On September 17, 2019 The Children’s Cancer Therapy Development Institute (cc-TDI) reported the creation of Artisan Biopharma (artisanbio.com), a Public Benefit Corporation pediatric cancer biopharmaceutical company, wholly owned by the 501c3 nonprofit, cc-TDI (Press release, Children’s Cancer Therapy Development Institute, SEP 17, 2019, View Source [SID1234631990]).

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Artisan Biopharma (EIN 84-3079359) is a newly formed, angel-funded for-profit benefit corporation wholly-owned by the 501(c)3 nonprofit, cc-TDI. Our mission is to create a quiet cultural revolution in the way new drugs are brought to market for pediatric cancers. We incorporated September 17, 2019, and we are currently engaged with tax and security counsel to finalize our operational structure with respect to the nonprofit. Our stated mission as a public benefit corporation is to provide research and interventions related to the prevention and treatment of cancer in children.

Target market: Orphan drug indications in pediatric cancers
Few rare cancer patient populations with unmet clinical need are as vulnerable and in need of advocacy as children with cancer. Pharmaceutical companies have historically faced significant financial disincentives to pursue pediatric oncology therapeutics, including low incidence, high costs of conducting pediatric trials, and a lack of funding for early-stage research. We are leveraging the deep preclinical domain expertise of cc-TDI to more efficiently identify and in-license compounds. Our goal is to reverse the 40+ year drought represented by only 8 drug approvals for pediatric cancer. To achieve this goal, we aim to have 5 new compounds reach the clinic annually for children with high risk cancers.

Artisan advantage
The rapid advancement of new oncology drugs has created a massive, de-risked discovery tool for translational science, many of which remain novel molecular entities ready to match to rare disease indications. The founding equity investor of Artisan Biopharma, the Children’s Cancer Therapy Development Institute (cc-TDI.org), is an established partner to industry (NVS, PFE, LLY) for preclinical sciences. Artisan was formed as a natural opportunity to develop and market cancer drugs for childhood cancer, generating sustainable funding for cc-TDI’s drug discovery engine. Artisan launched with 15 pipeline candidates and a network of over 1200 families directly touched by pediatric cancer.

On September 17, 2019 Nordic Nanovector ASA (OSE: NANO) reported that it will today host an R&D day in Oslo (Press release, Nordic Nanovector, SEP 17, 2019, View Source [SID1234553445]). The programme will include presentations from three external experts and by Nordic Nanovector’s senior management team. The full programme of the event is available at www.nordicnanovector.com under press releases.

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The R&D day presentations will cover

the progress of the company’s research and pre-clinical projects
the clear medical need in the patient populations suffering from the diseases targeted by Nordic Nanovector products in development and
the latest data on some of the clinical trials currently being conducted.
In addition, the company will provide an update on its work and progress on the CMC (Chemistry, Manufacturing and Control) area, which will be a key part of the planned regulatory filing for Betalutin in the first half of 2021.

The pivotal Phase 2b PARADIGME trial of Betalutin in advanced recurrent follicular lymphoma (FL) is progressing with 83 sites in 24 countries open for enrolment as of September 16th, 2019.

"The clinical results obtained so far with Betalutin demonstrate that the rationale behind its design for the treatment of non-Hodgkin’s lymphoma was right", commented Dr Jostein Dahle, Chief Scientific Officer and Co-founder of Nordic Nanovector. "Over the last ten years we have continued to advance our knowledge of the biology of the disease and the peculiarities of our treatment modality in general and Betalutin in particular. We are very excited with the data we continue to generate and the opportunities that this information will provide to keep the company at the forefront of this race towards finding new and improved therapies or combinations that will benefit the thousands of patients still at need".

Dr J.P. Pouget, PhD, Radiobiology and targeted radiotherapy group Montpellier Cancer Research Institute (IRCM), French National Institute of Health and Medical Research (INSERM) will present interesting new pre-clinical results with Betalutin, including its increased therapeutic activity when combined with cell cycle inhibitors.

Dr Jostein Dahle will summarize the focus and most recent advances of Nordic Nanovector’s research. During his presentation, he will preview data that will be presented at the EANM (European Association of Nuclear Medicine) Congress in Barcelona in October that shows the synergistic effect of Humalutin with the PARP inhibitor Olaparib in DLBCL (Diffuse Large B Cell Lymphoma) cell lines.

Dr Jostein Dahle will also explain in detail some of the data that the company has generated with Alpha37 (an anti-CD37 mAb linked to alpha-particle generating lead 212). This will include demonstration of the superiority of Alpha37 to ibrutinib in an ibrutinib-resistant mouse model of CLL (chronic lymphocytic leukaemia). Ibrutinib is today the most widely used product in this indication, both first line and second line. These data have been selected for the highlights session of the already mentioned EANM Congress in Barcelona. Alpha37, which is partnered with OranoMed, has recently been awarded a grant of NOK 6 million by the Eurostar programme.

Prof Pier Luigi Zinzani, Professor of Hematology at Bologna University, will analyse the therapeutic landscape in recurrent FL and marginal zone lymphoma (MZL), reviewing the efficacy and safety profile of approved agents and products in development. Despite the availability of new therapies, the unmet medical need in recurrent FL and MZL is still high.

Dr Arne Kolstad from the Department of Oncology, Oslo University Hospital, and the Principal Investigator of the LYMRIT-37-01 trial, will hold a presentation which provides the latest update from this trial of Betalutin in patients with relapsed indolent NHL.

With a median follow-up time for responders of 30 months, this latest update confirms a median duration of response (mDoR) of 13.6 months for all 45 responders and an even more durable response of 32.0 months for the 22 patients showing a complete response (compared with 9.0 and 20.7 respectively last December at ASH (Free ASH Whitepaper)).

Dr Arne Kolstad will also present data from the first safety cohort of three patients of the Phase 1b Archer-1 study of Betalutin + rituximab (RTX) in relapsed/refractory follicular lymphoma. This open label, single-arm dose escalation study in 2L FL expects to recruit a total of 20-25 patients to evaluate the safety and tolerability of Betalutin in combination with RTX and to evaluate the preliminary anti-tumour activity of combination treatment.

In the first safety cohort an overall response rate of 100% was observed with three complete responders and importantly no dose limiting toxicities. Full data read out from this study is expected in the second half of 2020.

With Nordic Nanovector’s strategic priorities focused on efforts to maximize the value of Betalutin across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments, we decided together with our partner Heidelberg Pharma to discontinue development of NNV014 (anti-CD37 ADC), an early stage discovery project in leukaemia.

"The data presented during this R&D day highlights our potential to become a leader in radiopharmaceuticals and our commitment to deliver innovative products for the patients suffering from these devastating diseases", commented Eduardo Bravo, CEO of Nordic Nanovector. "We are very pleased with the latest results from the LYMRIT-37-01 study and with the early indications from the first safety cohort in Archer-1. These encouraging data support our decision to broaden the clinical development of Betalutin in NHL and to develop the regulatory and commercial strategy for a commercial launch in the US. We are entering an exciting phase in the company’s development with key data due to be reported next year and the prospect of our first regulatory filing for Betalutin in third line FL in the first half of 2021."

On September 17, 2019 IGM Biosciences, Inc. (Nasdaq: IGMS) reported the pricing of its initial public offering of 10,937,500 shares of its common stock at a price to the public of $16.00 per share (Press release, IGM Biosciences, SEP 17, 2019, View Source [SID1234539635]). The shares are expected to begin trading on The Nasdaq Global Select Market on September 18, 2019 under the symbol "IGMS." The offering is expected to close on September 20, 2019, subject to customary closing conditions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by IGM, are expected to be approximately $175.0 million. In addition, the underwriters have a 30-day option to purchase up to 1,640,625 additional shares of common stock at the initial public offering price less underwriting discounts and commissions.

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Jefferies, Piper Jaffray, Stifel and Guggenheim Securities are acting as joint book-running managers for the offering.

A registration statement relating to the offering has been filed with the United States Securities and Exchange Commission and was declared effective on September 17, 2019. The offering is made only by means of a prospectus. When available, a copy of the prospectus relating to this offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; Piper Jaffray & Co, Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected].

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

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