On June 26, 2020 PharmAbcine (KRX: 208340) (GM: Jin-san Yoo), biotech company focusing on the development of antibody therapeutics, reported on 18th that it had signed a contract manufacturing organization(CMO) agreement with biologics contract development and manufacturing organization (CDMO) Binex for additional production of investigational Olinvacimab (TTAC-0001), PharmAbcine’s leading antibody therapeutics pipeline in oncology (Press release, PharmAbcine, JUN 26, 2020, View Source [SID1234561504]).

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Under the agreement, Binex is responsible for large-scale manufacturing of clinical investigational material for PharmAbcine for its global Phase 2 trials on olinvacimab + immunotherapy combination for metastatic triple negative breast cancer (the U.S. included) and trials on various common solid tumors. Binex has been a clinical manufacturing partner of PharmAbcine since early global clinical trials on olinvacimab.

"Contract manufacturing organization agreement with Binex enables us to secure the steady supply of investigational material for multinational clinical trials and trials on various common solid tumors. We will remain fully committed to the swift development of olinvacimab in use for treatment of recurrent glioblastoma multiforme (rGBM) and metastatic triple negative breast cancer (mTNBC)," said Jin-san Yoo, GM, PharmAbcine.

Olinvacimab, an anti-vascular endothelial growth factor receptor 2 (VEGFR2), targets and inhibits tumor angiogenesis-inducing VEGFR2. PharmAbcine is conducting a Phase 2 clinical trial on olinvacimab in patients with Avastin-refractory rGBM in the U.S. and Australia. In addition, Phase 1b trials on olinvacimab plus PD-1 antibody Keytruda (pembrolizumab) combination for rGBM and mTNBC are still going on in Australia in collaboration with MSD (Merck).

PharmAbcine gave an update about how far the development of olinvacimab had come at the world’s largest conference of the pharmaceutical and biotechnology industry ‘2020 Bio International Convention’ hosted virtually from 8th till 12th. It is working with multiple pharmaceutical and biotech companies to further discuss olinvacimab technology transfer.

On June 26, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application (MAA) for pexidartinib for the treatment of a subset of adult patients with severe tenosynovial giant cell tumor (TGCT) (Press release, Daiichi Sankyo, JUN 26, 2020, https://www.businesswire.com/news/home/20200626005278/en/Daiichi-Sankyo-Update-CHMP-Review-Pexidartinib-CSF1R [SID1234561503]). The European marketing authorization application was based on results of the pivotal phase 3 ENLIVEN study, which were published in The Lancet on June 19, 2019.1

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"We will evaluate feedback received from the Committee in order to determine the appropriate next steps for pexidartinib in the EU. Despite this setback, we continue to believe in the potential of pexidartinib for people with TGCT, who often face debilitating symptoms and currently have no approved systemic treatment option," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo.

About Pexidartinib

Pexidartinib is an oral small molecule that inhibits CSF1R (colony stimulating factor-1 receptor), which is a primary growth driver of abnormal cells in the synovium that cause TGCT. Pexidartinib also inhibits KIT and FLT3-ITD. Pexidartinib was discovered by Plexxikon Inc., the small molecule structure-guided R&D center of Daiichi Sankyo.

About TGCT (PVNS/GCT-TS)

TGCT, also referred to as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is a rare, typically non-malignant tumor that can be locally aggressive. TGCT affects the synovium-lined joints, bursae and tendon sheaths, resulting in reduced mobility in the affected joint or limb.2,3,4 Given TGCT is rare, it’s not known exactly how many people are diagnosed with the condition each year.

The current standard of care for TGCT is surgical resection.2,5 However, in patients with a recurrent, difficult-to-treat, or diffuse form of TGCT, the tumor may wrap around bone, tendons, ligaments and other parts of the joint. In these cases, the tumor may be difficult to remove and/or may not be amenable to improvement with surgery. Multiple surgeries for more severe cases can lead to significant joint damage, debilitating functional impairments and reduced quality of life, and amputation may be considered.5,6,7

Recurrence rates for localized TGCT are estimated to be up to 15 percent following complete resection.8,9 Diffuse TGCT recurrence rates are estimated to be about 20 percent to 50 percent following complete resection.4,9,10 TGCT affects all age groups; the diffuse type on average occurs most often in people below the age of 40, and the localized type typically occurs in people between 30 and 50 years old. 2

On June 26, 2020 OncoNano Medicine, Inc. reported the publication of Phase 1 clinical trial data in Nature Communications featuring OncoNano’s intraoperative tumor imaging product candidate, ONM-100 (Press release, OncoNano Medicine, JUN 26, 2020, View Source [SID1234561502]). The study evaluated safety, pharmacokinetics and feasibility of ONM-100 in image-guided surgery, occult tumor detection and visualization of tumor margins in four different cancer types . Following tumor resection, ONM-100 detected residual tumor positive margins in 9 of 9 patients in whom histology confirmed tumor positive margins, and also detected occult lesions in an additional 5 patients whose tumors were undetected by standard of care. The research paper, Exploiting metabolic acidosis in solid cancers using a tumor-agnostic pH-activatable nanoprobe for fluorescence-guided surgery, will appear in the June 26 issue of Nature Communications.

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Surgical resection remains a cornerstone treatment strategy for solid tumors today and incomplete tumor removal can be predictive of cancer recurrence and metastasis. Despite imaging advances, there are no approved imaging options to provide real-time feedback to surgeons that specifically target tumor masses but are agnostic to cancer type. ONM-100, a pH-sensitive micelle conjugated to a fluorescent tag, targets the relatively acidic pH of the tumor microenvironment – a universal biomarker of solid tumors – to precisely label tumor masses. ONM-100 is intravenously administered prior to surgery and visualized during surgery using existing surgical fluorescent imaging equipment. Exploiting this universal biomarker of solid tumors confers the potential for ONM-100 to be used in various cancer types, irrespective of tissue of origin.

"We are extremely pleased to have this critical work published in Nature Communications," commented Gooitzen Michell van Dam, MD, PhD, CEO of TRACER BV and professor at the University Medical Center of Groningen, Netherlands. As Principal Investigator and corresponding author of the manuscript he states, "ONM-100 was able to detect tumor positive resection margins and several cancerous lesions that standard of care procedures missed in diverse types of solid cancers. We eagerly anticipate seeing ONM-100’s potential further explored in Phase 2 clinical trials."

"We are delighted to see the scientific community’s validation of ONM-100 that is demonstrated by this acceptance in Nature Communications," commented Ravi Srinivasan, PhD, Cofounder and CEO of OncoNano. "ONM-100 has the potential to substantially simplify and enhance the effectiveness of tumor resection surgeries, and given its possible tumor-agnostic applications, it may be used in broad patient populations in the future. We look forward to this same pH-sensitive micelle technology being utilized for other oncology applications, such as tumor-specific therapeutic delivery."

ONM-100 is currently being evaluated in Phase 2 clinical trials in the United States in several unique cancer indications, including breast, ovarian, prostate and colorectal cancers. Learn more about this trial at www.clinicaltrials.gov.

About ONM-100

ONM-100 is OncoNano’s lead product candidate that utilizes the pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidic pH of the tumor microenvironment – to intraoperatively image tumors. ONM-100 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and fluorescent tag expression, making tumors visible during surgery with standard surgical imaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded for clinical research by the Cancer Prevention and Research Institute of Texas.

On June 26, 2020 Orion reported that Half-Year Financial Report for January-June 2020 on Friday 17 July 2020 (Press release, Orion , JUN 26, 2020, View Source [SID1234561501])

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Orion will publish Half Year Report for January-June 2020 on Friday, 17 July 2020 approximately at 12.00 noon EEST. The report and related presentation material will be available on the company’s website at www.orion.fi/en/investors after publishing.

Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held on Friday, 17 July 2020 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.

On June 26, 2020, Veru Inc. (the "Company") reported that it entered into a common stock purchase agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC, an Illinois limited liability company ("Aspire Capital"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company has the right, from time to time in its sole discretion during the 36-month term of the Purchase Agreement, to direct Aspire Capital to purchase up to $23.9 million of the Company’s common stock (the "Common Stock") in the aggregate (Filing, 8-K, Veru, JUN 26, 2020, View Source [SID1234561499]). Upon execution of the Purchase Agreement, the Company issued and sold to Aspire Capital under the Purchase Agreement 1,644,737 shares of Common Stock at a price per share of $3.04, for an aggregate purchase price of $5,000,000 (the "Initial Purchase Shares"). Based on information currently available including giving effect to the sale of the Initial Purchase Shares to Aspire Capital under the Purchase Agreement, the Company expects its cash and cash equivalents as of June 30, 2020 to be approximately $13.5 million, compared to $2.6 million as of March 31, 2020.

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Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with Aspire Capital (the "Registration Rights Agreement"), pursuant to which the Company agreed to file with the Securities and Exchange Commission (the "SEC") one or more registration statements (each, a "Registration Statement") as necessary to register for sale under the Securities Act of 1933, as amended (the "Securities Act"), the Initial Purchase Shares, the Commitment Shares (as defined below) and the additional shares of Common Stock that may be issued to Aspire Capital under the Purchase Agreement. The Company has filed with the SEC a prospectus supplement to the Company’s effective shelf registration statement on Form S-3 (File No. 333-221120) registering all of the shares of Common Stock that may be offered to Aspire Capital from time to time under the Purchase Agreement.

Under the Purchase Agreement, on any trading day selected by the Company, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a "Purchase Notice"), directing Aspire Capital (as principal) to purchase up to 200,000 shares of Common Stock per business day at a per share price (the "Purchase Price") equal to the lesser of the lowest sale price of the Common Stock on the purchase date or the arithmetic average of the three lowest closing sale prices for the Common Stock during the ten consecutive trading days ending on the trading day immediately preceding the purchase date.

In addition, on any date on which the Company submits a Purchase Notice to Aspire Capital in an amount equal to 200,000 shares of Common Stock and the closing sale price of the Common Stock is equal to or greater than $0.50 per share, the Company also has the right, in its sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a "VWAP Purchase Notice") directing Aspire Capital to purchase shares of Common Stock equal to up to 30% of the aggregate shares of the Common Stock traded on its principal market on the next trading day (the "VWAP Purchase Date"), subject to a maximum number of shares of Common Stock the Company may determine. The purchase price per share pursuant to such VWAP Purchase Notice is generally 97% of the volume-weighted average price for the Common Stock traded on its principal market on the VWAP Purchase Date.

The Purchase Price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the period(s) used to compute the Purchase Price. The Company may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed.

The Purchase Agreement provides that the Company and Aspire Capital shall not effect any sales under the Purchase Agreement on any purchase date where the closing sale price of the Common Stock is less than $0.25 per share. There are no trading volume requirements or restrictions under the Purchase Agreement, and the Company will control the timing and amount of sales of shares of Common Stock to Aspire Capital. Aspire Capital has no right to require any sales by the Company, but is obligated to make purchases from the Company as directed by the Company in accordance with the Purchase Agreement. There are no limitations on use of proceeds, financial or business covenants, restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. In consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase Agreement, the Company issued to Aspire Capital 212,130 shares of Common Stock (the "Commitment Shares"). The Purchase Agreement may be terminated by the Company at any time, at its discretion, without any cost to the Company. Aspire Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging of the Common Stock during any time prior to the termination of the Purchase Agreement. Any proceeds the Company receives under the Purchase Agreement are expected to be used for working capital and general corporate purposes, which may include research and development, clinical trial and marketing expenditures.

The foregoing is a summary description of certain terms of the Purchase Agreement and the Registration Rights Agreement and, by its nature, is incomplete. Copies of the Purchase Agreement and Registration Rights Agreement are filed herewith as Exhibits 10.1 and 10.2, respectively, to this report and are incorporated herein by reference. All readers are encouraged to read the entire text of the Purchase Agreement and the Registration Rights Agreement.