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 PolyPid Ltd. (Nasdaq: PYPD), a Phase 3 clinical-stage pharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, reported the pricing of its initial public offering of 3,750,000 ordinary shares at a price to the public of $16.00 per share, for gross proceeds of $60.0 million (Press release, PolyPid, JUN 26, 2020, View Source [SID1234561507]). All of the ordinary shares are being offered by PolyPid.

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The shares are expected to begin trading on The Nasdaq Global Market under the symbol "PYPD" on June 26, 2020. The offering is expected to close on June 30, 2020, subject to customary closing conditions. In addition, PolyPid has granted the underwriters a 30-day option to purchase up to 562,500 additional ordinary shares at the initial public offering price less underwriting discounts and commissions.

Barclays and BMO Capital Markets acted as joint book-running managers. Raymond James acted as lead manager. National Securities Corporation, ODDO BHF and A.G.P/Alliance Global Partners acted as co-managers.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on June 25, 2020. The offering is being made only by means of a prospectus, copies of which may be obtained from Barclays Capital Inc. c/o Broadridge Financial Solutions by mail at 1155 Long Island Avenue, Edgewood, NY, 11717, by email at [email protected] , or by calling 888-603-5847 or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, New York, New York 10036, telephone: 1-800-414-3627 or by emailing [email protected] .

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.