On September 28, 2020 Accent Therapeutics reported that it has been named by Fierce Biotech as one of 2020’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Accent Therapeutics, SEP 28, 2020, View Source [SID1234567691]).

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Accent is a leader in the development of small molecule therapies that selectively inhibit RNA-modifying proteins (RMPs) that drive cancer. By targeting RMPs, the company is taking a novel approach to unlocking the potential of RNA biology by targeting enzymes responsible for post-transcriptional chemical modifications of RNA. Accent is developing a rich pipeline of oncology-focused therapies in a new class of medicines that target RMPs.

"We are honored to be recognized by Fierce Biotech as a leader in the biotech landscape, pursuing novel RMP-targeted therapies to bring new and potentially life-changing medicines to patients," said Shakti Narayan, Chief Executive Officer, Accent Therapeutics. "This recognition is a tribute to our team’s fierce commitment to giving patients living with cancer greater hope, fewer burdens and the promise of a life beyond disease."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is Fierce Biotech’s 18th annual Fierce 15 selection.

"The 2020 Fierce 15 comes at a time when the world is focused on a pandemic, but even as coronavirus remains a threat, patients with cancer, rare diseases and other disorders still need treatment," Fierce Biotech Senior Editor Ben Adams said. "This year, we’ve chosen from a diverse range of those fighting COVID, as well as those fighting longer term plagues against our biology," Adams said.

An internationally recognized daily report reaching a network of over 285,000 biotech and pharma industry professionals, Fierce Biotech provides subscribers with an authoritative analysis of the day’s top stories. Every year Fierce Biotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

On September 28, 2020 Carmine Therapeutics reported that it has been named by FierceBiotech as one of 2020’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Carmine Therapeutics, SEP 28, 2020, View Source [SID1234567822]).

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The 2020 Fierce 15 comes at a time when the world is focused on a pandemic, but even as coronavirus remains a threat, patients with cancer, rare diseases and other disorders still need treatment, FierceBiotech Senior Editor Ben Adams said. "This year, we’ve chosen from a diverse range of those fighting COVID, as well as those fighting longer term plagues against our biology," Adams said.

Carmine Therapeutics is pioneering a novel class of therapeutics based on its REGENT technology – an innovative approach which leverages red blood cell extracellular vesicles (RBCEVs). First published in Nature Communications in 2018, an initial focus is non-viral gene therapies.

In June 2020, Carmine Therapeutics signed a research collaboration agreement with Takeda Pharmaceutical Company Limited to discover, develop and commercialize transformative non-viral gene therapies. Carmine Therapeutics will be eligible for over $900M USD in total milestone payments plus tiered royalties.

XQ Lin, Founding CEO of Carmine Therapeutics and Managing Partner of Esco Ventures X, commented, "We are thrilled to be recognized as a Fierce 15 company, an honor that reflects the innovative nature of our RBCEV platform and the dedication of our team. This comes following a year of successes and we are excited to build on this momentum. We believe that our novel approach will have a tremendous impact on transforming patient lives."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is FierceBiotech’s 18th annual Fierce 15 selection.

An internationally recognized daily report reaching a network of over 285,000 biotech and pharma industry professionals, FierceBiotech provides subscribers with an authoritative analysis of the day’s top stories. Every year FierceBiotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

On September 28, 2020 bluebird bio, Inc. (NASDAQ: BLUE) reported that members of the management team will participate in the Jefferies Cell Therapy Virtual Summit, Tuesday, October 6, at 2:00 p.m. ET (Press release, bluebird bio, SEP 28, 2020, View Source [SID1234567668]).

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To access the live webcast of bluebird bio’s presentation, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcast will be available on the bluebird bio website for 90 days following the event.

On September 28, 2020 Diaceutics PLC, (AIM: DXRX), reported three new partnerships on its DXRX platform, as it continues with its mission to get every patient the treatment they deserve (Press release, Diaceutics, SEP 28, 2020, View Source [SID1234567693]). The company has signed agreements with external quality assessment (EQA) organizations Canadian Pathology Quality Assurance – Assurance Qualité Canadienne en Pathologie (CPQA-AQCP), European Molecular Genetics Quality Network (EMQN CIC) and Nordic Immunohistochemical Quality Control (NordiQC). The partnerships will help to establish best-in-class global laboratory standards for diagnostic testing through in-lab quality assurance and will provide the transparency which pharmaceutical companies need to reach more patients with their precision medicines.

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"Establishing partners in quality within the industry is important for CPQA-AQCP and we are excited with this opportunity to evolve our relationship with Diaceutics and participate in the DXRX network. "

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By partnering with CPQA-AQCP, EMQN CIC and NordiQC on DXRX – the world’s first diagnostic network for precision medicine – Diaceutics will support the implementation of accurate and high-quality testing across its 2500+ laboratory relationships.

These collaborations facilitate a critical piece of the end-to-end solution which DXRX enables for the development and commercialization of precision medicine diagnostics. They are also part of multiple partnerships which Diaceutics is building with industry providers across the globe to help achieve their mission of getting every patient the treatment they deserve.

Currently focused on the Canadian market, CPQA-AQCP is dedicated to monitoring and improving the proficiency of immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) testing. DXRX is a global platform which will enable CPQA-AQCP to expand its services further worldwide. The organization is currently collaborating with Diaceutics on a project sponsoring the HER2 biomarker modules for gastric cancer. Using IHC and FISH, they are assessing the landscape and efficiency of HER2 gastric cancer testing, which has now been on the market for more than 10 years.

UK-based EMQN CIC provides molecular genetics, molecular pathology, and technique-specific EQA schemes for the global molecular testing market. It is currently collaborating with Diaceutics on a pilot study involving mutations in the EGFR, PIK3CA, KRAS, HRAS, NRAS, KIT, TP53 and BRAF genes, which will help laboratories using high throughput technologies – such as NGS – to accurately validate assay sensitivity and specificity. Data will be generated for a white paper to demonstrate a real-world review on NGS usage for clinical purposes: where we are today and the market readiness for additional biomarkers.

NordiQC is a global and scientific proficiency program for diagnostic Immunohistochemistry with more than 500 participants. NordiQC provides a broad range of relevant modules for immunohistochemical proficiency testing within diagnostic pathology and with special attention to predictive biomarkers. By joining the DXRX network, NordiQC strengthens its mission to bridge all stakeholders in diagnostic precision testing to optimize and standardize this field.

The addition of CPQA-AQCP, EMQN CIC and NordiQC on DXRX complements recent partnerships announced with HistoCyte Laboratories and Targos Molecular Pathology, which provide control slide materials and training for laboratories respectively.

John Garratt, Director, CPQA-AQCP, said: "Establishing partners in quality within the industry is important for CPQA-AQCP and we are excited with this opportunity to evolve our relationship with Diaceutics and participate in the DXRX network.

"Personalized medicine requires precision diagnostics to ensure the therapies are targeted accurately, thus providing optimum outcomes for patients. There is a greater demand on labs to provide prognostic biomarker testing of more esoteric targets and we, in EQA organizations, need to provide support for establishing the tests and for maintaining quality of the tests so that patients and their oncologists are confident that the most effective therapy is being used.

"Working with Diaceutics and its established partners is a great opportunity for CPQA-AQCP to assure accurate and sustainable pharma-diagnostic testing."

Simon Patton, Managing Director, EMQN CIC, said: "EMQN CIC and Diaceutics have a shared vision on improving the quality and accuracy of testing to ensure all patients get access, where possible, to the most effective treatments. We are delighted to be offering our ISO 17043 accredited Oncogene panel testing EQA scheme through the DXRX platform to support these goals."

Søren Nielsen, Director of NordiQC, said: "It’s with great expectations and excitement we enter the cooperation with Diaceutics. The partnership is driven by mutual interest and goal to raise and secure the global level of immunohistochemical precision testing and only by broad collaboration between laboratories, pharma, industry, regulatory bodies and EQA programs this can be accomplished."

Karina Hjort, Senior Director of Innovation, Diaceutics, said: "The precision medicine market is growing rapidly. Approximately 1,000 precision medicine drugs are currently in development and our research shows that by next year, the FDA will be approving more personalized oncology drugs than one-size-fits-all treatments. As they shift towards a personalized approach to treating patients, pharmaceutical companies must ensure that they are choosing the correct solutions and services to fulfil the promise of their precision medicines.

"We are delighted to have CPQA, EMQN CIC and NordiQC join the DXRX network to enable a critical piece of an end-to-end development and commercialization solution designed to get every patient the treatment they deserve."

On September 28, 2020, Sorrento Therapeutics, Inc. (the "Company") and Fortis Advisors LLC, in its capacity as representative of the former holders of equity (the "Equityholders’ Representative") of Semnur Pharmaceuticals, Inc. ("Semnur"), reported that it entered into an amendment (the "Amendment") to that certain Exchange and Registration Rights Agreement, dated as of March 18, 2019, by and among the Company and the stockholders and stock option holders of Semnur, as set forth on Schedule A thereto (the "Original Exchange Agreement") (Filing, 8-K, Sorrento Therapeutics, SEP 28, 2020, View Source [SID1234567978]). The Original Exchange Agreement was entered into in connection with the Agreement and Plan of Merger entered into among the Company, Scilex Holding Company ("Scilex Holding"), Sigma Merger Sub, Inc. and the Equityholders’ Representative, as amended by that certain Amendment No. 1 to Agreement and Plan of Merger, dated August 7, 2019 (as amended, the "Merger Agreement"), pursuant to which Merger Sub merged with and into Semnur and Semnur became a wholly-owned subsidiary of the Company (the "Merger").

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Pursuant to the Original Exchange Agreement, if by September 18, 2020, 100% of the outstanding equity of Scilex Holding had not been acquired by a third party and Scilex Holding had not entered into a definitive agreement with respect to, or otherwise consummated a firmly underwritten offering of Scilex Holding capital stock on a major stock exchange that met certain requirements, then the former holders of Semnur capital stock and holders of options to purchase Semnur’s common stock (collectively, the "Semnur Equityholders") could elect to exchange, during the 60-day period commencing on September 18, 2020 (the "Share Exchange"), the shares of Scilex Holding issued to the Semnur Equityholders in the Merger (the "Stock Consideration") for shares of the Company’s common stock with a value of $55.0 million, based on a price per share of its common stock equal to the greater of (a) the 30-day trailing volume weighted average price of one share of its common stock as reported on The Nasdaq Stock Market LLC as of the consummation of the Share Exchange and (b) $5.55 (such greater price, the "Exchange Price").

The Amendment amends the Original Exchange Agreement to, among other things, provide that if the Company receives notice from the Semnur Equityholders that the Semnur Equityholders will proceed with the Share Exchange (an "Exchange Notice"), the Company may, in its sole discretion, elect, within seven days of receipt of an Exchange Notice, to exchange all the Stock Consideration and the rights to receive cash from Scilex Holding held by certain of the Semnur Equityholders under the Merger Agreement for an amount in cash equal to $55.0 million, in lieu of issuing $55.0 million of shares of the Company’s common stock at the Exchange Price.

The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment filed herewith as Exhibit 10.1 and the full text of the Original Exchange Agreement that was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 22, 2019, each of which are incorporated by reference herein.