On January 28, 2022, Shenzhen Aixindawei Pharmaceutical Technology Co., Ltd. (hereinafter referred to as: "Aixindawei" or "the Company") reported that the company’s independently developed small molecule targeted conjugate new drug (project number: AST-001) based on the AKR1C3 enzyme-activated prodrug platform has obtained NMPA’s implicit approval to enter clinical trials (acceptance number CXHL2101680) (Press release, Ascentawits Pharmaceuticals, JAN 28, 2022, View Source [SID1234650302]). The indication is malignant solid tumors. This is another major milestone in the company’s development after the company’s first project AST-3424 obtained NMPA’s implicit approval to enter clinical trials on June 13, 2019.

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Dr. Jianxin Duan, founder and chairman of Aixindawei Pharmaceuticals, said: "We are very pleased that the AST-001 project, another small molecule targeted conjugate new drug independently developed based on the AKR1C3 enzyme-activated prodrug platform, has obtained implicit approval for clinical trials from the NMPA. Multiple preclinical in vitro and in vivo studies have demonstrated that AST-001 has good safety and broad-spectrum anti-tumor activity. In addition, AST-001 has shown encouraging pharmacodynamic effects in multiple in vivo tumor models with high expression of AKR1C3 and KRAS G12D mutations. We are very much looking forward to the clinical performance of AST-001, which will bring more effective and more beneficial treatment options to patients with different tumor types and contribute to a healthy China."

On January 28, 2022 Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that the Company entered into an agreement with certain institutional investors for the private placement of 1,000,000 shares of Series D convertible redeemable preferred stock (Press release, Advaxis, JAN 28, 2022, View Source [SID1234607473]). The shares to be sold will have an aggregate stated value of $5,000,000. Each share of the Series D preferred stock has a purchase price of $4.75, representing an original issue discount ("OID") of 5% of the stated value. The shares of Series D preferred stock are convertible into shares of the Company’s common stock, upon the occurrence of certain events, at a conversion price of $0.25 per share of common stock. The conversion, at the option of the stockholder, may occur at any time following the receipt of the stockholders’ approval for a reverse stock split. The Company will be permitted to compel conversion of the Series D preferred stock after the fulfillment of certain conditions and subject to certain limitations. The Series D preferred stock will also have a liquidation preference over the common stock, and may be redeemed by the investors, in accordance with certain terms, for a redemption price equal to 105% of the stated value, or in certain circumstances, 110% of the stated value. The Company and the holders of the Series D preferred stock will also enter into a registration rights agreement to register the resale of the shares of common stock issuable upon conversion of the Series D preferred stock.

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Total gross proceeds from the offering, before deducting the financial advisor’s fees and other estimated offering expenses, are $4.75 million.

The Series D 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 a special meeting of Company stockholders, with the holders of the Series D preferred stock having the right to cast 30,000 votes per share of Series D preferred stock on such proposal. The holders of the Series D preferred stock agreed to vote their shares in the same proportions as the shares of common stock are voted on that proposal. The Series D preferred stock will not be permitted to vote on any other matter. The holders of the Series D preferred stock agreed not to transfer their shares of preferred stock until after a special meeting of Company stockholders to be held in the first half of 2022.

The closing of the offering is expected to occur on January 31, 2022, subject to the satisfaction of customary closing conditions. Additional information about the offering and the terms of the offering will be included in the Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission ("SEC").

The Series D preferred stock and shares of common stock into which these preferred shares are convertible are being issued in reliance upon the exemption from the securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act") and/or Rule 506 of Regulation D as promulgated by SEC under the 1933 Act.

Neither the Series D preferred stock nor the shares of common stock into which these preferred shares are convertible have been, nor will be, registered under the 1933 Act and may not be offered or sold in the United States absent registration under the 1933 Act or an applicable exemption from the registration requirements of the 1933 Act.

The closing of the offering is expected to occur on January 31, 2022, subject to the satisfaction of customary closing conditions. Additional information about the offering above and the terms of the offering will be included in the Current Report on Form 8-K to be filed with the SEC.

On January 28, 2022 Curaleaf Holdings, Inc. (CSE: CURA /OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis, reported that it will report its financial and operating results for the fourth quarter and fiscal year ended December 31, 2021 after market close on March 3, 2022 (Press release, Curaleaf Holdings, JAN 28, 2022, View Source [SID1234607489]).

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Management will host a conference call and audio webcast that evening at 5:00 p.m. ET consisting of prepared remarks followed by a question and answer session related to the Company’s operational and financial highlights.

For interested individuals unable to join the conference call, a dial-in replay of the call will be available until March 10, 2022 and can be accessed by dialing +1-877-344-7529 (U.S.), +1-855-669-9658 (Canada) or +1-412-317-0088 (International) and entering replay pin number: 4919700.

On January 28, 2022 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported the signing of a partnership agreement with the Hangzhou Qiantang New Area in China to manufacture its innovative drugs locally and accelerate its transition to commercialization (Press release, I-Mab Biopharma, JAN 28, 2022, View Source [SID1234607474]). This strategic partnership will accelerate I-Mab’s commercialization strategy with an execution plan and timeline to commercialize its innovative assets, including felzartamab (TJ202/MOR202), and meet unmet medical needs for patients in China.

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"Today’s announcement demonstrates the Company’s commitment to translating our scientific innovation into clinical and commercial value as soon as possible so that we can provide more high-quality, affordable options for patients through locally-manufactured, innovative drugs," said Yifei Zhu, Chief Commercial Officer, I-Mab. "This brings us one step closer to our new commercial model that integrates manufacturing, distribution and sales."

I-Mab Hangzhou has commenced pilot operation in phase I facility, which is equipped with process development and analytical laboratories and in parallel the construction of phase II facility with an 80,000-square-meter manufacturing floor space was completed in December 2021. The GMP operations and quality systems will be fully compliant with standards and requirements of China’s National Medical Product Administration (NMPA), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA). It also lays the foundation for I-Mab to meet IND (investigational new drug) supply and future commercial demand.

The first planned I-Mab’s innovative assets to be locally manufactured at I-Mab Hangzhou is felzartamab (TJ202/MOR202), a differentiated antibody drug. I-Mab has completed third line Multiple Myeloma (MM) trial of felzartamab successfully, achieving primary and secondary clinical endpoints which validate the product’s differentiated clinical advantages. In addition, patient enrollment for a randomized, open-label, parallel-controlled phase 3 trial for felzartamab, in combination with lenalidomide, for second-line MM treatment was completed in the second half of 2021. I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.

About Felzartamab

Felzartamab (TJ202/MOR202) is an investigational human monoclonal antibody derived from MorphoSys’ HuCAL antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, which has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. According to its suggested mode of action, the antibody recruits cells of the body’s immune system to kill the tumor through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The antibody does not involve complement dependent cytotoxicity, or CDC, an additional immune mechanism involved in tumor cell killing. Scientific research suggests that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on a licensing agreement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.

HuCAL is a registered trademark of MorphoSys AG.

About Multiple Myeloma in China

Multiple myeloma (MM) is the second most common hematologic malignancy in China, accounting for approximately 1 percent of all cancers and 13 percent of all blood malignancies. Being primarily a disease of the elderly, the incidence of MM in China, which was about 1.6 per 100,000 in 2020, is expected to grow exponentially with the country’s aging population.1 The prognosis of patients with relapsed or refractory MM remains poor, with a huge unmet need for expanding the progression-free survival and overall survival of MM patients.

On January 28, 2022 Nanjing Bioheng Biotech Co., Ltd. ( hereinafter referred to as Bioheng) reported that its anti-claudin 18.2 autologous CAR-T cell therapy product CTB001 received Orphan Drug Designation (ODD) from the Food and Drug Administration (FDA) for the treatment of gastric cancer (Press release, Bioheng Biotech, JAN 28, 2022, View Source;t-product-received-orphan-drug-designation-odd-from-the-us-fda-301470432.html [SID1234607490]). Gastric cancer has a high incidence in Asian countries such as China and Japan, and the mortality rate ranks the third in the global mortality rate of malignant tumors, behind lung cancer and colorectal cancer. At present, conventional chemotherapy and surgical resection are mainly applied for the gastric cancer treatment, therefore the treatment drugs and methods are very limited.

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About CTB001:

Claudin18.2 is a pan-cancer target and is abnormally expressed in various primary tumors and metastases, including gastric cancer, pancreatic cancer, cholangiocarcinoma, ovarian cancer and lung adenocarcinoma. CTB001 is a fourth-generation autologous CAR-T cell therapy product targeting claudin18.2, which uses Bioheng Explored CAR-T platform technology to enhance the anti-tumor efficacy of the product.

The breakthrough of CAR-T therapy provides a new solution for cancer treatment, with high unmet clinical needs. CTB001 shows excellent efficacy and safety in exploratory clinical studies, and provides strong data support for the upcoming domestic declaration.

Bioheng indicates:

CTB001 is the first clinical validation of Bioheng Explored CAR-T platform technology. It is a very promising immunotherapy that can accurately, quickly and efficiently bring good benefits to claudin18.2-positive cancer patients.

The qualification of CTB001 obtained by FDA for orphan drugs will further accelerate the development and commercialization of cell and gene therapy, and promote Bioheng to enter the global innovative drug market. In the future, we look forward to bringing more products to clinical trials and providing more choices for solving the unmet medical needs.

About ODD:

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US or meets cost recovery provisions of the act. After obtaining the ODD, pharmaceutical companies could receive various incentives for the drug development, including 25% federal tax credit for expenses incurred in conducting clinical research within the United States, Waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, qualified to compete for research grants from the Office of Orphan Products Development (OOPD) to support clinical studies for orphan drugs, eligibility to receive regulatory assistance and guidance from the FDA in the design of an overall drug development plan and 7-year marketing exclusivity.