On April 24, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), and Adagene Inc., an antibody engineering and discovery company, reported that they have entered into a discovery collaboration and license agreement (Press release, ADC Therapeutics, APR 24, 2019, View Source [SID1234596063]). ADC Therapeutics will use Adagene’s SAFEbody technology to generate a masked antibody that will be combined with ADC Therapeutics’ pyrrolobenzodiazepine (PBD) cytotoxic payload technology for the development of a novel ADC against a solid tumor target.

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Adagene has developed the SAFEbody technology to produce masked antibodies that are activated to bind to an antigen in the tumor microenvironment by factors present in tumor tissues but not in healthy tissues. This enables enhanced specificity for targeting of an ADC and minimizes off-target toxicity on healthy cells, potentially enhancing the therapeutic index of the ADC.

"The SAFEbody technology requires specific conditions within the tumor microenvironment to unleash the ADC’s full therapeutic potential," said Patrick van Berkel, Senior Vice President of Research and Development at ADC Therapeutics. "Combining a SAFEbody with highly potent PBD-based payloads will allow us to develop potent new tumor-specific ADCs that depend on the unique conditions in the local tumor microenvironment for full activation."

ADC Therapeutics has entered into the agreement with Adagene for one exclusive target, with the option to leverage SAFEbody technology for one additional exclusive target. Both potential programs will focus on targets in which healthy tissue expression does not permit development of ADCs incorporating traditional antibodies.

Under the terms of the agreement, Adagene will receive research funding for the discovery phase. Upon success of the discovery collaboration, Adagene will receive an upfront payment, development and commercial milestone payments, and royalties on net sales. ADC Therapeutics has granted Adagene certain commercial rights for Greater China. No other financial terms were disclosed.

"We are very pleased to partner our SAFEbody technology with ADC Therapeutics," said Peter Luo, Chief Executive Officer and Co-Founder of Adagene. "Adagene’s innovative protein engineering ability enables us to tailor-make products to limit their on-target off-tumor toxicity. Together with ADC Therapeutics’ experience in developing ADCs with highly potent PBD payloads, we have the potential to unlock new treatment options for patients with unmet medical needs."

"We’re excited to collaborate with Adagene to work toward the next generation of masked ADCs," said Chris Martin, Chief Executive Officer at ADC Therapeutics. "As we continue evaluating our potent ADCs in ongoing clinical trials, we look forward to exploring how Adagene’s SAFEbody technology incorporated in our ADCs may enable us to further improve anti-tumor activity while minimizing side effects."

On April 24, 2019 Tiziana Life Sciences plc (NASDAQ: TLSA / AIM: TILS), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, reported results from the interim safety review conducted by the Independent Data Monitoring Committee ("IDMC") on 21 March 2019 (Press release, Tiziana Life Sciences, APR 24, 2019, View Source [SID1234535366]). The IDMC reviewed safety data from patients as of 26 February 2019, and concluded that the administration of milciclib to patients with advanced hepatocellular carcinoma ("HCC") was not associated with unexpected signs or signals of toxicity. Additionally, a number of patients are continuing with treatment under compassionate use. Topline data from this multi-center trial is expected to be available by the end of Q3 2019.

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Tiziana’s Milciclib Phase 2a clinical trial is a single-arm, repeated-dose (100 mg once daily; 4 days on/3 days off every 4 weeks defining each cycle), 6-month duration study to evaluate the safety, tolerability and anti-tumor activity of Milciclib in Sorafenib-refractory or intolerant patients with unresectable or metastatic advanced HCC, the most common form of liver cancer. Enrollment of 31 patients in Italy, Greece, and Israel was completed on 30 November 2018.

The IDMC evaluated data from 28 out of the 31 patients who were evaluable. As of 16 April 2019, a total of 10 out of 27 patients have completed the study per protocol (6 cycles, 6 months). Four patients are still under treatment, while 3 are in cycle 6 and 1 is in cycle 5. Eight out of the 10 patients who completed treatment initially expressed interest to continue with treatment. Seven of these 8 patients were approved to continue with treatment under compassionate use by their respective ethical committees. Three of the patients under compassionate use have completed 9, 13, and 16 months of treatment with Milciclib. The other 4 patients are continuing with treatment.

To date, no drug-related deaths have been recorded. Overall, the treatment with Milciclib is well-tolerated with manageable drug-related toxicities. These safety and clinical activity are consistent with the earlier reported long-term safety and clinical activity of Milciclib in thymic carcinoma, thymoma and other solid cancers.

"Demonstration of safety and clinical activity is an important milestone to move forward with strategic options for further clinical development of Milciclib either as a single agent or in combination with one of the FDA approved drugs for treatment of HCC patients," said Dr Kunwar Shailubhai, CEO & CSO of Tiziana. "We previously reported data from preclinical studies demonstrating that Milciclib produced pronounced synergistic anti-HCC activity in combination with any one of the U.S. Food and Drug Administration approved drugs such as sorafenib (Nexavar), regorafenib (Stivarga), and lenvatinib (Lenvima)."

The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO of Tiziana.

Cited References

Besse, B,, Garassino, M,, Rajan, A., Novello, S.,Mazieres, J., Weiss, G., Kocs, D., Barnett, J, Davite, C, Crivori, P and G. Giaccone. Efficacy of Milcicilib (PHA-848125AC), a pan-cyclin D -dependent kinase inhibitor in tow phase II studies with Thymic carcinoma and B3 thymoma patients. (2018) J. Clin. Onc 36 (15 suppl): 8519

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.

Jindal, A., Palejwala, V. and Shailubhai, K. (2018). Oral treatment with milciclib either alone or in combination with sorafenib inhibited tumor growth in an orthotopic model of hepatocellular carcinoma. Hepatology 68 Number 1 (Suppl): 879A (Abstract 1543)

About HCC

HCC is the fifth most common cancer and the third highest cause of cancer mortality worldwide. In 2007, the approval by the European Medical Agency and U.S. Food and Drug Administration of Sorafenib (Nexavar), an inhibitor of several receptor tyrosine kinases, 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, with a response rate less than 3%, an improvement in median survival of 2-3 months and drug-related symptoms that are not ordinary. More recently, lenvatinib (Lenvima ), another multi-tyrosine kinase inhibitor was also approved for first line treatment of HCC. The complex multi-factorial etiology of HCC warrants a need for systemic therapies that target different signaling cascades to provide improved efficacy and safety 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 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 signaling pathways that regulate cell cycles have been frequently associated with development of resistance towards chemotherapies. In a Phase 1 study, oral treatment with Milciclib was well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma. Additionally, milciclib met its primary endpoint in two separate Phase 2 multi-center clinical trials (CDKO-125A-006: 72 patients and CDKO-125A-007: 30 patients) in thymic carcinoma and thymoma patients.

On April 24, 2019 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales for the first quarter of 2019 (Press release, Ipsen, APR 24, 2019, View Source [SID1234535347]).

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Q1 2019 Group sales growth of 17.0% as reported, or 15.8%1 at constant exchange rates and consolidation scope driven by:
Specialty Care sales growth of 17.6%1, with continued strong momentum across all major products and geographies
Consumer Healthcare sales growth of 3.3%1

Full Year 2019 guidance confirmed following the completion of the acquisition of Clementia Pharmaceuticals on 17 April:
Group sales growth greater than 13.0%1 at constant exchange rates and consolidation scope. Based on the current level of exchange rates, there is an expected +2.0% impact from currencies.
Core Operating Income margin around 30.0% of net sales (excluding incremental investments in pipeline expansion initiatives)

David Meek, Chief Executive Officer of Ipsen stated: "With robust double-digit sales growth in the first quarter, Ipsen is on track for another year of outstanding business execution. The Specialty Care business continues to thrive across all major products and geographies with volume and market share gains. We are accelerating the ongoing transformation of Ipsen by executing on our external innovation strategy to strengthen the R&D pipeline with novel first and best-in-class assets.

"Notably, in the first quarter, we announced and completed the acquisition of Clementia Pharmaceuticals, a company focused on the treatment of rare and severely-disabling bone disorders. Palovarotene is a largely de-risked near-term launch opportunity with significant upside potential. Together, with our new colleagues from Clementia, we will leverage our combined scientific and development expertise to deliver new treatments to patients with high unmet medical needs."

Conference call

Ipsen will host a conference call on Wednesday 24 April 2019 at 2:30 p.m. (Paris time, GMT+1). A conference call will take place and a web conference (audio and slides) will be available at www.ipsen.com. Participants should dial in to the call approximately 5 to 10 minutes prior to its start. No reservation is required to participate in the conference call.

Standard International: +44 (0) 2071-928-000

France and continental Europe: + 33 (0) 1 76 70 07 94

UK: 08-445-718-892

U.S.: 1-6315-107-495

Conference ID: 9846139

A recording will be available for 7 days on Ipsen’s website.

1 At constant exchange rates and reflecting a change in the consolidation method for joint arrangements related to the Consumer Healthcare Schwabe partnership. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

On April 24, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its first quarter 2019 financial results on Tuesday, May 7, 2019, before the open of the U.S. financial markets (Press release, Clovis Oncology, APR 24, 2019, View Source [SID1234535367]). Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss first quarter 2019 results on Tuesday, May 7, at 8:30 a.m. ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 877.698.7048, International participants 647.689.5448, conference ID: 8567356.

On April 24, 2019 Medicure Inc. ("Medicure") (TSXV:MPH, OTC:MCUJF), a pharmaceutical company, reported that it will release financial results for the year ended December 31, 2018 after markets close on Monday, April 29, 2019 (Press release, Medicure, APR 24, 2019, View Source [SID1234535368]). The financial statements will be made available on the Company’s website at www.medicure.com. Medicure will hold a conference call and webcast regarding the results on Tuesday, April 30, 2019 at 7:30 AM Central Time (8:30 AM Eastern Time).

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Conference Call Info:

Topic: Medicure’s Fiscal Year End 2018 Results

Call date: Tuesday, April 30, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 8925377#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.