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 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 10, 2019 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) reported that it will hold an investor conference call on Wednesday, January 16th, at 4:00 p.m. to update investors on the previously announced and pending acquisitions that offer significant value to the Generex parent company (Press release, Generex, JAN 10, 2019, View Source [SID1234532615]). Joseph Moscato, Generex President & Chief Executive Officer, will discuss the company’s financing plans related to the acquisitions, as well as the strategic focus of Generex for 2019 and beyond. Additionally, Mr. Moscato will provide guidance on the recent merger of Antigen Express into the newly-formed NuGenerex Immuno-oncology, and the proposed spin-out of the company as an independent, public company with a new direction and strategic focus to advance the Ii-Key technology for the immunotherapy of cancer, which includes plans for a rights offering and stock dividend for Generex shareholders in NuGenerex Immuno-Oncology. Further, Mr. Moscato will discuss plans to up-list Generex to a major stock exchange.

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Mr. Moscato stated, "We have worked diligently over the last several years to transform Generex into an integrated healthcare holding company. In the last two years, we have completed a complex reorganization plan, and we continue to execute on the strategic acquisition of several exciting companies with revenues, products, and new technologies.

"We are in the early stages of our plan that has begun with acquisitions of an MSO network of physicians and surgeons, pharmacies, a laboratory, a surgical supply business, a manufacturer of surgical implants, and two regenerative medicine companies, Regentys and Olaregen. These and future acquisitions will enable Generex to grow through generating significant product and service revenues, while creating exponential value for our shareholders through development of our deep pipeline of clinical-stage assets. I look forward to addressing my fellow Generex shareholders to provide details about recent and pending acquisitions, our growth strategies for NuGenerex Distribution Solutions, and the launch of Generex’s first commercial product Excellagen. I will also discuss the strategy to spin out NuGenerex Immuno-Oncology as an independent public company, with an update on the plan for up-listing Generex."

Dial-in instructions for the investor conference call will be announced on Monday, January 14, 2019.

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 9, 2019 ArQule, Inc.’s (Nasdaq: ARQL) partner, Basilea Pharmaceutica Ltd. (SIX: BSLN), reported results from the interim analysis of the registrational Phase 2 study with the orally administered pan-fibroblast growth factor receptor (FGFR) kinase inhibitor derazantinib (BAL087) (Press release, ArQule, JAN 9, 2019, View Source [SID1234532595]). The analysis showed promising activity in patients with FGFR2 gene fusion-expressing intrahepatic cholangiocarcinoma (iCCA) and also confirmed the safety profile and tolerability of the drug candidate observed in previous clinical studies.

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The interim analysis in the ongoing registrational Phase 2 study was conducted after 42 patients had been enrolled in the study, with a subset of 29 evaluable patients who had at least one post-baseline imaging assessment. The objective response rate (ORR) in the 29 evaluable patients was 21%. The disease control rate (DCR), reflecting the proportion of patients with a partial response or with stable disease, was 83%. The safety data obtained from all 42 patients enrolled to date was consistent with the results from previous clinical studies with derazantinib.

View Source

Peter Lawrence, President and Chief Operating Officer of ArQule, said, "We are pleased with derazantinib’s continued progress since it was licensed to Basilea Pharmaceutica in April 2018 in the US, EU, Japan and rest of world excluding Greater China. Under the terms of the license agreement, ArQule is eligible to receive up to $326 million in regulatory and commercial milestone payments, and we look forward to further progress and updates from Basilea."