On July 30, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company") reported the approval of its Investigational New Drug ("IND") application by the U.S. Food and Drug Administration ("FDA") for eftilagimod alpha ("efti" or "IMP321"), a LAG-3Ig fusion protein.

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The FDA approval of the IND allows the Company, subject to the completion of other preparatory steps, to initiate the TACTI-002 Phase II clinical study in the U.S. that will evaluate the combination of efti and anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with non-small cell lung carcinoma ("NSCLC") or head and neck carcinoma. Immutep expects to commence the TACTI-002 trial in the second half of 2018 and to report the first data from the trial in 2019.

"We are very excited to be able to initiate the Phase II study soon, now that we have received the approval from the FDA of the IND for efti, especially as it enables us to start clinical development of efti in the U.S." said Marc Voigt, CEO of Immutep. "This is one more important milestone for the Company’s pipeline of LAG-3 immunotherapeutic products that aim to transform the treatment of cancer and autoimmune diseases. Through our clinical programs, and the efforts of our partners, we believe Immutep is securely positioned to play an important role in the development of combination therapies utilizing LAG-3."

The IND application allows Immutep to ship efti across U.S. state borders to U.S. clinical investigators participating in the Company’s planned TACTI-002 Phase II clinical study.

About the TACTI-002 clinical trial

Up to 120 patients will be recruited for the TACTI-002 (Two ACTive Immunotherapies) Phase II study which will take place across approximately 15 study centres in the U.S., Europe and Australia. The trial is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It will evaluate the safety and efficacy of the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in patients with non-small cell lung carcinoma or head and neck carcinoma. It will be a Simon two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Patients participating in the trial will be given the combination treatment from day 1 of cycle 1 of KEYTRUDA treatment.

About Eftilagimod Alpha

Eftilagimod alpha is a MHC II agonist that is a soluble recombinant fusion protein consisting of the Fc portion of a human antibody and the four extracellular domains of LAG-3. Efti has been engineered to be

soluble rather than expressed on the surface of cells, is very stable, and has a high affinity for dendritic cells. It is a first-in-class antigen presenting cell ("APC") activator, which has been proven to induce sustained immune responses in cancer patients when used at low dose, as a cancer vaccine adjuvant or used at higher doses to get a systemic effect (i.e. general APC activation). Efti binds to MHC II on immature dendritic cells, with high affinity, which results in boosting and sustaining CD8+ T cell responses.

Efti has been shown to be safe and well tolerated, thus making it an ideal combination partner for other drugs or drug candidates, which is the most promising way to fight cancer.

On July 30, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported the expansion of its immuno-oncology collaboration with Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada) for the support of a Phase 2a program investigating BioLineRx’s BL-8040 in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA, in patients with metastatic pancreatic cancer (Press release, BioLineRx, JUL 30, 2018, View Source;p=RssLanding&cat=news&id=2360649 [SID1234527957]). Under the expansion, a triple combination arm investigating the safety, tolerability and efficacy of BL-8040, KEYTRUDA and chemotherapy will be added to the ongoing COMBAT/KEYNOTE-202 study. The triple combination arm will focus on second-line pancreatic cancer patients. Regulatory submissions required to conduct the additional arm of the study have been made and the trial is planned to be initiated in the fourth quarter of 2018.

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BioLineRx previously disclosed partial results from the BL-8040 monotherapy portion of the COMBAT/KEYNOTE-202 study at the ASCO (Free ASCO Whitepaper) 2018 Gastrointestinal Cancers Symposium in January 2018. The partial monotherapy results showed that BL-8040 is safe and well tolerated and that BL-8040 increases infiltration of T cells into the tumor in patients with metastatic pancreatic cancer, confirming the mechanism of action of BL-8040 in this difficult-to-treat patient population. In addition, BL-8040 also induced an increase in the number of total immune cells in the peripheral blood, while the frequency of peripheral blood regulatory T cells (Tregs), known to impede the anti-tumor immune response, was decreased. Topline clinical results of the combination will be reported in H2 2018 as planned.

"We are very excited to report the expansion of our immuno-oncology collaboration with Merck and the inclusion of an additional arm in the COMBAT/KEYNOTE-202 study. The decision to investigate the combination of BL-8040 and KEYTRUDA, together with chemotherapy, stems from the encouraging results we have seen in the trial," stated Philip Serlin, Chief Executive Officer of BioLineRx. "These results continue to demonstrate the safety and tolerability of BL-8040, as well as validate its mechanism of action, namely that BL-8040 mobilizes immune cells into the peripheral blood, promotes T-cell infiltration into tumors, and has an effect on immuno-suppressive cells."

"In light of this," continued Mr. Serlin, "the addition of cytotoxic chemotherapy may be synergistic with the existing combination, due to the fact that besides helping to reduce the overall tumor burden, chemotherapy induces immunogenic cell death, thus leading to activation and expansion of new tumor-reactive T cells. Based on its demonstrated mechanism of action, BL-8040 should facilitate the infiltration of these T cells into the tumor core, alongside the restoration of T-cell activity within the tumor by KEYTRUDA. We look forward to presenting results from the dual combination arm of BL-8040 and KEYTRUDA in the COMBAT/KEYNOTE-202 study later this year, and expect to present results from the new triple combination arm of the study in the second half of next year."

About the COMBAT/KEYNOTE-202 Study

The COMBAT/KEYNOTE-202 study, a Phase 2a study, is currently an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of the combination of BL-8040 and KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in over 30 subjects with metastatic pancreatic adenocarcinoma. The study is primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies, and is being carried out in the US, Israel and additional territories. The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary, to support a Phase 2a program investigating BioLineRx’s BL-8040 in combination with KEYTRUDA in patients with metastatic pancreatic cancer.

BL-8040, BioLineRx’s lead oncology platform, is a CXCR4 antagonist that has been shown in several clinical trials to be a robust mobilizer of immune cells to peripheral blood and to be effective at inducing direct tumor cell death. In addition, clinical findings have demonstrated the ability of BL-8040 to mediate infiltration of T cells into tumors that were previously immunologically "cold" and devoid of immune cell infiltrate. Immune checkpoint inhibitors (such as KEYTRUDA) produce anti-cancer effects by increasing the activity of T cells through blockade of the interaction between the immune checkpoint receptor PD-1, on T cells, and its ligand PD-L1, on tumor cells. Pancreatic cancers have very little T-cell infiltrate, making them less susceptive to checkpoint blockade than other tumors that are infiltrated by T cells. Therefore, combining BL-8040 with immune checkpoint blockade is predicted to increase the responsiveness of pancreatic cancer patients to immunotherapy. Further increase in the sensitivity of pancreatic cancer cells to BL-8040 and KEYTRUDA may be achieved by chemotherapy-mediated immunogenic cell death and exposure of new tumor antigens resulting in activation of new anti-cancer T cell clones.

About BL-8040

BL-8040 is a short synthetic peptide for the treatment of hematological malignancies, solid tumors, and stem cell mobilization. It functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis). BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On July 30, 2018 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported that it will release its financial and operating results for the second quarter of 2018, ended June 30, 2018, on Tuesday, August 14, 2018, after the close of the U.S. financial markets (Press release, Oncocyte, JUL 30, 2018, View Source [SID1234527958]). The Company will host a conference call on Tuesday, August 14, 2018, at 4:30 pm ET / 1:30 pm PT to discuss the results along with recent corporate developments.

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The dial-in number in the U.S./Canada is 800-458-4148; for international participants, the number is +1-323-794-2598. For all callers, please refer to Conference ID 5162879. To access the live webcast, go to the investor relations section on the Company’s website, View Source." target="_blank" title="View Source." rel="nofollow">View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 5162879. Additionally, the archived webcast will be available at View Source

On July 27, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported that the Company will release its second quarter 2018 financial results on Thursday, August 2, 2018, before the U.S. financial markets open (Press release, Curis, JUL 27, 2018, View Source [SID1234527930]). The Company’s management will also host a conference call on the same day at 8:30 a.m. EDT.

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To access the live conference call, please dial (888) 346-6389 from the United States or 1 (412) 317-5252 from other locations, shortly before 8:30 a.m. EDT. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

On July 27, 2018 MannKind Corporation (Nasdaq: MNKD) reported that it will host a conference call to discuss the 2018 second quarter and year-to-date financial results and other corporate developments at 5:00 PM (Eastern Time) on Thursday, August 2, 2018 (Press release, Mannkind, JUL 27, 2018, View Source [SID1234527931]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna, Chief Financial Officer, Steven Binder, Chief Commercial Officer, Patrick McCauley and Chief Medical Officer, David Kendall.

To view and listen to the earnings call webcast live via the Internet, visit the Company’s website at www.mannkindcorp.com and click on the "Q2 2018 MannKind Earnings Conference Call" link in the Webcasts section of News & Events. To participate in the live call by telephone, please dial (800) 239-9838 toll-free or (323) 794-2551 toll/international and use the conference passcode: 5195402.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 toll-free or (412) 317-6671 toll/international and use the replay passcode: 5195402. A replay will also be available on MannKind’s website for 14 days.