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MorphoSys and I-Mab Biopharma Announce IND Clearance to Initiate Clinical Trials of MOR202/TJ202 for the Treatment of Multiple Myeloma in Mainland China

On October 14, 2019 I-Mab Biopharma ("I-Mab"), a China and U.S.-based clinical stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases and German biopharma company MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;Nasdaq: MOR), reported that I-Mab has received Investigational New Drug (IND) clearances from the National Medical Products Administration (NMPA) of China to expand the ongoing phase II and III clinical trials of TJ202/MOR202, MorphoSys’s human monoclonal anti-CD38 antibody for the treatment of multiple myeloma (MM), also to mainland China (Press release, MorphoSys, OCT 14, 2019, View Source [SID1234540982]). I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in China, Taiwan, Hong Kong and Macao.

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I-Mab is currently conducting two clinical trials with TJ202/MOR202 in Taiwan. The phase II study, which was initiated in March 2019, is designed to evaluate the efficacy and safety of TJ202/MOR202 as third-line treatment in patients with relapsed or refractory MM. The phase III study, initiated in April 2019, assesses the efficacy and safety of the combination of TJ202/MOR202 plus lenalidomide (LEN) and dexamethasone (DEX) versus the combination of LEN and DEX in patients with relapsed or refractory MM who received at least one prior line of treatment. Under the fast-to-market development strategy, I-Mab will now be expanding these trials into mainland China.

"Receiving two IND clearances for TJ202/MOR202 from the China NMPA marks an important milestone for us and demonstrates I-Mab’s capability and commitment to the advancement of immunological technology for the market. We will move forward with the clinical development of TJ202/MOR202 in China to bring it to the market as efficiently as possible. I-Mab will continue to expand our portfolio in innovative therapeutics to benefit patients in need," commented Dr. Jingwu Zang, MD., PhD., Founder and Chairman of I-Mab Biopharma.

"We are very pleased that our partner I-Mab now also received the IND clearances for TJ202/MOR202 for China, allowing the expansion of the clinical development of TJ202/MOR202 in multiple myeloma to mainland China," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "There is a high need for alternative treatment options for patients with multiple myeloma in the Chinese region and we look forward to the further development of TJ202/MOR202 by our partner I-Mab in this indication."

About TJ202/MOR202

TJ202/MOR202 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 researche 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.

Forbius Completes Enrollment into Phase 1a Solid Tumor Trial of AVID200, First-in-Class TGF-beta 1 & 3 Inhibitor; Closes Series C Financing

On October 14, 2019 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported that the Phase 1a solid tumor trial exploring the safety and tolerability of AVID200, a first-in-class TGF-beta 1 & 3 selective inhibitor, administered as a monotherapy has fully enrolled (Press release, Forbius, OCT 14, 2019, View Source [SID1234540981]). Simultaneously, the company completed a Series C financing led by HBM Partners with participation from new and existing investors.

AVID200 is rationally designed to selectively and potently inhibit the main pathogenic TGF-beta isoforms 1 and 3. AVID200 spares TGF-beta 2 for optimal safety. Inhibition of TGF-beta 2 is undesirable as this isoform is important for normal cardiac functioning and hematopoiesis. These and other toxicities have curtailed the development of earlier generation, non-selective TGF-beta inhibitors.

The AVID200-03 trial (NCT03834662) is an open label, multicenter, dose-escalation study focused on demonstrating safety of AVID200 monotherapy in patients with advanced or metastatic solid tumor malignancies and no other treatment options. Following a standard 3 + 3 design, a total of 15 patients received AVID200 at 5, 15 and 30 mg/kg once every three weeks. Pharmacokinetics and target engagement were also evaluated.

The recently completed financing funds the company into 2021 which will allow advancement of AVID200 through its clinical proof-of-principle program. HBM Partners led the round, with a number of new and existing investors also participating.

Ilia Tikhomirov, CEO of Forbius, commented: "This Phase 1a dose-escalation study delivers important data that selective inhibition of TGF-beta isoforms 1 & 3 via AVID200 efficiently blocks the TGF-beta pathway with potentially best-in-class tolerability. Together these data position AVID200 as an attractive agent for development in a variety of clinical settings and compelling combinations. We look forward to reporting details of this trial at upcoming immune oncology congresses."

Salarius Pharmaceuticals to Present at Two Upcoming Investor Conferences

On October 14, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported its participation at two upcoming investor conferences (Press release, Flex Pharma, OCT 14, 2019, View Source [SID1234540980]).

Management will provide an overview of Salarius’ business during a live presentation at The Microcap Rodeo taking place October 15 – 16, 2019 in Austin, TX. Salarius’ management will be available to participate in one-on-one meetings during the event with investors who are registered to attend the conference. On October 17, 2019, management will participate in a panel at the Oppenheimer Oncology Summit in Houston, TX.

Details on Salarius’ participation in the conferences are as follows:

Event: The Microcap Rodeo

Date: Wednesday, October 16, 2019

Time: 10:55 a.m. CT

Location: Meeting Room 415A
Hilton Austin – Downtown, Street, Austin TX

Live Webcast: View Source

Event: Oppenheimer Oncology Summit

Panel: The Evolving Strategies in Targeted Drug Development

Date: Thursday, October 17, 2019

Time: 9:45 a.m. to 10:35 a.m. CT

Location: Rotary House Hotel, Houston, TX

ImaginAb signs multi-party collaboration agreement with three global pharmaceutical companies to help further develop company’s CD8 ImmunoPET technology

On October 13, 2019 ImaginAb, Inc., a leading clinical-stage immuno-oncology imaging company, reported the signing of a multi-party collaboration agreement with AstraZeneca (LSE/STO/NYSE: AZN), Pfizer Inc. (NYSE: PFE) and Takeda Pharmaceutical Company Limited (Takeda) focused on furthering the clinical development of ImaginAb’s CD8 ImmunoPET technology (Press release, ImaginAb, OCT 13, 2019, View Source [SID1234540977]). Using its ‘Minibody’ platform, ImaginAb’s technology targets and visualizes CD8+ T cells to provide highly-specific, quantitative assessment of the immunological status of each cancer lesion within a patient, potentially enabling treatment to be tailored quickly and specifically to the needs of that patient.

Under the terms of the agreement, the collaborators will help guide a current ImaginAb-sponsored clinical trial that aims to evaluate the utility and value of CD8 ImmunoPET in immuno-oncology drug development. In return, the collaborators will gain early access to clinical and imaging data and collectively contribute to the post-trial data analysis.

Commenting on the agreement, Ian Wilson, Chief Executive Officer of ImaginAb, said: "One of our key objectives is to streamline the clinical development of next-generation cancer immunotherapies so that ultimately cancer patients have access to the best possible treatments. We believe that working with global leaders in immuno-oncology will help us further develop CD8 ImmunoPET as a pharmacodynamic marker for use in drug development and, in the future, as a diagnostic and predictive test for use in hospitals."

Chris Arendt, Head of the Oncology Drug Discovery Unit at Takeda, said: "We are excited to participate in this pre-competitive alliance, which brings together a rich network of expertise and resources to develop and evaluate an imaging tracer for CD8+ T cells. The ability to track, both spatially and temporally, immune responses associated with novel immuno-oncology therapies and relate these to anti-tumor responses in patients has the potential to deepen our understanding of the cancer immunity cycle and how it can be leveraged for curative intent, which is the primary focus of our oncology research efforts at Takeda."

Axial Biotherapeutics to Participate in 5th Annual BMO Private Company Showcase

On October 11, 2019 Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted programs for neurodegenerative diseases and neurodevelopmental disorders, reported that the company will present at the 5 th Annual BMO Private Company Showcase on Friday, October 18, 2019 at 9:40 AM ET (Press release, Axial Biotech, OCT 11, 2019, View Source [SID1234540985]).