On December 18, 2020 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported top-line results from a Phase 2 clinical study evaluating the targeted immunotherapy candidate, BN-Brachyury in the treatment of advanced chordoma, a rare cancer occurring in the base of the skull and spine (Press release, Bavarian Nordic, DEC 18, 2020, View Source,of%20the%20skull%20and%20spine. [SID1234573079]). While the study failed to meet its primary endpoint, it provided evidence of clinical activity.

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The Phase 2 study enrolled 29 patients, which were treated with a combination of the prime-boost vaccine candidate, BN-Brachyury and the current standard of care, radiation therapy. Whereas radiation has been shown to inflame the tumor, thereby releasing cancer antigens, BN-Brachyury has been designed to teach T cells to attack and kill brachyury-expressing tumor cells. Patients were monitored over a period of 12 months after radiation therapy, a timeframe during which historical controls show an objective response rate (ORR) of less than 5% with radiation alone. The overall goal of the study was to achieve four patients with objective responses, corresponding to an ORR of approximately 14% for all patients enrolled.

Two patients achieving objective responses were observed in the study, as measured by the predefined conventional assessment criteria (RECIST) according to the study protocol. In addition, 19 patients have stable disease, while the rest progressed, or left the study before the assessment was performed. The RECIST criteria assumes tumors are spherical and assesses their size by measuring the tumor diameter. This method may, however, underestimate the chordoma tumor shrinkage, as a retrospective analysis of six of the patients enrolled into the study revealed four of these patients had an objective response when tumor shrinkage was evaluated by a volumetric assessment. These intriguing signs of clinical efficacy are also supported by two chordoma patients that have recorded either a volumetric objective response, or a symptomatic response following the intravenous administration of BN-Brachyury in a separate on-going trial.

While no further studies of BN-Brachyury administered subcutaneously are planned, the signs of clinical efficacy that have been observed support brachyury as a potentially important immunotherapy target, particularly for chordoma. The Company is now looking to adapt ongoing trials to investigate MVA-based vaccines encoding brachyury administered intravenously – a promising approach designed to utilize broader aspects of the immune response while improving T cell activation and function.

"Chordoma is known for its refractoriness to all treatments investigated so far. The observation of some hints of efficacy with our immunotherapy approach is encouraging enough for us to continue with our efforts to develop a new treatment for this highly unmet medical need," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.

On December 18, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported favorable results for the cost-effectiveness of Vicineum based on an independent analysis issued by ICER in its final report published on December 17, 2020 (Press release, Sesen Bio, DEC 18, 2020, View Source [SID1234573078]).

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ICER is the leading Health Technology Assessment body in the United States, and is an independent non-profit, research organization that conducts assessments to examine the clinical and economic value of health care innovations such as prescription medications.

The final report used publicly available clinical data from the Company’s Phase 3 VISTA trial, and focused on adults with BCG-unresponsive, high-risk non-muscle invasive bladder cancer (NMIBC), including those with Carcinoma in situ, as well as those with high-risk Papillary (Ta/T1) disease.

The ICER report states that for many patients with NMIBC that is unresponsive to BCG, there are limited treatment options that are bladder preserving. As a potential treatment option for patients with NMIBC, the report describes Vicineum as demonstrating Complete Response and Recurrence-Free Survival rates that appear to be greater than would be expected, based on historical data, with few serious adverse events and low discontinuation rates.

The majority of the ICER Council (8 yes votes; 3 no votes) judged that the evidence was adequate to demonstrate that the net health benefit of Vicineum is superior to that of best supportive care.

The report estimates that treatment with Vicineum results in an additional per-patient cost of approximately $123,000 in year one — with net savings in the following years, leading to a decline in cumulative health care costs, compared to usual care, of approximately $101,000 by year five.

"We are very pleased with the final ICER report and found the entire process to be transparent, evidence-based and professional," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "The findings in the ICER report give us confidence in the value and cost-effectiveness of Vicineum. It is our goal to bring Vicineum to market to improve patient outcomes while reducing health care costs. The ICER report is very encouraging in that regard, and we look forward to working physicians, patients and payers to make that goal a reality."

The full report, including relevant disclaimers and assumptions, can be accessed at the following link: View Source

The Company is on track to complete and submit its Biologics License Application for Vicineum to the FDA by next week.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the sixth most commonly diagnosed cancer in the United States, and approximately 80 percent of patients have non-muscle invasive bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and more than 60 percent of all patients diagnosed with NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.

On December 18, 2020 In accordance with Section 3 of the Articles of Association of Orion Corporation, 8,242 A shares reported that have been converted into 8,242 B shares (Press release, Orion , DEC 18, 2020, View Source [SID1234573076]). The conversion has been entered into the Trade Register on 18 December 2020.

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The total number of shares in Orion Corporation is 141,134,278 which, after the conversion, consists of 35,122,793 A shares and 106,011,485 B shares. The number of votes of the company’s shares is after the conversion 808,467,345.

On December 18, 2020 SOM Biotech reported its participation at the BIO-Partnering at JP Morgan Healthcare Conference 2021, being held virtually on January 11th – 15th (Press release, SOM Biotech, DEC 18, 2020, View Source;utm_medium=rss&utm_campaign=som-biotech-at-the-bio-partnering-jpm-virtual-event-2021 [SID1234573075]).

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The conference, a leading virtual partnering and business development initiative for the biotechnology industry organized by Biotechnology Innovation Organization, provides a One-on-One partnering platform to give companies access to potential strategic partners and qualified investors worldwide.

Raúl Insa, CEO of SOM Biotech highlights: "This is an excellent opportunity to present the advances in our portfolio and explore mutual interest with pharmaceutical and other life science companies to seek new drug discovery and development project based on our proprietary AI-based drug discovery technology – SOMAIPRO – which is one of the most powerful tools for drug discovery at present. After closing the remarkable year 2020, with positive results obtained from the Phase 2a related to our Huntington´s disease candidate SOM3355, we are also excited to present our pipeline assets and our strategic plan to investors interested in taking part in our future valuable launches and growth prospects".

On December 18, 2020 Scopus BioPharma Inc. (Nasdaq: SCPS) reported the closing of its initial public offering (Press release, Scopus BioPharma, DEC 18, 2020, View Source,over%2Dallotment%20option%20in%20full. [SID1234573074]). The underwriters for the initial public offering exercised their over-allotment option in full.

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The company offered 575,000 shares of common stock, including shares issued for the over-allotment option, at a public offering price of $5.50 per share.

The company’s common stock trades on the Nasdaq Global Market under the ticker symbol "SCPS".

The Benchmark Company, LLC acted as Sole Bookrunning Manager and Joseph Gunnar & Co., LLC acted as Co-Manager for the offering.

Greenberg Traurig, LLP acted as counsel to the company. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. acted as counsel to the underwriters.

Scopus BioPharma intends to use the proceeds of the offering principally to further development of the company’s lead drug candidate, a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers.

An offering statement relating to the shares of common stock was filed with the U.S. Securities and Exchange Commission ("SEC") and became qualified on December 14, 2020. An offering circular relating to the offering was filed with the SEC and is available on the SEC’s website at View Source Copies of the offering circular may be obtained by contacting: The Benchmark Company, LLC, Attention: Prospectus Department, 150 E. 58th Street, 17th Floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected]; or Joseph Gunnar & Co., LLC, Attention: Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004, by calling (212) 440-9600 or by email at [email protected].

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