On November 14, 2022 GICELL reported the data from the preclinical studies on T.O.P. NK (Tumor targeting, Optimally Primed NK), an allogeneic NK cell therapy which had been presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held in Boston, MA, US (Press release, GICELL, NOV 14, 2022, View Source [SID1234624049]). The SITC (Free SITC Whitepaper) is one of the world’s top three cancer societies and has been known as the largest conference in the field of immuno-oncology.

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The company presented the preclinical study results as a poster titled "Highly potent Tumor-targeting Optimally Primed Natural Killer cells produced under feeder-cell free conditions in a 50L-scale bioreactor with cytokine-fusion proteins elicits robust anti-tumor response in preclinical study."

In general, cancer cell-derived feeder cell culture is a common method for NK cell expansion, but GICELL is harnessing its wholly-owned platform to culture NK cells on a large scale without feeder cells which is a safer and simpler way for NK cell therapy. One of the key features of T.O.P. NK cell is the mass cultivation of NK cells from healthy donors. T.O.P. NK showed high expression rates of activating receptors, cytotoxic proteins, and chemokine receptors that are important for anti-tumor activity. In particular, T.O.P. NK displays a high expression rate of CCR5 and CXCR4 among chemokine receptors. Through this, the company explained that it is expected to have excellent targeting and anti-tumor abilities against solid tumors expressing the chemokine ligands.

Cryopreservation technology for long-term storage and distribution is the key to the commercialization of allogeneic NK cell therapy. GICELL also proved its cryopreservation technology with no significant difference expression rate of the functional markers and viability of T.O.P. NK even after freezing and thawing.

T.O.P. NK shows excellent anticancer activity in tumor-bearing animal models. According to the data in immunodeficient mice (NOG mice) implanted with human cancer cell lines, the growth of various solid tumors (4 types of colorectal cancer, 1 type of head and neck cancer, 1 type of breast cancer) was significantly inhibited by T.O.P. NK administrated via intravenous route compared to the control. In addition, there were no treatment-related adverse events in the toxicity study performed at a Good Laboratory Practice (GLP) institution.

Based on these preclinical data, GICELL submitted an IND for a phase 1 clinical trial for patients with solid tumors and hematologic cancer to the Ministry of Food and Drug Safety (MFDS) in September. Through this clinical trial, GICELL will evaluate the safety, tolerability, and efficacy of T.O.P. NK.

Chun Pyo Hong, CEO of GICELL, said, "There are many other companies that are developing off-the-shelf cell therapies but we find there are still unmet needs in cell therapies that can be manufactured on a large scale. We expect to initiate phase 1 clinical trial in earlier 2023 and hope to treat patients with malignant tumors as soon as possible."

GICELL has recently signed the R&D partnership agreements of CAR-NK with HK inno.N Corp. and Cartexell Inc. based on its outstanding immune cell expansion technology.

On November 14, 2022 TriSalus Life Sciences (the "Company" or "TriSalus"), a privately held oncology therapeutics company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors, reported it has entered into a definitive merger agreement with MedTech Acquisition Corporation (Nasdaq: MTAC) ("MedTech"), a publicly traded special purpose acquisition company (Press release, TriSalus Life Sciences, NOV 14, 2022, View Source [SID1234624048]). Upon the closing of the transaction, the combined company will be a publicly traded company and its common stock is expected to be listed on the NASDAQ Stock Exchange under the ticker "TLSI". The transaction represents a post-transaction market capitalization of approximately $244.4 million for TriSalus upon closing.

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TriSalus Combines Proprietary Drug Delivery Technology and Therapeutics Platform to Drive Better Patient Outcomes

TriSalus’ proprietary platform approach addresses immune dysfunction in liver and pancreatic tumors by combining its highly effective drug delivery technology with immunotherapeutics. The TriSalus platform comprises:

TriNav Infusion System: Launched in 2020, TriNav is an FDA-cleared device that is designed to administer established and emerging therapeutics, including SD-101, the Company’s investigational TLR9 agonist, to selected sites, including tumors in the liver with the ability to treat disease throughout the entire organ. TriNav is the latest TriSalus asset for the proprietary Pressure-Enabled Drug Delivery (PEDD) method of administration which has been shown to overcome intra-tumoral pressure through modulation of pressure and flow to increase delivery of therapeutic agents and improve patient outcomes.
SD-101: TriSalus is developing SD-101, a class C toll-like receptor 9 (TLR9) agonist, that promotes T Cell infiltration, reduction of myeloid derived suppressor cells (MDSC) and broad immune activation to reverse immunosuppression in the liver and pancreas. TriSalus is investigating SD-101 as a therapeutic candidate delivered by PEDD to enable deeper and more durable responses to other immunotherapeutics (e.g., checkpoint inhibitors) in a range of liver and pancreatic cancers for which limited therapeutic options currently exist. Thus far, across two clinical trials, over 100 infusions of SD-101 have been delivered at several dose levels as monotherapy and in combination with checkpoint inhibitors in more than 20 patients with safety data indicating treatments were well-tolerated.
Management Comments

"TriSalus is scaling a differentiated, integrated and disruptive approach to the treatment of tumors in the liver and pancreas, and this transaction is an important step forward in enabling better patient outcomes," said Mary Szela, president and CEO of TriSalus. "Our commercial-stage drug delivery technology, together with the continued development of our promising immunotherapeutic, positions TriSalus to capitalize on a significant opportunity in an area with high unmet need. Partnering with MedTech accelerates our access to financial resources and brings us an experienced partner as we continue to commercialize our TriNav device and advance our SD-101 clinical programs. We look forward to working together to achieve accelerated growth and to bring hope to patients with liver and pancreatic tumors."

"This is an exciting day for our shareholders, and we could not be more pleased to announce the signing of our merger agreement with TriSalus," said Chris Dewey, CEO of MedTech. "With multiple value inflection points anticipated over the next 18 months, we believe that TriSalus’ first-of-its-kind technology and deep expertise in immuno-oncology, coupled with our team’s success in commercializing medical device companies, will create significant value in the years ahead."

Transformational Upside Potential

Fast-Growing Device Business: While TriSalus is pursuing commercialization of additional technologies leveraging the PEDD approach, such as the Pancreatic Retrograde Venous Infusion (PRVI) System, the TriNav Infusion System is already a commercial-stage, high margin, and FDA cleared drug delivery device. The TriNav Infusion System using the PEDD approach has been validated in peer-reviewed studies at multiple clinical sites and performed in more than 17,000 cases to date. TriNav already has a strong customer base and support from key opinion leaders. With its ability to optimize Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Radioembolization (TARE) procedures that to date have underperformed in patients with liver and pancreatic cancers, the platform has near-term expansion opportunities by partnering with companies advancing checkpoint inhibitors, CAR-T therapies and other cell immunotherapies. Longer term, TriNav is expected to support the growth and effectiveness of SD-101. In 2021, TriNav achieved $8.4 million in net sales and it is on track to achieve $12.6 million in 2022.
Significant Potential Upside From SD-101 Program in Development: SD-101’s tolerable safety profile and therapeutic activity was substantiated in over 300 patients enrolled in various Phase 1 and Phase 2 studies of melanoma, lymphoma, and head and neck squamous cell carcinoma. TriSalus’ targeting of orphan indications and rare disease creates an opportunity for expedited development and the potential for an accelerated path to approval and commercialization. Phase 1/1b early response data for the uveal melanoma and intrahepatic cholangiocarcinoma indications are expected in the fourth quarter of 2022, with a potential New Drug Application (NDA) submission as early as 2025.
Targeting a $15 Billion Addressable Market Opportunity: There are significant limitations in existing immunotherapy treatment success for liver and pancreatic cancers. More than 41,000 people are expected to be diagnosed with primary liver cancers this year, and more than 96,000 people are expected to have liver metastases in the United States this year.1 Additionally, there is a high global incidence in key targeted indications, providing an attractive non-U.S. opportunity.
Successful Track Record of Value Creation: The MedTech team’s strong track record of value creation across an array of medical device companies, together with the TriSalus team’s deep clinical expertise and strategic partnerships with leading cancer centers, positions the Company to successfully develop and bring to market life-saving cancer treatments.
Transaction Overview

The pending merger has been unanimously approved by the Boards of Directors of both TriSalus and MedTech and is expected to close in the first quarter of 2023, subject to the satisfaction of the necessary regulatory approvals and customary closing conditions, including the approval of MedTech’s shareholders.

The board of the combined company post-close would be comprised of nine members, of which seven are selected by TriSalus and two from MedTech. The leadership team will be the existing TriSalus team led by Mary Szela.

At the completion of the transaction, the company expects to have at least $60 million in cash, assuming significant redemptions. The expected cash at closing includes up to $50 million from a convertible note for which MedTech and the Company have entered into a non-binding term sheet with a leading institutional investor.

Additional information about the proposed merger, including a copy of the merger agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by MedTech with the Securities and Exchange Commission ("SEC") and available at www.sec.gov.

Advisors

Cooley LLP is acting as legal counsel to TriSalus. Raymond James is acting as exclusive financial advisor to MedTech and as the sole placement agent on the convertible offering, and Paul Hastings LLP is serving as legal counsel to the placement agent. Foley & Lardner LLP is acting as legal counsel to MedTech.

Conference Call Information

TriSalus and MedTech will host a joint conference call to discuss the proposed merger today, November 14, 2022, at 8:30 am Eastern Time. A live webcast of the conference call and associated presentation materials will be accessible on TriSalus’ investor relations page at View Source A replay of the conference call will be available after completion of the conference call and can be accessed on the investor relations page.

On November 14, 2022 -VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that members of the management team will participate in analyst-led fireside chats at the following investor conferences (Press release, VBI Vaccines, NOV 14, 2022, View Source [SID1234624047]):

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Guggenheim’s 4th Annual Immunology and Neurology Day

Jefferies London Healthcare Conference

Live webcasts of the presentations will be available on the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the Company’s website following the presentation.

On November 14, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported the launch of FoundationReport+, a new interactive digital report to enhance the useability of comprehensive genomic profiling (CGP) results (Press release, Foundation Medicine, NOV 14, 2022, View Source [SID1234624046]). The digital view of the Foundation Medicine report provides physicians with an adaptable experience to view genomic insights and supports more efficient and streamlined treatment decisions for their patients.

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Accessible through the Foundation Medicine online portal, the new digital reporting tool is customizable to each user’s preference and allows healthcare providers to control the depth of information they would like to see within the digital reporting experience. With improved navigation to actionable insights, the interactive functionality improves overall clarity of patients’ results compared to the traditional PDF report. In order to create an optimal user experience, FoundationReport+ will continue evolving to include new features and functionality in the months ahead based on customer feedback.

"Foundation Medicine continuously strives to deliver complex molecular information in a way that is digestible and actionable for clinicians," says Foundation Medicine Chief Medical Officer Mia Levy, M.D. "We know that healthcare teams in the clinic are busy and looking for increased efficiency – therefore, our new digital report enables a dynamic experience to support a range of workflows and help providers more easily access targeted treatment options for their patient’s unique cancer."

FoundationReport+’s digital reporting functionality is one of many updates Foundation Medicine is making to increase digital integration, on-the-go access, and connectivity in order to provide customers with the flexibility they need. This launch complements other recent initiatives to integrate Foundation Medicine reporting into electronic medical records with partners including Epic, OncoEMR, Cerner, and more.

"Having easily navigable access to patients’ genomic insights will help remove some of the barriers we as oncologists can face in our efforts to get individuals on the right treatments in an informed and efficient manner," said Lee Schwartzberg, M.D., Chief of Oncology/Hematology, Renown Health-Pennington Cancer Institute. "Foundation Medicine’s solutions-oriented approach to customer service is paving the way to more accessible precision care for cancer patients."

On November 14, 2022 bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive diagnosis of early-stage cancer and diseases of the lung, and targeted cancer treatment, reported its financial results for the third quarter of 2022 and provided a business update (Press release, BioAffinity Technologies, NOV 14, 2022, View Source [SID1234624045]).

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"We have begun a limited test-market launch in the San Antonio area and recently have started to recognize revenue from sales of CyPath Lung by our licensee, Precision Pathology Services, a CAP-accredited, CLIA-certified clinical pathology laboratory"

"Since our founding, bioAffinity Technologies has been dedicated to addressing the urgent need for noninvasive, early-stage cancer diagnosis and cancer treatment," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. "Now that we have successfully raised the needed funds, we are confident that the outstanding scientific and commercialization team we have assembled will demonstrate the clinical value of CyPath Lung in the marketplace. We will continue the development of additional non-invasive diagnostics for early-stage disease. With funds raised from our recent IPO and the exercise of warrants, bioAffinity Technologies also will pursue its promising research and development of broad-spectrum cancer therapeutics.

"We have begun a limited test-market launch in the San Antonio area and recently have started to recognize revenue from sales of CyPath Lung by our licensee, Precision Pathology Services, a CAP-accredited, CLIA-certified clinical pathology laboratory," Zannes said. "The limited launch allows us to evaluate our marketing program and help ensure each step in the care pathway – from the initial order by physicians, to sputum collection and processing, to generating and delivering the patient report – is efficient and effective. This limited test-market approach allows us to refine future positioning and develop strategic insight for our CyPath Lung test before expanding to a larger national market. We believe our current efforts will be essential to developing a strategic and cost-effective plan for a robust national rollout."

Corporate Highlights

Award of Therapeutic Patents in China, Mexico and Australia: In October, the Company was pleased to announce that its wholly owned subsidiary, OncoSelect, has been awarded patents to protect novel porphyrin-conjugated compounds for selective delivery of cancer treatments by the People’s Republic of China.

Additionally, bioAffinity Technologies announced that Mexico and Australia recently awarded the Company therapeutic patents with claims directed to novel compounds of porphyrin-conjugates for selective delivery of cancer treatment. The patents grant protection to 2037.

Presentation at CHEST Conference: Also in October, bioAffinity Technologies announced that results of its research into the use of flow cytometry for analyzing the lung environment to detect diseases of the lung were accepted for presentation at the American College of Chest Physicians (CHEST) 2022 conference. The data showed how flow cytometry can be used in development of diagnostics for COPD and asthma – similar to how the Company successfully uses flow cytometry in the CyPath Lung test to detect early-stage lung cancer.

Publication of Peer-Reviewed Results in PLOS ONE: In September, the Company announced publication of its research in high-throughput flow cytometry analysis of sputum in the journal, PLOS ONE. The article, titled Sputum analysis by flow cytometry; an effective platform to analyze the lung environment, reports on results of analyzing sputum by flow cytometry as the basis for high-throughput diagnostic tests to determine the health of the lung.

Successful Closing of IPO: On September 6, bioAffinity Technologies announced the successful closing of its Initial Public Offering (IPO) of 1,282,600 units, each consisting of one share of common stock, one tradeable warrant to purchase one share of common stock at an exercise price of $7.35 per share, and one non-tradeable warrant to purchase one share of common stock at an exercise price of $7.656 per share, for aggregate gross proceeds of approximately $7.8 million, prior to deducting underwriting discounts, commissions, and other offering expenses.

Subsequent to the close of the IPO, the Company announced receipt of approximately $7.7 million in additional gross proceeds from the exercise of tradeable and non-tradeable warrants. Specifically, investors exercised a total of 725,576 tradeable warrants at a price of $7.35 per share and 310,910 non-tradeable warrants at a price of $7.656 per share. Combined with the Company’s underwritten public offering, the Company received an aggregate of approximately $15.6 million as of September 28, 2022. In addition, the Company converted almost $11 million in debt and related accrued interest as a result of the IPO.

Financial Highlights

bioAffinity Technologies reported revenue of about $1,150 for the three months ended September 30, 2022. There was no revenue to report the prior year.

bioAffinity Technologies reported a net loss of $4.6 million or $1.10 per share, for the three months ended September 30, 2022, compared to a net loss of $1.5 million or $0.57 per share for the same period in 2021.

Research and development expenses for the three months ended September 30, 2022, were $319,744 compared to $330,772 for the third quarter of 2021. The decrease is primarily due to a decrease in legal costs related to patents and annuities compared to the prior year.

General and administrative expenses were $596,476 for the third quarter of 2022, compared to $161,549 for the same period in 2021. The increase was primarily attributable to an increase in consulting, legal and professional fees incurred in 2022 compared to 2021 and costs due to the activities associated with being a public company.

Cash and cash equivalents totaled $13.5 million at September 30, 2022, compared to $1.4 million at December 31, 2021. In September 2022, the Company completed an Initial Public Offering resulting in net proceeds to the Company of approximately $15.6 million.

Conference Call and Webcast Details

bioAffinity Technologies will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the Company’s financial results and provide a general business update. The webcast and subsequent replay may be accessed by visiting the Company’s website at View Source Please connect to the Company’s website at least 5 minutes prior to the webcast to ensure adequate time for any necessary software download. Alternately, please call 1-800-579-2543 (U.S.) or 1-203-518-9856 (international) to listen to the conference call. The conference ID for the call is BIAFQ322. Please dial in approximately 10 minutes prior to the call. The webcast will be available on the Company’s website for approximately 45 days.