On June 8, 2020 Oasmia Pharmaceutical AB reported that partnered with the Swiss Group for Clinical Cancer Research (SAKK) to conduct the first clinical trial of Oasmia’s docetaxel micellar compound in advanced prostate cancer (Press release, Oasmia, JUN 8, 2020, View Source [SID1234560887]). Prostate cancer in men is a significant health problem worldwide and is a leading cause of cancer death in men. Oasmia’s docetaxel micellar formulation uses Oasmia’s proprietary solubility technology platform enabling the intravenous administration of water-insoluble compounds without traditional solubility enhancers. Oasmia’s solubility technology platform has been utilized in another product, Apealea, which has obtained Marketing Authorization in the EU in 2018, in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive ovarian cancer.

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Docetaxel (INN) is a widely approved anticancer drug with proven activity against a wide range of solid malignancies and represents a standard of care option for advanced prostate cancer. The new Oasmia formulation of docetaxel, to be investigated in this clinical trial, docetaxel micellar, is intended to improve the solubility of docetaxel and avoid the mandatory use of steroid pre-medication.

The Executive Board of SAKK was unanimous in making the decision to carry out the clinical trial. In view of the urgent need for new treatment options in this disease stage, affecting many men all over the world, several Swiss qualified hospital centres have confirmed their participation in this initial study in patients suffering from advanced prostate cancer.

Pursuant to the collaboration agreement, SAKK is the legal sponsor of the project and responsible to conduct the phase 1B trial in accordance with the protocol and applicable rules and regulations. Oasmia’s main role in the project is to supply its formulation of docetaxel and carry the cost of the trial, which are deemed not material to Oasmia.

Prof.Dr. med. Markus Jörger MD-PhD, President of the SAKK Project Group "Developmental Therapeutics", commented on the trial: "The investigational drug docetaxel micellar may be a promising alternative to solvent-based docetaxel formulations in advanced prostate cancer, to avoid mandatory use of steroid premedication".

Francois Martelet, M.D., CEO of Oasmia, comments: "We are pleased to enter into this agreement. It provides an cost-efficient opportunity to test our formulation in collaboration with SAKK, an organization with extensive clinical trial experience, and take us further in our goal to develop new drugs based on our proprietary technology platform XR17."

On June 8, 2020 Quantum Leap Healthcare Collaborative (Quantum Leap) reported an evaluation of SAR439859, an oral estrogen receptor degrader (SERD) in a new I-SPY 2 study arm targeting patients with newly diagnosed hormone receptor-positive (HR+) clinical stage 2/3 invasive breast cancer (Press release, QuantumLeap, JUN 8, 2020, View Source [SID1234560884]).

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This study arm, known as the I-SPY-2 Endocrine Optimization Pilot Protocol (EOP), is focused on patients with molecularly low risk (MammaPrint low risk signature), clinically high risk, hormone receptor positive (HR+), and HER2-negative breast cancer. These patients historically have been excluded from the I-SPY2 trial due to the predicted lack of chemotherapy benefit. However, these patients often have late risk of recurrence (after 5 years), and thus also need novel strategies that are more tolerable and more effective than the current standard. The EOP is a sub-study within the main I-SPY-2 clinical trial utilizing an endocrine therapy backbone for patients whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy provides little or no benefit.

The selective estrogen receptor degrader (SERD) class of compounds have demonstrated benefit in HR+ HER2-negative metastatic breast cancer, including tumors with estrogen receptor activating mutations. They appear to be very well tolerated. Next-generation orally-bioavailable SERDs with improved pharmacokinetic properties are promising potential therapies for HR+ breast cancer. The EOP study will use an oral SERD as the endocrine therapy backbone. Sanofi’s SAR439859 has been selected as the oral SERD for this study. SAR439859 is a potent, orally bioavailable, and selective estrogen receptor (ER) inhibitor that belongs to the selective estrogen receptor degrader (SERD) class of compounds. SAR439859 antagonizes the binding of estradiol to ER but also promotes the transition of ER to an inactive conformation that results in up to 98% receptor degradation at nanomolar concentrations in cellular assays. These dual properties of SAR439859 we hope will translate to a deeper inhibition of ER pathways and a more effective antiproliferative activity in ER-dependent breast cancer cell lines driven by mutant or wild-type ER compared to other ER inhibitors. SAR439859 is an investigational compound and its safety and efficacy have not been evaluated by any regulatory authority.

In EOP, Sanofi’s oral SERD will be evaluated alone and in combination with up to three other investigational agents for a total of up to four study arms. The combination partner agents will be selected based on complementary biology utilizing orthogonal mechanisms of action. I-SPY 2 principal investigator, Dr. Laura Esserman of the University of California San Francisco, stated, "The whole I-SPY team is excited to have Sanofi as a partner in this endeavor. This is an important advance for patients with hormone positive high clinical risk breast cancer profiles who are not responsive to chemotherapy and for whom standard hormonal therapies may not be sufficient. As well, we need endocrine therapies that are easier for women to tolerate. We are committed to finding more effective, less toxic treatments and this partnership with Sanofi will help us to achieve this goal. Using the I-SPY model we can accelerate the development of new cancer treatments and target new and innovative treatments to the patients who will benefit most."

Sanofi will supply SAR439859 and provide financial support for this study. Quantum Leap, as sponsor, will provide the clinical sites and clinical expertise.

On June 7, 2020 ArcherDx reported that it has filed a regulatory document with the US Securities and Exchange Commission to go public with plans to raise up to $100 million (Press release, ArcherDX, JUN 7, 2020, View Source [SID1234560915]).

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The Boulder, Colorado-based company has not priced the offering or said how many shares it expects to offer in its Form S-1 filed on Friday. JP Morgan, Bank of America Securities, Stiffel, and Evercore ISI are listed as the proposed offering’s underwriters. ArcherDx plans to list its stock on the Nasdaq under ticker symbol "RCHR".

Founded in 2013, the company has leveraged next-generation sequencing to develop and commercialize more than 325 research-use-only products that it has sold to more than 300 academic and reference laboratories and more than 50 biopharmaceutical firms and contract research organizations in 40 countries, it said in its Form S-1.

Its RUO product lines include DNA-based VariantPlex panels for detecting copy number variations, single-nucleotide variants, and indels; RNA-based FusionPlex panels for generating target-enriched libraries to characterize gene fusions, splice variants, SNVs, indels, and relative expression levels; DNA-based LiquidPlex panels for targeted NGS of ccfDNA, cfDNA, and ctDNA from 28 genes associated with solid tumor type cancers; and RNA-based Immunoverse panels to characterize the human immune repertoire. The company collectively refers to the panels as personalized cancer monitoring (PCM).

ArcherDx also offers Stratafide, a pan-solid tumor diagnostic test designed to identify actionable genomic alterations in tissue or blood samples, and it is developing in vitro diagnostics and provides services for clinical applications.

It intends to submit Stratafide to the US Food and Drug Administration this year and PCM in the future for approval and/or clearance to be marketed as in vitro diagnostics.

The firm said in its SEC document that proceeds from its IPO will go toward R&D and the regulatory submission and commercialization of Stratafide. Proceeds will also be used for working capital and general corporate purposes, including sales and marketing activities, operating expenses, and capital expenditures, as well as possible acquisitions and investments in complementary businesses, technologies, and other assets.

Recent transactions by the company include a collaboration announced in May with AstraZeneca to develop assay to detect minimal residual disease in patients with early-stage non-small cell lung cancer. The month before that, it and Bayer announced a collaboration to develop and commercialize an NGS-based companion diagnostic for Bayer’s Vitrakvi (larotrectinib).

In April it said it reached a two-part deal with Premier to deliver personalized genomic testing to patients, and in January ArcherDx and Illumina inked a partnership to broaden access to NGS-based oncology testing, including companion diagnostics, personalized monitoring, and new recurrence surveillance IVDs.

The company had $50.6 million in total revenues in 2019, up from $28.5 million in 2018. It had a net loss of $50 million in 2019 compared to a net loss of $5.6 million in 2018.

This past December, it raised $55 million in a Series C financing round, and in May 2019 it raised $60 million in a Series B financing.

Through the first three months of 2020, ArcherDx recorded $14.8 million in revenues and a net loss of $19.3 million. It had $36.8 million in cash and cash equivalents as of March 31, 2020.

Jason Myers is the firm’s president and CEO while Josh Stahl is its chief scientific officer and chief operating officer.

On June 7, 2020 Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, reported the completion of a US$ 24 million Series B-2 financing from GL Ventures (Press release, Clover Biopharmaceuticals, JUN 7, 2020, View Source [SID1234560883]). This financing round brings Clover’s total capital raised since 2016 to over US$ 140 million.

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"We are pleased to complete this financing round with GL Ventures, as it will allow us to continue our efforts in expanding internal R&D capabilities and building a world-class team," said Joshua Liang, Chief Strategy Officer & Board Director of Clover Biopharmaceuticals.

"We are thrilled to partner with Clover. We look forward to supporting this wonderful team as they create innovative therapies to address unmet medical needs across the globe," stated the GL Ventures team.

Clover Biopharmaceuticals is the innovator of Trimer-Tag©, an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. Many major disease targets are trimerization-dependent such as the tumor necrosis factor (TNF) superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells. Clover is using its Trimer-Tag© technology with global IP position to develop recombinant trimerized fusion proteins that are able to effectively target these previously undruggable pathways. Trimer-Tag© has significant implications for the treatment of some of the most prevalent diseases across the world.

On June 7, 2020 HitGen (688222.SH) reported that it has entered into a drug discovery research collaboration with Evotec SE to identify small molecule leads against targets of interest to Evotec SE in the field of anti-infectives (Press release, HitGen, JUN 7, 2020, View Source [SID1234560882]). HitGen will apply its platform technology, based on the design, synthesis and screening of DNA-encoded libraries (DEL) to discover compounds that bind to certain targets. The identified compounds will be exclusively licensed to Evotec SE. Under the terms of the agreement, HitGen will receive an undisclosed upfront payment and license fee from Evotec SE.

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"We are delighted to enter this collaboration with Evotec SE, a leading drug discovery alliance and development partnership company with tremendous success in collaborative R&D. We look forward to working closely with Evotec SE research teams to deliver novel small molecules to their programs," said Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen.

"HitGen DEL screening platform offers tremendous potential to identify a small molecule binder to Evotec’s target of interest," said Kara Carter, Executive Vice President Infectious Disease from Evotec SE.