On October 8, 2020 Philogen S.p.A., a clinical-stage biotechnology company focused on antibody-based therapeutics, reported that the publication of a peer-reviewed scientific article in Science Translational Medicine (Press release, Philogen, OCT 8, 2020, View Source [SID1234568206]). The article is entitled: "Immunocytokines are a promising immunotherapeutic approach against glioblastoma" (T. Weiss, E. Puca, M. Silginer, T. Hemmerle, S. Pazahr, A. Bink, M. Weller, D. Neri, P. Roth, Immunocytokines are a promising immunotherapeutic approach against glioblastoma. Sci. Transl. Med. 12, eabb2311 (2020)) and can be accessed here.

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The findings of the study show how Philogen’s proprietary antibody-cytokine fusions, called immunocytokines, demonstrated striking single-agent anti-cancer activity in immunocompetent preclinical models bearing orthotopic glioblastoma. Moreover, the treatment induced long-term tumor eradications in a proportion of the treated animals. These findings were of particular relevance as preclinical models with glioblastoma cannot be cured by any current standard of care.

The article also discusses initial clinical results of the first patients recruited in the PH-L19TNFGLIO-02/18 Phase I/II trial. Early findings showed that Philogen’s proprietary treatment, onkekafusp alpha (L19TNF), when used as a monotherapy induced not only a selective tumor necrosis in all patients (evidenced by contrast-enhanced and perfusion Magnetic Resonance Imaging), but also provided cases of prolonged disease stabilization. During the study, the treatment was shown to be safe and well tolerated.

The ongoing Phase I/II clinical study (PH-L19TNFGLIO-02/18, View Source) is investigating the use of L19TNF as a single-agent for the treatment of high-grade glioma at first recurrence/relapse, a patient population with an otherwise very poor prognosis. TNF is delivered to cancer lesions by the L19 antibody specific to the EDB domain of Fibronectin, a marker for angiogenesis that is expressed in virtually all patients with malignant glioma. The Company has previously demonstrated by nuclear medicine procedures in more than 50 patients, that the L19 antibody could efficiently localize in primary and secondary brain tumors.

The phase I/II study is open label, in subjects with glioblastoma at first recurrence/relapse and will be conducted in two parts: (i) a dose finding part to determine the recommended dose of L19TNF (the data of this part of the study are published in the paper), (ii) followed by a signal seeking part that investigates first signs of activity.

"We are very excited about the excellent preclinical results obtained in collaboration with Philogen, which is a leader in the field of targeted delivery of cytokine therapeutics. The emerging clinical results of the ongoing study with L19TNF in glioblastoma – the most malignant brain tumor – provides hope for an alternative therapeutic opportunity for patients suffering from this terrible disease. In a next step, we aim at understanding the potential of L19TNF by investigating the product in larger randomised trials." commented Prof. Michael Weller, Chairman of the Department of Neurology at the University Hospital in Zurich.

Prof. Dario Neri, Co-Chief Executive Officer of Philogen, added: "Our treatment is demonstrating effectiveness at switching the immunologically cold glioma microenvironment into a hot one, enabling effective antitumor immunity. We are delighted with the progress being made with our immunocytokine and are pleased with the great promise this could bring to patients with malignant brain tumors."

The clinical study is led by Prof. Michael Weller, Dr. Patrick Roth and Dr. Tobias Weiss at the Department of Neurology of the University of Zurich. Philogen acts as the sponsor of the trial.

On October 7, 2020 Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH) ("Mereo" or "the Company"), reported a clinical-stage biopharmaceutical company focused on oncology and rare diseases, filed with the U.S. Securities and Exchange Commission ("SEC") a shelf registration statement on Form F-3 (File No. 333-249341) (the "Registration Statement") pursuant to which the Company may offer up to $200,000,000 of its ordinary shares nominal value £0.003 per ordinary share (the "Ordinary Shares") in the form of American Depositary Shares ("ADSs"), with each ADS representing five Ordinary Shares, and entered into a Sales Agreement dated October 6, 2020 (the "Sales Agreement") with SVB Leerink LLC (the "Agent"), pursuant to which the Company may sell, from time to time, at its option, up to $50,000,000 of its Ordinary Shares in the form of ADSs through the Agent (the "ATM Program") (Press release, Mereo BioPharma, OCT 7, 2020, View Source [SID1234568617]). The Sales Agreement contains customary representations, warranties and indemnities and provides that the Company pay the Agent a customary commission of 3% on the sale of any ADSs sold through the Agent under the Sales Agreement.

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The Registration Statement has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the Registration Statement becomes effective. A copy of the Registration Statement may be obtained on the SEC’s website at www.sec.gov. The filing of the Registration Statement does not affect the statutory pre-emption rights of shareholders in the Company.

The specifics of any future offering, including the prices and terms of the ADSs offered by the Company, will be determined at the time of any such offering and will be described in detail in a prospectus supplement filed by the Company with the SEC in connection with such offering. The Company has no immediate plans to offer ADSs pursuant to the Registration Statement or to sell ADSs under the ATM Program.

The establishment of the ATM Program follows the resolutions adopted at the Company’s Annual General Meeting on June 29, 2020. The ADSs to be sold under the Sales Agreement, if any, will be issued and sold by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or in negotiated transactions, if authorized by the Company, in each case, pursuant to the Registration Statement. The Registration Statement contains a preliminary prospectus supplement relating to the ATM Program. Any sales under the ATM Program will be made pursuant to a final prospectus supplement to be filed by the Company with the SEC following the effectiveness of the Registration Statement.

Unless otherwise indicated in a prospectus supplement, the Company expects to use the net proceeds from sales of any ADSs pursuant to the Registration Statement for advancing the Company’s clinical development programs, general corporate purposes and other business opportunities.

This announcement shall not constitute an offer to sell or the solicitation of an offer to buy the Ordinary Shares or ADSs, nor shall there be any sale of the Ordinary Shares or ADSs in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Neither this announcement nor the Registration Statement forms part of an offer of transferable securities to the public in the United Kingdom and no prospectus has been, or is required to be, submitted to the U.K. Financial Conduct Authority for approval.

On October 7, 2020 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing personalized yet off the shelf immunotherapies for cancer and infectious diseases, reported the completion of a $28.5 million equity financing (Press release, Sensei Biotherapeutics, OCT 7, 2020, View Source [SID1234568267]). The financing was co-led by Cambrian Biopharma and H&S Ventures, along with participation from new investors Future Ventures, Christian Angermayer’s Apeiron Investment Group, and Presight Ventures, Apeiron’s U.S. arm.

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Sensei is currently advancing multiple clinical and pre-clinical studies with their lead Immunophage program, SNS-301, a bacteriophage engineered to express aspartate β-hydroxylase (ASPH), a tumor associated antigen. The proceeds from the Series AA financing will enable the further development of SNS-301 and enable the advancement of Sensei’s pipeline of novel immunotherapies based on its Immunophage platform, which combines a vaccine’s ability to generate antigen-specific B- and T-cells with payloads of immunomodulatory nanobodies. Sensei Bio is building an extensive R&D infrastructure for the discovery of Immunophage, including GMP manufacturing, and is creating libraries of Immunophage that will be combined to create personalized yet off the shelf cocktails based on the genetic profile of each patient’s tumor.

"With this new funding, we advance our vision for establishing a new and disruptive class of immunotherapies called Immunophage, based on engineered bacteriophage," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We are poised for significant progress as this funding enables us to expand our clinical programs for SNS-301 and operate our Immunophage platform at scale. We are grateful for the support from both new and existing investors and I look forward to further realizing Sensei’s potential and building out this new class of immunotherapies."

"Sensei’s phage platform represents a transformative leap in immuno-oncology, with a cancer vaccine that can induce all the elements of a robust anti-tumor immune response. With experienced management and scientific teams, Sensei is well positioned to become a leader in next generation of immune-oncology therapeutics," said James Peyer, CEO of Cambrian Biopharma. "We are pleased to support their highly unique platform approach and advance these therapies clinically."

In its next stage of growth, Sensei Bio will employ its proprietary platform to discover novel classes of cancer immunotherapies and advance lead candidates toward the clinic. These approaches include the following:

The development of select immunomodulatory nanobodies, camelid-based antibodies, that can be deployed as Immunophage payloads or stand-alone therapeutics.
The expansion of Sensei’s library based approach by engineering Immunophage targeting additional tumor associated antigens.
The deployment of customized yet off-the-shelf Immunophage cocktail therapies targeting tumor associated antigens, neoantigens, and virally-based cancer antigens.
A novel antibody-based approach to novel checkpoint inhibition and other methods of altering the tumor microenvironment toward anti-tumor immunity.
Potential expansion of its therapeutic area focus into infectious diseases based on partnerships with Pharma companies and government entities.

On October 7, 2020, Cumberland Pharmaceuticals Inc. (the "Company" or "Cumberland") reported that it entered into a Third Amendment to the Revolving Credit Note and Fourth Amendment ("Fourth Amendment") to the Revolving Credit Loan Agreement with Pinnacle Bank (the "Pinnacle Agreement") (Filing, 8-K, Cumberland Pharmaceuticals, OCT 7, 2020, View Source [SID1234568266]). The original Pinnacle Agreement was dated July 31, 2017. The Fourth Amendment provides for a principal available for borrowing of up to $15 million and Cumberland has the ability to request an increase of up to an additional $5 million, upon the satisfaction of certain conditions and approval by Pinnacle Bank. If fully expanded, the Fourth Amendment would provide a maximum principal available for borrowing of up to $20 million, which was also the maximum aggregate principal available for borrowing under the previously amended Pinnacle Agreement.

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The Fourth Amendment extends the maturity date of the Pinnacle Agreement through October 1, 2022.
The interest rate on the Pinnacle Agreement, as amended, is based on LIBOR plus an interest rate spread. The pricing provides for an interest rate spread of 1.75% to 2.75% above LIBOR with a minimum LIBOR of 0.90%. Cumberland is subject to a financial covenant, maintenance of either the Funded Debt Ratio or a Tangible Capital Ratio, as defined, determined on a quarterly basis. Borrowings under the line of credit are collateralized by substantially all of the Company’s assets.

On October 7, 2020 Genor Biopharma of Shanghai reported that it raised $371 million in its Hong Kong IPO, pricing the offering at the top of the range (Press release, Genor Biopharma, OCT 7, 2020, View Source [SID1234568220]). In early trading, Genor rose 22%, giving the company a market capitalization of $1.8 billion. Founded in 2007, Genor has a portfolio of 15 mAbs and recombinant fusion proteins, comprising novel drugs and biosimilars that target indications in cancer, metabolic and autoimmune diseases. Hillhouse, which led a $160 million Series B financing in Genor earlier this year, owns 30% of the company’s shares post-IPO.

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