On September 17, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company") is reported the grant of patent no. 6576962 entitled "Antibody molecules to LAG-3 and uses thereof" by the Japanese Patent Office (Press release, Immutep, SEP 17, 2019, View Source [SID1234539611]).

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The claims of the patent are directed to LAG525, and to the use of LAG525 in the treatment of cancer and infectious disease. LAG525 is a humanised form of Immutep’s IMP701 antibody that was originally developed by Immutep S.A. (now Immutep S.A.S.), a wholly owned subsidiary of the Company. The patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 13 March 2035.

About IMP701 and LAG525

IMP701 is a therapeutic antibody originally developed by Immutep S.A. to target LAG-3. This antagonist antibody plays a role in controlling the signalling pathways in both effector T cells and regulatory T cells (Treg). The antibody works to both activate effector T cells (by blocking inhibitory signals that would otherwise switch them off) and at the same time inhibit Treg function that normally prevent T cells from responding to antigen stimulation. The antibody therefore removes two brakes that prevent the immune system from responding to and killing cancer cells. In contrast, some other checkpoint antibodies in development target only the effector T cell pathway and don’t address the Treg pathway.

Rights to the development and commercialisation of IMP701 were licensed to CoStim Pharmaceuticals in 2012, which was subsequently acquired by Novartis in 2014.

LAG525, a humanised form of IMP701 is currently being evaluated in five Phase I and/or Phase II clinical trials, in combination with Novartis’ PD-1 inhibitor spartalizumab for the treatment of various cancers. Novartis has full responsibility for the continued development of the antibody program and Immutep is eligible to receive development-based milestone payments and royalties on sales following commercialisation of the antibody.

On September 17, 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 its financial results for the quarter ended June 30, 2019 (Press release, ERYtech Pharma, SEP 17, 2019, View Source [SID1234539610]).

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"The second quarter of 2019 remained focused on the execution of our late stage clinical trials of eryaspase and the extension of our manufacturing capacity. Patient enrollment in TRYbeCA 1, our pivotal Phase 3 trial in second-line metastatic pancreatic cancer, continues at a strong pace in Europe, and we expect enrollment in the United States to begin shortly," said Gil Beyen, CEO of ERYTECH. "Our new manufacturing site in Princeton and our expanded Lyon facility are on track to support our increasing clinical trial demand."

Recent Business Highlights

Patient enrollment in TRYbeCA1, the pivotal Phase 3 trial evaluating ERYTECH’s lead product candidate eryaspase in second-line metastatic pancreatic cancer, is on track. The trial began enrolling patients in Spain in September 2018 and is now actively enrolling patients in several European countries. In May of this year, the U.S. Food and Drug Administration (FDA) accepted ERYTECH’s Investigational New Drug (IND) application for the trial. Patient enrollment in the United States is expected to start in Q4 of this year. The trial is plans to enroll approximately 500 patients at more than 120 clinical sites in Europe and the United States. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival. An interim superiority analysis, planned for when approximately two-thirds of events have occurred, is anticipated to be conducted within the next twelve months.

TRYbeCA2, a randomized Phase 2 trial in patients with previously untreated metastatic triple-negative breast cancer (TNBC), started patient enrollement in June. The trial is evaluating eryaspase in combination with gemcitabine and carboplatin chemotherapy, compared to chemotherapy alone.

To ensure supply of the product for the clinical trials and potential future initial commercial demand, the Company has extended its manufacturing capacity in Lyon, France, and established a new GMP manufacturing facility in Princeton, New Jersey. The Lyon facility began producing clinical batches for the TRYbeCA1 trial in July, and the recently inaugurated Princeton site is expected to do so as well in the fourth quarter of this year.

In June, ERYTECH entered into a strategic collaboration with SQZ Biotechnologies (SQZ), a cell therapy company developing novel treatments in multiple therapeutic areas, granting SQZ an exclusive worldwide license to develop antigen-specific immune modulating therapies employing red blood cell-based technology. ERYTECH is eligible to receive up to $57 million in combined upfront and potential development, regulatory and commercial milestone payments for the first product successfully developed by SQZ under this agreement. ERYTECH will also be eligible to receive sales royalties, and up to a total of $50 million in commercial milestone payments related to each additional approved product or approved indication. The strategic collaboration with SQZ is aligned with ERYTECH’s strategy to leverage its unique red blood cell capabilities beyond its initial lead programs while increasing the Company’s focus on advancing its late-stage product pipeline.

In preparation for the next stage of the company’s development, Jean-Paul Kress was appointed as a director at the Company’s Annual General Meeting of Shareholders held on June 21, 2019. He was subsequently elected as Chairman by the Company’s Board of Directors. Dr. Kress has over 25 years’ experience as a senior executive in international biotech and pharma groups in Europe and the United States. He was recently appointed Chief Executive Officer of Morphosys AG.

Allene Diaz has notified ERYTECH of her intention to resign from the Company’s Board of Directors, effective September 30, 2019. Ms. Diaz’s resignation was not caused by any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. The Company thanks Allene for her years of service on the board.

1H 2019 Financial Results

Key financial figures for the first half of 2019 compared with the same period of the previous year are summarized below:

Net loss for the second quarter of 2019 was €29.3 million, up €10.3 million (+54%) as compared to the same period in 2018, with a €8.4 million increase (+38%) in operating loss and a €1.9 million decrease in financial income. The €8.4 million increase in operating loss was attributable to the €6.0 million increase in preclinical and clinical development expenses, mostly related to expenses incurred related to the Company’s Phase 3 clinical trial in pancreatic cancer, the €3.1 million increase in G&A expenses, of which €1.8 million related to the launch readiness of the Company’s additional manufacturing capacity, and the €0.7 million increase in operating income, of which €0.9 million of milestone payment upon the signature of the license agreement with SQZ Biotechnologies, while research tax-credit income decreased €0.2 million. The €1.9 million decrease in financial income was mainly related to the translation into euro of the portion of the Company’s cash position denominated in U.S. dollars.

As of June 30, 2019, ERYTECH had cash and cash equivalents totaling €94.5 million (approximately $107.5 million), compared with €134.4 million on December 31, 2018. The €39.9 million decrease in cash position in the first half of 2019 was the result of a €40.5 million net cash utilization, comprised of a €23.8 million net cash utilization in operating activities, €17.6 million in investing activities and €0.8 million in financing activities, while the appreciation in the period of the U.S. dollar against the euro lead to a €0.6 million favorable currency exchange impact. After a peak in capital expenditure disbursements in the first quarter of 2019 related to the expansion of manufacturing facilities in Lyon and in Princeton, cash utilization has lowered in the second quarter as expected, and the Company’s cash position at the end of June is in line with the earlier guidance of sufficient cash resources to fund operations until the end of 2020.

Key News Flow and Milestones Expected over Next 12 Months

Start of U.S. patient enrollment in TRYbeCA 1, Phase 3 clinical trial in second-line pancreatic cancer

Start of GMP production at Princeton facility

Initiation of investigator sponsored Phase 1 trial with eryaspase in first-line pancreatic cancer

Results of Phase 2 IST in second-line acute lymphoblastic leukemia (ALL)

Anticipated interim (superiority) analysis in TRYbeCA1

Q2 2019 Conference Call Details

ERYTECH management will hold a conference call and webcast on Wednesday, September 18th, 2019 at 02:30pm CEST / 08:30am EDT on business highlights and financial results for the second 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#: 1396310#

USA/Canada: +1 (833) 818-6807 France: +33 1 70 80 71 53

International Dial-In Number: +1 (409) 350-3501 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: 1396310#.

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

2019 Financial Calendar

Next quarterly financial update:

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:

Investir Day, October 3rd, Paris

Jefferies Healthcare Conference, November 20-21, London

Salon Actionaria, November 22, Paris

On September 17, 2019 Pfizer Inc. reported investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, October 29, 2019 (Press release, Pfizer, SEP 17, 2019, View Source [SID1234539606]). The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Third Quarter 2019 Performance Report, to be issued that morning.

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To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to pre-register in advance of the conference call.

You can also listen to the conference call by dialing either (855) 895-8759 in the United States and Canada or (503) 343-6044 outside of the United States and Canada. The password is "Third Quarter Earnings".

Visitors to www.pfizer.com/investors will be able to view and listen to an archived copy of the webcast of the conference call.

On September 17, 2019 PTC Therapeutics, Inc. (Nasdaq: PTCT) reported that it is commencing an offering of $250.0 million aggregate principal amount of its convertible senior notes due 2026 (the "Notes"), subject to market conditions and other factors (Press release, PTC Therapeutics, SEP 17, 2019, View Source [SID1234539592]).

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The Notes are to be offered and sold in a private offering only to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The interest rate, conversion rate, conversion price and other terms will be determined by negotiations among PTC and the initial purchaser of the Notes. PTC also expects to grant to the initial purchaser a 30-day option to purchase up to an additional $37.5 million aggregate principal amount of the Notes.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction. Any offers of the Notes will be made only by means of a confidential offering memorandum. The Notes and the shares of PTC’s common stock underlying these securities have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States without registration or an applicable exemption from registration requirements.

On September 17, 2019 Leap Therapeutics, Inc. (Nasdaq: LPTX) reported an oral and poster presentation of updated clinical data from its ongoing Phase 2 clinical trial of DKN-01, its anti-Dickkopf-1 (DKK1) antibody, as both a monotherapy and in combination with paclitaxel chemotherapy in patients with advanced gynecological malignancies will be presented at the 2019 International Gynecologic Cancer Society Annual Global Meeting taking place September 19-21, 2019 in Rio de Janeiro, Brazil (Press release, Leap Therapeutics, SEP 17, 2019, View Source [SID1234539601]). The poster will be presented on Friday, September 20 at 6:15 p.m. (BRT).

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"We are very enthusiastic about the single agent and combination activity of DKN-01 observed in this heavily pre-treated patient population. DKN-01 targets DKK1, which is a modulator of Wnt signaling. In this study, patients with Wnt activating mutations and high levels of DKK1 have had clinical benefit and prolonged progression-free survival (PFS)," commented Rebecca C. Arend, M.D., Department of Obstetrics and Gynecology at the University of Alabama at Birmingham School of Medicine, who presented the data on behalf of the study group. "A monotherapy complete response and the correlation of patient outcomes with prevalent tumor biomarkers are impressive signals of activity in these patients, who have poor prognosis and few treatment options."

Key Findings from the P204 Study include:

DKN-01 single agent complete response: Following the data cut-off date, one patient with Wnt signaling alterations has had her monotherapy partial response deepen into a complete response. She has remained on DKN-01 monotherapy for 14 months after enrolling in July 2018 and having a partial response after cycle 8. This represents the first complete response for a patient on DKN-01 monotherapy.
Patients with Wnt activating mutations have longer PFS: Across the study, patients with Wnt activating mutations have demonstrated a longer PFS (n=21, 175 days) as compared to patients without Wnt activating mutations (n=67, 63 days). The benefit observed in patients with Wnt activating mutations was statistically maintained regardless of treatment type (monotherapy or combination therapy) and cancer type (endometrial or ovarian cancer).
Patients with DKK1-high tumors have longer PFS:DKK1 expression as measured by in situ hybridization RNAscope assay is currently available for 54 of the patients on the study, and 13 patients (24.1%) were identified as DKK1-high tumoral expression. Similar to the results from Leap’s study in patients with esophagogastric cancer, patients whose tumors are DKK1-high have prolonged PFS (n=13, 168 days) as compared to patients with tumors that are DKK1-low (n=41, 63 days). The benefit observed in patients with DKK1-high tumors was statistically maintained regardless of monotherapy or combination therapy treatment and cancer type (endometrial or ovarian cancer).
Few survival events in Wnt activating mutation or DKK1-high populations: Median overall survival (OS) has not yet been reached for the patients with Wnt activating mutations as compared to 321 days OS for patients without Wnt activating mutations. Only 3 of 21 patients with Wnt activating mutations (14.3%) have had events as compared to 18 of 67 patients (26.9%) without Wnt activating mutations. Median OS has also not been reached for the DKK1-high patients as compared to 365 days for the patients who are DKK1-low. Only 2 of 13 DKK1-high patients (15.4%) have had events as compared to 12 of 41 (29.3%) DKK1-low patients. Patient follow-up remains ongoing.
About the P204 Study
The P204 study is a Phase 2 basket study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with relapsed/refractory endometrioid endometrial cancer (EEC), endometrioid ovarian cancer (EOC) or carcinosarcoma. Ninety-two patients have been enrolled in the first four groups that were designed to evaluate the efficacy, safety, and pharmacodynamics of DKN-01 monotherapy and combination therapy in both EEC and EOC. The study has been expanded to include DKN-01 monotherapy and paclitaxel combination cohorts in patients with carcinosarcoma. Approximately fifty percent (50%) of patients in each cohort were required to have Wnt pathway alterations, which included Wnt activating mutations and Wnt signaling mutations. Additional patient follow-up is expected in the first half of 2020.

About DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling, a signaling pathway frequently implicated in tumorigenesis and suppressing the immune system. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK ligands on tumor cells.