On March 9, 2020 Elevar Therapeutics, a late stage biopharmaceutical company focused on promising therapies for unmet medical needs in cancer, reported the initiation of a pivotal trial for the treatment of adenoid cystic cancer (ACC) with the enrollment of the first patient at the University of California, San Francisco Division of Hematology and Oncology (Press release, LSK BioPharma, MAR 9, 2020, View Source [SID1234555331]). This study is designed to evaluate the efficacy and safety of rivoceranib in subjects with recurrent or metastatic ACC of all anatomic sites of origin. Chief Drug Development Officer, Dr. Steven Norton, said, "The opportunity to study the impact Rivoceranib has on ACC could lead to a shift in the way ACC patients are treated. We recognize the high unmet need for these patients and are committed to advancing care for these patients."

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Adenoid cystic carcinoma (ACC) is a relatively uncommon tumor with a reported 1,200 new cases diagnosed each year in the United States. Elevar is preparing to file for orphan drug designation (fewer than 200,000 patients) in the United States. ACC is considered a low-grade malignancy, and is characterized by slow growth and invasion of the tumor to the space surrounding nerves. ACC typically occurs in salivary glands, but can also occur in secretory glands located in other tissues such as the esophagus, breast and lungs. Although good local control is usually achieved by resection of the primary tumor and adjuvant radiation therapy, more than half of patients eventually have recurrent and/or metastatic disease. There is no standard of care treatment option for ACC, and there is an unmet need for patients with recurrent and/or metastatic ACC.

Dr. Hyunseok Kang, Associate Professor of Clinical Medicine at University California, San Francisco, said, "Adenoid cystic cancer has been a very challenging disease with no standard treatment options other than repeated surgeries and/or radiation. We are glad to dose our first patient with Rivoceranib, which seems to be a very promising approach for these patients. Based on data we have seen out of China, I am optimistic that Rivoceranib would be proved to be a valuable treatment option for patients suffering advanced ACC."

The primary endpoint for this study is the frequency of patients with partial or complete responses to treatment (objective response rate). Secondary objectives include Overall Survival, Progression Free Survival, Duration of Response and Time to Progression. The study is being conducted at multiple centers across the United States and South Korea. Additional information can be found at ClinicalTrials.gov (Identifier: NCT04119453).

About Rivoceranib (Apatinib)

Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder, Jiangsu Hengrui Medicine Co., Ltd. Elevar Therapeutics holds the global rights (ex-China). The Company has completed a global (12 countries across Asia, US, and Europe) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric/gastroesophageal junction cancer patients ("ANGEL study"). Elevar Therapeutics is also developing rivoceranib for the treatment of patients with earlier lines of gastric cancer, colorectal cancer, hepatocellular carcinoma, and adenoid cystic carcinoma. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. Elevar Therapeutics has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea. The Company is in discussions with the FDA to receive advice on regulatory submissions for monotherapy gastric cancer treatment.

On March 9, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the year ending December 31, 2019 (Press release, Innate Pharma, MAR 9, 2020, View Source [SID1234555330]). The consolidated financial statements are attached to this press release.

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"2019 was a defining moment for Innate Pharma, as we successfully executed our Nasdaq listing in the US and announced plans to advance the Company’s first molecule into Phase III, monalizumab. In addition, we started building out our commercial infrastructure in the US. Collectively, these achievements marked a significant step in raising the Company’s global profile and executing on our corporate, clinical and commercial strategy," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We thank our employees and all of our external stakeholders who have contributed to Innate’s success. We look forward to another exciting year ahead where we’ll continue to deliver on our broad and balanced portfolio, and work to get innovative medicines to patients as quickly as possible."

Financial highlights for 2019:
The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2019 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €255.9 million (€m) as of December 31, 2019 (€202.7m as of December 31, 2018), including non-current financial instruments amounting to €37.0m (€35.2m as of December 31, 2018).
Net proceeds of €66.0m from the Company’s global offering in October 2019, including its initial public offering on the Nasdaq Global Select Market.
Net proceeds of €44.9m from the final payments under the October 2018 agreements with AstraZeneca, after payments received from AstraZeneca and payments made to AstraZeneca, Novo Nordisk A/S and Orega Biotech.
As of December 31, 2019, financial liabilities amounted to €18.7m (€4.5m as of December 31, 2018) as a result of the draw down in August 2019 of the remaining portion of €13.9m of the €15.2m loan granted in July 2017 by Société Générale.
Revenue and other income amounted to €85.8m in 2019 (2018: €94.0m) and mainly comprise:
Revenue from collaboration and licensing agreements mainly resulting from the spreading of the upfront and opt-in payments received from AstraZeneca. Revenue from collaboration and licensing agreements for monalizumab decreased by €19.0m to €42.5m in 2019 (2018: €61.5m), primarily due to its exercise of the option by AstraZeneca in October 2018 which resulted in a catch up additional revenue of €32.0m in 2018. Revenue from collaboration and licensing agreements for IPH5201 increased by €3.2m to €18.8m in 2019 (2018: €15.6m). Revenue from invoicing of R&D costs for IPH5401 and IPH5201 was €6.9m in 2019 (2018: €2.2m)..
Research tax credit increased by €3.2m to €16.7m (2018: €13.5m) mainly as a result of an increase in the amortization expense for the intangible assets related to acquired licenses (monalizumab, Lumoxiti, IPH5201).
Operating expenses of €104.6m in 2019 (2018: €87.7m), of which 75.3% are related to research and development (R&D).
R&D expenses increased by €9.3m to €78.8m in 2019 (2018: €69.6m), including amortization expenses of €15.5m in 2019 (2018: €6.7m). This increase in amortization expenses is primarily due to the full year impact of the amortization of Lumoxiti and IPH5201.
Selling, general and administrative (SG&A) expenses increased by €7.7m to €25.8m in 2019 (2018: €18.1m) in the context of the structuration of the US subsidiary and commercialization of Lumoxiti as well as general reinforcement of support functions in light of Innate’s corporate evolution.
The Lumoxiti distribution agreement generated a net loss of €8.2m in 2019 (2018: loss of €1.1m). In 2019, the Company had a cost sharing mechanism with AstraZeneca that will be reimbursed in 2020.
A net loss of €20.8m in 2019 (2018: net income of €3.0m).

On March 9, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that the first patient was dosed in a Phase I clinical trial evaluating IPH5201, an anti-CD39 blocking monoclonal antibody, in adult patients with advanced solid tumors (Press release, Innate Pharma, MAR 9, 2020, View Source [SID1234555329]). The purpose of the study, which is sponsored by AstraZeneca (LSE/STO/NYSE: AZN), is to evaluate IPH5201 as monotherapy and in combination with durvalumab (anti-PD-L1) with or without oleclumab (anti-CD73 monoclonal antibody).

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The IPH5201 Phase I program is supported by positive pre-clinical results presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Congress, which demonstrated that blocking CD39 in combination with PD-L1 checkpoint inhibitors provides increased antitumor efficacy over PD-L1 alone and supports the rationale for assessing this combination in clinical trials. Pre-clinical data recently published by Innate Pharma1 also demonstrates the rationale to further evaluate the combination of CD39 and CD73 blockade in cancer indications, given their potential synergistic effect on an anti-tumor response. The blockade of CD39 not only prevents production of immunosuppressive adenosine, but also promotes accumulation of immunostimulatory adenosine triphosphate (ATP). It is increasingly recognized that the adenosine pathway is critical in tumor immunosuppression.

"We’re pleased that the IPH5201 clinical studies have started, as blockade of CD39 represents an innovative and differentiated approach to potentially reverse immunosuppression mediated by adenosine in the cancer microenvironment. In particular, IPH5201’s potential to unleash immune responses makes it an interesting molecule to investigate for the treatment of solid tumors, particularly in combination therapies," said Pierre Dodion, Chief Medical Officer of Innate Pharma. "AstraZeneca is a very valuable partner given their expertise in the adenosine pathway and leadership in this field. We’re excited to see our first molecule progressing to the clinic from our multi-faceted partnership, helping to accelerate our Company strategy and advance our immuno-oncology portfolio."

The multicenter, open-label, dose-escalation Phase I study will evaluate the safety, tolerability, antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of IPH5201 alone, or in combination with AstraZeneca’s anti-programmed cell death ligand 1 (PD-L1) therapy, durvalumab, with or without its anti-CD73 monoclonal antibody, oleclumab. More information on the Phase I clinical trial can be found at View Source

About IPH5201:
In October 2018, Innate Pharma and AstraZeneca entered into a development collaboration and option agreement for further co-development and co-commercialization for IPH5201.

IPH5201 is a blocking antibody targeting the CD39 immunosuppressive pathway.

CD39 is an extracellular enzyme that is expressed in the tumor microenvironment, on both tumor infiltrating cells and stromal cells in several cancer types. CD39 inhibits the immune system by degrading adenosine tripohsphate (ATP) into adenosine monophosphate (AMP), that is then further degraded into adenosine by CD73. By promoting the accumulation of immune-stimulating ATP, and preventing the production of immune-suppressive adenosine, the blockade of CD39 may stimulate anti-tumor activity.

On March 9, 2020 GenFleet Therapeutics (Shanghai) reported that it has closed a $57 million Series B financing, co-led by CDH Investments and Shenzhen Capital Group (Press release, GenFleet Therapeutics, MAR 9, 2020, View Source [SID1234555328]). Founded in 2017, GenFleet is developing novel large and small therapeutic molecules for oncology and immunology targets. The company says its projects are potential first-in-class therapeutics with technical advantages and large markets. It will use the capital for ex-China development and clinical trials of its existing pipelines, plus expanding its immunology platform, working on new projects and building an industrial base.

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On March 9, 2020 Curadigm, an early-stage nanotechnology company committed to improving treatment outcomes by redefining the therapeutic balance between bioavailability, toxicity, and efficacy, reported the selection of its Nanoprimer technology by the National Cancer Institute’s (NCI) Nanotechnology Characterization Laboratory (NCL) for characterization, based on its potential to significantly impact treatments in multiple disease indications, including cancer (Press release, Curadigm, MAR 9, 2020, View Source [SID1234555326]).

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The broad utility of the Nanoprimer technology is due to its unique nanomedicine approach to improve therapeutic action without modifying the therapeutic in any way. Rather, the Nanoprimer is administered intravenously just prior to a therapeutic, specifically and transiently occupying the liver pathways responsible for clearance. This temporarily increases the therapeutic’s bioavailability and subsequent accumulation in target tissue. This mechanism, targeting the universal upstream pathways involved in intravenous drug clearance, means the Nanoprimer can be used in combination with multiple classes of nanomedicines including nucleic acid and small molecule therapeutics or gene editing technologies.

Through this collaboration, the NCL, a leader in the characterization and development of Nanomedicines, will perform in-depth pre-clinical characterizations. These studies will support the Nanoprimer’s development, driving advancement toward filing an Investigational New Drug (IND) with the Food and Drug Administration (FDA) and future clinical development. This work will also support ongoing and future collaborations combining the Nanoprimer with therapeutics across diverse clinical indications.

Curadigm is a 2019 Nanobiotix spin-off, that aims to reshape and elevate the efficacy of intravenously administered therapeutics. The Nanoprimer technology is based on engineered, biocompatible nanoparticles that are administered just prior to the therapeutic and acts rapidly to temporarily occupy the Kupffer and liver sinusoidal endothelial (LSEC) cells. This precision-based approach leads to enhanced systemic bioavailability for increased therapeutic action.

The NCL was established to study the use of nanoparticles and nanomedicines to advance cancer research and to accelerate the development of promising and safe nanotechnology-based cancer therapeutics. The program provides pre-clinical testing and services on a competitive acceptance basis to companies, such as Curadigm, and is working in concert with other US agencies such as the FDA to accelerate the use of nanomedicines from early-stage development to clinical applications.

"The selection of our nanoprimer by the NCL is a major step for Curadigm," said Matthieu Germain, CEO of Curadigm. "The standardized cascade assay developed by the NCL is a great opportunity to accelerate the development of the Nanoprimer by providing additional data about its physico-chemical properties, safety and mechanism of action that will facilitate regulatory review. The results generated through this collaboration will also be instrumental in supporting our discussions with partners to develop their therapeutics with the Nanoprimer."