On January 11, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that it has entered into an exclusive License Agreement with Knight Therapeutics Inc. (TSX: GUD) that grants Knight the exclusive right to commercialize NERLYNX (neratinib) in Canada (Press release, Puma Biotechnology, JAN 11, 2019, https://investor.pumabiotechnology.com/press-release/puma-biotechnology-and-knight-therapeutics-enter-exclusive-license-agreement-commercia [SID1234532621]).

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Puma Biotechnology filed a new drug submission for NERLYNX with Health Canada in July 2018 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. Under the terms of the License Agreement, Knight will be responsible for all commercial activities and future regulatory submissions for NERLYNX in Canada. Puma will receive upfront and milestone payments up to $7.2 million USD throughout the term of this agreement, as well as double digit royalties on net sales of NERLYNX in Canada.

"Our new agreement with Knight demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "We are confident this new partnership will help patients in Canada access NERLYNX at the earliest opportunity."

"We are excited to partner with Puma to offer a new treatment option to Canadian breast cancer patients," said Jonathan Ross Goodman, Chief Executive Officer of Knight. "While adjuvant trastuzumab-based therapy has been shown to reduce the risk of recurrence in early stage HER2-positive breast cancer, up to 25% of patients treated with adjuvant trastuzumab will have a recurrence. NERLYNX has been shown to significantly reduce the risk of recurrence in those patients who were previously treated with trastuzumab."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

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 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 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 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that the first patient has been dosed in a Phase 1 study evaluating the investigational agent TP-1287, an oral cyclin-dependent kinase 9 (CDK9) inhibitor, in patients with advanced solid tumors (Press release, Tolero Pharmaceuticals, JAN 10, 2019, View Source [SID1234532624]). The open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study will evaluate the maximum tolerated dose and dose-limiting toxicities of TP-1287 administered in patients with advanced solid tumors.

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"The initiation of this study is an important step forward in understanding the potential of TP-1287 in patients with solid tumors," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals. "We believe that the oral administration of TP-1287 may be beneficial in disease settings where this form of administration is preferred or when used in combination with other targeted agents."

The primary objective of the Phase 1 study is to determine the maximum tolerated dose and dose-limiting toxicities of oral TP-1287 administration in patients with advanced solid tumors. The study is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03604783).

About TP-1287
TP-1287 is an investigational oral cyclin-dependent kinase 9 (CDK9) inhibitor entering into a Phase 1 study in patients with advanced solid tumors (NCT03604783). TP-1287 has shown favorable oral bioavailability in preclinical models.