On January 28, 2022 Roche reported that it will publish its Full Year Results for 2021 prior to the opening of the Swiss Stock Exchange on Thursday, 3 February 2022 (Press release, Hoffmann-La Roche, JAN 28, 2022, View Source [SID1234607476]).

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On January 28, 2022 Eli Lilly and Company (NYSE: LLY) reported that plans to invest over $1 billion to create a new manufacturing site, along with nearly 600 new jobs in Concord, North Carolina (Press release, Eli Lilly, JAN 28, 2022, View Source [SID1234607475]). The brand-new facility will utilize the latest technology to manufacture parenteral (injectable) products and devices and increase the company’s manufacturing capacity.

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"Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world," said Edgardo Hernandez, senior vice president and president, Lilly Manufacturing Operations. "Expanding our manufacturing footprint in North Carolina enables us to continue to produce today’s medicines while providing additional capacity to manufacture the medicines of tomorrow. We are pleased to again partner with North Carolina to bring jobs to American workers and provide more medicines that patients need to address health challenges."

Lilly selected Concord because of the manufacturing technology experience of the local labor force; its proximity to universities with strong science, technology, engineering and math (STEM) programs; and its access to major transportation infrastructure. In 2020, Lilly announced a $470 million investment in North Carolina’s Research Triangle Park. In conjunction with this site, the new facility in Concord will allow the company to strengthen relationships with local governments and universities and diversify its growing presence in the state.

Lilly plans to create nearly 600 new jobs for highly skilled workers such as scientists, engineers and manufacturing personnel, who will use advanced technology to produce life-changing treatments and devices to make life better for people around the world. In addition, an estimated 500 additional positions will be required while the facility is under construction.

"Lilly’s choice brings more good jobs to North Carolina from one of our most important industries," said North Carolina Governor Roy Cooper. "North Carolina has become a premier hub for the world, thanks to our exceptional workforce and commitment to education."

Over the last five years, Lilly has invested over $4 billion in global manufacturing, including more than $2 billion in the U.S. The company also reported plans to invest $500 million in a new biopharmaceutical manufacturing facility in Limerick, Ireland. Lilly anticipates additional future investments in manufacturing to address growth expected from potential new medicines to treat diabetes, Alzheimer’s disease, cancer and autoimmune conditions.

The investment in Concord is contingent upon completion of county and municipal government permitting and related approvals. Lilly partnered with several organizations throughout the project, including the Office of the Governor, the Department of Commerce, Cabarrus Economic Development Corporation, the City of Concord, Cabarrus County, the Economic Development Partnership of North Carolina, the North Carolina Biotechnology Center, Rowan Cabarrus Community College, and the North Carolina Community College System.

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 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 Spago Nanomedical reported that positive preclinical data in its cancer treatment project Tumorad (Press release, Spago Nanomedical, JAN 28, 2022, View Source [SID1234607471]). After treatment with the candidate 177Lu-SN201, a significant reduction in tumour growth was shown in a colorectal cancer model. In addition, the survival was extended by 39 per cent compared to the control group. BioStock contacted CEO Mats Hansen for a comment on the development work with Tumorad.

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In mid-January, First North-listed Spago Nanomedical reported interim results from its clinical study with the tumour-directed contrast agent Spagopix for diagnostics with magnetic resonance imaging. Now, the company is following up with new preclinical data in colorectal cancer in its cancer treatment project Tumorad.

New data provides additional support
Within the Tumorad project, Spago Nanomedical is developing the drug candidate 177Lu-SN201, which is a new radionuclide treatment for aggressive and metastatic cancers. The company’s polymer nanomaterials have been shown to accumulate in tumour tissue and by combining the material with the clinically validated isotope lutetium 177 (177Lu), a local radiation treatment can be carried out in the tumour.

The potential of 177Lu-SN201 is to be able to treat cancers that today are difficult or impossible to access with external radiation or surgery. Spago Nanomedical plans to start the first human studies with the candidate in 2022.

Previously, the company has been able to show positive preclinical data for the candidate in aggressive breast cancer and has now been able to demonstrate efficacy in a preclinical model for colorectal cancer. The study shows that 177Lu-SN201 significantly reduces tumour growth and prolongs survival by 39 per cent compared to the control group.