On January 10, 2019 BioFluidica, a privately held cancer diagnostics company, reported that it has been awarded an SBIR Phase II National Institutes of Health grant of $1.7 million for a clinical trial in support of "Increased sensitivity of minimal residual disease monitoring using peripheral blood in pediatric patients with acute lymphoblastic leukemia (Press release, BIOFLUIDICA MICROTECHNOLOGIES, JAN 10, 2019, View Source [SID1234532625])."

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In Promise of True Liquid Biopsy for Cancer, Chip Company BioFluidica Awarded $1.7 Million by National Cancer Institute/National Institutes of Health for Clinical Trial in Children with Acute Lymphoblastic Leukemia
In Promise of True Liquid Biopsy for Cancer, Chip Company BioFluidica Awarded $1.7 Million by National Cancer Institute/National Institutes of Health for Clinical Trial in Children with Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood and accounts for approximately 30% of all cancers diagnosed before the age of 18 years. The primary cause of death for ALL patients is disease relapse. Therefore, monitoring for minimal residual disease (MRD) is considered the most powerful predictor of outcome in acute leukemias.

Rolf Muller, CEO of BioFluidica, states that with BioFluidica’s technology, "We are able to program microfluidic chips to isolate any kind of diagnostically relevant cell from blood samples, whether from solid tumors or blood cancer. In the case of ALL we are detecting complex panels of Circulating Leukemic Cells (CLCs) to monitor cancer recurrence. The expansion of BioFluidica’s technology into the blood-born cancers is added to the clinical validation we have already achieved from 9 other cancers including lung, breast, pancreatic, prostate, and colorectal cancer. The high through-put instrumentation for cell isolation will now be used in clinical trials."

On January 10, 2019 Black Diamond Therapeutics, Inc., a biotechnology company developing next-generation precision medicines for cancer, reported the completion of an oversubscribed Series B financing of $85 million co-led by New Enterprise Associates and RA Capital Management (Press release, Black Diamond Therapeutics, JAN 10, 2019, View Source [SID1234532915]). Additional new investors NexTech Invest, The Invus Group and Perceptive Advisors joined founding investor Versant Ventures in the round. Following Black Diamond’s recent debut after operating in stealth mode in Versant’s Basel-based Ridgeline Discovery Engine, the company now has raised $105 million.

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Proceeds from the financing will be used to accelerate the development of Black Diamond’s pipeline and to expand its mutation, allostery and pharmacology (MAP) computational and discovery platform for identifying and targeting allosteric oncogenic mutations. Specifically, the round will allow the company to establish its new corporate headquarters in Cambridge, MA, advance two-to-three existing development candidates into the clinic in the next 24 months, and bolster its platform’s ability to rapidly identify precision medicines for mutant cancers intractable to standard care.

"We are pleased to have such strong support from this syndicate of blue-chip investors who recognize our potential to discover and produce transformative therapies that will help millions of people with cancer based on our unique and powerful MAP platform," said David Epstein, Ph.D., president and CEO of Black Diamond. "We are now well-resourced to advance our lead programs and set the course for clinical success."

In connection with the Series B round, NEA’s Ali Behbahani, M.D., and RA Capital’s Rajeev Shah joined Black Diamond’s Board of Directors. They join existing board members Dr. Epstein and Versant’s Brad Bolzon, Ph.D., and Alex Mayweg, Ph.D.

"Black Diamond has tremendous potential to usher in the next step-change in targeted cancer therapies, and this investment represents a chance to build a new type of precision medicine oncology company," said Dr. Behbahani.

Mr. Shah added, "The approach that Black Diamond is taking offers the potential to reshape and extend the pipeline of precision oncology medicines available to oncology patients, and we see a great growth opportunity here."

Black Diamond’s MAP platform has generated a pipeline of five programs, including three that have progressed compounds through lead optimization or into IND-enabling studies. The fourth and fifth programs are in lead identification. Black Diamond’s first two disclosed programs are targeting groups of EGFR and HER2 allosteric mutants.

Black Diamond’s MAP: a unique platform

Black Diamond’s industry-leading MAP platform identifies and drugs allosteric mutant disease targets. Oncogenes are activated by kinase domain mutations or by allosteric mutations. While kinase domain mutations have been successfully drugged with selective inhibitors and are standard of care in many malignancies, allosteric mutations represent an undrugged and unexplored space.

As genomic profiling and sequencing of cancer patients is becoming standard, Black Diamond’s MAP can pinpoint new druggable mutation baskets from the thousands of lesions identified across genes and patients, and can create high-impact precision medicines. Some of the allosteric mutation baskets represent two-to-15 percent of patients in a given tumor tissue or across tumor sites.

On January 10, 2019 EMMAC, the European independent medical cannabis company, is reported a research collaboration with Imperial College London to deliver a long-term comprehensive research programme designed to inform and shape the future of the medical cannabis therapeutic industry (Press release, EMMAC Life Sciences, JAN 10, 2019, View Source [SID1234554039]). The programme aims to investigate mechanisms of action of cannabis-based medicinal products related to several clinical applications including pain and cancer, as well as characterise cannabis-based medicinal products in disease models with particular focus of chronic pain, spasticity and cancer.

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The initial clinical study, which is currently going through regulatory approval processes, is a feasibility randomised controlled trial of patients undergoing major hepatopancreatobiliary surgery evaluating the efficacy of perioperative cannabinoids on pain, nausea and vomiting. The first stage, conducted with the Imperial Clinical Trials Unit (ICTU) and involving comprehensive patient and public involvement activities, is estimated to be completed by March 2019.

Under the terms of the Collaboration Agreement signed between the parties EMMAC will fund research staff for an extendable 3-year period to explore the basic science opportunities uncovered through clinical trials.

Strategic Highlights

Collaboration Agreement with Imperial College London;
EMMAC to fund research staff for an extendable 3-year period to explore the basic science opportunities uncovered through clinical trials;
Research provides valuable data and intellectual property in relation to the use of cannabinoids to treat acute pain, nausea and vomiting;
EMMAC expected to partner with Imperial on additional cannabinoid research programmes focused across different therapeutic areas;
Partnership with world-renowned institution confirms EMMAC as a European leader in research supporting the growing medical cannabis industry.
Professor Nagy Habib, Professor of Hepatobiliary Surgery at Imperial College London, said: "We are delighted to partner with EMMAC Life Sciences and to collaborate on this exciting research programme. Translational research lies at the heart of our academic aims at Imperial College London and our first collaborative project illustrates the potential scope of cannabinoids to improve the quality of life and outcomes of patients undergoing surgery. As we gain a greater understanding of the therapeutic properties for a range of clinical conditions, this research will inform a portfolio of basic science work packages. This project is therefore the first step of a broad research programme aimed at shaping the global future of medicinal cannabinoid therapeutics."

Antonio Costanzo, CEO of EMMAC, commented: "The strategic partnership with Imperial College London puts EMMAC at the very forefront of research in the UK into the medical benefits of cannabis in relation to pain relief. As an industry, all participants must recognise that significant further research is needed to improve the understanding of the medical benefits of cannabis, with basic science and much greater clinical data under-pinning what we consider to be a huge potential market with enormous public health benefits (for patients and clinicians). We are delighted to partner with Imperial in relation to this important work. Imperial is one of the leading research institutions for science and medicine globally and we are delighted they have chosen EMMAC as their partner as they begin their work in this field. The expectation is that the research partnership with Imperial will be extended throughout Europe, with Imperial working with leading European institutions as the clinical trials commence."

On January 10, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported a business update regarding the company’s progress and plans for 2019 (Press release, Heat Biologics, JAN 10, 2019, View Source [SID1234532613]).

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Key highlights:

Phase 2 trial expanded to evaluate the benefit of HS-110 in combination with a different anti-PD-1 checkpoint inhibitor to treat patients earlier in the course of their metastatic disease
Selected to deliver podium presentation of interim Phase 2 lung cancer data at ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium on February 28, 2019
Remains on track to complete enrollment of Phase 2 lung cancer trial in Q2, 2019
Strong balance sheet entering 2019
Jeff Wolf, Heat’s CEO, commented, "We have postponed reporting our most recent interim data to enable us to present this data at a leading oncology conference. We are honored that our lead investigator, Daniel Morgensztern, MD, Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine, has been selected to deliver an oral presentation of this data at the 2019 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium on February 28."

Mr. Wolf continued, "We continue to make rapid progress on our Phase 2 trial and remain on track to complete enrollment in this trial in Q2, 2019. The resources provided by our recent funding have enabled us to explore a variety of options to expand the current trial to evaluate the benefit of HS-110 in combination with a different anti-PD-1 checkpoint inhibitor to treat patients earlier in the course of their metastatic disease. The details of this expansion will be announced shortly."

"Our balance sheet is strong as we head into the new year. We recently completed a capital raise of $13.8 million in addition to our cash balance of $21.0 million at the end of the third quarter of 2018. We also expect to receive an additional $6.9 million in CPRIT grant funds later this year. The strength of our balance sheet provides us much greater flexibility to expand our lead Phase 2 trial, accelerate our internal programs and explore complementary opportunities within the lung cancer market and beyond."

On January 9, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class drug candidates targeting AXL kinase to treat aggressive diseases including immune-evasive and therapy resistant cancers, reported that the first subject has been dosed in a Phase I clinical trial evaluating the anti-AXL therapeutic monoclonal antibody BGB149 in healthy volunteers (Press release, BerGenBio, JAN 9, 2019, View Source [SID1234532614]).

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BGB149 is the first functional blocking anti-AXL monoclonal antibody to enter clinical development and is BerGenBio’s second clinical stage drug development programme targeting AXL.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are delighted to initiate this Phase I study as planned. BGB149 has cleared all required regulatory pre-clinical evaluations. This AXL functional blocking antibody is BerGenBio’s second drug candidate to enter clinical trials: An important milestone in expanding our pipeline of first-in-class AXL targeting drug candidates positioned to treat aggressive diseases with severe unmet medical need. We are expecting results from this Phase I trial in 2019 and are looking forward to announcing BGB149’s further clinical development strategy in the coming months."

END

About BGB149 and the Phase I Healthy Volunteer Trial
BGB149 is a fully humanised anti-AXL functional blocking monoclonal antibody, developed and fully-owned by BerGenBio. A robust, high yielding manufacturing process has been established and preclinical studies have confirmed its mechanism of action as well as efficacy.

The Phase I healthy volunteer trial BGB149-101 will enrol up to 36 subjects andinvestigate the safety, tolerability and pharmacokinetics of BGB149 following single dose administration.The study is being sponsored by BerGenBio.

For more information, see ClinicalTrials.gov: NCT03795142

About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that Axl mediates other aggressive diseases