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 Numab reported the closing of its Series B financing round at a total volume of CHF 22M (approximately USD 22.6M) (Press release, Numab, MAR 9, 2020, View Source [SID1234637794]). New investors in this round included 3SBio Group’s subsidiary Sunshine Guojian Pharmaceutical（Shanghai）Co., Ltd., Mitsubishi UFJ Capital Co., Ltd. and Eisai Co., Ltd. as well as Numab’s board member Dr. Daniel Vasella. Numab’s existing shareholders also contributed to the financing round. Sunshine Guojian invested CHF15M in this series B financing in December 2019. Dr. Zhenping Zhu, MD, PhD, President of Research and Development, Chief Scientific Officer of 3SBio, has joined the Numab’s board of directors. With the financing secured, Numab plans to further broaden its proprietary pipeline and accelerate the development for a number of programs towards the clinic. The company also plans to initiate a clinical trial for its lead oncology program ND021 during the course of 2020.

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Mitsubishi UFJ Capital is one of Asia’s leading venture capital firm focusing on life science, information and communications technology and high technology investments. Numab and Eisai entered into a global research and option agreement to discover and develop a portfolio of multi-specific antibody immunotherapies for cancer in October 2019. In December 2019, Numab added a regional alliance with Sunshine Guojian to its growing roster of pharmaceutical partnerships.

"We are very pleased to have attracted a renowned institutional investor in Mitsubishi UFJ Capital to the Numab story and likewise appreciate the additional display of confidence in our platform and pipeline strategy by our partners as well as by our existing Series A investors and our board member Dr. Daniel Vasella," commented Dr. David Urech, Chief Executive Officer of Numab Therapeutics.

"3SBio is committed to developing innovative cancer cures. The investment and collaboration with Numab are consistent with our strategies. we are looking forward to collaborating with the Numab team to explore cutting edge immunotherapies in oncology." said Dr. Jing Lou, Chairman and Chief Executive Officer of 3SBio。

Multi-specific antibodies have the potential to unlock entirely novel modes-of-action aiming at superior benefit-to-risk profiles relative to conventional cancer immune therapies. Numab’s proprietary MATCH technology platform represents one of the most versatile and flexible sources for multi-specific antibodies. MATCH molecules can incorporate up to six binding specificities in true plug-and-play fashion. The individual antibody Fv building blocks are designed for maximum stability and developability.

On March 9, 2020 Numab Therapeutics reported the closing of its Series B financing round at a total volume of CHF 22M (approximately USD 22.6M) (Press release, Numab, MAR 9, 2020, View Source [SID1234555313]). New investors in this round included 3SBio/Sunshine Guojian, Mitsubishi UFJ Capital Co., Ltd. and Eisai Co., Ltd. as well as Numab’s board member Dr. Daniel Vasella . Existing shareholders that participated in Numab’s Series A round also contributed to today’s financing. With the financing secured, Numab plans to further broaden its proprietary pipeline and accelerate the development for a number of programs towards the clinic. The company also plans to initiate a clinical trial for its lead oncology program ND021 during the course of 2020.

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Mitsubishi UFJ Capital is one of Asia’s leading venture capital firm focusing on life science, information and communications technology and high technology investments. Numab and Eisai entered into a global research and option agreement to discover and develop a portfolio of multi-specific antibody immunotherapies for cancer in October 2019. In December 2019, Numab added a regional alliance with 3SBio’s subsidiary Sunshine Guojian Pharmaceutical Co., Ltd. to its growing roster of pharmaceutical partnerships.

"We are very pleased to have attracted a renowned institutional investor in Mitsubishi UFJ Capital to the Numab story and likewise appreciate the additional display of confidence in our platform and pipeline strategy by our partners as well as existing Series A investors and our board member Daniel Vasella," commented Dr. David Urech, Chief Executive Officer of Numab Therapeutics.

Multi-specific antibodies have the potential to unlock entirely novel modes-of-action aiming at superior benefit-to-risk profiles relative to conventional cancer immune therapies. Numab’s proprietary MATCH technology platform represents one of the most versatile and flexible sources for multi-specific antibodies. MATCH molecules can incorporate up to six binding specificities in true plug-and-play fashion. The individual antibody Fv building blocks are designed for maximum stability and developability

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 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the fourth quarter and year ended December 31, 2019 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAR 9, 2020, View Source [SID1234555314]).

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"2019 was a year of outstanding execution for Deciphera," said Steve Hoerter, President and Chief Executive Officer. "In 2020, our top priority is preparing for the potential approval and launch of ripretinib now that the NDA has been accepted by the FDA for Priority Review. Patients with GIST are in need of a new treatment option, and we believe ripretinib has the potential to transform the treatment of this disease."

Mr. Hoerter continued, "Our broad development program for ripretinib is on track, and we look forward to the completion of enrollment in INTRIGUE, our pivotal Phase 3 study of ripretinib in second-line GIST, in the second half of this year. Beyond ripretinib, we remain focused on the balance of our wholly-owned, clinical-stage pipeline, with updated clinical data for both DCC-3014 and rebastinib, as well as an IND submission for DCC-3116, expected later this year."

Recent Program Highlights

Ripretinib
Announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) seeking approval for ripretinib for the treatment of patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2020.

The NDA is being reviewed by the FDA under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) pilot program. This pilot program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality. Additional information about RTOR can be found at: View Source

Received Priority Review, under the Project Orbis initiative, for the marketing authorization applications in Canada and Australia. Project Orbis, an initiative of the FDA Oncology Center of Excellence, is designed to provide a framework for concurrent submission and review of oncology products among international partners. Additional information about the Project Orbis initiative can be found at: View Source
DCC-3014
Presented preliminary data from the ongoing Phase 1 study of DCC-3014, including anti-tumor activity in three initial patients with diffuse-type tenosynovial giant cell tumor (TGCT). These data, which provide clinical proof-of-concept for DCC-3014’s potential in diffuse-type TGCT, were presented at the Connective Tissue Oncology Society (CTOS) 2019 Annual Meeting. DCC-3014 was also shown to be generally well tolerated with no reported grade 3 or higher treatment-emergent adverse events in initial diffuse-type TGCT patients.
Rebastinib
Announced the selection of the Phase 2 dose for rebastinib in the Phase 1b/2 study in combination with carboplatin and activation of Part 2 of the study in patients with breast cancer, ovarian cancer, and mesothelioma.
Recent Corporate Updates

Announced the closing of an underwritten public offering of 3,659,090 shares of common stock at a public offering price of $55.00 per share in February 2020. Total net proceeds to Deciphera were approximately $188.4 million, after deducting underwriting discounts and commissions and other offering expenses.
Announced the appointment of Ron Squarer to its Board of Directors. Mr. Squarer served as Chief Executive Officer and a member of the Board of Directors of Array BioPharma, Inc. from 2012 until its acquisition by Pfizer Inc. in August 2019 following the successful commercial launches of both Braftovi and Mektovi and brings over two decades of experience in the biopharmaceutical industry.
Announced the appointment of Frank S. Friedman to its Board of Directors. Mr. Friedman recently served as the global Chief Operating Officer of Deloitte Touche Tohmatsu Limited, culminating a 40-year career at the organization.
Fourth Quarter 2019 Financial Results

Cash Position: As of December 31, 2019, cash, cash equivalents, and marketable securities were $579.6 million, compared to cash and cash equivalents of $293.8 million as of December 31, 2018. The increase was primarily due to the follow-on public offering in the third quarter of 2019 and did not include the proceeds from the Company’s follow-on public offering completed in February 2020. We expect our current cash, cash equivalents, and marketable securities, together with the proceeds from our recent follow-on public offering in February 2020, will enable us to fund our operating and capital expenditures into the second half of 2022.
R&D Expenses: Research and development expenses for the fourth quarter of 2019 were $46.6 million, compared to $27.4 million for the same period in 2018. The increase was primarily due to personnel costs as well as clinical trial costs related to ripretinib, DCC-3014, and rebastinib. Non-cash stock-based compensation was $2.5 million and $1.0 million for the fourth quarters of 2019 and 2018, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the fourth quarter of 2019 were $23.7 million, compared to $6.5 million for the same period in 2018. The increase was primarily due to personnel costs as well as external spend associated with commercial readiness and moving to our new headquarters. Non-cash stock-based compensation was $2.9 million and $1.8 million for the fourth quarters of 2019 and 2018, respectively.
Net Loss: For the fourth quarter of 2019, Deciphera reported a net loss of $67.2 million, or $1.31 per share, compared with a net loss of $32.3 million, or $0.86 per share, for the same period in 2018. The increase in the net loss is primarily due to the increase in R&D expenses and G&A expenses discussed above.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, March 9, 2020 at 4:30 PM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 1669368. A live audio webcast of the event may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.