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, 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 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.

On April 13, 2018 Kitov Pharma (NASDAQ and TASE: KTOV), reported that TyrNovo Ltd., a company majority-owned by Kitov, will present pre-clinical data on TyrNovo’s anti-tumor resistance drug candidate, NT219, in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018, to be held on April 14-18, at the McCormick Place, Chicago, Illinois (Press release, Kitov Pharmaceuticals , APR 13, 2018, View Source [SID1234525304]).

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The poster highlights recent promising results, further demonstrating NT219’s efficacy in synergy with immuno-oncology therapies. The recent results, achieved using double autologous PDX models, demonstrated that NT219 converted non-responding tumors to responders to pembrolizumab (Keytruda). The models also demonstrated the efficacy of NT219 in enhancing the immunotherapeutic potential of cetuximab (Erbitux).

Details on the poster presentations are as follows:

Session Title: Immune Mechanisms Invoked by Therapies 1

Session Time: 4/16/2018 1:00 PM – 5:00 PM ET
Location: Poster Section 33
Poster Board Number: 2754 / 16

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation and inhibiting the phosphorylation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1 and signal transducer and activator of transcription 3 (STAT3), respectively. While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers, by preventing the tumors from developing drug resistance and reversing resistance after it had been acquired.

About TyrNovo

TyrNovo Ltd., a Kitov Pharma (NASDAQ/TASE: KTOV) company, is a developer of novel small molecules in the oncology therapeutic field. TyrNovo is developing NT219, an oncology product designed to be used in combination with other oncology drugs. NT219 is a small molecule that presents a new concept in cancer therapy. In combination with various approved oncology drugs, NT219 has demonstrated potent anti-tumor effects and increased survival in various cancer models, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers. Its mechanism of action is through the prevention of acquired resistance in tumors and by regression of resistant tumors. For more information on TyrNovo please visit View Source

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.