI3-Kinase (PI3K) inhibitor, in reprogramming the pro-tumoral inflammatory environment", investigates the role of MEN1611 in targeting inflammatory cells of the tumor microenvironment, through its ability to inhibit the PI3Kϒ isoform expressed by myeloid cells.

The results from Menarini Ricerche’s R&D programs will be presented in the following poster sessions: "MEN1611, a novel α-selective PI3K inhibitor in solid tumors" Abstract no. 2160, will take place on Monday, April 16, between 1:00PM – 5:00PM, during the session "Translational Therapeutics in Cancer Models 2" in the McCormick Place South, Exhibit Hall A, Poster Section 7, Poster Board #15.

"The role of MEN1611, a class I PI3-Kinase (PI3K) inhibitor, in reprogramming the pro-tumoral inflammatory environment" Abstract no. 2145, will take place on Monday, April 16, between 1:00PM – 5:00PM, during the session "The Metastatic Microenvironment" in the McCormick Place South, Exhibit Hall A, Poster Section 6, Poster Board #30

About MEN1611

MEN1611 is a novel orally available PI3-Kinase class I selective inhibitor, targeting with nanomolar potency the mutant PI3Kα isoforms and PI3Kϒ. The results of the Phase I study showed that MEN1611 was well tolerated and the maximum tolerated dose was determined. MEN1611 will enter this year a combination Phase IB study in breast cancer patients carrying mutations in the PI3K gene.