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.

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 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 Imugene (ASX: IMU) reported a new clinical trial supply agreement with Roche to evaluate the safety and efficacy of Imugene’s PD1-Vaxx, a B-cell activating immunotherapy, in combination with atezolizumab (Tecentriq), an immune checkpoint inhibitor targeting PD-L1, in patients with non-small cell lung cancer (NSCLC) (Press release, Imugene, JAN 28, 2022, View Source [SID1234607523]).

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The objectives of the phase 1b trial, "An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1 Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab, in Adults with Non-Small Cell Lung Cancer," are to determine safety, efficacy, and optimal dose of PD1-Vaxx in combination with atezolizumab as either first-line therapy in ICI treatmentnaïve NSCLC patients or ICI pretreated patients. The study will be conducted at sites in USA and Australia.

Dual targeting of the PD-1/PD-L1 axis is an area of considerable interest with ongoing clinical results providing treatment options for patients with cancer. Combination with PD1-Vaxx may overcome treatment resistance to ICIs with dual inhibition of the PD-1/PD-L1 axis extending the treatment benefit of atezolizumab. In contrast to combination of two monoclonal antibodies, PD1-Vaxx has the advantage that it induces a unique polyclonal immune response which may increase response rates for the combination therapy.

Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the US. In addition to becoming the first approved cancer immunotherapy for adjuvant NSCLC, Tecentriq was also the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies.

"It’s an outstanding accomplishment to see Imugene collaborate with Roche, in combination with our PD1-Vaxx drug. PD1-Vaxx has shown a tolerable safety profile and encouraging efficacy in patients with NSCLC, and we are looking forward to evaluating PD1-Vaxx with atezolizumab in ICI treatment-naïve and pretreated NSCLC patients." said Leslie Chong, Managing Director & Chief Executive Officer of Imugene.

Imugene and Roche have entered into a supply agreement for a period of up to five years for the supply of atezolizumab. Imugene will be the sponsor of the study and will fund the clinical study from existing budgets and resources. Roche will supply atezolizumab for the duration of the study. In accordance with the terms of the supply agreement, all data generated in the performance of the study shall be the property of Imugene as the sponsor and all rights to all inventions and discoveries made or conceived in the course of the study relating to the combination of atezolizumab and PD1-Vaxx shall belong jointly to Roche and Imugene.

About NSCLC
Lung cancer is one of the leading causes of cancer death globally Each year 1.8 million people die as a
result of the disease; this translates into more than 4,900 deaths worldwide every day. Lung cancer
can be broadly divided into two major types: NSCLC and SCLC. NSCLC is the most prevalent type,
accounting for around 85% of all cases.