On April 29, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, reported that the first patient has been dosed in a phase 3 randomized and multi-center clinical study in Taiwan to evaluate MorphoSys’s investigational human CD38 antibody MOR202/TJ202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma (Press release, MorphoSys, APR 29, 2019, View Source [SID1234556333]). I-Mab has exclusive rights for development and commercialization of MOR202/TJ202 in China, Taiwan, Hong Kong and Macao.

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"The initiation of our first phase 3 trial represents another important milestone in advancing MOR202/TJ202 towards registration with the hope of providing more therapeutic options for multiple myeloma patients globally. With planned enrollment of 291 patients, this will be a broad trial of this second most common blood cancer worldwide," said Dr. Joan Shen, M.D., Head of R&D at I-Mab. "In parallel with our pivotal phase 2 trial of MOR202/TJ202 in combination with dexamethasone, the phase 3 study will further assess the efficacy of MOR202/TJ202 as a potential second line treatment in multiple myeloma."

Under I-Mab’s fast-to-market development strategy, the phase 3 study, if successful, could lead to a biologics license application (BLA) in Greater China. The randomized, open-label, parallel-controlled, multicenter study will be conducted in mainland China and Taiwan to evaluate the efficacy and safety of the combination of MOR202/TJ202 plus lenalidomide (LEN) and dexamethasone (DEX) versus the combination of LEN and DEX in patients with relapsed or refractory multiple myeloma who received at least one prior line of treatment. The primary endpoint is to evaluate the progression-free survival (PFS) comparing the efficacy of MOR202/TJ202 plus LEN/DEX versus LEN/DEX.

The dosing of the first patient triggers a milestone payment of USD 3 million to MorphoSys.

"We are delighted that our partner I-Mab has started a phase 3 trial of MOR202/TJ202 in combination with lenalidomide in Asia in addition to the ongoing phase 2 trial of MOR202 in combination with dexamethasone. We see a high medical need for the treatment of patients with multiple myeloma in the Chinese region and look forward to supporting I-Mab in developing this investigational compound for these patients," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG.

With MorphoSys’s support through a licensing agreement in November 2017, I-Mab is currently leading the clinical development of MOR202/TJ202 in Greater China, including mainland China, Hong Kong, Macao and Taiwan. In addition to Taiwan, I-Mab has filed an investigational new drug (IND) application to China’s National Medical Products Administration in August 2018. Previously on March 20, 2019, MorphoSys and I-Mab announced the first patient dosing of MOR202/TJ202 in a phase 2 multi-center clinical study in Taiwan in patients with relapsed or refractory multiple myeloma.

About MOR202/TJ202
MOR202/TJ202 is an investigational human monoclonal antibody derived from MorphoSys’s 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 suggest that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on an exclusive regional licensing agreement signed in late 2017, I-Mab owns the exclusive rights for development and commercialization of MOR202/TJ202 in China, Taiwan, Hong Kong and Macao.

On April 29, 2019 NexImmune and the Multiple Myeloma Research Foundation (MMRF) reported that they have entered into a partnership to advance a promising new therapy into clinical trials for multiple myeloma patients (Press release, NexImmune, APR 29, 2019, View Source [SID1234554879]).

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The MMRF’s newly formed Myeloma Investment Fund aims to attract the most promising companies and technologies to the field to advance new therapies for myeloma patients. The MIF has made an equity investment in NexImmune to help support the initial clinical development of NEXI-002, which is one of the company’s lead product candidates, and to help further develop the Company’s Artificial Immune Modulatory (AIM) technology platform.

"Regrettably, multiple myeloma remains an incurable malignancy. Patients who are refractory to standard treatments, or who have relapsed disease after at least three prior therapies, face a very poor prognosis. Newly approved, targeted agents have significantly improved short-term outcomes for these patients, however, most will eventually develop drug resistance and succumb to their disease within one year. This highlights the need for novel therapies with curative potential," said Scott Carmer, President and CEO of NexImmune. "That’s why we are very excited to partner with the MMRF to make our AIM adoptive cellular therapy (ACT) available to this specific patient population".

NexImmune is advancing immunotherapy products based on the Company’s proprietary Artificial Immune Modulatory (AIM) nanotechnology platform. The AIM technology enables simultaneous enrichment, expansion and priming of cytotoxic CD8+ T cells directed against multiple tumor-associated antigen (TAA) targets across a broad range of both solid and hematologic malignancies.

NEX-I002 is designed to generate cytotoxic T cells directed against multiple tumor antigens associated with MM. The Company has completed pre-IND discussions with the FDA, and expects to submit an IND to support this Phase I/II clinical trial in 3Q2019.

"Investments made by the Myeloma Investment Fund underscore the commitment of the MMRF to bring the most promising immunotherapy agents to myeloma patients as quickly as possible," commented Paul Giusti, President and CEO of the MMRF. "We chose to partner with NexImmune because of the potential for this technology to benefit highly refractory patients who have limited treatment options and significant unmet need."

On April 29, 2019 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported that it will report first quarter 2019 financial results and provide a corporate update on Monday, May 6, 2019 at 8:30 am ET (Press release, Protalix, APR 29, 2019, View Source;p=RssLanding&cat=news&id=2396034 [SID1234535695]).

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To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1 (844) 358-6760; International: +1 (478) 219-0004. Conference ID number: 6169584.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

On April 29, 2019 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC) and Everest Medicines II Limited ("Everest Medicines"), a C-Bridge Capital-backed biopharmaceutical company, reported an exclusive license agreement to develop, register, and commercialize sacituzumab govitecan in Greater China, South Korea and certain Southeast Asian countries (Territory) (Press release, Immunomedics, APR 29, 2019, View Source [SID1234535687]).

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"We are pleased to be partnering with Everest Medicines to commercialize sacituzumab govitecan in the Asian market outside Japan and further develop the product in solid tumor indications of high unmet need in the territory," said Usama Malik, Chief Financial Officer and Chief Business Officer of Immunomedics. "This agreement sets a new benchmark for a single-asset licensing deal for regional China and exemplifies our commitment to expand the geographic footprint and clinical use of sacituzumab govitecan for the benefit of cancer patients worldwide."

"Sacituzumab govitecan is an innovative and unique ADC with a highly favorable clinical benefit rate across solid tumors and provides us the opportunity to address hard to treat cancers in key underserved regions across Asia. We look forward to partnering with Immunomedics’ clinical and regulatory teams to accelerate the development of sacituzumab govitecan across multiple indications in Greater China where there is great need for innovative cancer therapeutics of major impact," said Eric Rowinsky, M.D., U.S. Chief Medical Officer for Oncology, and Yang Shi, M.D., China Chief Medical Officer for Oncology of Everest Medicines.

Immunomedics will receive an upfront payment of $65 million and an additional $60 million based on U.S. FDA approval of sacituzumab govitecan in metastatic triple-negative breast cancer. Everest will develop and commercialize the product in various global and local indications across the Territory. The Company is eligible to receive development and sales milestone payments of up to $710 million, as well as escalating tiered royalties that begin in the mid-teens based on net sales within the Territory.

Pursuant to the agreement, Everest Medicines will be responsible for all costs associated with the clinical development and commercialization of sacituzumab govitecan in the Territory, while a Joint Steering Committee will be established between the companies to oversee the overall strategy and priorities.

"This transformative deal reinforces Everest Medicines’ position as the preeminent biopharmaceutical company to develop and commercialize globally innovative products in Greater China and other emerging Asia Pacific markets," said Ian Woo, President and Chief Financial Officer of Everest Medicines.

"Everest Medicines’ highly experienced team has a proven track record of delivering industry leading execution and we look forward to leveraging our deep knowledge and cumulative insights to address diseases with unmet need that are highly prevalent in these underserved regions," said Sean Cao, Interim CEO of Everest Medicines.

"Today’s announcement culminates a thoughtful and deliberate process, that expedites regional expansion of our lead product candidate in the world’s fastest growing pharmaceutical market and significantly enhances shareholder value. This partnership allows the Company to continue on its path to becoming a global biopharmaceutical company, and importantly maintaining the strategic optionality in core established markets worldwide," said Behzad Aghazadeh, Chairman of the Board of Directors of Immunomedics.

About Sacituzumab Govitecan

Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate targeting the Trop-2 receptor expressed by many solid cancers and delivering the moderately-toxic drug, SN-38, directly to the tumor. Sacituzumab govitecan has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of patients with metastatic triple-negative breast cancer who have received two prior therapies for metastatic disease.

On April 29, 2019 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported that it will be presenting at the following pharmaceutical industry and financial events in Q2 2019 (Press release, NicOx, APR 29, 2019, View Source [SID1234535676]):

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Michele Garufi, Chairman and CEO, will present at the 2019 Ophthalmology Innovation Summit (OIS) on May 2, 2019, prior to the 2019 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The conference is being held at the Hilton San Diego Bayfront in San Diego, U.S.
Gavin Spencer, Chief Business Officer, will present at the JMP Securities Life Sciences Conference on June 20, 2019 to be held at the St. Regis hotel in New York, U.S.
Emmet Purtill, Senior Director of Business Development, will present at the BIO 2019 International Convention to be held from June 3-6, 2019 in Philadelphia, U.S.

The presentations will be available on the Nicox website (www.nicox.com) in the "Presentations & Events" section.

Nicox management will also participate in the following events for 1:1 meetings with investors:

May 16: European MidCap Event, Copenhagen, Denmark
June 18-19: European MidCap Event, Paris, France
June 24-25: HealthTech Investor Day, Paris, France