On June 26, 2020 Tikcro Technologies Ltd. (OTCQB: TIKRF), a pre-clinical stage developer of antibodies for cancer immune-therapy, reported its financial results for the first quarter ended March 31, 2020 (Press release, Tikcro, JUN 26, 2020, View Source [SID1234561506]).

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"We are exploring strategic opportunities for our anti-CTLA-4 antibody, which shows strong comparative results in pre-clinical cancer treatment assays. We reduced our operating expenses and are also considering businesses for a reverse merger and other corporate alternatives," said Aviv Boim, CEO of Tikcro.

Financial Results for the First Quarter Ended March 31, 2020
Net loss for the first quarter of 2020 was $96,000, or $0.01 per diluted share, compared to a net loss of $271,000, or $0.03 per diluted share, for the same period last year.

As of March 31, 2020, the company reported $4.3 million in cash, cash equivalents and short-term bank deposits.

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2019
Net loss for the fourth quarter of 2019 was $173,000, or $0.02 per diluted share, compared to a net loss of $421,000, or $0.04 per diluted share, for the same period last year.

Net loss for the year ended December 31, 2019 was $929,000, or $0.09 per diluted share, compared to a net loss of $1,405,000, or $0.14 per diluted share, for the year ended December 31, 2018.

The company’s audited financial statements for the year ended December 31, 2019 are included in its annual report on Form 20-F, which was filed with the Securities and Exchange Commission on June 1, 2020. Attached are the company’s results for the three months ended December 31, 2019.

Results of the Extraordinary General Meeting of Shareholders
On March 12, 2020, the Company’s shareholders duly approved the proposal on the agenda by the requisite majority, as described in the proxy statement dated February 6, 2020.

On June 26, 2020 Philogen S.p.A., a privately-owned biotechnology company, reported that the Swiss national competent authority Swissmedic issued the authorization to run a clinical phase II study in patients with locally advanced, not metastatic nonmelanoma skin cancer (Press release, Philogen, JUN 26, 2020, View Source [SID1234561505]). A favorable opinion about the study has now also been obtained by EKOS (Ethics Committee of Eastern Switzerland).

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Patients enrolled in the clinical study will be treated with intralesional injections of NidlegyTM. NidlegyTM, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional neoadjuvant treatment of patients with resectable Stage III melanoma in two phase III clinical trials. The durable responses, the excellent safety profile and the favorable cosmetic outcome of injected melanoma lesions have reinforced the investigation of efficacy and safety of NidlegyTM in injectable, locally advanced and not metastatic lesions of basal cell carcinoma or cutaneous squamous cell carcinoma.

"We are delighted to start the clinical phase II study in Switzerland and to explore the potential of NidlegyTM in patients with locally advanced, not metastatic nonmelanoma skin cancer," commented Prof. Dario Neri, co-founder and President of the Scientific Advisory Board of Philogen.

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.