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Ultivue Announces Co-Marketing Agreement with Fluidigm for Biomarker Imaging Solutions for Precision Medicine

On August 5, 2021 Ultivue, Inc. and Fluidigm Corporation (Nasdaq:FLDM) reported a co-marketing agreement in which the companies will offer customers a comprehensive portfolio of workflow solutions for biomarker discovery and drug development (Press release, Ultivue, AUG 5, 2021, View Source [SID1234585948]).

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Ultivue, a leader in advancing precision medicine solutions by accelerating tissue biomarker discovery and validation develops unique assays for use in multiplex immunofluorescence imaging and analysis. Its proprietary InSituPlex technology is designed for fast and comprehensive exploration of biologically-relevant markers combined with same slide-H&E analysis in precious tissue samples.

Fluidigm is a leader in high-parameter imaging for the clinical translational research and clinical testing markets. It’s Imaging Mass Cytometry (IMC) technology is designed for highly multiplexed targeted interrogation of tissue sections for 40 or more protein markers in one scan, with distinct non-overlapping signals from element-labeled antibodies detected simultaneously for each sub-micrometer pixel.

The collaboration provides reseachers with end-to-end service capability for clinical and translational work. For example, InSituPlex technology is well suited to identify regions of interest that may require downstream, deep profiling with IMC. Customer access to both technologies can improve the efficiency of drug discovery programs and, in translational research, enable patient stratification to triage cases that require further investigation.

"Imaging Mass Cytometry has become integral to the clinical translational research and clinical testing markets," said Chris Linthwaite, Fluidigm President and CEO. "Through Fluidigm Therapeutic Insights Services, we will offer our customers access to our technology as well as that of Ultivue, providing optimum imaging solutions for biomarker discovery and drug development."

"Ultivue is at the forefront of innovation to provide unique biological insights for our customers," said Mark Rees, Vice-President of Business Development at Ultivue. "Our InSituPlex technology offers valuable profiling of the tissue and expands the depth of information possible from a single section that is complementary to the high-parameter capabilities of Imaging Mass Cytometry. We believe this joint offering with Fluidigm will now provide researchers a seamless workflow enabling a far more efficient biomarker discovery and drug development process."

Yossi Borenstein, CEO and Founder of Shizim Group, has been Elected to the Can-Fite Board

On August 5, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that bind specifically to the A3 adenosine receptor (A3AR), addressing cancer, liver and inflammatory diseases, reportedy that Yossi Borenstein, Shizim group CEO, was elected as an External Director at the Company’s recent annual general meeting (Press release, Can-Fite BioPharma, AUG 5, 2021, View Source [SID1234585947]).

During the past 35 years, Mr. Yossi Bornstein has played key roles in the Israeli biomed industry. He was the General Manager of Bristol-Myers Squibb (Israel). Mr. Bornstein is the CEO and the founder of Shizim group, a life science holding company. He is the Founder of ShizimXL, International Medical Devices & ShizimVS, Digital Health innovation centers. He is the Chairman of GCP Clinical Studies Ltd., one of the top providers of clinical research services and educational programs in Israel. He served as the Biotechnology Committee Chairman of the United States-Israel Science & Technology Commission (the "USISTC"). Mr. Bornstein is the founder of ILSI – Israel Life Science Industry Organization and Founder of ITTN – Israel Tech Transfer Organization. He is a Co-Founder and director of Microbot Medical (NASDAQ: MBOT) and a Director of XACT Robotics.

"We welcome Yossi Borenstein as an External Director and trust that his skills will be highly valuable for Can-Fite," stated Can-Fite CEO Pnina Fishman.

Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal™ Dx Lung and Colon Cancer Assay

On August 5, 2021 Pillar Biosciences, an innovative next-generation sequencing (NGS) solutions in-vitro diagnostics (IVD) company, reported the U.S. Food and Drug Administration (FDA) has given Premarket Approval (PMA) to its oncoReveal Dx Lung and Colon Cancer Assay, an NGS tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal (CRC) cancer tumors (Press release, Pillar Biosciences, AUG 5, 2021, View Source [SID1234585946]).

The oncoReveal Dx Lung and Colon Cancer Assay PMA was based on clinically validated data, and allows for the test to be used as a companion diagnostic (CDx) for all FDA approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies for NSCLC targeting EGFR mutations (Exon 19 In Frame Deletions and Exon 21 L858R Substitution Mutations), and KRAS wild-type tumor tissue (absence of mutations in codons 12 and 13) for metastatic colorectal cancer (mCRC) patients, guiding clinicians where targeted treatment with Erbitux (cetuximab) or Vectibix (panitumumab) is warranted. This panel is intended to be used on the Illumina MiSeq Dx instrument, Illumina’s NGS platform for in vitro diagnostic testing.

"We are committed to providing high quality and accurate IVD tests to enable better treatment decisions for cancer patients," said Gang Song, Ph.D., Founder and CEO at Pillar Biosciences. "Our FDA-approved product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients."

"Increasing patient access to content on our Dx instrument fleet through partnerships such as those with Pillar Biosciences speaks to our mission to improve human health by unlocking the power of the genome," said Joydeep Goswami, Chief Strategy and Corporate Development Officer at Illumina. "We are committed to our ongoing partnership with the team at Pillar."

"We believe high quality specialty tests should be provided closest to where a patient resides, especially for a cancer patient. We look forward to accelerating our future development plans and bringing more innovative FDA-approved products to the providers and partners in the community setting," said Zhaohui Wang, Ph.D., Co-founder and Chief Scientific Officer at Pillar Biosciences.

Syros Reports Second Quarter 2021 Financial Results and Highlights Key Accomplishments and Upcoming Milestones

On August 5, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended June 30, 2021, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, AUG 5, 2021, View Source [SID1234585945]).

"As Syros advances toward becoming a commercial-stage company, we are focused on execution across our growing portfolios in targeted hematology and selective CDK inhibition and made great strides in the second quarter," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "As announced today, we entered into an agreement with Roche to explore SY-5609 in combination with atezolizumab in colorectal cancer patients, marking the first clinical investigation of a selective CDK7 inhibitor with immunotherapy. Additionally, data from the Phase 1 dose-escalation trial of SY-5609 has been selected for an oral presentation at the ESMO (Free ESMO Whitepaper) Congress in September, at which time we plan to detail next steps for advancing the development of SY-5609 to further explore its potential as a novel targeted approach for difficult-to-treat cancers."

Dr. Simonian continued, "We also continued to progress our targeted hematology portfolio with the ongoing SELECT-MDS-1 Phase 3 trial of tamibarotene in RARA-positive higher-risk MDS patients, as well as the SELECT-AML-1 randomized Phase 2 study of tamibarotene in RARA-positive unfit AML patients and our dose confirmation study of SY-2101 in APL patients, both of which are on track to start in the second half of this year. As we advance these programs through the clinic, we are engaging more deeply with the clinical community to realize the potential of tamibarotene and SY-2101 to address high unmet needs and set new standards of care in these targeted patient populations."

Syros recently hosted a three-part key opinion leader (KOL) webinar series, reviewing both the progress and the opportunities for tamibarotene in higher-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) and for SY-2101 in acute promyelocytic leukemia (APL). The KOLs discussed the evolving treatment landscape as well as the unmet need in these diseases. An archived replay of each KOL event can be found on the Investors & Media section of Syros’ website www.syros.com.

UPCOMING MILESTONES

Targeted Hematology

Tamibarotene (formerly SY-1425): Oral RARa agonist

Initiate SELECT-AML-1 randomized Phase 2 trial of tamibarotene in combination with venetoclax and azacitidine in the second half of 2021 in RARA-positive newly diagnosed AML patients who are not suitable candidates for standard intensive chemotherapy.
Report initial data from SELECT-AML-1 in 2022.
SY-2101: Oral arsenic trioxide (ATO)

Initiate dose-confirmation study of SY-2101 in the second half of 2021.
Report confirmatory dose and pharmacokinetic data in the first half of 2022.
Initiate Phase 3 trial in patients with newly diagnosed APL in 2022.
Selective CDK Inhibition

SY-5609: Oral CDK7 inhibitor

Present additional dose-escalation data, including clinical activity data, in an oral presentation at the ESMO (Free ESMO Whitepaper) Congress 2021 from the ongoing Phase 1 trial of SY-5609 in patients with breast, colorectal, lung, ovarian and pancreatic cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations.
Also at ESMO (Free ESMO Whitepaper), present new preclinical data in two poster presentations, one evaluating the antitumor and pharmacodynamic activity of intermittent dosing regimens for SY-5609 in ovarian cancer models and the other evaluating SY-5609 as a single agent and in combination with chemotherapy in KRAS-mutant models.
Initiate expansion portion of Phase 1 trial in the second half of 2021.
Gene Control Discovery Engine

Nominate next development candidate in 2022.
RECENT PIPELINE UPDATES

In a separate press release today, Syros announced that it has entered into an agreement with Roche, under which it will provide SY-5609 for a combination dosing cohort with atezolizumab in Roche’s Phase 1/1b INTRINSIC trial. The INTRINSIC trial is evaluating multiple targeted therapies or immunotherapy as single agents or in rational specified combinations in molecularly defined subsets of colorectal cancer patients. SY-5609 will be evaluated in combination with atezolizumab in patients with BRAF-mutant disease.
Syros also announced today that due to changes in the development landscape with the emergence of oral selective estrogen receptor degrader, or SERD, therapies, the company is no longer exploring SY-5609 in combination with fulvestrant in patients with CDK4/6 inhibitor-resistant HR-positive breast cancer.
Second Quarter 2021 Financial Results

Revenues were $5.2 million for the second quarter of 2021, consisting of $3.3 million in revenue recognized under Syros’ collaboration with Global Blood Therapeutics, Inc. (GBT) and $1.9 million recognized under its collaboration with Incyte Corporation (Incyte). Syros recognized $3.2 million in revenue in the second quarter of 2020, including $2.5 million under its collaboration with GBT and $0.7 million under its collaboration with Incyte.
Research and development expenses were $25.8 million for the first quarter of 2021, as compared to $14.8 million for the second quarter of 2020. This increase was primarily attributable to the advancement of Syros’ clinical programs and an increase in employee-related expenses.
General and administrative (G&A) expenses were $5.5 million for the second quarter of 2021, as compared to $5.1 million for the second quarter of 2020. This increase was primarily attributable to increased employee-related expenses.
For the second quarter of 2021, Syros reported a net loss of $22.5 million, or $0.36 per share, compared to a net loss of $17.2 million, or $0.38 per share, for the same period in 2020.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of June 30, 2021 were $195.3 million, as compared with $174 million on December 31, 2020. This increase reflects the gross proceeds of $75.6 million that Syros received from its January 2021 public offering, partially offset by cash used to fund its operations.

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2023.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2021 financial results and provide a corporate update.

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international), and refer to conference ID 4156527. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

TransCode Therapeutics Awarded Funding from National Institutes of Health (NIH) to Support Clinical Evaluation of TTX-MC138

On August 5, 2021 TransCode Therapeutics, Inc. (Nasdaq: RNAZ), a platform company solving the challenge of RNA delivery in oncology, reported that it has been awarded a Fast-Track Small Business Innovation Research (SBIR) grant from the NIH to support the clinical evaluation of TTX-MC138, TransCode’s lead therapeutic candidate for the treatment of metastatic solid tumors (Press release, TransCode Therapeutics, AUG 5, 2021, View Source [SID1234585944]). The award totals $2.3 million expected over three years.

"We are honored that the NIH recognizes and supports our mission to overcome the obstacles of RNA delivery in oncology," said Michael Dudley, President and Chief Executive Officer of TransCode. "We believe our TTX delivery platform offers tremendous potential across a range of indications. Specifically, this SBIR grant will help fund our planned first-in-human study of our lead candidate, TTX-MC138, in patients with metastatic breast cancer. We look forward to submitting an eIND application in the first quarter of next year. This trial is designed to evaluate and demonstrate proof-of-concept for the mechanism of action for our novel delivery platform, potentially enabling TransCode to pursue a diverse pipeline of TTX-based therapeutics."

TransCode’s proprietary TTX platform leverages an iron oxide nanoparticle as a novel, image-guided system to safely and efficiently deliver oligonucleotides to their intended RNA target. TTX-MC138 targets MicoRNA-10b, believed to drive metastatic disease. The therapeutic has been validated preclinically in multiple indications and has been shown to induce durable regressions of metastatic disease in murine models of disseminated breast cancer.