On May 7, 2019 AstraZeneca reported positive results from the Phase III ASCEND trial of Calquence (acalabrutinib) in previously-treated patients with chronic lymphocytic leukaemia (CLL) (Press release, AstraZeneca, MAY 7, 2019, View Source [SID1234535787]). Results showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with Calquence monotherapy compared to a combination regimen of rituximab plus physician’s choice of idelalisib or bendamustine. Importantly, the safety and tolerability of Calquence was consistent with the known profile.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

José Baselga, Executive Vice President, R&D Oncology said: "Calquence is the first BTK inhibitor to show benefit in a Phase III trial as a monotherapy compared to current standard-of-care combinations used in relapsed or refractory chronic lymphocytic leukaemia. We look forward to presenting detailed results at a forthcoming medical meeting."

Within AstraZeneca’s robust development programme for Calquence, ASCEND is the first of two Phase III CLL trials expected to read out in 2019. The second is ELEVATE-TN (ACE-CL-007) in treatment-naïve, front-line CLL. Calquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, the UAE, and Qatar, and is being developed for the treatment of CLL and other blood cancers.

About ASCEND

ASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in previously-treated patients with CLL. In the trial, 310 patients were randomised (1:1) into two groups. Patients in the first group received Calquence monotherapy (100mg twice daily until disease progression). Patients in the second group received rituximab plus physician’s choice of idelalisib or bendamustine.1

The primary endpoint is PFS assessed by an independent review committee (IRC), and key secondary endpoints include physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient reported outcomes and time to next treatment (TTNT).1

About Calquence

Calquence (acalabrutinib) was granted accelerated approval by the US Food and Drug Administration (FDA) in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

Calquence is an inhibitor of Bruton tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity2. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 26 clinical trials that are company-sponsored. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenstrom macroglobulinaemia, follicular lymphoma, and multiple myeloma and other haematologic malignancies. Several Phase III clinical trials in CLL are ongoing, including ASCEND, ELEVATE-TN, ELEVATE-RR (ACE-CL-006) evaluating Calquence vs. ibrutinib in previously-treated CLL and ACE-CL-311 evaluating Calquence in combination with venetoclax and obinutuzumab in previously-untreated fit patients with CLL.

About chronic lymphocytic leukaemia (CLL)

CLL is the most common type of leukaemia in adults3. In the US, it accounts for approximately one in four new cases of leukaemia, with the average age at the time of diagnosis being approximately 70 years of age4. In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections3. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets3. This could result in anaemia, infection and bleeding3. B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

About AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Company’s haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZeneca’s haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

In October 2018, AstraZeneca and Innate Pharma announced a global strategic collaboration that included Innate Pharma licensing the US commercial rights of Lumoxiti (moxetumomab pasudotox-tdfk), and with support from AstraZeneca, will continue EU development and commercialisation, pending regulatory submission and approval.

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On May 7, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that data from the investigator-initiated study evaluating the effects of remetinostat in basal cell carcinoma patients, will be presented during the 2019 Society for Investigative Dermatology (SID) annual meeting in Chicago, USA (Press release, Medivir, MAY 7, 2019, View Source [SID1234535776]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data will be presented on a poster and orally on May 10 and 11, respectively. The title of the abstract is: "An Open-Label Phase 2 Clinical Trial of Topical Remetinostat Gel for Basal Cell Carcinoma".

Authors: Nicole Urman B.S., Shaundra Eichstadt M.D., Hanh Do B.S., Amar Mirza B.S., Irene Bailey Ph.D., Shufeng Li Ph.D., Stanley T. Hollmig, Jean Y. Tang M.D. Ph.D., Anthony E. Oro M.D. Ph.D., Sumaira Aasi M.D., and Kavita Y. Sarin M.D. Ph.D.

Details of all presentations for the 2019 SID annual meeting are available at the conference website:View Source

For further information, please contact:
Uli Hacksell, CEO, Medivir AB, phone: +46(0)73-125-0615

On May 6, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has directly entered into an agreement for the sale of its common stock in a private placement with three institutional investors, namely Perceptive Advisors, Avoro Capital Advisors (formerly known as venBio Select Advisor) and OrbiMed (Press release, Athenex, MAY 6, 2019, View Source [SID1234573891]). The transaction is expected to result in gross proceeds to Athenex of approximately $100 million, before deducting offering expenses. Net proceeds from the transaction are expected to be used to fund clinical development and regulatory activities of Oraxol (oral paclitaxel and encequidar (also known as HM30181A)); clinical regulatory activities of KX2-391 ointment for the treatment of actinic keratosis; commercialization activities, including pre-launch activities for Oraxol; manufacturing infrastructure; and working capital and general corporate purposes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company will issue 10 million shares of common stock for a purchase price of $10.00 per share, for aggregate gross proceeds of $100 million. The closing of the private placement is expected to occur on or about May 7, 2019, subject to customary closing conditions.

"We are extremely delighted by the support from these leading healthcare investment firms," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "We believe the financing from this private placement will position us well to further advance our Phase 3 clinical programs for Oraxol and KX2-391 ointment and support our pre-launch and commercialization efforts."

The offering of shares of common stock has not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and the shares are being offered pursuant to an exemption from the registration requirements of the Securities Act and similar exemptions under applicable state securities laws. At the closing of the offering, the Company will enter into a registration rights agreement with the investors, pursuant to which the Company will agree to file a registration statement with the Securities and Exchange Commission registering for resale the shares issued in this private placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On May 6, 2019 Lidds reported the preliminary data from a voluntary open label extension (OLE) study indicates that the time to re-treatment with Liproca Depot in prostate cancer patients is potentially longer than anticipated (Press release, Lidds, MAY 6, 2019, View Source [SID1234555914]). This information comes from the OLE phase of the Phase IIb study, LPC-004. Data from the main study is currently being collected according to plan. Preliminary study results will be available during the third quarter of this year.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The voluntary open label extension (OLE) study involves a number of patients who participated in the Liproca Depot Phase IIb clinical study. In the OLE phase, a second injection of Liproca Depot was administered once the patient’s PSA level (a biomarker for prostate cancer) had returned to its pre-treatment level.

-Preliminary information from the OLE study looks promising as it indicates a longer than expected anti-androgen effect from Liproca Depot treatment, says Monica Wallter, CEO of LIDDS.

Earlier Phase II studies have shown that Liproca Depot can be an effective anti-androgen treatment without the resulting hormonal side effects associated with current treatments that have a physical and psychological impact on patients.

– Patients who have participated in the voluntary open label extension study so far say they would be prepared to be treated with Liproca Depot again, says Monica Wallter.

Liproca Depot is based on LIDDS proprietary NanoZolid technology that allows active anti-cancer drugs to be injected directly into a tumor and for the drugs to be released over an extended period of time. Liproca Depot is currently in the final stage of a Phase IIb study at clinics in Canada, Finland and Lithuania.

One in every six men is diagnosed with prostate cancer and there is currently no standard drug treatment for prostate cancer patients at low risk of progression. The global drug market for prostate cancer is expected to grow to more than USD 8 billion by 2022.

Facts about the open label extension (OLE) study:
The voluntary OLE study involves patients who participated in the Liproca Depot Phase IIb clinical study. A second injection of Liproca Depot was administered once the patient’s PSA level (a biomarker for prostate cancer) had returned to its pre-treatment level.
The rationale for conducting the OLE study is to understand the long-term anti-androgen efficacy of Liproca Depot and to follow these patients for a further year to assess safety and quality of life parameters after a repeated Liproca Depot injection.

On May 6, 2019 ERYTECH Pharma (Euronext: ERYP—Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business update and reports its financial results for the quarter ended March 31, 2019 (Press release, ERYtech Pharma, MAY 6, 2019, View Source [SID1234536954]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The first quarter of 2019 has been particularly intense in terms of execution of our late stage clinical trials and the extension of our manufacturing capacity, all while making progress on our earlier stage programs. Patient enrollment for TRYbeCA 1, our pivotal Phase 3 trial in second-line metastatic pancreatic cancer, continues ahead of plan in Europe, and we recently filed an IND in the United States in order to begin enrollment there," said Gil Beyen, CEO of ERYTECH. "Construction of the new manufacturing site in Princeton and the expansion of our Lyon manufacturing facility have been completed and validation is now ongoing."

Recent Business Highlights

TRYbeCA1, the pivotal Phase 3 trial evaluating ERYTECH’s lead product candidate eryaspase in second-line metastatic pancreatic cancer, is actively enrolling patients in several European countries. In view of opening the trial to patients in the United States, the company recently submitted an IND application to the US FDA. In this trial, ERYTECH is evaluating eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) compared to standard chemotherapy alone. The primary endpoint of the trial is overall survival. An interim efficacy analysis is planned when approximately two-thirds of events have occurred. The trial is expected to enroll approximately 500 patients at more than 120 sites in Europe and the United States.

TRYbeCA2, a Phase 2 proof-of-concept trial in patients with previously untreated metastatic triple-negative breast cancer (TNBC), is evaluating eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone in approximately 64 patients. The primary endpoint is objective response rate. First sites were initiated in December 2018, and the trial is now open for enrollment in Spain and France.

To ensure supply of the product for the clinical trials and potential initial commercial needs, the Company is establishing a GMP manufacturing facility in Princeton, New Jersey. It is also expanding its European manufacturing capacity in Lyon, France. Construction has now been completed at both sites and validation activities are ongoing, as planned.

ERYTECH is also advancing the preclinical programs to leverage its proprietary ERYCAPS encapsulation platform. The Company’s lead preclinical program and next product candidate is erymethionase, methionine-gamma-lyase encapsulated in red blood cells. Activities in support of initiating a Phase 1 clinical trial of erymethionase in solid tumor indications are ongoing. The company expects to begin this Phase 1 trial in Europe in the first quarter of 2020.

In preparation for the next stage of the company’s development, ERYTECH recently announced that its Board of Directors will propose the appointment of Jean-Paul Kress as a Director at the Annual General Meeting on June 21, 2019, with a view to appointing him as Chairman of the Board of Directors. Dr. Kress has over 25 years’ experience as a senior executive in international biotech and pharma groups. He was President and Chief Executive Officer of Syntimmune (Cambridge, MA, US) until the end of 2018, when the company was acquired by Alexion Pharmaceuticals.

Q1 2019 Financial Results

Net loss for the first quarter of 2019 was €11.7 million, stable from the same period in 2018. The €4.0 million increase in operating loss was offset in the period by the €4.1 million improvement in financial Income. The €4.0 million increase in operating loss was attributable to the €1.5 million increase in preclinical and clinical development expenses, mostly related to the Phase 3 clinical trial in pancreatic cancer, the €2.1 million increase in G&A expenses, primarily driven by professional fees in relation to the launch readiness of the Company’s additional production capacity, and the €0.4 million decrease in research tax-credit income. The €4.1 million improvement in financial Income was mainly related to the translation into Euro of the portion of the Company’s cash position denominated in U.S. Dollar, which had a positive foreign exchange impact and explained most of the €1.6 million financial Income in the first quarter of 2019, compared to a negative foreign exchange impact and a €2.5 million financial expense in the first quarter of 2018.

As of March 31, 2019, ERYTECH had cash and cash equivalents totaling €110.5 million (approximately $124 million), compared with €134.4 million on December 31, 2018. The €23.9 million decrease in cash position in the first quarter of 2019 was the result of a €25.2 million net cash utilization, comprised of a €15.9 million net cash utilization in operating activities, €8.9 million in capital expenditures and €0.4 million in loan and lease reimbursement, while the appreciation in the period of the U.S. Dollar against the Euro lead to a €1.3 million favorable currency exchange impact. Cash utilization in the first quarter of 2019 was, as anticipated, relatively high due to the non-recurring capital expenditure disbursements

for the production facility expansions in Lyon and in Princeton. As both projects are now close to completion, cash utilization is expected to be lower again in the coming quarters and the Company continues to expect its cash resources to be sufficient to fund operations until the end of 2020.
Key News Flow and Milestones Expected over Next 12 Months

First patient enrolled in TRYbeCA-2, Phase 2 proof-of-concept clinical trial in TNBC

Start of GMP production at Princeton facility and Lyon extension

Start of US patient enrollment in TRYbeCA 1, Phase 3 trial in second-line pancreatic cancer

Initiation of Phase 1 clinical trial with erymethionase

Q1 2019 Conference Call Details

ERYTECH management will hold a conference call and webcast on Tuesday, May 7th, 2019 at 02:30pm CEST / 08:30am EDT on business highlights and financial results for the first quarter of 2019. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 2199912#:

USA/Canada: +1 (833) 818-6807

International Dial-In Number: +1 (409) 350-3501

France: +33 1 70 80 71 53

United-Kingdom: +44 2031070289

The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 2199912#

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

2019 Financial Calendar:

General Assembly Meeting of Shareholders: Friday, June 21, 2019 at 9:30am CET in Paris

Quarterly financial updates:

Business Update and Financial Highlights for the 2nd quarter and first-half of 2019: September 17, 2019 (after U.S. market close), followed by a conference call and webcast on September 18, 2019 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the 3rd quarter of 2019: November 7, 2019 (after U.S. market close), followed by a conference call and webcast on November 8, 2019 (2:30pm CET/8:30am ET)

ERYTECH will Present at the Following Upcoming Investor Conferences:

Gilbert Dupont Annual Healthcare Conference, May 23, Paris

Jefferies 2019 Global Healthcare Conference, June 4-7, New-York

European Midcap Event – Spring, June 18-19, Paris

JMP Securities Life Sciences Conference, June 19, New York

France Biotech, Health Tech Investor Day, June 25, Paris