Protalix BioTherapeutics to Hold First Quarter 2019 Financial Results and Corporate Update Conference Call on May 6, 2019

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.

IMMUNOMEDICS AND EVEREST MEDICINES ANNOUNCE EXCLUSIVE LICENSE AGREEMENT FOR SACITUZUMAB GOVITECAN IN EAST AND SOUTHEAST ASIA EXCLUDING JAPAN

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.

Nicox to Present at Upcoming Pharmaceutical Industry and Financial Events

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

Forbius’ AVID200, a Novel TGF-beta 1 & 3 Inhibitor, Cleared by Health Canada to Commence Phase 1 Clinical Trial in Solid Tumors

On April 29, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, announced that it has received a no objection letter from Health Canada for its clinical trial application (CTA) to conduct a Phase 1 trial in solid tumors with immuno-oncology candidate AVID200, a rationally designed and highly potent inhibitor of TGF-beta 1 & 3 (Press release, Forbius, APR 29, 2019, View Source [SID1234535642]).

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AVID200-03 (NCT03834662) is a Phase I, open label, dose-escalation trial to establish the recommended phase 2 dose (RP2D) of AVID200 in patients with advanced or metastatic malignancies. The trial is currently enrolling patients at centers in the U.S. and will now be expanded to additional clinical sites in Canada to recruit a total of up to 36 patients.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors and represent promising immuno-oncology targets. These TGF-beta isoforms are implicated in T-cell suppression, fibrosis in the tumor microenvironment, and resistance to immunotherapeutics such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

About AVID200 and the AVID200-03 Trial
AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3 undergoing Phase 1 clinical testing in solid tumors and fibrotic diseases. TGF-beta 1 & 3 are the principal disease-driving isoforms, while TGF-beta 2 is responsible for normal cardiac function and hematopoiesis.

AVID200’s selectivity for TGF-beta 1 & 3 was designed to achieve optimal efficacy while circumventing cardiac and other safety issues that have limited the applicability of older-generation, non-selective TGF-beta inhibitors. Therefore, AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings, including in combination with anti-PD-(L)1 therapy.

AVID200-03 (NCT03834662) is an open label, multicenter, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor effects of AVID200 in patients with advanced or metastatic solid tumor malignancies.

Teneobio Announces US FDA Approval of the Investigational New Drug Application for TNB-383B and the Initiation of Phase I Clinical Studies in Multiple Myeloma Patients

On April 29, 2019 Teneobio, Inc. and its affiliate TeneoOne, Inc. reported that their investigational new drug application (IND) for TNB-383B, a bispecific T-cell engaging antibody for the treatment of multiple myeloma, was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on April 24th, 2019 (Press release, TeneoBio, APR 29, 2019, View Source [SID1234535622]). The ongoing development of TNB-383B is being pursued in collaboration with AbbVie, Inc.

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TNB-383B is a fully human bispecific antibody with two binding moieties for B-Cell Maturation Antigen (BCMA) on one arm and a unique anti-CD3 on the other. In preclinical studies, TNB-383B induced T-cell dependent killing of myeloma cells (which express BCMA) but with reduced cytokine secretion, a feature that could limit immune mediated toxicities while retaining cytotoxic activity.

Roland Buelow, CEO of Teneobio, Inc. added "We are looking forward to starting clinical studies with TNB-383B. We believe that Teneobio’s differentiated anti-BCMAxCD3 (TNB-383B), which incorporates a unique T-cell activation anti-CD3, will provide a better therapeutic window for the treatment of multiple myeloma than current BCMA-targeting bispecific antibodies in the clinic. Our T-cell redirecting anti-CD3 platform is also the foundation for additional therapeutics that we are rapidly advancing in our pipeline. These include TNB-486 (anti-CD19xCD3) and TNB-585 (anti-PSMAxCD3) for the treatments of lymphoma and prostate cancer, respectively. We look forward to filing INDs on these additional programs in H2 of 2020."