On November 9, 2021 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf memory natural killer (NK) cell therapies to treat a broad range of hematological and solid tumor malignancies, reported it will present new data highlighting the preclinical development of Wugen’s lead product WU-NK-101 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, Wugen, NOV 9, 2021, View Source [SID1234594939]).

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The data highlight Wugen’s proprietary large-scale feeder-cell free manufacturing process and demonstrate WU-NK-101’s robust memory phenotype and enhanced anti-tumor activity. Further, the data demonstrate that in combination with monoclonal antibodies, WU-NK-101 exhibits enhanced efficacy against solid tumor cell lines. In summary, the data provide support for development of WU-NK-101 as an off-the-shelf cell therapy for the treatment of acute myelogenous leukemia (AML) and solid tumors.

The details of Wugen’s presentation at SITC (Free SITC Whitepaper) are as follows:

Title: Development of WU-NK-101, a feeder cell-free expanded allogeneic memory NK cell product with potent anti-tumor activity
Presenting Author: Mary E. Mathyer, Ph.D.
Abstract Number: 188
Abstracts will be available Tuesday, November 9, 2021, at 8:00 a.m. ET
Additional meeting information can be found on the SITC (Free SITC Whitepaper) website at:
View Source

On November 9, 2021 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported new preclinical immunotherapy data for novel, potentially solid tumor- and therapeutic combination-agnostic radioenhancer NBTXR3 that will be presented at the 2021 Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Nanobiotix, NOV 9, 2021, View Source [SID1234594955]). The Company believes that these data are consistent with recently presented clinical immunotherapy data and support advancement of development with anti-PD-1 and emerging immune checkpoint inhibitors.

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"Our view is that the potential immune priming effect we have observed with NBTXR3 could make our product candidate an important combination therapy with immune checkpoint inhibitors to improve treatment outcomes for patients," said Laurent Levy, co-founder and chief executive officer of Nanobiotix. "The new preclinical data at SITC (Free SITC Whitepaper), along with data we have evaluated in the clinical setting, present a promising path forward in immunotherapy."

Preclinical data to be presented at the meeting by Nanobiotix (Abstract #740) show that radiotherapy-activated NBTXR3 increases CD8+ T cell infiltration and modulates the T cell receptor ("TCR") repertoire, as well as marked modulation of immunopeptidome in treated tumor cells in a mouse model. Taken together, these variations could indicate that radiotherapy-activated NBTXR3 triggers more robust immune priming than radiotherapy alone and merits further evaluation of CD8+ response and abscopal effect.

The Company’s perspective is that these data further support the mechanistic rationale of combining NBTXR3 with immune checkpoint inhibitors. The preclinical data follows preliminary clinical data presented earlier in the fourth quarter of 2021 from the phase I trial ("Study 1100") evaluating NBTXR3 in combination with the anti-PD-1 checkpoint inhibitors nivolumab (Opdivo) or pembrolizumab (Keytruda) in patients with locoregional recurrent ("LRR") or recurrent and metastatic ("R/M") head and neck squamous cell carcinoma ("HNSCC") or with lung or liver metastases from any primary cancer that is eligible for anti-PD-1 therapy. This preliminary data for Study 1100 showed an overall AE profile consistent with radiotherapy or anti-PD-1 monotherapies. A 56% target lesion objective response rate (80% in anti-PD-1 naïve patients; 45% in prior non-responders) was observed in evaluable patients (n=16). A 50% overall objective response rate (% response in target and non-target lesions) was observed (80% in anti-PD-1 naïve patients; 36% for prior non-responders) in evaluable patients. The potential immune priming effect of radiotherapy-activated NBTXR3 was observed in non-responders as well as anti-PD-1 naïve patients, suggesting that NBTXR3 may reverse or circumvent resistance to prior anti-PD-1 treatment.

Evaluation of novel combination approaches to immunotherapy continues to be a priority for Nanobiotix, as investigators seek to expand the impact of I/O agents for the 80-85% of patients that receive limited benefits, or no benefit at all, by improving response rates and overcoming resistance to anti-PD-1. TIGIT and LAG3, members of the same receptor class as CTLA-4 and PD-1, could be the next generation of immunotherapy targets and are being investigated alone and in combination with existing anti-PD-1 agents aiming to improve patient outcomes in clinical trials.

The preclinical data to be presented at SITC (Free SITC Whitepaper) by The University of Texas MD Anderson Cancer Center (Abstract #575) show that radiotherapy-activated NBTXR3 plus anti-PD-1, anti-TIGIT, and anti-LAG3 ("Combo therapy") significantly promotes the proliferation activity of CD8+ T cells, improves local and distant tumor control, and increases survival rate in mice. Only the group of mice treated with the Combo therapy had survivors and those cured mice were immune to re-injection of tumor cells, maintained a significantly higher percentage of memory CD4+ and CD8+ memory T cells, and had stronger anti-tumor immune activities than the control, suggesting the induction of long-term anti-tumor memory by the Combo therapy.

"We have long believed that radiotherapy has a critical role to play in immunotherapy and that innovation in the practice is key to achieving this ambition," said James Welsh, MD, Associate Professor of Radiation Oncology at MD Anderson. "Our preclinical research on NBTXR3 has consistently supported the potential of this new agent in combination with radiotherapy and immune checkpoint inhibitors in order to enhance immunogenic cell death. We look forward to continuing our evaluation, both in the lab and in the clinic, with the ultimate goal of improving treatment outcomes for patients."

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the planned phase III study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3 , Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

On November 9, 2021 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the third quarter and nine months ended September 30, 2021 and provided an update on recent developments (Press release, CorMedix, NOV 9, 2021, View Source [SID1234594991]).

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Recent Corporate and Regulatory Highlights:

As noted previously, there was a delay as a result of issues at the third-party manufacturer, or CMO, unrelated to the manufacture of DefenCath. Together with our CMO, we have been able to resume manufacturing activities and are continuing to complete the work that is required to address the deficiencies identified at the manufacturing facility.

CorMedix continues to work diligently toward the resubmission of the DefenCath NDA and plans to provide an update when we have clarity on the submission timeline.

CorMedix announced in October that its Board had appointed Matt David M.D., CorMedix’s EVP and Chief Financial Officer, as interim Chief Executive Officer. In addition, CorMedix expanded the responsibilities of Phoebe Mounts, Ph.D., Esq., EVP, General Counsel, and Head of Regulatory, Compliance, and Legal to include leadership of the Technical Operations group.

CorMedix presented three abstracts at industry conferences including the Association of Managed Care Pharmacy (AMCP) Nexus conference in October and the American Society of Nephrology (ASN) conference in November. The presentations highlighted retrospective analyses that were conducted to better understand the incidence of and mortality related to CRBSIs and economic costs related to these infections.

Cash and short-term investments, excluding restricted cash, at September 30, 2021 amounted to $72.0 million.
Dr. Matt David, CorMedix interim CEO, commented, "We are pleased that we have been able to resume manufacturing activities at our CMO and look forward to providing updates over the coming months. As the recent industry conference presentations have highlighted, catheter related bloodstream infections are common in patients receiving hemodialysis via central venous catheters and are associated with significant morbidity and mortality. We remain steadfast in our commitment to these patients as we seek to bring DefenCath to market upon its approval."

Third Quarter and Nine Month 2021 Financial Highlights

For the third quarter of 2021, CorMedix recorded a net loss of $8.6 million, or $0.22 per share, compared with a net loss of $6.6 million, or $0.22 per share, in the third quarter of 2020. The higher net loss recognized during the third quarter of 2021 compared with 2020 was due to the net increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval.

Operating expenses in the third quarter of 2021 increased approximately 30% to $8.6 million, compared with $6.6 million in the third quarter of 2020. R&D expense increased approximately 62% to $4.7 million compared to $2.9 million in the third quarter of 2020, mainly due to net increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased approximately 4% to $3.8 million compared with $3.7 million in the third quarter of 2020. This increase was driven primarily by an increase in non-cash charges for stock-based compensation and an increase in personnel expenses, partially offset by decreases in costs related to market research studies in preparation for the potential marketing approval of DefenCath and in consulting fees.

For the nine months ended September 30, 2021, CorMedix recorded a net loss of $20.4 million, or $0.54 per share, compared with a net loss of $15.9 million, or $0.58 per share, in the first nine months of 2020. The increase in net loss in the first nine months of 2021 was driven primarily by a lower tax benefit from the New Jersey NOL program.

Operating expenses in the first nine months of 2021 were $21.7 million compared with $21.2 million during the comparable period in 2020, an increase of $0.5 million, or 2%. This increase was primarily due to higher SG&A expenses throughout the organization, partially offset by a net decrease in costs related to the manufacturing of DefenCath prior to its potential marketing approval.

Total cash on hand and short-term investments as of September 30, 2021 was $72.0 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at September 30, 2021, it has sufficient resources to fund operations at least through 2022, after taking into consideration the costs for re-submission of the NDA and initial preparations for the commercial launch for DefenCath.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, November 9, 2021, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

On November 9, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in a fireside chat during the B. Riley Securities’ Fall 2021 Growth Biotech Best Ideas Virtual Series, taking place on Thursday November 11, 2021, at 12:00 PM ET (Press release, TG Therapeutics, NOV 9, 2021, View Source [SID1234595042]).

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source A replay of the webcast will be available on TG’s website following the event.

On November 9, 2021 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), an emerging global drug discovery company, is rapidly identifying small and large molecule therapeutics to treat central nervous system (CNS) and oncology-related diseases (Press release, Vyant Bio, NOV 9, 2021, View Source [SID1234595122]). Today, Vyant Bio reported that an investor conference call and webcast will be hosted on Thursday, November 11, 2021 .

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Jay Roberts, Chief Executive Officer, and Andy LaFrence, Chief Financial Officer, of Vyant Bio will highlight corporate, scientific, financial, and operational results achieved in the third quarter of 2021. Please also visit the Investors section of the Vyant Bio web site for details on how to participate.

The live event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.