On May 6, 2019 Magenta Therapeutics, Inc. (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported that it has launched a proposed public offering of 4,250,000 shares of its common stock (Press release, Magenta Therapeutics, MAY 6, 2019, View Source [SID1234535786]).

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All shares of common stock will be offered by Magenta. Magenta expects to grant the underwriters a 30-day option to purchase up to an additional 637,500 shares of common stock. Magenta intends to use the net proceeds of the offering to advance its lead conditioning programs through preclinical studies and into Phase 1 clinical trials; to advance its first-line mobilization program, MGTA-145, through Phase 1 and into Phase 2 clinical trials; and to advance its cell therapy program, MGTA-456, through Phase 2 and into Phase 3 clinical trials. The remainder of the net proceeds will be used for research and development, working capital, and general corporate purposes. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

J.P. Morgan, Goldman Sachs & Co. LLC and Cowen are acting as joint book running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

The proposed offering will be made only by means of a prospectus. A preliminary prospectus supplement and accompanying prospectuses relating to and describing the terms of this offering has been filed with the U.S. Securities and Exchange Commission (the "SEC"). When available, copies of the preliminary prospectus may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 866-803-9204; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, telephone: 631-274-2806.

Important Information

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Phase 1 study of CA-170 has reached its target enrollment of mesothelioma patients (Press release, Curis, MAY 6, 2019, View Source [SID1234535748]). The company began enrolling and dosing patients in this study in January.

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"We are pleased to announce we have completed enrollment of the CA-170 study three months ahead of schedule. Last November, we outlined the reorganization of company resources to strengthen our focus on clinical execution. Today’s announcement is a direct result of those efforts," said James Dentzer, President & CEO of Curis. "If the data from this phase of the trial, which is expected in the 2nd half of this year, is positive, we expect to initiate an expansion of the study."

CA-170 is an orally available, dual inhibitor of VISTA and PDL1, which the company believes could provide benefit in tumors with high levels of VISTA expression. Over 90% of mesothelioma cancers express high levels of VISTA.

CA-170 is the only anti-VISTA therapeutic currently being studied in a clinical trial. CA-170 has demonstrated favorable safety and tolerability, as well as preliminary anti-tumor activity in patients across multiple tumor types. The Phase 1 study is the first clinical trial of CA-170 to specifically target a patient population characterized by high levels of VISTA expression.

About the Study
The Phase 1, open-label, dose escalation and dose expansion trial evaluating the safety, pharmacokinetics, pharmacodynamics, and clinical effects of orally administered CA-170 in patients with advanced tumors and lymphomas. The dedicated mesothelioma cohort will evaluate CA-170 at two dose levels.

About VISTA
VISTA (V-domain Ig-containing Suppressor of T cell Activation) is an independent, inhibitory T cell checkpoint protein that is expressed on both immune cells and tumor cells. VISTA has been identified as a potential resistance mechanism to treatment with anti-PD1 antibodies in melanoma and anti-CTLA4 antibodies in prostate cancer. Recent literature indicates that high levels of VISTA expression have been found on various tumors, including mesothelioma, ovarian cancer, endometrial cancer, triple negative breast cancer, gastric cancer, and non-small cell lung cancer.

On May 6, 2019 SpringWorks Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the first patient has been dosed in a Phase 1b study to evaluate the combination of SpringWorks Therapeutics’ investigational MEK inhibitor, PD-0325901, and BeiGene, Ltd.’s (Nasdaq: BGNE; HKEX: 06160) investigational RAF dimer inhibitor, lifirafenib (BGB-283), in patients with advanced or refractory solid tumors (Press release, SpringWorks Therapeutics, MAY 6, 2019, View Source [SID1234535767]).

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The Phase 1b clinical trial, being conducted by BeiGene, is an open-label, dose-escalation and expansion study to investigate the safety, pharmacokinetics (PK) and antitumor activity of PD-0325901 in combination with lifirafenib in patients with advanced or refractory solid tumors that harbor RAS mutations, RAF mutations and other MAPK pathway aberrations. The trial is designed to define the dose and tolerability of the combination as well as to capture early efficacy signals to allow for rapid cohort expansion.

"We are excited to explore this combination therapy approach in collaboration with BeiGene, as it could address the approximately one-fourth of solid tumor patients whose cancers are driven by RAS mutations, as well as those with RAF mutations and other MAPK pathway aberrations, which occur in many of the most devastating tumor types," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "Despite decades of research, no anti-RAS therapies have been approved to-date. This trial has the potential to meet a critical need for patients and is an important evolution for SpringWorks as it provides the opportunity to study our MEK inhibitor in patients with more commonly occurring tumors."

The rationale for the Phase 1b study is supported by data presented by BeiGene at the 2015 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper)1, which demonstrated that the combination of PD-0325901 and lifirafenib led to antitumor activity in preclinical models of RAS-mutated cancers. Vertical inhibition of the MAPK pathway, enabled by the combination of a MEK inhibitor with a RAF dimer inhibitor, has been further validated preclinically by multiple academic and industry investigators, and has the potential to overcome the drug resistance mechanisms that have impeded previous attempts to develop therapies for tumors with MAPK mutations and aberrations.

In addition to this Phase 1b study, SpringWorks Therapeutics is preparing to initiate a Phase 2b single-arm, open-label study of PD-0325901 as a monotherapy in patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-associated PN). NF1-associated PN is a rare genetic disorder characterized by the growth of painful, disfiguring and debilitating tumors along peripheral nerves throughout the body.

About the Phase 1b Trial in Advanced or Refractory Solid Tumors

The Phase 1b trial is a multicenter, open label, dose-escalation trial of PD-0325901 in combination with lifirafenib in adult patients with advanced or metastatic, unresectable tumors harboring K-RAS/N-RAS or B-RAF mutations, or any other MAPK pathway aberration. The study will enroll patients who have experienced disease progression during or after at least one line of systemic therapy or for which treatment is not available, not tolerated or refused.

The trial is designed in two parts; the first part will consist of a dose-escalation and dose-finding study to assess the safety and tolerability of combining PD-0325901 and lifirafenib, and to determine the maximum tolerated dose and/or the recommended Phase 2 dose for the combination. The second part is a multiple-group, noncomparative, indication expansion study to assess the preliminary antitumor activity of the combination in patients with selected tumor types, in addition to further assessing the safety, tolerability and PK of the combination.

The trial is being conducted under a global clinical collaboration agreement between SpringWorks Therapeutics and BeiGene, which was entered into in September 2018. Under the terms of the agreement, BeiGene is responsible for administering the Phase 1b clinical trial, with all costs of the clinical studies and governance responsibilities to be shared equally among both parties. More information about the study is available at www.clinicaltrials.gov under the identifier NCT03905148.

About PD-0325901

PD-0325901 is an investigational, selective, orally bioavailable small molecule inhibitor of MEK1 and MEK2, proteins that play key roles in the MAPK pathway. The MAPK pathway is critical for cell survival and proliferation, and overactivation of this pathway has been shown to help enable tumor growth. By blocking activity of the MAPK pathway, PD-0325901 may help arrest uncontrolled cellular growth associated with many types of tumors.

PD-0325901 has been tested in several Phase 1 and Phase 2 clinical trials, and approximately 260 subjects have been exposed to treatment. SpringWorks is evaluating PD-0325901 as a monotherapy for the treatment of patients with neurofibromatosis type 1-associated plexiform neurofibromas and is also pursuing PD-0325901 in combination with other rational anti-cancer agents across a range of solid tumors.

About Lifirafenib

Lifirafenib was discovered in BeiGene’s research facilities in Beijing, China, and is an investigational small molecule kinase inhibitor with RAF monomer and dimer inhibition activities. Lifirafenib has shown antitumor activities in preclinical models and in cancer patients with tumors harboring BRAF V600E mutations, non-V600E BRAF mutations, non-small cell lung cancer and endometrial cancer harboring KRAS mutations. To date, lifirafenib has been dosed in more than 150 patients globally.

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]).

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"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

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.

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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.