On April 25, 2022 Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, reported that it has acquired from Erytech Pharma its state-of-the-art, commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, for $44.5 million (Press release, Catalent, APR 25, 2022, https://www.catalent.com/catalent-news/catalent-acquires-commercial-scale-cell-therapy-development-and-manufacturing-facility-in-princeton-new-jersey-from-erytech/ [SID1234612892]). The deal includes an exclusive long-term supply agreement for Catalent to support Erytech’s lead product candidate eryaspase (GRASPA), a red blood cell-derived product, which is currently in late-stage development for the treatment of acute lymphoblastic leukemia.

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The 30,900-square-foot facility is located within the University Square Campus Park and houses 16 suites positioned for production of products in a cGMP-compliant manner, as well as laboratories for analytical, quality control and microbiology testing. The site will become a strategic campus for development as well as clinical- and commercial-scale manufacturing of cell therapies, and is located within easy reach of Catalent’s facilities around Baltimore, Maryland, where the company develops and manufactures viral vectors and plasmid DNA. It will also work in collaboration with Catalent’s existing U.S. clinical-scale cell therapy facility in Houston, Texas.

Concurrent with the acquisition, Catalent has agreed to terms to lease an adjacent 23,000-square-foot building that could be used for additional laboratory or cGMP capabilities, and another building on the campus for potential future expansions. All staff at the site will transfer to Catalent’s employment, and Catalent is developing its plans for its future recruitment needs.

Under the supply agreement, Catalent will continue to manufacture eryaspase (GRASPA) at the site. It will also support the development of Erytech’s pipeline of encapsulated red blood cell-based therapeutics for severe forms of cancer and orphan diseases.

"This acquisition is strategically important to Catalent’s commitment to support the development and clinical and commercial supply of cell therapies to meet rapidly growing demand," said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. "The talented and experienced staff already employed at the facility, the capabilities it has in place, and the opportunity to quickly add further capacity on the same site, allow Catalent to expand rapidly to create a U.S. campus and center of excellence for cell therapy development and manufacturing that will serve customers around the world."

"In Catalent we have found a great partner for the manufacturing of our innovative red blood cell-derived products," said Gil Beyen, Chief Executive Officer at Erytech. "Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics, and we believe this win-win strategic partnership will meet our long-term manufacturing needs in the United States. Erytech will now further focus its resources on seeking regulatory approval of GRASPA and on the development of potentially transformative therapeutics for serious diseases."

Catalent’s cell and gene therapy network includes six U.S. facilities across Maryland and Texas, a European center of excellence in Belgium, and its cell innovation facility in Germany. These sites offer a range of small- and large-scale clinical and commercial manufacturing, as well as fill/finish capabilities.

ABOUT CELL & GENE THERAPY
Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, oncolytic viruses, and live virus vaccines. An experienced and innovative partner, Catalent Cell & Gene Therapy has a global network of dedicated, small- and large-scale clinical and commercial manufacturing facilities, including an FDA-licensed viral vector facility, and fill/finish capabilities located in both the U.S. and Europe.

On April 25, 2022 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer cell therapies to treat cancer, reported that it has commenced a proposed underwritten public offering to issue and sell $150 million of shares of its common stock (Press release, Nkarta, APR 25, 2022, View Source [SID1234612908]). The Company also intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock on the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All shares in the offering are to be issued and sold by Nkarta.

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Nkarta intends to use the net proceeds from the offering to fund the continued clinical development of NKX101 and NKX019, preclinical studies for research stage programs and the continued buildout of internal manufacturing capabilities, and for working capital and for general corporate purposes.

Cowen, SVB Securities and Evercore ISI are acting as joint book-running managers for the offering.

The offering is being conducted pursuant to a shelf registration statement (File No. 333-258766), which was filed with the Securities and Exchange Commission ("SEC") on August 12, 2021 and declared effective by the SEC on September 2, 2021. The proposed offering will be made only by means of a prospectus supplement and accompanying prospectus describing the terms of the offering. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]. These documents may also be obtained for free on the SEC’s website located at View Source The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

On April 25, 2022 Suzhou Porton Advanced Solutions Ltd. (‘Porton Advanced’) and Guizhou Sinorda Biomedicine Co. Ltd (‘Sinorda Biomedicine’) reported a long-term strategic partnership in cell and gene therapy R&D and platform development (Press release, Jiangsu Sinorda Biomedicine Co, APR 25, 2022, View Source [SID1234612925]).

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Porton Advanced offers an end-to-end gene and cell therapy CDMO service platform covering plasmids, cell therapy, gene therapy, oncolytic virus, mRNA therapy and Bacterial Therapy. With broad experience in domestic and international new drug filing, Sinorda Biomedicine focuses on the R&D of innovative drugs for digestive tract diseases, tumor immunotherapy and oncolytic virus therapy, and has several new drug projects in clinical stage. Its subsidiary, Jiangsu Tairui Sinorda Biomedicine Pharmaceutical Technology Co. Ltd., provides pre-clinical and clinical research services for tumor immune pharmacology and efficacy.

Under the agreement, Porton Advanced will provide services to accelerate the development, production and registration of breakthrough cell therapies currently being developed by Sinorda Biomedicine, including its T-cell immunotherapy product for colorectal cancer, SND002 (Sentinel lymph node T cell) and other pipelines. Porton Advanced will also work with Sinorda Biomedicine to support its cell and gene therapeutic R&D and production.

SND002 (SLN-T), the first collaborated project, has received approval for the initiation of Phase II clinical trials in Europe. Previously, the product was also designated as a ‘Breakthrough New Drug’ by the Chinese National Science and Technology Major Project. The launch of this critical first project allows the integration of resources and capabilities from both Porton Advanced and Sinorda and promises greater synergy to accelerate the clinical development and approval of Sinorda’s SLN-T program.

Dr. Yangzhou Wang, CEO of Porton Advanced, said, "Sinorda Biomedicine has a proven track record in drug development in China, US and Europe. The company possesses great expertise in immunology and oncolytic viruses, as well as cutting-edge immune functional assays, technologies, and capabilities. I am excited to see how our end-to-end cell and gene therapy CDMO platforms and quality systems can complement these capabilities and enhance Sinorda’s pipeline. Supporting Sinorda’s development, production and regulatory filing and accelerating its cell therapy drugs to market is a great cause and a great opportunity. We look forward to the opportunity to help Sinorda establish advanced therapies that benefit patients globally."

Dr. Pingsheng Hu, founder of Sinorda Biomedicine, said, "The entering of the strategic collaboration between Sinorda and Porton Advanced is a significant milestone to speed up the clinical development of our novel immunotherapies for solid tumors. Sinorda has long-term experience in clinical application of immunotherapy in solid tumors. In addition, Sinorda has rich resources in clinical research, in clinical bio-bank for real world data study with cutting edge technologies for evaluation of immunotherapy. Porton Advanced brings an integrated CDMO platform, innovative technologies and an international team, with experience from R&D stage to market approval and commercial production. Those capabilities from both sides will bring great opportunities in future development, that will contribute to value creation in the long term for both companies."

On April 25, 2022 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer cell therapies to treat cancer, reported the pricing of an underwritten public offering of 13,333,334 shares of its common stock at a price to the public of $15.00 per share (Press release, Nkarta, APR 25, 2022, View Source [SID1234612946]). The Company has granted the underwriters a 30-day option to purchase up to 2,000,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. All shares in the offering are to be issued and sold by Nkarta.

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The offering is expected to close on or about April 28, 2022, subject to customary closing conditions.

Gross proceeds to Nkarta from this offering are approximately $200 million, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriters’ option to purchase additional shares. Nkarta intends to use the net proceeds from the offering to fund the continued clinical development of NKX101 and NKX019, preclinical studies for research stage programs and the continued buildout of internal manufacturing capabilities, and for working capital and for general corporate purposes.

Cowen, SVB Securities, Evercore ISI and Stifel are acting as joint book-running managers for the offering.

The offering was conducted pursuant to a shelf registration statement (File No. 333-258766), which was filed with the Securities and Exchange Commission ("SEC") on August 12, 2021 and declared effective by the SEC on September 2, 2021. The offering was made only by means of a prospectus supplement and accompanying prospectus describing the terms of the offering. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting the following: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; and Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104 or by telephone at (415) 364-2720 or by email at [email protected]. These documents may also be obtained for free on the SEC’s website located at View Source The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

On April 25, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first quarter of fiscal year 2022 (Press release, Chugai, APR 25, 2022, View Source [SID1234612893]).

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"The first quarter marked a strong start to 2022. Significant increases in both domestic and overseas sales resulted in record revenues and profits for the quarter. Domestic sales were driven by the supply of Ronapreve to the government and good penetration of our new products Enspryng, Polivy, and Evrysdi, while Hemlibra posted a remarkable increase in overseas sales. These products are on track to become our next growth drivers. In R&D, Vabysmo, a bispecific antibody in-licensed from Roche, obtained regulatory approval for two diseases that may potentially lead to vision loss. This unlocks Chugai’s first full-scale entry into ophthalmology. For Mitchga, the anti-IL-31 receptor A inhibitor created by Chugai, regulatory approval for itching associated with atopic dermatitis was obtained by Maruho, our partner for the Japanese market. Both of these products have novel modes of action, and I am very pleased that we can provide new treatment options based on innovation. We will continue to challenge ourselves to create innovative new drugs," said Dr. Osamu Okuda, Chugai’s President and CEO.

[First quarter results for 2022]

Chugai reported a significant growth in revenues and operating profit, achieving record highs for the first quarter (Core-basis).

Revenues increased by approximately 60% over the same period last year. Sales increased sharply by almost 90%, while royalties and other operating income decreased by approximately 30%. Domestic sales increased by approximately 70%. In the oncology field, sales remained almost flat over the same period last year. The contribution of the new product Polivy offset declines in mature products, including Avastin and Herceptin, due to NHI drug price revisions last year and biosimilars. In the primary field, sales almost tripled year-on-year due to the supply of Ronapreve to the government and the contribution of new products, Enspryng and Evrysdi. Overseas sales more than doubled given a five-hold growth of Hemlibra owing to the full-scale export to Roche at regular shipping price, and a 50% increase in Actemra, which obtained emergency use authorization and regulatory approval for severe COVID-19 in the U.S. and Europe, respectively, since last June. On the other hand, royalties and other operating income decreased by approximately 30%, mainly due to a significant decrease in royalty income related to the initial shipments of Hemlibra. Revenues on IFRS basis including Non-Core items totaled ¥360.6 billion (+113.6%), including the lump-sum income of ¥91.9 billion from the settlement agreement with Alexion Pharmaceuticals, Inc.

Cost to sales ratio rose by 4.8% points year-on-year to 47.0%, mainly due to a change in the product mix. Marketing and distribution, research and development, and general and administration expenses have all increased, resulting in an overall increase in operating expenses by almost 15%. Marketing and distribution expenses increased due to an increase in activities at overseas group companies and the effects of foreign exchange. Research and development expenses increased due to the progress of projects. General and administration expenses increased due to the enterprise tax and various expenses. As a result, Core operating profit totaled ¥98.9 billion (+51.2%).

The Company also made good progress in research and development. Chugai obtained regulatory approval in March 2021 for Vabysmo for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Vabysmo, in-licensed from Roche, is the first bispecific antibody in ophthalmology. Clinical development of RG6321, the port delivery system with ranibizumab in-licensed from Roche, was newly initiated also in the field of ophthalmology. In-house projects that will drive the company’s mid-to-long-term growth also progressed well, including Mitchga and several projects applying Chugai’s proprietary antibody engineering technologies. Maruho, the licensee of anti-IL-31 receptor A antibody Mitchga in Japan, obtained regulatory approval for the product in March for the treatment of pruritus associated with atopic dermatitis (only when existing treatment is insufficiently effective). As for the anti-C5 recycling antibody crovalimab, a phase III clinical trial conducted in China in paroxysmal nocturnal hemoglobinuria (PNH) met its primary endpoint. Application for regulatory approval will be filed in China ahead of other countries by the end of this year. Also, Roche started clinical development in sickle cell disease outside Japan.

Regarding development of treatments for COVID-19, WHO granted prequalification of Actemra for patients with severe or critical COVID-19 in February. Furthermore, in April, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental Biologics License Application (sBLA) for Actemra for the treatment of COVID-19 in hospitalized adults, granting priority review. In the U.S., Actemra has been used under the Emergency Use Authorization (EUA) since June 2021.

2022 Q1 R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and the basis for payment-by-results such as a return to shareholders.