On October 1, 2018 Arix Bioscience plc (LSE: ARIX) ("Arix" or the "Company"), a global healthcare and life science company supporting medical innovation, reported that it has invested in new Group Business, VelosBio Inc. ("VelosBio"), a next-generation oncology company, developing novel antibody-drug conjugates ("ADCs") to treat haematological cancers and solid tumours (Press release, VelosBio, OCT 1, 2018, View Source [SID1234533166]).

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As part of the financing, Arix has committed to invest $11 million (£8.4 million) for an 11.2% stake on a fully diluted basis. Arix Investment Director, Mark Chin, will join the VelosBio board of directors.

The financing was co-led by new investors Arix and Sofinnova Ventures and included Pappas Ventures and Chiesi Ventures, as well as existing investors Takeda Ventures, Inc and Decheng Capital. Proceeds from the financing will be used to complete nonclinical development and advance the company’s lead programmes into clinical studies.

Arix has built a diverse oncology portfolio that covers a range of different therapeutic modalities including CAR-T, DNA damage response / synthetic lethality, bi-specific antibodies, and targeted viruses. Arix’s position in oncology is further strengthened by the investment into VelosBio, extending its oncology investments into ADCs.

ADCs are a new class of highly potent drugs designed as a targeted therapy for the treatment of people with cancer. In contrast to traditional chemotherapeutic drugs, ADCs only target cancer cells so that healthy cells are less affected.

VelosBio has a highly experienced leadership team, led by Chief Executive Officer, Dave Johnson, the former CEO of Acerta Pharma, which developed the approved blood cancer treatment, CALQUENCE (acalabrutinib), acquired by AstraZeneca for up to $7 billion in 2015. Prior to Acerta, Mr. Johnson contributed to the development and commercialisation of numerous approved global oncology agents holding roles of increasing responsibility in Clinical Development, Medical Affairs, Pipeline Development, and Commercial at Roche, Immunex (acquired by Amgen), Millennium (acquired by Takeda), Gloucester (acquired by Celgene), and Calistoga (acquired by Gilead Sciences).

VelosBio’s Executive Vice President of Development and Chief Medical Officer, Langdon Miller, MD, is an accomplished drug development expert with over 25 years of experience in the design and conduct of translational and clinical drug development programmes in oncology and orphan diseases. Trained as a medical oncologist at Stanford University, he has held senior leadership positions at the National Cancer Institute, Pharmacia Corporation, PTC Therapeutics, Calistoga Pharmaceuticals, and Gilead, and has played a major role in the regulatory approvals of multiple clinically and commercially successful cancer therapeutics.

Joe Anderson, Chief Investment Officer of Arix, commented: "Cancer emerges through multiple molecular and cellular pathways and accordingly needs to be tackled with multiple therapeutic tools. Our strategy in oncology is to support a diverse portfolio of companies using novel and differentiated approaches to treat cancer and improve patient outcomes. VelosBio is led by an exceptional team developing a novel, high potential approach to the targeted killing of cancer cells. It is great to see such a strong syndicate come together to support the Series A, including leading venture capital groups and our strategic partner Takeda. We look forward to working with the VelosBio leadership team and our co-investors to help accelerate the development of this exciting company."

David Johnson, CEO of VelosBio, commented: "We are delighted with the strong support for the Series A financing from Arix, as well as our existing and new investors. The proceeds from the Series A will enable us to drive VelosBio’s business forward ambitiously as we approach our next stage of growth and development. VelosBio will also be strengthened by Arix’s extensive global networks and deep industry knowledge, and we are pleased to welcome Mark Chin to the Board."

On October 1, 2018 DCprime reported that Jeroen Rovers MD, PhD joins the company as its Chief Medical Officer with immediate effect (Press release, DCPrime, OCT 1, 2018, View Source [SID1234531233]). Jeroen trained as a pharmaceutical physician at the European Center of Pharmaceutical Medicine in Basel . In the past 15 years he worked in different academic institutes and companies, lastly at Kiadis Pharma where he in his role of Chief Medical Officer was part of the management team that took the company public on Euronext Amsterdam in 2015. Most of the products he worked on are related to specialized therapeutic areas, such as oncology, haematology and transplantation.

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Jeroen Rovers comments: "It is an exciting time to join DCprime, as it’s products are moving further into clinical development. Cell based vaccins will potentially be an additional asset in the immunotherapeutic arsenal to prevent or reduce recurrence of cancer and to improve the of life of people living with cancer."

Erik Manting, CEO of DCprime adds: "The appointment of Jeroen Rovers as Chief Medical Officer marks an important step in the development of DCprime as a company. We are transitioning from a technology-driven company to an organisation focused on achieving clinical results. We have launched an international PhII trial in AML with our lead product DCP-001 and aim to launch additional clinical trials in other cancer types in 2019. With Jeroen on board as an experienced CMO we will further strengthen our infrastructure and capabilities to bring cancer immunotherapeutics to clinic."

On October 1, 2018 Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported that the Food and Drug Administration (FDA) has granted orphan drug status to Corcept’s selective cortisol modulator relacorilant to treat patients with pancreatic cancer (Press release, Corcept Therapeutics, OCT 1, 2018, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-receives-orphan-designation-relacorilant [SID1234530684]). Corcept is conducting clinical trials of relacorilant in combination with nab-paclitaxel (Celgene Corporation’s drug, Abraxane) as a treatment for pancreatic cancer and other solid tumors.

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Orphan drug designation is granted by the FDA to encourage the development of treatments for diseases that affect fewer than 200,000 patients in the United States. Drugs that receive orphan status obtain seven years of marketing exclusivity from the date of drug approval, tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process. Receiving orphan drug designation does not alter the standard regulatory requirements and process for obtaining marketing approval.

"We are pleased the FDA has granted relacorilant orphan drug status for the treatment of pancreatic cancer. Pancreatic cancer has a poor prognosis and patients have few treatment options," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. "The data we have generated so far in this indication have been very encouraging. Five of nine patients who received the minimum therapeutic dose in our Phase 1/2 trial of relacorilant plus nab-paclitaxel demonstrated durable disease control. By year-end we expect to have learned enough to determine a potential path toward a pivotal study in this indication."

About Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer-associated mortality, with a five-year survival rate of five percent. In the United States, an estimated 33,000 patients are diagnosed with the disease each year.

On October 1, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it earned a $22 million payment from Verastem Oncology under the license agreement between the Company and Verastem for COPIKTRA (duvelisib) (Press release, Infinity Pharmaceuticals, OCT 1, 2018, View Source [SID1234530645]). The payment was earned upon the approval by the U.S. Food and Drug Administration (FDA) on September 24, 2018 of duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies, as well as accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies.

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"We are really pleased that duvelisib is now available for patients with CLL/SLL and follicular lymphoma and are proud of the role Infinity played in its development," said Adelene Perkins, Chief Executive Officer and Chair of Infinity. "This $22 million FDA approval payment from Verastem supports Infinity’s continued expansion of the development of IPI-549, our first-in-class, oral, immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase-gamma (PI3K-gamma), including in doublet and triplet combination trials to identify the best combination regimens to treat patients with specific types of cancer."

In 2016, Infinity entered into a license agreement granting Verastem an exclusive worldwide license for the research, development, commercialization, and manufacture of duvelisib and products containing duvelisib in oncology. Pursuant to the terms of the license agreement, Verastem has notified Infinity of its election to make the $22 million payment in cash, which Infinity expects to receive later this year. Infinity also is eligible for royalties on worldwide net sales of duvelisib ranging from the mid-to-high single digits, shared equally with Takeda.

Infinity’s updated 2018 financial guidance is:

Net Loss: Infinity expects net loss for 2018 to range from $10 million to $20 million.

Cash and Investments: Infinity expects to end 2018 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $50 million to $60 million.

Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company’s capital needs into 2020. Infinity’s financial guidance excludes additional funding or business development activities and does not include a potential $2 million payment from PellePharm, a private company, upon initiation of a Phase 3 study for the hedgehog inhibitor program, which Infinity licensed to PellePharm in 2013.

On October 1, 2018 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that four separate abstracts from its research and development portfolio will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in Washington, D.C. from November 7-11, 2018 (Press release, Aduro Biotech, OCT 1, 2018, View Source;p=RssLanding&cat=news&id=2369686 [SID1234530081]). Preliminary clinical data from the ongoing Phase 1 dose-finding study evaluating ADU-S100 (MIW815), an intratumoral STING agonist in patients with advanced solid tumors or lymphomas, were accepted for presentation on November 9, 2018.

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"We look forward to sharing preliminary clinical data from the dose escalation portion of the monotherapy trial which provides an initial understanding of the potential role of ADU-S100 in the treatment of cancer and which contribute to the broader scientific understanding of the STING pathway," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro Biotech. "In collaboration with our partner Novartis, our objective is to characterize the safety and mechanism of action of ADU-S100 across a wide array of solid tumors and lymphomas and provide a basis for continued development of ADU-S100 in combination with checkpoint inhibitors targeting PD-1 and CTLA-4."

Researchers will present additional preclinical data for ADU-S100 in combination with immune checkpoint inhibitors. They will also present the results of early research to identify and characterize an anti-SIRPa antibody ADU-1805.

Details of the poster and oral presentations are as follows:

Abstract 10763: Phase I dose-finding study of MIW815 (ADU-S100), an intratumoral STING agonist, in patients with advanced solid tumors or lymphomas
Date: November 9-10, 2018
Location: Poster Hall E, Walter E. Washington Convention Center

Abstract 10938: ADU-S100 (MIW815) Synergizes with Checkpoint Inhibition to Elicit an Anti-Tumor CD8+ T Cell Response to Control Distal Tumors
Date: November 9-10, 2018
Location: Poster Hall E, Walter E. Washington Convention Center

Abstract 10923: SIRPα blockade increases the activity of multiple myeloid lineage cells, enhances dendritic cell cross-presentation, and aids in remodeling the tumor microenvironment
Session: Rapid Oral Abstracts
Date/Time: November 9, 2018, 1:00 – 2:00 p.m. ET
Location: Poster Hall E, Walter E. Washington Convention Center

Abstract 10960: Pan-allele anti-SIRPα antibodies that block the SIRPα–CD47 innate immune checkpoint
Date: November 9-10, 2018
Location: Poster Hall E, Walter E. Washington Convention Center
About STING Pathway Activator Platform
The Aduro-proprietary STING pathway activator product candidates, including ADU-S100 (MIW815), are synthetic small molecule immune modulators that are designed to target and activate human STING. STING is generally expressed at high levels in immune cells, including dendritic cells. Natural activation of STING is not always sufficient to prevent the growth and spread of cancer cells. In preclinical models, ADU-S100 directly activates STING to further amplify the natural anti-tumor response. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of a systemic tumor antigen-specific T cell adaptive immune response.

Aduro’s lead molecule, ADU-S100, is the first therapeutic in development specifically targeting STING. In collaboration with Novartis, it is being tested in a Phase 1 clinical trial as a single agent and in combination with ipilimumab, and in a Phase 1b combination trial with spartalizumab (PDR001), an investigational anti-PD-1 compound. These studies are enrolling patients with cutaneously accessible, advanced/metastatic solid tumors or lymphomas. The trials are evaluating the ability of ADU-S100 to activate the immune system and recruit specialized immune cells to attack the injected tumor, leading to a broad immune response that seeks out and kills distant metastases.