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EORTC abstracts selected at ESMO 2019

On September 18, 2019 EORTC reported will be presenting 3 abstracts (2 oral presentations and 1 poster) at the ESMO (Free ESMO Whitepaper) Congress 2019 from 27 September until 1 October in Barcelona, Spain (Press release, EORTC, SEP 18, 2019, View Source [SID1234539604]).

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Andrew Bottomley, Head of the Quality of Life at EORTC, will chair a session about "Surviving a cancer diagnosis with a good QoL" on 30 September from 8:30 to 10:00 and give a lecture on "Can value frameworks (such as ESMO (Free ESMO Whitepaper)-MCBS) contribute to a higher QoL?"

During the same session, Madeline Pe, EORTC Specialist in QoL, will talk about EORTC’s work on survivorship.

Meet us at our booth located in the society village n°20.

Oral presentations

A phase II study of Monalizumab in patients with recurrent/metastatic (RM) squamous cell carcinoma of the head and neck (SCCHN): results of the I1 cohort of the EORTC-HNCG-1559 trial (UPSTREAM)

R Galot, C Le Tourneau, E Saada-Bouzid, A Daste, C Even, P Debruyne, S Henry, S Zanetta, A Rutten, L Licitra, JL Canon, MC Kaminsky, P Specenier, S Rottey, L Dirix, T Raveloarivahy, C Fortpied, M Vanlancker, A Govaerts, JP Machiels

Presentation number: 1109O

Speaker: Rachel Galot

Date: 30.09.2019 – Lecture time: 10:15 – 11:45 – Location: Cordoba Auditorium (Hall 7)

Redefining the IGCCCG Classification in advanced Non-Seminoma

Gillessen S, Collette L, Daugaard G, De Wit R, Tryakin A, Albany C, Stahl O, Fizazi K, Gietema J, De Giorgi U, Hansen AR, Feldman D, Cafferty FH, Tandstad T, Garcia del Muro X, Huddart R, Sweeney C, Heng DY, Sauvé N and Beyer J for the IGCCCG Update Consortium

Presentation number: 903O

Speaker: Silke Gillessen

Date: 28.09.2019 – Lecture time: 15:30 – 15:45 – Location: Sevilla Auditorium (Hall 2)

Poster

There is a lack of clinical research for patients with cancer in palliative care

M. Vinches, A. Neven, L. Fenwarth, M. Terada, G. Rossi, S. Kelly, J. Peron, M. Thomaso, M. Groenvold, T. De Rojas

Poster number: 1610P

Poster presenter: Marie Vinches

Date: 28.09.2019 – Lecture time: 12:20 – Location: Poster Area (Hall 4)

The children’s cancer therapy development institute announces creation of Artisan Biopharma

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]).

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.

Nordic Nanovector R&D Day unveils updates on several programs

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.

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."

IGM Biosciences Announces Pricing of Initial Public Offering

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.

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.

IMMUTEP ANNOUNCES JAPANESE PATENT GRANT FOR LAG525 ANTIBODY

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]).

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.