On January 17, 2023 Biocure Technology Inc. ("CURE" or the "Company") (CSE:CURE) BiocurePharm, Korea ("BPK"), a subsidiary of Biocure Technology Inc. ("CURE") reported that it has closed its non-brokered private placement through its Korean Subsidiary BiocurePharm, Korea ("BPK"), BPK has issued 12,500 shares at 4.328CAD per share for gross proceeds of $54,100 (Press release, Biocure Technology, JAN 17, 2023, View Source [SID1234628741]). All dollar values are based on the published Exchange Rate of CAD0.001082/KRW1 on January 13, 2023, Bank of Canada. After the issuance of new BPK shares, CURE holds now 93.42% interest in BPK.

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The net proceeds from the non-brokered private placement are intended to be used for general working capital.

On January 17, 2023 BioCentriq, Inc.—a New Jersey-based, cell and gene therapy contract development and manufacturing organization (CDMO)—reported that they have successfully completed tech transfer of AVB-001 from client Avenge Bio and initiated manufacturing of clinical grade material, which will support Avenge Bio’s ongoing phase 1/2 clinical trial (Press release, Avenge Bio, JAN 17, 2023, View Source [SID1234626316]).

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Additionally, Avenge Bio announced on the 9th of January that they successfully dosed the first patient in a First-in-Human Phase 1/2 clinical trial evaluating AVB-001 in relapsed refractory ovarian cancer. AVB-001, developed in the LOCOcyte platform, consists of proprietary engineered allogeneic human cells.

"We’re very enthusiastic about the advances our client has made in the development of their novel allogeneic cell therapy. Our goal now is to continue offering strong support and process development and manufacturing expertise as Avenge advances through their program," said BioCentriq CEO Haro Hartounian, Ph.D.

Avenge Bio’s first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT05538624) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AVB-001 delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.

The cells are encapsulated in a pro-inflammatory biomaterial that are delivered to the local tumor environment and generate high, sustained concentrations of native IL-2. The product initiates a robust and durable, local and systemic immune response while avoiding toxicities associated with systemic immunotherapies.

"This major milestone comes at a time when there are limited treatment options for those with relapsed refractory ovarian cancer," said Doug Carlson, Chief Operating and Financial Officer at Avenge Bio. Ovarian cancer is notoriously difficult to treat and ranks fifth in cancer deaths among women. "Our LOCOcyte platform addresses existing challenges and is a promising new potential treatment option for patients."

On January 17, 2023 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors, and its majority-owned subsidiaries Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or "Lucid Diagnostics"), a commercial-stage cancer prevention diagnostics company, and Veris Health Inc. ("Veris"), a private digital health company focused on enhanced personalized cancer care, reported a strategic business update, outlining near-term strategic priorities and resource reallocation (Press release, PAVmed, JAN 17, 2023, View Source [SID1234626324]). The companies will prioritize near-term Lucid and Veris Health commercialization efforts. They have implemented a workforce reduction of approximately 20 percent, product portfolio streamlining, and other cost-cutting measures which seek to lower quarterly cash burn by at least 25 percent.

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"PAVmed and Lucid Diagnostics Strategic Business Update Conference Call"

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"Over the past few quarters, we have engaged in a systematic effort to maximize our cash runway and protect our long-term shareholder interests, while executing on our strategic objectives in what remain challenging market conditions," said Lishan Aklog, M.D., PAVmed’s and Lucid’s Chairman and Chief Executive Officer. "We have decided to further extend this initiative by aggressively streamlining operations to focus substantially all our resources and near-term efforts on accelerating the commercialization of Lucid’s and Veris’ products, resulting in a meaningful reduction in our workforce and quarterly cash burn. We believe these groundbreaking commercial products, with their large market opportunities, are our most valuable assets and focusing on them provides our shareholders the greatest near and long-term value creation opportunity. Our leaner, more commercially focused posture puts us in the best position to realize this opportunity."

Lucid’s EsoGuard Esophageal DNA Test ("EsoGuard") utilizing its EsoCheck Cell Collection Device remains the first and only commercially available diagnostic test recommended by clinical practice guidelines to prevent esophageal cancer deaths through early precancer detection. EsoGuard targets a well-established population of approximately 30 million at-risk patients and an estimated $60 billion addressable market based on an effective Medicare payment rate of $1,938, which is consistent with our per-test gross margins targets. The volume of EsoGuard tests performed at Lucid’s dedicated CLIA-certified laboratory has grown steadily in recent quarters. The company began submitting claims to commercial insurers in late third quarter of 2022 and is starting to generate claims histories necessary to drive in-network commercial contract discussions. Out-of-network payments received to date have respected the Medicare rate.

Pursuant to this initiative, Lucid plans to:

continue to drive EsoGuard testing volume through ongoing engagement of sales personnel with primary care physicians, specialists and institutions, with an increasing focus on closing larger strategic accounts and new market development initiatives;
maintain current team of approximately forty sales professionals, having completed targeted layoffs and closed prior vacancies;
shift sales leadership attention from recruiting and hiring to ongoing engagement with large institutional and strategic accounts, while continuing to drive productivity of the current team;
maintain its team of nurse practitioners and other clinical personnel to support testing volume growth through existing Lucid Test Centers (LTC) in eleven states, and its burgeoning satellite LTC program, whereby Lucid personnel perform EsoCheck cell sampling procedures at prescribing physicians’ offices;
continue to invest in LucidDx Labs to assure EsoGuard testing capacity and drive quality improvements and cost efficiencies;
complete ongoing clinical utility studies to support in-network coverage;
delay completion of the EsoGuard BE-2 study to the second half of 2023; and
pause further development of the EsoCure Esophageal Ablation device.
The Veris Cancer Care Platform, which commercially launched last month, is a digital cancer care platform with symptom reporting, telehealth functions, and advanced data analytics, designed to improve personalized cancer care through remote patient monitoring (RPM). Veris’ software-as-a-service recurring-revenue business model allows oncology practices to leverage existing RPM codes, providing attractive margins to the oncology practice and to Veris. The company is concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris Cancer Care Platform. The implantable monitor will further enhance the clinical and commercial value of the platform by providing continuous RPM data independent of patient compliance. With several million US patients undergoing cancer treatment each year, the addressable market opportunity for Veris’ products is substantial. Importantly, commercial success is not predicated on securing third-party reimbursement, only on sales and product development execution.

Veris plans to:

continue to drive commercial adoption of the Veris Cancer Care Platform utilizing its existing sales personnel, and expand the commercial team only when commercial traction has been well-established;
delay development and regulatory submission of the implantable physiologic monitor to the second half of 2023; and
focus its workforce on near-term commercialization, having already eliminated certain technology positions focused on future data analytics, while retaining personnel directly involved in customer integration and technical support.

PAVmed plans to:

continue research and product development activities in support of Lucid commercialization, including next generation EsoGuard and EsoCheck products;
continue product development activities in support of Veris commercialization, namely its implantable physiologic monitor, as above;

continue its joint early-stage research and development project with Novosound Ltd. to explore applying its groundbreaking ultrasound technology to next-generation intravascular ultrasound imaging;
continue limited business development activities focused on high value, near-term accretive opportunities that are synergistic with existing commercial activity;

indefinitely pause or halt all other product development activities including CarpX, PortIO and NextFlo; and
pursue additional cost-cutting initiatives including not paying annual cash bonuses.

Conference Call

To access the conference call, listeners should dial 877-407-3982 toll-free in the U.S. or 201-493-6780 and ask to join the "PAVmed and Lucid Diagnostics Strategic Business Update Conference Call". The conference call will be available live at the investor relations section of PAVmed’s website at ir.pavmed.com and the investor relations section of Lucid Diagnostics’ website at ir.luciddx.com. Following the conclusion of the conference call, a replay will also be available for one week and can be accessed by dialing 844-512-2921 toll-free in the U.S. or 412-317-6671, followed by the PIN number 13735527.

On January 17, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported the publication of a new study in Nature Medicine, which demonstrates the ability of the SignateraTM molecular residual disease (MRD) test to identify patients with stage II-IV colorectal cancer (CRC) who are at an increased risk of recurrence and predict who is likely to benefit from adjuvant chemotherapy (ACT) (Press release, Natera, JAN 17, 2023, View Source [SID1234626323]). With this study, data supporting the clinical validity and utility of Signatera has now been published in 40 peer-reviewed publications.

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The paper describes results from the GALAXY arm of the ongoing CIRCULATE-Japan trial, which is one of the largest and most comprehensive prospective studies of MRD testing in resectable CRC. The data builds on results previously presented at the 2022 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), now with median clinical follow-up extended to 16.74 months and DFS assessment at 18 months.

In the study, 1,039 patients with stage II-IV resectable CRC were monitored prospectively using the Signatera MRD test. Key takeaways include:

Post-surgical MRD status was predictive of chemotherapy benefit.
Patients who were MRD-positive four weeks after surgery (18%) derived significant benefit from ACT (adjusted HR 6.59, p-value <0.001).
MRD-negative patients (82%) did not see a significant benefit from ACT (p-value <0.167).
Post-surgical MRD status was the most significant prognostic risk factor for recurrence, in a multivariate analysis that accounted for all clinicopathological risk factors currently used for prognostication (HR 10.82, p-value <0.001).
Pre-surgical detection rate of 95.9% in patients with pathologic stage II-III disease and 93.1% in patients with stage II-IV disease.
Signatera dynamics are indicative of treatment response. Among the MRD-positive patients who were treated with ACT, those with ctDNA clearance had superior DFS compared to those without ctDNA clearance (adjusted HR 11, p-value <0.0001).
"Until now, oncologists did not have adequate tools to determine which colorectal cancer patients are likely to benefit from adjuvant systemic therapy," said the study’s principal investigator, Dr. Takayuki Yoshino, of the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. "This study provides strong evidence that Signatera MRD-positive patients will benefit significantly from adjuvant therapy, while MRD-negative patients may be safely observed, regardless of clinical or pathological stage."

"This is a practice-changing study for the colorectal cancer community, demonstrating the predictive power of Signatera in the adjuvant setting," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "We are proud to partner with the CIRCULATE consortium and look forward to making Signatera accessible to all colorectal cancer patients in the U.S., Japan and worldwide."

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.

On January 17, 2023 Eclipse Bioinnovations (Eclipsebio), a leading RNA genomics company developing and commercializing novel, data-driven technologies that interrogate RNA, reported its new research demonstrating the optimization of Eclipsebio’s industry-standard eCLIP technology to improve the study of RNA-binding protein interactomes, which promises to accelerate the study of human diseases caused by failed RNA processing (Press release, Eclipse Bioinnovations, JAN 17, 2023, View Source [SID1234626322]). The study, published in Nature Methods, was led by Eclipsebio’s Associate Director of Research Daniel Lorenz, Ph.D., and co-founder Gene Yeo, Ph.D.

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"Multiplexed transcriptome discovery of RNA-binding protein binding sites by antibody-barcode eCLIP"

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Enhanced cross-linking immunoprecipitation followed by high-throughput sequencing, or eCLIP, is a powerful technique to uncover RNA sequences where RNA-binding proteins (RBPs) bind, known as RBP interactomes. RBPs regulate RNA molecules, controlling the function and quantity of proteins expressed in a cell. RBP mutations have been associated with cancer, amyotrophic lateral sclerosis, and a number of other diseases.

"eCLIP is a powerful technique that scientists utilize to study disease samples with RBP mutations, and this optimized antibody-barcode eCLIP (ABC) technology will allow a faster and more efficient study of RBP interactomes to gain new insights into novel disease targets and therapeutics," said Eclipsebio CEO and cofounder Peter Chu, Ph.D. "ABC is designed to optimize the study of RNA-binding protein interactomes in clinically relevant samples, including disease tissues, where source materials are rare and often scarce."

In this published study, Eclipsebio and UC San Diego scientists developed the ABC methodology that bypasses electrophoresis and membrane transfer and allows the study of interactomes of more than one RBP in the same reaction tube, which will support small sample volumes and sizes.

"We proved that ABC methodology maintains a comparable sensibility and specificity to eCLIP while improving the number of RBP interactomes that can be studied in one reaction tube," explained Dr. Yeo. "We showed that a single ABC library obtained from one reaction tube generates similar data to ten separate eCLIP experiments."

During eCLIP, there is an immunoprecipitation (IP) step, where an antibody against the RBP of interest is used to "grab" the binding RNA. In ABC, the IP step allows using more than one antibody in the same reaction tube, where each antibody is tagged with a different DNA barcode. After the IP step, a multiplex reverse transcriptase (RT) reaction identifies to which one of the RBP antibodies the RNA sequences were bound since the DNA barcode used serves as a primer for the RT reaction.

Dr. Chu concluded, "The Eclipsebio team is committed to developing the leading technologies to accelerate the study of RNA regulation, and this study opens the door to even further scaling. By increasing the number of barcodes used in each reaction tube, more interactomes could be studied simultaneously. We look forward to supporting important RBP research with our current and future eCLIP products that will include the ABC technology."

The publication entitled, "Multiplexed transcriptome discovery of RNA-binding protein binding sites by antibody-barcode eCLIP," is available open access on Nature Methods.

About Eclipsebio’s RNA Genomics Platform and Products

Eclipsebio’s comprehensive RNA genomics platform is poised to build the world’s most detailed multi-dimensional RNA maps through transcriptome-wide views of RNA interactions with RNA binding proteins (RBP-eCLIP), RNA modifications such as m6A (m6A-eCLIP), alternative transcription start site and polyadenylation site usage (EndSeq), and microRNA-mRNA interactions (miR-eCLIP). Upcoming products in development are designed to profile translation (eRibo) and probe RNA structure