On January 25, 2021 EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) reported that the Biologics License Application (BLA) for SYLVANT (siltuximab for injection) was accepted by the China National Medical Products Administration (NMPA) and granted priority review (Press release, BeiGene, JAN 25, 2021, View Source [SID1234575010]). Siltuximab is a monoclonal antibody approved by the European Medicines Agency (EMA) and Food and Drug Administration (FDA) for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD). iMCD is a rare, life-threatening and debilitating condition of the lymph nodes and related tissues. Siltuximab is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA.

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"The BLA acceptance of siltuximab for review, an important treatment approved in more than 40 countries worldwide for iMCD, is good news for Chinese patients with this rare condition," commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "We’re glad to see continued progress in our collaboration with EUSA, which was built upon our shared commitment to bringing impactful therapies to patients in China and around the world."

Lee Morley, Chief Executive Officer of EUSA Pharma, said, "The BLA acceptance of siltuximab for review in China represents another exciting step in delivering therapies to patients in need worldwide. We will continue in our close collaboration with BeiGene and the NMPA to potentially bring siltuximab to iMCD patients in China."

About Siltuximab

Siltuximab is a monoclonal antibody that directly neutralises IL-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions. Siltuximab (SYLVANT) is currently approved by the US Food and Drug Administration (FDA) and the European Commission (EC), as well as regulatory authorities in several other jurisdictions worldwide, for the treatment of adult patients with Multicentric Castleman Disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Indications and Usage – See EMA Summary of Product Characteristics (SmPC) and FDA Prescribing Information for additional information.

On January 25, 2020 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN; the "Company" or "Biohaven"), a biopharmaceutical company with a portfolio of innovative, late-stage product candidates reported preliminary net product revenue of NURTEC ODT (rimegepant) for the fourth quarter of 2020 (Press release, Biohaven Pharmaceutical, JAN 25, 2021, View Source [SID1234574529]).

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Based on preliminary unaudited financial information, the Company reported $35 million in net product revenue from sales of NURTEC ODT in the fourth quarter of 2020. Net product revenue increased by approximately 98% from the previous quarter. Total prescriptions of NURTEC ODT for the full year 2020 were over 337,000, with over 24,000 unique prescribers. There were no material changes in channel inventory between third and fourth quarter.

The foregoing information reflects the Company’s estimate with respect to net product revenue for NURTEC ODT based on currently available information which is preliminary and unaudited, is not a comprehensive statement of the Company’s financial results and is subject to completion of the Company’s financial closing procedures. The Company’s final results that will be issued upon completion of its closing procedures may vary from these preliminary estimates.

Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "The launch of NURTEC ODT continues to build strong momentum, despite continued headwinds from the pandemic, as reflected by strong fourth quarter net product revenue. We continue to hear positive feedback from patients and physicians regarding the important role that NURTEC ODT is playing in the acute treatment of migraine. The impressive market growth of NURTEC ODT reflects the significant unmet need that exists for patients suffering from the debilitating effects of acute migraine, our strong commercial and managed markets team, and the differentiated product label compared to competitors. We’re proud of our commercial and R&D team members who have been dedicated to delivering this important medication to patients despite the challenges of the past year."
BJ Jones, Chief Commercial Officer, added, "Even in the unprecedented market conditions of a global pandemic, our commercial team remained committed to the needs of patients suffering from migraine, creating demand and access to NURTEC ODT significantly outperforming our initial volume projections during the first three quarters of launch. We look forward to continuing to grow the market for NURTEC ODT in the acute treatment of migraine, especially as in-market dynamics improve as the vaccines roll out and the impact of the COVID-19 pandemic is expected to attenuate later this year."
Rimegepant was approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in February 2020, with commercial launch commencing the second week of March. Rimegepant is marketed as NURTEC ODT, and is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in an orally disintegrating tablet (ODT) designed for rapid onset of action and sustained efficacy for 48 hours.

On January 25, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported an update on main achievements in 2020 and key expected milestones for 2021, and its end of year 2020 cash position (Press release, ERYtech Pharma, JAN 25, 2021, View Source [SID1234574340]).

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"ERYTECH is entering 2021 with great expectations on its full scope of activities," said Gil Beyen, CEO of ERYTECH Pharma. "After more than three years of dedicated operational execution on the pipeline of development projects, 2021 is expected to bring results in all four of ERYTECH’s clinical programs, with a potential for market authorization filings in two indications with high unmet medical need."

Key 2020 Achievements and Expected 2021 Milestones

TRYbeCA-1, pivotal Phase 3 clinical trial in second-line metastatic pancreatic cancer
Fast Track designation granted in April 2020
Enrollment completed in December 2020; 512 patients enrolled, 6% above enrollment target of 482 patients
On track for interim superiority analysis in Q1 2021 with two possible outcomes:
Trial can conclude early for superiority if compelling improvement of overall survival demonstrated
Trial to continue as planned with final analysis expected to report in Q4 2021
If trial concludes at interim, filings for approval in the United States and in Europe targeted by year end 2021

NOPHO-sponsored Phase 2 trial in acute lymphoblastic leukemia
Enrollment completed in August 2020
Positive results presented at the ASH (Free ASH Whitepaper) Annual Meeting in December 2020
Ongoing dialogue with FDA to explore path to approval based on positive Phase 2 results; FDA feedback expected in 1H 2021
In case of a path to approval, BLA filing expected in 2021

TRYbeCA-2, Phase 2 clinical trial in triple-negative breast cancer
Trial enrolling patients in three countries in Europe
Top-line results expected in Q4 2021

rESPECT, Phase 1 investigator-sponsored trial (Georgetown University) in first-line metastatic pancreatic cancer
Trial initiated in Q4 2020. First patient enrolled
Determination of maximum tolerated dose expected by end of 2021
2020 Year-End Cash and Guidance

As of December 31, 2020, ERYTECH had cash and cash equivalents totaling €44.4 million (approximately $54.4 million), compared with €73.2 million on December 31, 2019. The €28.8 million decrease in cash position during the twelve months of 2020 resulted mostly from a net cash utilization of €56.3 million and financings totalling €27.5 million and including:

The draw down of five tranches of €3 million each under the convertible bond financing agreement with Alpha Blue Ocean, for net proceeds of €14.2 million. All five tranches have already been converted and have resulted in the issuance of 2,430,925 new shares, representing 13% of the Company’s outstanding share capital to date.

€10 million non-dilutive, state-guaranteed PGE loan from Bpifrance and Société Générale, and €3.3 million in loan and grant milestone payments from Bpifrance on the preclinical R&D Tedac project.

The above information is based on preliminary unaudited financial results as of December 31, 2020. Fourth Quarter and Full-Year 2020 financial results will be disclosed on March 8, 2021.

§ The Company believes that its cash position and cash equivalents as of December 31, 2020 can fund its planned operating expenses and current programs into the third quarter of 2021, and together with the remaining option of potential proceeds available under the convertible bonds financing and its ATM program, until the end of 2021.

Financial Calendar 2021

Business Update and Financial Highlights for the Fourth Quarter and Full Year 2020: March 8, 2021 (after U.S. market close), followed by a conference call & webcast on March 9, 2021 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the First Quarter of 2021: May 4, 2021 (after U.S. market close), followed by a conference call & webcast on May 5, 2021 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the Second Quarter of 2021: September 20, 2021 (after U.S. market close), followed by a conference call & webcast on September 21, 2021 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the Third Quarter of 2021: November 15, 2021 (after U.S. market close), followed by a conference call & webcast on November 16, 2021 (2:30pm CET/8:30am ET)

On January 25, 2021 Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported that expansion of its preclinical dataset on StemVacs, an umbilical cord generated dendritic cell immunotherapy (Press release, Therapeutics Solutions International, JAN 25, 2021, View Source [SID1234574277]). In a series of laboratory experiments, StemVacs administration was demonstrated to induce regression of GL261 glioma, CT-26 colorectal cancer, and Lewis Lung Carcinoma tumors grown in mice.

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Last week the Company reported that StemVacs administration effectively reduces breast cancer through immune stimulation in a natural killer cell dependent manner1. Mechanistically, regression in glioma, colorectal and lung cancer was also dependent on mice possessing a functional natural killer cells repertoire.

"There are companies developing "off the shelf" natural killer based immunotherapeutics for cancer such as Fate Therapeutics (Market Cap $8.9 Billion) and NantKwest (Market Cap 1.8 Billion)" said Dr. James Veltmeyer, Chief Medical Officer of the Company. "To our knowledge we are the only group working at developing a cellular drug using dendritic cells, which are upstream of natural killer cells during immune activation."

Dendritic cells are usually utilized in an autologous manner, meaning they are generated from the same person that they are used upon. Technologies developed by Therapeutic Solutions International allow for the manufacture of unique dendritic cells from cord blood stem cells, which can be used in a universal donor manner.

"The consistency, reproducibility, and ease of scalability is an attractive feature of StemVacs as a "cellular drug" stated Famela Ramos Vice President of Business Development. "We are seeing more and more acceptance of cellular immunotherapies in the market ranging from the $11 Billion acquisition of Kite by Gilead2, to the enormous public and private valuations for cell therapy companies in early phases of clinical development. Given that we have already treated patients with StemVacs, and we have filed an Investigational New Drug (IND) application for this product, we are excited in its development prospects."

"Immunotherapy has been a priority of our company from the beginning. Dr. Thomas Ichim, co-inventor of StemVacs, has routinely published on the feasibility of using the immune system to selectively kill cancer with key opinion leaders in the field3,4,5" said Timothy Dixon, President and CEO of the Company, and co-inventor of StemVacs. "Through leveraging our internationally renowned scientific advisors and collaborators, we aim to rapidly introduce StemVacs as a novel off-the-shelf immunotherapeutic drug for treatment of advanced cancers."

On January 25, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a late-stage biotechnology company focused on designing, developing and commercializing innovative therapies and proprietary medical approaches to stimulate and guide an anti-tumor immune response for the treatment of cancer reported the closing of a previously announced underwritten public offering of 7,711,284 shares of its common stock at a price of $5.45 per share (Press release, OncoSec Medical, JAN 25, 2021, View Source [SID1234574276]). The gross proceeds to OncoSec from the offering, before deducting underwriting discounts, commissions and other offering expenses payable by OncoSec, were approximately $42 million.

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BTIG, LLC acted as sole book-running manager for the offering. A.G.P./Alliance Global Partners and ThinkEquity, a division of Fordham Financial Management, Inc. acted as lead managers for the offering, and Maxim Group LLC and Dawson James Securities, Inc. acted as co-managers for the offering

OncoSec intends to use the net proceeds from this offering for (i) clinical, regulatory, manufacturing and, if and when approved, potential commercial activities of its product candidates; (ii) clinical development of the company’s product candidates; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.

OncoSec has filed a final prospectus supplement and accompanying base prospectus to its effective shelf registration statement on Form S-3 (File No. 333-233447), and the related registration statement on Form S-3 (File No. 333-252281), filed under Rule 462(b) of the Securities Act of 1933, as amended, with the U.S. Securities and Exchange Commission ("SEC") for the public offering of its common stock. Copies of the final prospectus supplement and the accompanying base prospectus relating to these securities may also be obtained by contacting BTIG, LLC 65 East 55th Street, New York, NY, 10022, or by telephone at (212) 593-7555 or by e-mail at [email protected].

The offering of these securities is being made under an effective shelf registration statement on file with the SEC. 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 under the securities laws of any such state or jurisdiction.

About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 ("IL-12"), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer ("TNBC"). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.