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.

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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."

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]).

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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

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.

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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."

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]).

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On October 11, 2019 SHINE Medical Technologies, LLC reported the creation of a new division of the company — SHINE Therapeutics. The establishment of the division enhances the company’s ability to focus on filling critical future needs in the rapidly growing therapeutic isotope market, while continuing to leverage its radioisotope production expertise.

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The company’s Therapeutics division will initially focus on the development and commercialization of lutetium‑177, or Lu‑177, a therapeutic isotope that is combined with a disease-specific targeting molecule to treat cancer. Targeting molecules deliver Lu‑177 atoms to cancer sites throughout the body, where they directly irradiate cancer cells.

The first Lu‑177-based targeted radiotherapy (for neuroendocrine tumors) reached the market in 2018. Many high-potential targeted molecules for the treatment of a range of other cancers with Lu-177 are currently under investigation. SHINE is also evaluating additional medical isotopes with therapeutic properties for future development.

Katrina Pitas, a 10-year veteran of SHINE who served most recently as the company’s vice president of business development, has been appointed vice president and general manager of SHINE Therapeutics.

"Targeted radiotherapy has the potential to fundamentally change the way cancer patients are treated," Ms. Pitas said. "But a robust, reliable supply of therapeutic isotopes will be crucial as both the discipline and associated market continue to grow. Our Lu‑177 development program is well underway, and we look forward to bringing high-purity Lu‑177 to market."

In May, the company entered an agreement with the Institute of Organic Chemistry and Biochemistry of the Czech Academy of Sciences (IOCB Prague) that provides SHINE with a global, exclusive license to a novel separation technology that it will use to separate lutetium from enriched ytterbium targets. The technology will enable SHINE to produce non-carrier-added, high-specific-activity Lu‑177.

"We are excited to bring our core competencies and technology to serve the rapidly emerging therapeutic market," said Greg Piefer, SHINE’s founder and CEO. "This market is particularly exciting, as it offers very promising therapies for patients who before now had difficult or impossible to treat late stage cancers. The focus of our new division is to ensure cancer patients have a reliable supply chain of isotopes as new drugs are approved."

SHINE is continuing its efforts to bring molybdenum-99, or Mo‑99, to a global market experiencing shortages that directly affect patient care. Construction of the company’s first-of-its-kind isotope production facility in Janesville, Wis., where it will produce Mo‑99 using the company’s patented technology, is underway and progressing well.

European Association of Nuclear Medicine Annual Congress

SHINE will be exhibiting at the European Association of Nuclear Medicine (EANM) Annual Congress in Barcelona, Spain. The exhibit hall will be open Oct. 13-15. You can find SHINE at booth no. 23 near the center entrance to the exhibit hall