On February 28, 2022 Patrys reported that it has now developed and optimised a stable cell line for production of our full-sized IgG deoxymab, PAT-DX3 (Press release, Patrys, FEB 28, 2022, View Source [SID1234609081]).

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Establishing a stable, high-yield cell line suitable for commercial production of clinical-grade material is a critical milestone for the Company. Work can now commence on the development of a commercial scale manufacturing process for GMP‑grade (Good Manufacturing Practice) PAT-DX3 deoxymab.

Patrys CEO and Managing Director, Dr James Campbell said:

"There is significant of interest in PAT-DX3 both as a therapeutic agent in its own right and for the intracellular delivery of therapeutic payloads intracellularly, and across the blood brain barrier. With this key reagent now developed and in hand, we can rapidly move into optimising a commercial-scale production process to support both the clinical and partnering opportunities we have for PAT-DX3."

On February 27, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the National Medical Products Administration (NMPA) of China accepted the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) (Press release, JW Therapeutics, FEB 27, 2022, View Source [SID1234609085]). This is the second marketing application on Carteyva submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of r/r FL patients. Carteyva was granted Breakthrough Therapy Designation by NMPA in September 2020.

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The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China. The study results were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021. The cohort B results showed that Carteyva demonstrated very high rates of durable disease response (Best Complete Response Rate and Overall Response Rate at 3 months was 92.6% and 100%, respectively) and controllable CAR-T associated toxicities in patients with r/r FL (42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), while 0% and 3.6% of the patients experienced CRS and NT of Grade 3 or above).

Professor Yuqin Song, Chief Physician of Lymphoma Department at Peking University Cancer Hospital, Director of China Society of Clinical Oncology (CSCO), noted at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: "The RELIANCE study results show that Carteyva demonstrated very excellent efficacy and safety profile in patients with r/r FL and we are looking forward to the sNDA approval in China."

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

About RELIANCE Study (NCT04089215)

RELIANCE study was a single-arm, multi-center, pivotal study to evaluate the efficacy and safety of Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma (cohort A: relapsed or refractory large B-cell lymphoma, cohort B: relapsed or refractory follicular lymphoma) in China.

RELIANCE cohort B study enrolled 28 patients with r/r FL who had failed the second-line (or above) therapy, including an anti-CD20 agent and anthracycline. Patients received 100*106 CAR-T or 150*106 CAR-T cell of Carteyva infusion, and followed up until 2 years or above for long term outcomes. As of the cut-off date of September 10, 2021, of 27 evaluable patients, the Complete Response Rate (CRR) and Overall Response Rate (ORR) at 3 months were 85.19% and 100%, and the Best Complete Response Rate and Overall Response Rate was 92.6% and 100%, respectively. Of 28 treated patients, 42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), Among these AEs, no CRS of Grade 3 or above occurred, and only 3.6% of the patients experienced NT of Grade 3 or above.

On February 27, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported the successful dosing of first patient in China Phase IIa Study of TST001, a Claudin18.2 monoclonal antibody, combined with Cisplatin and Gemcitabine for the first line treatment of systemic treatment-naïve locally advanced or metastatic biliary tract cancer patients (Press release, Transcenta, FEB 27, 2022, View Source [SID1234609084]). Globally Transcenta is the first company exploring the potential of Claudin 18.2 targeting agent in biliary tract cancer.

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Biliary tract cancer is a relatively rare malignancy, which includes cholangiocarcinoma and gallbladder carcinoma. Cholangiocarcinoma is further classified into extrahepatic and intrahepatic cholangiocarcinoma. In the treatment of biliary tract cancer, radical resection is the standard and only approach for patients at the early stage. However, most of the patients cannot receive surgical resection, as the cancer has stepped into the metastatic stage by the time of diagnosis. For biliary tract cancer, few effective therapies are available for these patients, which leaves significant unmet clinical needs.

This Phase IIa clinical trial is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and anti-tumor efficacy of TST001 in patients with systemic treatment-naïve locally advanced or metastatic biliary tract cancer. These patients will be screened using an immunohistochemistry assay developed by Transcenta and validated by central lab that specifically detects Claudin18.2 but not Claudin 18.1.

"Biliary tract cancer has poor prognosis and the combination of Cisplatin and Gemcitabine is the standard of care for first line treatment." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta." Using our proprietary IHC antibody, Transcenta has shown that Claudin18.2 is over-expressed in the tumor of a subset of biliary tract cancer patients. As the combination of Claudin18.2 targeting agent with chemo backbone has shown promising activity in first line gastric cancer, the addition of TST001 to the first line chemotherapy regimen may also provide better treatment benefit to biliary tract cancer patients with Claudin18.2-expressing tumor."

About TST001
TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).

On February 25, 2022 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company"), reported that it has entered into a securities purchase agreement with certain institutional investors to purchase 11,000 shares of Series O redeemable convertible preferred stock and 11,000 shares of Series P redeemable convertible preferred stock (Press release, Spherix, FEB 25, 2022, View Source [SID1234609382]). Each share of Series O and Series P preferred stock has a purchase price of $952.38, representing an original issue discount of 5% of the $1,000 stated value of each share. Each share of Series O and Series P preferred stock is convertible into shares of AIkido’s common stock at an initial conversion price of $1.00 per share. Shares of the Series O and Series P preferred stock are convertible at the option of the holder at any time following the Company’s receipt of stockholder approval for a reverse stock split of the Company’s common stock. AIkido will be permitted to compel conversion of the Series O and Series P preferred stock after the fulfillment of certain conditions and subject to certain limitations. Total net proceeds from the offerings, before deducting the placement agent’s fees and other estimated offering expenses, is approximately $20.9 million.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The Series O and Series P preferred stock permit the holders thereof to vote together with the holders of the Company’s common stock on a proposal to effectuate a reverse stock split of the Company’s common stock at an annual or special meeting of Company stockholders. The Series O preferred stock permits the holder to vote on such proposal on an as-converted to common stock basis. The Series P preferred stock permits the holder to cast 30,000 votes per share of Series P preferred stock on such proposal. The Series O and Series P preferred stock will not be permitted to vote on any other matter. The holders of the Series O and P preferred stock agreed not to transfer their shares of preferred stock until after the meeting of Company stockholders. The holders of the Series O preferred stock agreed to vote their shares in favor of the reverse stock split proposal and the holders of the Series P preferred stock agreed to vote their shares on such proposal in the same proportions as the shares of common stock and Series O preferred stock are voted on that proposal. The holders of the Series O and Series P preferred stock have the right to require the Company to redeem their shares of preferred stock for cash at 105% of the stated value of such shares commencing after the earlier of the Company’s stockholders’ approval of the reverse stock split and 90 days after the closing of the issuances of the Series O and Series P preferred stock and until 120 days after such closing.

The closing of the offering is expected to occur on or about February 24, 2022, subject to the satisfaction of customary closing conditions. Additional information regarding the securities described above and the terms of the offering are included in a Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission ("SEC").

To the extent Series O or P preferred stock is converted or otherwise not redeemed after 120 days from closing, the Company will use such net proceeds from this offering for working capital and general corporate purposes.

The Series O and Series P preferred stock and shares of common stock into which such preferred stock are convertible are being offered pursuant to a registration statement on Form S-3 (333-238172), which was declared effective by the Securities and Exchange Commission on June 18, 2020. The offerings will be made only by means of prospectus supplements and a prospectus that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of preferred stock and underlying shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

On February 25, 2022 Johnson & Johnson and its U.S.-based Janssen Pharmaceutical Companies (collectively, the "Company") reported there is sufficient level of participation to move forward with the nationwide settlement agreement to resolve opioid-related claims and litigation by states, cities, counties, and other subdivisions in the United States (Press release, Johnson & Johnson, FEB 25, 2022, View Source [SID1234609126]).

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As previously announced on July 21, 2021, the Company will contribute up to $5 billion to the nationwide settlement, which is designed to directly support state and local efforts to make meaningful progress in addressing the opioid crisis in the United States. This settlement agreement is not an admission of any liability or wrongdoing, and the Company will continue to defend against any litigation that this final settlement agreement does not resolve. The Company no longer sells prescription opioid medications in the United States as part of our ongoing efforts to focus on transformational innovation and serving unmet patient needs.

The Company announced separate settlement agreements that are consistent with the terms of the nationwide settlement agreement with the States of New York in June 2021, Texas in October 2021, and Nevada and New Mexico in January 2022. The Company also announced a settlement agreement with the federally recognized Tribes in February 2022. The dollar amounts to be received in these settlement agreements are the pro-rated shares that would have been received under the nationwide settlement agreement and will be deducted from the $5 billion all-in settlement amount.