On May 16, 2018 Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, reported that the independent data monitor committee (IDMC) completed a second, interim analysis of tolerability data from the first eleven treated patients and recommended expansion of the initial cohort to continue enrolment of an additional 20 patients to complete the trial (Press release, Tiziana Life Sciences, MAY 16, 2018, View Source;intolerable-Unresectable-or-Metastatic-Hepatocellular-Carcinoma-HCC-Patients [SID1234526674]).

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This phase 2a multi-centre and multi-country clinical trial (CDKO-125A-010) in sorafenib-refractory or -intolerable patients with unresectable or metastatic HCC is being conducted in Greece, Italy and Israel. Since, this was the first trial with milciclib in HCC patients, a second, interim analysis was scheduled following completion of treatment for the first 11 patients before initiating enrolment of the next 20 patients. Thus, demonstration of good tolerability with acceptable incidence of serious adverse events is an important milestone to initiate a phase 2b trial evaluating combination of milciclib with sorafenib (Nexavar; Bayer Germany (BAYN.GR)) in HCC patient.

Major findings were as follows:

Milciclib treatment was well-tolerated with manageable drug-related toxicities. The IDMC concluded that there were no major signals of tolerability concerns and therefore favours proceeding to expand enrolment.

Four patients have completed the study per protocol (6 cycles of treatment in 6 months). Two of these patients and their care provider opted to continue receiving milciclib at full dose as part of compassionate use. A third patient is awaiting ethical committee (EC) approval.

Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented: ”Establishment of tolerability of milciclib as a single agent in HCC patients is a key pre-requisite to initiate the phase 2b trial to evaluate dosing, tolerability and clinical activity of milciclib in combination with sorafenib (Nexavar; Bayer Germany) in HCC patients”.

Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences, commented: "We are pleased with the conclusion of IDMC that milciclib treatment showed no major signals of tolerability concerns in sorafenib-refractory or -intolerable HCC patients. These findings are consistent with the findings reported earlier on the long-term tolerability and clinical activity of milciclib in thymic carcinoma, thymoma1 and other solid cancers2. Results from these clinical studies strongly warrant further clinical development of milciclib for treatments of HCC and other cancers".

Cited References

1. Press Release on announcement of clinical data in thymoma and thymic carcinoma.
www.tizianalifesciences.com

2 . Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. (2017). Phase I dose-escalation study of Milciclib in combination with gemcitabine in patients with refractory solid tumors. Cancer Chemother Pharmacol. 79:1257-1265

About Hepatocellular Carcinoma

Hepatocellular cancer is the 5th most common cancer and the 3rd cause of cancer mortality worldwide. In 2007 the approval by the European Medical Agency (EMA) and Food and Drug Administration (FDA) of sorafenib in HCC represented the first systemic therapy for improving outcome in patients unsuitable for loco-regional and surgical therapies and created a new standard of treatment for the disease. However, although significant in respect to placebo, the benefits of sorafenib are modest; the response rate is less than 3%, the improvement in median survival is 2-3 months and the drug-related symptoms are not ordinary. Therefore, more effective systemic therapy is required for both naive patients presenting with unresectable, advanced stage and those who suffer recurrence after curative treatments (resection, ablation and transplantation).

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases (CDKs) such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in thymic carcinoma, pancreatic carcinoma and colon cancer.

About Sorafenib

Sorafenib (co-developed and co-marketed by Bayer and Onyx Pharmaceuticals as Nexavar) is a small molecular multi tyrosine kinase inhibitor drug approved for the treatment of primary kidney cancer (advanced renal cell carcinoma), advanced primary liver cancer (HCC), and radioactive iodine resistant advanced thyroid carcinoma. Treatment with sorafenib induces autophagy, which may suppress tumor growth. However, autophagy can also cause drug resistance.

On May 16, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies*, reported that the complete safety and efficacy results of the Phase 1 study of its lead proprietary oncology drug, MP0250, will be presented at the Annual Meeting 2018 of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Press release, Molecular Partners, MAY 16, 2018, View Source [SID1234526673]).

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MP0250 is a multi-DARPin candidate targeting simultaneously VEGF and HGF, two prominent escape pathways, and has the potential to reverse resistance that has built to standard of care cancer therapies. MP0250 is currently evaluated in a Phase 2 study in combination with bortezomib and dexamethasone in patients with relapsed refractory multiple myeloma. An additional Phase 1b/2 study will evaluate MP0250 in combination with osimertinib in patients with EGFR-mutated NSCLC (Non-small cell lung cancer).

The data to be presented at ASCO (Free ASCO Whitepaper) include the complete safety and efficacy results and pharmacokinetics data from the First-in Human Phase 1 study of MP0250 in advanced solid tumor patients.

"We are very pleased with the Phase 1 data of MP0250," commented Andreas Harstrick, Chief Medical Officer of Molecular Partners. "MP0250 was well tolerated and about half of the patients stayed on treatment for three months or longer, with the longest treatment duration beyond one year. We are looking forward to additional results from our Phase 2 combination studies."

The MP0250 data will be presented in the following sessions:

Monday, June 4, 2018, 8.00 am ET, Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics / Abstract 2520 (Poster Board: #346):
First-in-class phase I study evaluating MP0250, a VEGF and HGF neutralizing DARPin molecule, in patients with advanced solid tumors (Azaro et al.)
Monday, June 4, 2018, 3:00 pm – 4:15 pm ET, room S406:
Discussion of the abstract at the Poster Discussion Session
Full details on the Molecular Partners’ session at ASCO (Free ASCO Whitepaper) 2018 as well as all presentations can be found here. Following its presentation at the ASCO (Free ASCO Whitepaper), the poster will also be available one the Molecular Partners website.

*DARPin is a registered trademark owned by Molecular Partners AG.

Financial Calendar
August 30, 2018 – Publication of 2018 Half-year Results
November 01, 2018 – Q3 2018 Management Statement
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.
With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan.
Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and in Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On May 16, 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 that it is scheduled to attend the following investor conferences in May and June 2018 (Press release, Kiadis, MAY 16, 2018, View Source [SID1234526672]):

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Bio€quity Europe
May 14-16, 2018, Het Pand, Ghent, Belgium
Arthur Lahr, Chief Executive Officer, will present on Wednesday May 16, 2018 at 2:40 p.m. CEST

Jefferies 2018 Global Healthcare Conference
June 5-8, 2018, Grand Hyatt, New York, USA
Arthur Lahr, Chief Executive Officer, will present on Thursday June 7, 2018 at 2:00 p.m. EDT

On May 16, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its revenues and cash position for the first three months of 2018 (Press release, Innate Pharma, MAY 16, 2018, View Source [SID1234526671]).

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Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, commented: "During the first quarter we have continued to advance our broad and innovative portfolio of differentiated, first-in-class immunotherapies, with significant clinical momentum across our key antibody, monalizumab, and have also entered into an important clinical collaboration on our proprietary IPH5401 program with our partner, AstraZeneca/MedImmune. We also welcomed Professor Eric Vivier to Innate Pharma as Chief Scientific Officer. Eric has brought world-renowned expertise in immunology, which is already helping us to step up innovation in our R&D operations. With a robust financial position and strong partnerships, we have several near-to-medium term read-outs in 2018, and are confident of demonstrating continued progress in meeting the needs of patients and delivering investor value."

FINANCIAL RESULTS:

Cash, cash equivalents and financial assets of the Company amounted to €153.8 million* as of March 31, 2018. At the same date, financial liabilities amounted to €5.6 million.

Revenues for the first three months of 2018 amounted to €8.7 million (€7.8 million for the same period in 2017). New accounting rules required a change from IAS 18 in 2017 to IFRS 15 in 2018 (under IAS 18 revenues in the first three months of 2018 would have been €11.3 million). This revenue results from the co-development and commercialization agreement with AstraZeneca, corresponding to the recognition over the period of the initial payment received in June 2015.

PIPELINE UPDATE:

Monalizumab: Innate Pharma and its partner AstraZeneca/MedImmune have reported significant progress on the monalizumab program. In March, partner MedImmune expanded patient cohorts in the ongoing Phase I dose escalation and expansion trial to evaluate monalizumab in combination with durvalumab and standard of care in 1st- and 2nd-line treatment of colorectal cancer patients. First data on the combination of monalizumab and durvalumab in colorectal cancer patients will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois, June 1-5, 2018 (abstract #3540).

Post period, preliminary data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting (poster ID: CT158) suggested promising anti-tumor activity resulting from the combination of monalizumab and cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Updated data from the ongoing Phase I/II trial will be presented at upcoming medical conferences.

IPH4102: A Phase I trial with IPH4102 in patients with Sézary syndrome (SS), an advanced form of cutaneous T-cell lymphoma, is ongoing. Accrual of patients with SS for a cohort expansion part of the ongoing trial has been completed and data will be presented at a medical conference.

IPH5401: In January, the Company entered into a clinical trial collaboration with MedImmune that will accelerate development activities for IPH5401 in combination with PD-1/L1 blockers. IPH5401, which targets the tumor microenvironment, will enter the clinic in selected solid tumors in 2018. Innate will sponsor the Phase I dose escalation and expansion study with development costs equally shared by both parties.

Preclinical projects: The Company presented four posters at AACR (Free AACR Whitepaper) 2018 in April, which underpinned the ongoing clinical program for monalizumab and highlighted the next wave of immunotherapies in cancer. New preclinical data further supported the development of monalizumab in combination with other cancer therapies, showcased a differentiated approach to addressing the immunosuppressive adenosine pathway by developing both anti-CD39 and anti-CD73 neutralizing antibodies and highlighted a new first-in-class anti-Siglec-9 antibody as a potential new checkpoint inhibitor.

On May 16, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, obtained approval from the Taiwan Food and Drug Administration (TFDA), for "Alecensa," anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of "patients with ALK-positive, advanced non-small cell lung cancer (NSCLC) (Press release, CHUGAI PHARMACEUTICAL CO, MAY 16, 2018, View Source [SID1234526670])."

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"The results of the J-ALEX study conducted by Chugai and the ALEX study conducted overseas showed that Alecensa will greatly contribute to the treatment of patients who receive at an early stage." said Dr. Yasushi Ito, Chugai’s Senior Vice President, Co-Head of Project & Lifecycle Management Unit. "Following approval for first line treatment in the US and the EU in 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in Taiwan followed by Japan and South Korea in the Asia region."

This approval is based on results from the phase III ALEX study. The ALEX study evaluates the efficacy and safety of Alecensa compared with crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy (first-line).

In the study, Alecensa significantly reduced the risk of disease worsening or death by 47% (primary endpoint, HR=0.53, 95%CI: 0.38-0.73, stratified log-rank test, p<0.0001) compared to crizotinib as assessed by independent review committee. Median progression-free survival (PFS) was 25.7 months (95%CI: 19.9-not estimable) for people who received Alecensa compared with 10.4 months (95%CI: 7.7-14.6) for people who received crizotinib.

The safety profile of both drugs was consistent with that observed in previous studies, with no new findings.

In addition, Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95%CI: 0.10-0.28, stratified log-rank test, p<0.0001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).

About Alecensa
Alecensa is a highly selective oral ALK inhibitor created by Chugai. Outside of Japan, Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Taiwan, Thailand, Liechtenstein, Argentina, United Arab Emirates, Saudi Arabia and Turkey for the treatment of people with metastatic (advanced) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in the US, EU, Australia, Turkey, Switzerland and South Korea for the treatment of first line therapy on ALK-positive metastatic NSCLC.

In Japan, Alecensa is available to patients with "ALK fusion gene positive unresectable, recurrent/advanced NSCLC" and is marketed by Chugai. The approved dosage and administration in Japan is "300mg alectinib administered orally twice daily for adult patient."

Note: The dosage and administration of the ALEX study is "600mg alectinib administered orally twice daily," which is different from the Japanese dosage and administration.

Trademarks used or mentioned in this release are protected by law.