On June 17, 2021 Orion Biotechnology Canada Ltd., a clinical-stage biotechnology company, reported that it has raised $11.5M USD in a Series A financing (Press release, Orion Biotechnology, JUN 17, 2021, View Source [SID1234584176]).

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The oversubscribed round was led by Keiretsu Forum, a global group of investors and included corporate/institutional investors, venture capitalists and existing shareholders. Howard Lubert, President Keiretsu Forum Mid-Atlantic, commented "As early investors in disruptive life sciences companies, we have seen how cutting-edge technologies like Orion’s can bring significant value to the industry and lead to the delivery of innovative new treatments for patients. We believe that Orion has developed a truly innovative technology for effectively targeting G Protein-Coupled Receptors (GPCRs)." The investment includes conversion of a Simple Agreement for Future Equity (SAFE) as well as closing the first tranche of a Series A investment.

"It’s rewarding to see a Canadian biotech company receive support for their novel technology from across the Keiretsu Forum ecosystem following our cross border due diligence process. Our investors are excited to be a part of their growth and innovation" said Kevin Sterling, President Keiretsu Forum Toronto.

Proceeds from the financing will be used to advance Orion’s pipeline of novel precision-engineered therapeutics, including its lead oncology candidate, which is a first-in-class Chemokine Analog with best-in-class potency. The investment will also enable the company to extend its proprietary discovery platform for effectively targeting complex GPCRs that have proven difficult to target using traditional drug classes.

"We are pleased to have the support and confidence of a large network of seasoned life science investors" said Mark Groper, President and CEO of Orion Biotechnology. "With the completion of this funding round, we are positioned to build on the momentum we have created, advance our multi-asset portfolio, and further leverage our proprietary discovery platform to deliver new precision engineered therapies in collaboration with industry partners".

On June 17, 2021 Apollo Therapeutics, a unique collaboration between three leading universities (University College London, Imperial College and University of Cambridge) and three global pharmaceutical companies (AstraZeneca, GlaxoSmithKline and Johnson & Johnson) set up in 2016 has received £100m in investment to further develop and translate early-stage science into clinical development for patient benefit(Press release, UCLB, JUN 17, 2021, View Source [SID1234584101]).

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In order to translate research in the most time and capital efficient way possible, Apollo Therapeutics has been set up as a portfolio-based biopharmaceutical company and has completed a £100m Series A financing deal. The financing was led by Patient Square Capital, with participation from additional investors including UCL Technology Fund, Rock Springs Capital and Reimagined Ventures. Proceeds from the investment will support rapid advancement of the pipeline with over 15 therapeutic programs currently in development across oncology, major inflammatory disorders and rare disease. Apollo will continue to collaborate with UCL, University of Cambridge and Imperial College to source new projects for further development.

Apollo is grounded in research from UCL, Imperial College and University of Cambridge. The collaboration between the three universities and three pharmaceutical companies – AstraZeneca, GlaxoSmithKline and Johnson & Johnson is unique and is a capital efficient innovative way to ensure more research can be translated and commercialised at scale.

The three British universities are in the top 10 universities in the world and are at the forefront of developing basic and translational research including oncology, major inflammatory disorders and rare disease, that provides opportunities for drug discovery.

Apollo also secured its first out-licensing deal last summer from technology developed at UCL with Axovia, a company backed by Deerfield, another U.S. healthcare investment firm and with support from UCL Technology Fund.

On June 17, 2021 KIYATEC, Inc. reported the publication of new peer-reviewed data that establishes clinically meaningful prediction of patient-specific responses to standard of care therapy, prior to treatment, in newly diagnosed glioblastoma (GBM) and other high-grade glioma (HGG) patients(Press release, EurekAlert!, JUN 17, 2021, View Source [SID1234584121]). The results, the interim data analysis of the company’s 3D-PREDICT clinical study, were published June 16, 2021 in Neuro-Oncology Advances, an open access clinical journal.

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A goal of the study, which continues to enroll, was for the test’s prospective, patient-specific response prediction to achieve statistical significance for predictive accuracy. The 3D-PREDICT study met this goal early, at its interim data analysis, an achievement that is uncommon for innovations in oncology. For clinicians and payors, the publication establishes the successful analytical validation and early clinical validation of KIYATEC’s 3D Predict Glioma assay.

The recent bipartisan resolution passed by the US Senate designating July 21, 2021 as Glioblastoma Awareness Day highlights the severity of this aggressive brain cancer. Fewer than 10% of patients survive longer than five years. Pharmaceutical and clinical efforts have only resulted in modest increases in overall survival since the disease was first described in the 1920s. Today, most newly diagnosed patients receive the same treatment regimen (radiation therapy and temozolomide), presenting an opportunity to improve care through shifting the paradigm toward individualized medicine for HGG treatment.

KIYATEC’s test results accurately identified the patients as future temozolomide responders or future non-responders prior to the initiation of drug treatment. The future responder group had a statistically significant 6-month comparative increase in overall survival. Since test results are available only seven days after surgery, this creates an opportunity to improve outcomes for each predicted non-responder by providing the possibility of patient-specific treatment strategies. In the future, KIYATEC’s results may also prove useful to improve outcomes for each predicted responder through patient-specific combination strategies.

Successful response-prediction for newly diagnosed patients follows the company’s previous success with predicting treatment response in recurrent high-grade glioma patients. In December 2020, KIYATEC announced a clinical case series demonstrating that use of their test doubled these patients’ median time to progression over what would be expected without use of the test. In addition, the earlier announcement demonstrated successful clinical use of the targeted agent dabrafenib in two patients that were not identified by genetic sequencing. By identifying successful response to drugs that would have been missed by today’s testing, KIYATEC’s results expanded the successful treatment options for these patients.

"Decision making in our framework is based on patient-specific evidence, embodying truly personalized medicine. Evidence of response before the first dose is administered creates options that were not previously available when it comes to treatment," said Matthew Gevaert, PhD, CEO of KIYATEC.

Versus other approaches, tests developed using KIYATEC’s 3D ex vivo cell culture platform demonstrate increased biological fidelity, which was first reported in 2019 in ovarian cancer. In newly diagnosed ovarian cancer patients, KIYATEC’s test prospectively and accurately predicted response to first-line chemotherapy with 89% accuracy. The new GBM results now establish comparable predictive accuracy in two solid tumors, with eight additional cancers in the company’s pipeline.

On June 17, 2021 Kiromic reported that it is being recognized as a pioneer of Gamma Delta T (GDT) cell therapy manufacturing and has been invited to present its off-the-shelf allogeneic CAR-T technology at the prestigious Gamma Delta T Cell Summit in July 2021 (Press release, Kiromic, JUN 17, 2021, View Source [SID1234584160]).

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— April 2021. KRBP presented its manufacturing of GDT cells at the recent AACR (Free AACR Whitepaper) 2021 annual meeting.

— June 2021. KRBP received an invitation from the GDT cell summit organizers to present Kiromic’s technology.

— July 2021. KRBP will present at the GDT Cell summit.

— 3Q 2021. Projected First In-Human dosing for solid tumors.

Early clinical data is starting to come in. The excitement is building. The race is on.

The Annual Gamma Delta T Therapies Summit is gathering the world leaders in Gamma Delta T therapies who will harness GDT cells and bring to market the first effective, allogeneic GDT cell therapy for solid tumors. Gamma Delta T-cell Summit Link: View Source

Chief Executive Officer of Kiromic, Maurizio Chiriva-Internati, DBSc, PhDs, stated:

"We are developing what we believe is ground-breaking innovative technologies and have demonstrated that our chPD1 receptor was effective on solid tumors in both in vitro and in vivo models with minimal toxicity.

This invitation to present at the July conference is a recognition of our progress and we are grateful for this opportunity.

GDT cell manufacturing has been a challenge for the cell therapy space.

At this conference, we will be reviewing how we have faced the challenges of cell extraction, cell gene edits, manufacturing yields, and product purity."

Chief Operating & Manufacturing Officer of Kiromic, Ignacio Núñez comments:

"Our end-to-end operations organization, including manufacturing, supply chain, QA, QC and compliance continues the preparation and readiness for Phase 1 of the clinical trials targeted for 3Q 2021.

Our operations team is growing, incorporating industry veterans with exceptional cell and gene therapy experience.

We are excited with the launch of this high performing team and a revolutionary process around a continuous improvement mindset."

Chief Strategy and Innovation of Kiromic, Gianluca Rotino, stated:

"The GDT cell industry is taking notice of our progress, and as such our GDT cell technology will be the exclusive domain of Kiromic for years to come."

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About Kiromic Scientific Posters Presented at AACR (Free AACR Whitepaper) 2021

Session

PO.IM02.01

Focus

Adoptive Cell Therapy

Poster No.

LB148

Link to AACR (Free AACR Whitepaper) Poster

Gamma delta T cells engineered with a chimeric PD-1 receptor effectively control PD-L1 positive tumors in vitro and in vivo with minimal toxicities.

Take Away

Chimeric PD-1 (chPD1)

Demonstrated that Kiromic’s chPD1 receptor was effective on solid tumors in both in vitro and in vivo models with minimal toxicity.

Previous Press Release:

Kiromic announces 6 posters presented at AACR (Free AACR Whitepaper) 2021 showcasing our Artificial Intelligence (AI) Biomarker engine

About AACR (Free AACR Whitepaper) (American Association of Cancer Research)

On June 17, 2021 Seelos Therapeutics reported ACKNOWLEDGMENT AND TERMINATION AGREEMENT (this "Agreement") made and entered into as of June 14, 2021, by and between Seelos Therapeutics, Inc., a Nevada corporation (the "Company"), and Lind Global Asset Management II, LLC, a Delaware limited liability company ("Lind" and, together with the Company, the "Parties")(Press release, Apricus Biosciences, JUN 17, 2021, View Source [SID1234584103]).

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