On April 15, 2018 NewLink Genetics Corporation (NASDAQ:NLNK), reported initial data from NLG2105, a Phase 1 study evaluating indoximod, its IDO pathway inhibitor, in combination with radiation and chemotherapy for the treatment of pediatric patients with progressive brain tumors during the "Multimodality Immuno-oncology Approaches" session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting in Chicago.

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The presentation reviewed NewLink Genetics’ trial evaluating the combination of indoximod with radiotherapy and chemotherapy for children with malignant brain tumors. Indoximod has immunostimulatory effects involving multiple immune cell types. Indoximod works by reversing the effects of low tryptophan by increasing proliferation of effector T cells, and directly reprogramming T regulatory cells into helper T cells. Initially, 29 heavily pretreated patients were enrolled in a dose-escalation protocol with initial data presented at the Society for Neuro-Oncology Conference, November 2017. Seventeen of the 29 patients were appropriate candidates for re-irradiation of their tumors and were treated with a combination therapy including indoximod plus conformational radiotherapy followed by maintenance indoximod combined with temozolomide chemotherapy. The other 12 patients were treated with immuno-chemotherapy consisting of indoximod and temozolomide. In aggregate, with further follow-up, the 29 subjects in the dose-escalation phase of the study had a median progression-free survival (mPFS) of 6.2 months and median time on study (time to regimen failure, TTRF) of 11.7 months. The treatment continued to be well tolerated with minimal toxicity attributed to indoximod.

"These early data, though from a small cohort of pediatric patients, demonstrate the potential of the indoximod plus radiochemotherapy combination without an increase in toxicity for these children," said Dr. Theodore S. Johnson, M.D., Ph.D., Associate Professor of Pediatrics at Augusta University, lead investigator for the trial.

Once initial safety data were generated, an additional pilot cohort of newly-diagnosed patients with diffuse intrinsic pontine glioma (DIPG) was opened using indoximod during front-line radiotherapy (RT) followed by maintenance indoximod plus temozolomide. Six newly diagnosed DIPG patients initiated treatment, with all 6 having completed induction radioimmunotherapy. Treatment was well tolerated with symptomatic improvement in all 6 patients. Site-reported radiographic review indicated near resolution of tumor in one patient at the end of radiotherapy and observable improvement in 5 out of 6 patients overall. A seventh patient with progressive DIPG received re-RT combined with indoximod, which was well tolerated with symptomatic improvement and objective tumor reduction per site-reported assessment on post-RT MRI.

Exhibit 99.1

"These initial findings further support the potential for indoximod in combination with other agents," said Charles J. Link, Jr., M.D., Chairman and Chief Executive Officer. "We look forward to working with our investigators toward gathering more data on the effects of indoximod on this deadly disease."

NewLink will also present during poster session PO.IM02.07, Immunomodulatory Agents and Interventions 1, Abstract 3753, entitled: Indoximod modulates AhR-driven transcription of genes that control immune function, from 8:00 AM – 12:00 PM CT on Tuesday, April 17, 2018.

Separately, the Company has determined that it will not initiate the randomization portion of Indigo301, its study of indoximod in combination with pembrolizumab or nivolumab for patients with advanced melanoma. NewLink’s clinical team will evaluate the design, trial size and feasibility of an alternative randomized evaluation of indoximod in melanoma in the context of the failure of a competitor’s trial of its enzymatic IDO inhibitor in a similar clinical setting. The evaluation will include analysis of the full data set from the Company’s single-arm Phase 2 melanoma study, the differentiated mechanism of action of indoximod, and the opinions of experts in the field. The Company will present final results from its Phase 2 trial in melanoma and its single-arm Phase 2 trial in pancreatic cancer at an upcoming medical conference in the first half of 2018.

About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, cancer vaccines, radiation and chemotherapy across multiple indications such as melanoma, pancreatic cancer and other malignancies.

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, 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 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.