On March 24, 2021 Exacis Biotherapeutics Inc., a development-stage immuno-oncology company working to democratize access to the most advanced and effective cancer treatments, reported several important steps in the preclinical development of its ExaNK engineered NK cell-therapy candidates (Press release, EirGenix, MAR 24, 2021, View Source [SID1234577107]).

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ExaNK cells are generated from induced pluripotent stem cells (iPSCs) that are made using mRNA-based cell-reprogramming and gene-editing technologies. ExaNK cells are designed to resist rejection when administered to patients, with the goal of reducing or eliminating the need for costly and dangerous lymphodepletion, a procedure normally performed using cytotoxic chemotherapy, which carries risks of neurotoxicity and infection. These engineered iPSCs will form the basis for Exacis’ tumor-targeted ExaCAR-NK cells as well as non-CAR-bearing ExaNK cells designed to improve the effect of monoclonal antibodies against both liquid and solid tumors.

Exacis produces rejection-resistant ExaNK cells by performing functional editing of key stealthing targets in its proprietary mRNA-reprogrammed iPSCs. These engineered iPSCs are then differentiated to the final NK-cell product using Exacis’ proprietary high-yield differentiation process. The resulting ExaNK cells show higher tumor cell-killing activity and cytokine production in vitro than peripheral blood-derived NK cells, with no evidence of self-killing (i.e., "fratricide").

Exacis develops its off-the-shelf products using iPSCs to avoid the need for donors. This approach aims to lower the cost and increase the availability and consistency of engineered immuno-oncology cell therapies in comparison to currently approved products.

The discoveries announced today were made in collaboration with Exacis’ parent company, Factor Bioscience, and have been submitted for presentation at a major conference later this year. Exacis has also disclosed the details of these discoveries in a provisional patent application filed earlier this month.

"These results illustrate the sound scientific basis for Exacis’ approach to the development of next-generation engineered NK-cell therapies," said Matt Angel, PhD, CEO of Factor Bioscience and Chair of Exacis’ Scientific Advisory Board. "Combining cell reprogramming with gene editing allows the production of a near-unlimited supply of genetically uniform engineered cells, while using mRNA for both the cell-reprogramming and gene-editing steps uniquely enables the generation of footprint-free cells with no risk of vector integration."

"We continue to be encouraged by the rapid progress we are making towards developing accessible, next-generation engineered cell therapies that will improve patient experiences and outcomes. This first opportunity to expand our substantial intellectual property portfolio marks a key milestone for the company," stated Gregory Fiore MD, CEO and President of Exacis Biotherapeutics.

Next steps for Exacis include scaling the iPSC expansion and differentiation processes to prepare for IND-enabling studies to be conducted later this year.

On March 24, 2021 United Therapeutics Corporation (Nasdaq: UTHR) reported that Dr. Gil Golden, Executive Vice President and Chief Medical Officer of United Therapeutics, will provide an overview and update on the company’s business during a fireside chat session at the 10th Annual J.P. Morgan Napa Valley Forum (Press release, United Therapeutics, MAR 24, 2021, View Source [SID1234577106]).

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The session will take place virtually on Wednesday, March 31, 2021, from 12:00 p.m. to 12:45 p.m., Eastern Daylight Time, and can be accessed via a live webcast on the United Therapeutics website at View Source An archived, recorded version of the session will be available approximately 24 hours after the session ends and can be accessed at the same location for 30 days.

On March 24, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the pricing of an underwritten public offering of 15,853,658 shares of its common stock at a price to the public of $2.05 per share (Press release, CASI Pharmaceuticals, MAR 24, 2021, View Source [SID1234577105]). CASI has granted the underwriters an option to purchase up to an additional 2,378,048 shares of common stock, which terminates on the earlier of 30 days and the day before CASI files to the U.S. Securities and Exchange Commission ("SEC") its Annual Report on Form 10-K for the fiscal year ended December 31, 2020. The offering is expected to close on or about March 26, 2021, subject to satisfaction of customary closing conditions. The gross proceeds to CASI from the offering, excluding any exercise by the underwriters of their option to purchase additional shares, are expected to be approximately $32.5 million, before deducting underwriting discounts and commissions and other offering expenses payable by CASI.

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Oppenheimer & Co. Inc., Mizuho Securities USA LLC, and BTIG LLC are acting as joint book-running managers for the offering.

CASI intends to use the net proceeds of the offering for working capital and general corporate purposes, which include, but are not limited to advancing CASI’s product portfolio, acquiring the rights to new product candidates and general and administrative expenses.

The securities described above are being offered by CASI pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed on November 20, 2020 and declared effective by the SEC on December 2, 2020. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected]; or Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY, 10020; by phone at (212) 205-7600; or by email at [email protected].

Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that CASI has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about CASI and the offering.

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

On March 24, 2021 EirGenix, Inc. (6589.TT) reported that the Phase III clinical trial (Trial No.: EGC002, NCT03433313) of its breast cancer biosimilar, EG12014 (proposed trastuzumab biosimilar, also called EGI014), has met its primary endpoint (Press release, EirGenix, MAR 24, 2021, View Source [SID1234577104]). EG12014 has shown equivalent efficacy to Herceptin in regards to its clinical response (pathologic complete response, pCR), in addition to demonstrating a comparable safety profile. EirGenix will proceed with the preparations for submissions of Biologics License Application (BLA) to the U.S. FDA, Market Approval Application (MAA) to European Medicines Agency (EMA) and New Drug Application to TFDA, exact timings remain confidential.

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This phase III clinical trial is a multi-national, multi-center, randomized, double-blinded study involving female with early, HER2-positive breast cancer. The purpose of the trial was to demonstrate the therapeutic equivalence in terms of efficacy between EG12014 to Herceptin, and to compare the safety, immunogenicity and PK between the two trastuzumab products. A total of 807 enrolled patients were randomly assigned in a 1:1 ratio to one of the two parallel treatment groups and received anthracycline-based chemotherapy every 3 weeks for 12 weeks (cycle 1 to 4). After chemotherapy, patients received EG12014 or Herceptin in combination with paclitaxel, every 3 weeks for 12 weeks (cycle 5 to 8). All patients were scheduled for tumor removal surgery (breast and axillary lymph nodes) 3 to 6 weeks after completion of neoadjuvant therapy (pre-operative treatment). Two (2) to 6 weeks after surgery, eligible patients continued with trastuzumab therapy in the adjuvant study to complete 12 months of overall trastuzumab treatment (adjuvant cycle 1 to 13), followed by a 20-week long-term safety follow-up (after final dose of trastuzumab).

During tumor removal surgery, samples were collected for assessment of a pathologic complete response (pCR) by an independent central laboratory. The primary endpoint of pCR is defined as absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ (ypT0/is ypN0). Demonstration of therapeutic equivalence in regards to the pCR between the two treatment groups (EG12014 vs Herceptin) in the pre-operative treatment setting was based on the pre-specified risk ratio (0.741 – 1.349) and probability difference (-0.13 – 0.13). The topline results demonstrated that EG12014 met equivalence to Herceptin in terms of clinical response in both analysis populations (per-protocol and full-analysis sets). Additionally, the safety profiles of the two treatment arms were shown to be comparable in the pre-operative treatment setting.

According to Roche’s annual report, global sales of Herceptin totaled 3.73 billion CHF in 2020. The US and EU market are 1.36 billion CHF and 0.67 billion CHF respectively. Herceptin sales were 34% lower than in 2019, driven by biosimilar competition, which was introduced in the second half of 2019 in the US and mid-2018 in Japan and Europe. Upon approval Sandoz AG, a global leader in generics and biosimilars will sell EG12014 globally in all markets except for Taiwan and Mainland China, as per the licensing agreement signed with EirGenix in April 2019. The licensing agreement included a signing fee and milestone payments , and a profit sharing of product sales in the authorized markets after product launch. The revenue from the milestone payments will be recognized in stages in accordance to standard accounting procedures and will serve to benefit the company’s current operations and further development. In 2019, Taiwan’s National Health Insurance (NHI) paid approximately 1.657 billion New Taiwan Dollars (NTD) for Herceptin.

Current demand for complex biological drugs has increased and will continue to rise in the future. With the drug patents of major biological drugs set to expire in the near future, the development of biosimilars has been greatly encouraged within the industry. The demand has been driven by the need for more cost-effective drugs in countries with limited medical resources. EirGenix is currently the first and only biopharmaceutical company in Taiwan to have successfully signed a licensing agreement with a global pharmaceutical company for a biosimilar. EirGenix is also one of only a handful of Taiwanese biopharmaceutical companies to have independently developed a biosimilar product into Phase III clinical trials and successfully demonstrating its equivalent efficacy. With such developmental achievements, EirGenix is rightfully worthy of investors’ attention and expectations.

On March 24, 2021 Bioheng Biotech Co., Ltd, a clinical-stage biotechnology company dedicated on developing novel cellular immunotherapy for cancer, reported that it had secured $80 million in Series B Financing (Press release, Bioheng Biotech, MAR 24, 2021, View Source [SID1234577103]). The Series B was co-led by GL Ventures, the venture capital unit of Hillhouse Capital, Decheng Capital and Octagon Capital, with the participation of BlueRun Ventures China and Shenzhen Capital Group Company.

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Dr. Xiaohong He, Founder and Chief Executive Officer of Bioheng, stated, " We are thrilled to get recognition from such an excellent group of biotech investors and proud of the continued support from existing shareholders. Bioheng focuses on the development of allogeneic immuno-cell therapy. At present, we have made progress in several indications with promising clinical data. Proceeds from this financing will continue to be used to advance R&D capabilities, process development and clinical trials. We are looking forward to providing more affordable ‘off-the-shelf’ immuno- cell therapies to patients soon. "

"It is a great honor to continue supporting Bioheng in Series B financing. We have strong confidence in company’s technologies and management team," said Dr. Xiangmin Cui, Founder and Managing Director of Decheng Capital. "In the past two years, company has enriched the pipeline and made solid progress in multiple assets’ clinical development, demonstrating strong research and development capabilities."

Dr. Ting Jia, Founder and Chief Investment Officer of Octagon Capital, expressed, "Bioheng has a clear scientific vision, an outstanding teamwork spirit and unswerving sense of innovation. We are excited to have the opportunity to work with such an excellent team and will accompany them for a long journey."