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 27, 2022 EORTC reported The MINDACT (EORTC 10041/BIG3-04) study, a multicentre, randomised phase 3 clinical trial, aims to identify those women with early-stage breast cancer who can be spared chemotherapy after surgery through the use of a genomic and clinical risk assessment. Between 2007 and 2011, 6693 patients aged 18 to 70 whose cancer had either not spread to the lymph nodes under the arm, or to no more than three nodes, were enrolled to the trial, which was carried out in 112 institutions in nine European countries (Press release, EORTC, JAN 27, 2022, View Source [SID1234607424]).

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The latest sub-group analysis, published recently in the Journal of Clinical Oncology* looked at the 15% of patients who had an ultra-low genomic risk of recurrence based on the 70-gene signature MammaPrint. After a median follow-up of 8.7 years, 99% of these patients had not died from their disease, and their risk of cancer spreading to other parts of the body (distant metastasis) was significantly less than for patients with low-risk tumours. Patients with ultra-low risk tumours had an excellent prognosis regardless of the result of their clinical risk assessment.

Of the ultralow-risk patients, 67% were aged 50 years or more, and 99% were estrogen receptor (ER)-positive. Systemic therapy was received by 84% of patients (69% endocrine therapy (ET), 14% endocrine therapy plus chemotherapy, 1% other) and 16% received no adjuvant systemic treatment.

"Although trials have shown that gene signatures can be used to identify subgroups of patients who can safely be spared chemotherapy, current guidelines still include the use of ET in all hormone receptor positive patients, even those at very low risk" said Dr Josephine Lopes Cardozo, from the Netherlands Cancer Institute and EORTC. "ET side effects are often underestimated, and, as a result, adherence to the treatment is poor, with only half of all patients finishing a five-year course. Our analysis of ultra-low risk patients shows that these patients might be candidates for further reduction of treatments such as ET."

The investigators hope that the ultra-low risk gene signature will be used in future trials investigating the de-escalation of ET in order to achieve a better balance between benefit and harm. Findings from earlier studies have suggested that the introduction of population-based screening programmes has led to an increase of tumours with low-risk and ultra-low risk molecular profiles, and that these are over-represented within screen-detected cancers. "Being able to identify these patients who may have a limited benefit from ET could help to personalize treatment by reducing treatment durations or completely omitting ET and ultimately preventing overtreatment," says Dr Lopes Cardozo. "This would have benefits not only for patients, but also save money for healthcare systems."

On January 27, 2022 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in cancer and neurodegenerative disease, reported that the company entered into a stock purchase agreement before the market close on January 27, 2022 with a syndicate of new and existing investors for a private placement of 5,945,943 shares of common stock at a purchase price of $1.11 per share for aggregate gross proceeds of approximately $6.6 million (Press release, Vaccinex, JAN 27, 2022, View Source [SID1234607441]). The private placement is expected to close on January 31, 2022, subject to customary closing conditions. No warrants, derivatives, or financial covenants are associated with the purchase agreement.

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Participants in the private placement include entities controlled by Dr. Maurice Zauderer, President and CEO of Vaccinex , and Albert D. Friedberg, Chairman of Vaccinex’s board of directors, each of which purchased $2 million worth of shares, as well as an entity controlled by Jacob Frieberg, another member of Vaccinex’s board of directors, and additional new and existing shareholders that are unaffiliated with Vaccinex, that together purchased the remaining $2.6 million worth of shares.

Vaccinex intends to use the net proceeds from the private placement to fund the ongoing development of its lead drug candidate, pepinemab, in cancer and neurodegenerative disease and for working capital and general corporate purposes.

Vaccinex also announced that during the month of January, prior to entering into the stock purchase agreement, Vaccinex sold approximately $3.5 million of shares of its common stock in January 2022 for a weighted average sales price of $1.16 per share under its existing open market sales agreement with Jefferies, LLC. This brings the total of new equity financing to date in 2022 to $10.1 million.

In connection with the private placement, Vaccinex will also enter into a registration rights agreement with certain of the private placement investors. Pursuant to the registration rights agreement, Vaccinex will agree to, among other things, use its reasonable best efforts to file with the Securities and Exchange Commission (the SEC) a registration statement covering the resale of the shares.

A description of the stock purchase agreement and registration rights agreement will be included in a Form 8-K to be filed with the SEC.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale are unlawful. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On January 27, 2022 HaemaLogiX Ltd (HaemaLogiX), the clinical-stage biotechnology company developing novel monoclonal antibody therapies for multiple myeloma, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, reported that they have entered into an agreement to manufacture the next clinical batch (cGMP) of HaemaLogiX’s lead multiple myeloma drug candidate, KappaMab (Press release, HaemaLogiX, JAN 27, 2022, View Source [SID1234607458]).

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KappaMab is a monoclonal antibody which binds to a cell surface target called kappa myeloma antigen (KMA) that is only found on myeloma cancer cells and not on normal plasma cells. Specific binding of KappaMab to the myeloma cell enables the patient’s immune system to recognize the cell as abnormal, triggering the natural response to attack and kill the myeloma cell. As a result, only the cancer cells are depleted and normal healthy plasma cells are spared from the patient’s immune system attack.

To date, KappaMab has been tested in three clinical trials where it showed a good safety profile with no dose-limiting toxicities following single and multiple doses[1],[2],[3]. In a recent phase 2b clinical trial, KappaMab synergized with the immune modulator drug (IMiD) lenalidomide in combination with dexamethasone to produce more disease responses and improved quality of response versus case-matched lenalidomide plus dexamethasone alone in patients with relapsed, refractory multiple myeloma[2].

Bryce Carmine, Chairman and CEO, HaemaLogiX, commented: "Multiple myeloma is the second most common haematological cancer worldwide, with an estimated 32,000 new cases and over 12,500 deaths annually in the US alone (2019), and a European incidence roughly equivalent. The incurable nature of multiple myeloma makes it necessary to expand treatment options available to patients. We look forward to taking KappaMab back into the clinic alongside standard of care, and this Lonza agreement is an important step toward providing the drug product for our upcoming trial."

According to the terms of the agreement, Lonza will manufacture drug substance of KappaMab for clinical supply at Lonza’s new state-of-the-art cGMP mammalian manufacturing facility in Guangzhou (CN), which houses two 1,000-liter and two 2,000-liter single-use bioreactors. HaemaLogiX will leverage Lonza’s regulatory expertise, global manufacturing footprint, and extensive experience in manufacturing monoclonal antibodies.

Jeetendra Vaghjiani, Executive Director, Clinical Development & Strategic Marketing, Lonza, commented: "We are looking forward to building a collaboration with HaemaLogiX to help advance their multiple myeloma candidate towards commercial launch. We will leverage our unique flexible offering and state-of-the-art expertise in manufacturing monoclonal antibodies at our site in Guangzhou (CN)."

The target completion date for the drug product is Q4 2022. The drug product will then be used in Australian-based clinical trials, currently scheduled to begin in late 2022.