On March 28, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for full-year 2022 and provided recent business updates (Press release, Sensei Biotherapeutics, MAR 28, 2023, View Source [SID1234629450]).

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"Over the last year the team has worked with urgency to test the biological rationale for our lead product candidate, SNS-101, as a potentially transformative therapeutic option for patients with solid tumors," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We remain committed to the belief that VISTA has tremendous potential as an immune checkpoint target and continue to take steps to prioritize the advancement of SNS-101. We are pleased that, despite industry headwinds, our work has culminated in the recent submission of an IND to begin a Phase 1/2 clinical trial with the support of our partners. We’re also excited about the overall progress of programs generated through our TMAb platform, including SNS-102 and SNS-103, and look forward to advancing other conditionally active antibodies that ignite and deploy the immune system’s full potential to fight cancer."

Added Mr. Celebi, "Following the streamlining and realignment of the Company’s resources to support its key indications and programs, including reductions in operating expenses, employee-related costs and occupancy costs, our programs are supported by a healthy cash position that provides runway into the second half of 2025. We are confident in our strategy and expect to continue achieving critical near-term milestones across our pipeline."

Highlights and Milestones

SNS-101

Sensei continues to advance SNS-101, a conditionally active antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), which is implicated in resistance to PD-1/PD-L1 therapy and whose expression correlates with poor survival across numerous cancers. Recent updates for SNS-101 include:

In March 2023, Sensei submitted an IND application to the U.S. Food and Drug Administration for the planned Phase 1/2 clinical trial of SNS-101 in patients with solid tumors.
In November 2022, Sensei presented preclinical data on SNS-101 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, highlighting the antibody’s potentially improved safety, pharmacokinetic and efficacy profile over non-conditionally active VISTA-blocking antibodies. Presented data showed a significantly lower risk of inducing cytokine release syndrome (CRS), linear elimination kinetics and avoidance of target-mediated drug disposition and significant enhancement of anti-tumor effects in combination with anti-PD-1 antibodies.
Additional preclinical data presented at the Keystone Symposia on Next-Generation Antibody Therapeutics in February 2023 included crystal structure analysis further elucidating SNS-101’s mechanism of action, showing that the antibody directly blocks the pH-dependent interaction between VISTA and PSGL-1.
New preclinical efficacy data support a rationale for SNS-101 both as monotherapy and in combination with PD-1 blockade for patients with solid tumors.
Key Collaborations Supporting SNS-101

Sensei recently announced three collaborations key to the development of SNS-101 and the planned Phase 1/2 clinical trial in solid tumors:

A Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), executed in February 2023, is designed to further demonstrate the role of VISTA in checkpoint resistance and will enable Sensei to explore SNS-101’s potential as a combination therapy beyond anti-PD-1.
In January 2023, the Company signed a clinical supply agreement with Regeneron that will enable Sensei to evaluate SNS-101 in combination with the anti-PD1 therapy Libtayo (cemiplimab).
In November 2022, Sensei announced a Sponsored Research Agreement with Washington University in St. Louis to support research into the underlying molecular mechanisms that enable SNS-101 to overcome myeloid cell-driven immunosuppression within the tumor microenvironment.
Additional TMAb Platform Updates

Through its proprietary Tumor Microenvironment Activated biologics (TMAb) platform, Sensei is also advancing several pH-sensitive antibodies, including SNS-102 targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4) and SNS-103 targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39).

SNS-102: Eight parental pH-sensitive VSIG4 antibodies have been selected for lead optimization. Data on this program presented at SITC (Free SITC Whitepaper) in November 2022 characterized endogenous expression patterns of VSIG4 in polarized macrophage populations and showed robust VSIG4-mediated suppression of primary human T-cells. Additionally, Sensei reported that a ligand receptor capture-trifunctional chemoproteomic (LRC-TriCEPS)-based proteomics strategy identified receptors on primary human T-cells that interact with recombinant VSIG4 protein.
SNS-103: Sensei has identified eight parental pH-sensitive CD39 antibodies and begun further optimization on a lead antibody set.
Upcoming Milestones

Sensei will present preclinical data on its SNS-103 program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in a poster session on April 18, 2023.
Sensei remains on track to select product candidates for both SNS-102 and SNS-103 in 2023. Upon successful candidate selection, Sensei expects to advance at least one product candidate to IND-enabling studies.
The Company has initiated early discovery efforts for a fourth TMAb program.
Cost Savings

Following the streamlining and realignment of the Company’s resources to support its key indications and programs, including reductions in operating expenses, employee-related costs and occupancy costs, Sensei projects it has a cash runway into the second half of 2025.
As a result of the Company’s prudent fiscal strategy, Sensei expects significant cost savings while preserving the ability to fund development and continuation of programs for potential nearer-term data catalysts.
Corporate Updates

In December 2022, Sensei promoted Edward van der Horst, Ph.D., to Chief Scientific Officer.
Year End 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $107.1 million as of December 31, 2022, as compared to $147.6 million as of December 31, 2021. Sensei expects its current cash balance to fund operations into the second half of 2025.

Research and Development (R&D) Expenses: R&D expenses were $30.4 million for the year ended December 31, 2022, compared to $21.7 million for the year ended December 31, 2021. The increase in R&D expenses was primarily attributable to increased manufacturing and early development activities for the Company’s lead program SNS-101, partially offset by a decrease in clinical trial expenses.

General and Administrative (G&A) Expenses: G&A expenses were $19.8 million for the year ended December 31, 2022, compared to $15.8 million for the year ended December 31, 2021. The increase in G&A expense was primarily attributable to external professional services and personnel costs.

Net Loss: Net loss was $48.6 million for the year ended December 31, 2022, compared to $36.8 million for the year ended December 31, 2021.

Condensed Statements of Operations
(Unaudited, in thousands except share and per share data)

Twelve Months Ended
December 31,
2022 2021
Operating expenses:
Research and development $ 30,383 $ 21,662
General and administrative 19,805 15,820
Total operating expenses 50,188 37,482
Loss from operations (50,188 ) (37,482 )
Total other income 1,600 688
Net loss (48,588 ) (36,794 )
Net loss per share, basic and diluted $ (1.58 ) $ (1.33 )
Weighted-average common shares outstanding, basic and diluted 30,703,295 27,710,686

Selected Condensed Balance Sheet Data
(Unaudited, in thousands)


December 31,
2022 December 31,
2021
Cash and cash equivalents $ 17,795 $ 7,159
Marketable Securities 89,321 140,462
Total assets 118,375 153,225
Total liabilities 14,968 6,712
Total stockholders’ equity (deficit) 103,407 146,513

On March 28, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sonoma Biotherapeutics, Inc. reported a collaboration to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T cell (Treg) therapies for autoimmune diseases (Press release, Regeneron, MAR 28, 2023, View Source [SID1234629449]). The collaboration will bring together Regeneron’s industry-leading VelociSuite technologies for the discovery and characterization of fully human antibodies and T cell receptors (TCRs) with Sonoma Biotherapeutics’ pioneering approach to developing and manufacturing gene-modified Treg cell therapies.

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Under the terms of the agreement, Sonoma Biotherapeutics will receive $75 million in upfront payments, which includes a $30 million equity investment in Sonoma by Regeneron. Sonoma is also eligible to receive a $45 million development milestone payment. Regeneron and Sonoma will jointly research and develop Treg cell therapies for ulcerative colitis, Crohn’s disease and two other undisclosed indications, with a Regeneron option for a fifth indication. The parties will equally co-fund research and development for all potential products and share equally any future commercial expenses and profits. Regeneron will have the option to lead late-stage development and commercialization on all products globally, with Sonoma retaining rights to co-promote all such products in the United States. Sonoma will also retain full ownership of its lead cell therapy candidate, SBT-77-7101, and other programs in development.

"We are thrilled to collaborate with Regeneron with the goal of developing best-in-class Treg therapies for ulcerative colitis, Crohn’s, and other diseases," said Jeff Bluestone, Ph.D., Co-founder and Chief Executive Officer of Sonoma Biotherapeutics. "Regeneron has a track record of seeking out pioneers in their fields and forging successful partnerships. This collaboration will combine Regeneron’s proven technology and clinical expertise with Sonoma Bio’s proprietary Treg platform and Treg research enterprise to develop therapies that restore balance to the immune system and potentially cure disease."

"Regeneron’s investigational pipeline includes a diverse range of cutting-edge scientific approaches, and we are pleased to expand this toolkit further through a partnership with Sonoma to explore the potential of engineered Treg cell therapies with enhanced functionality and the ability to target specific tissues," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. "Both Regeneron and Sonoma have strong foundations in basic scientific research, and by bringing together our complementary expertise, we hope to harness the power of Tregs to make further progress in the treatment of autoimmune and inflammatory diseases."

Treg cells act as sentinels that survey the body for unwanted immune attacks and rebalance the immune system. Tregs as a therapeutic modality potentially possess multiple therapeutic effects, within a single medicine, helping overcome the multifaceted nature of autoimmune and inflammatory disease. Emerging research shows that enhanced Treg cells work directly at the site of inflammation and have the potential to create a durable response. This paradigm-shifting approach could possibly transform treatments for autoimmune and inflammatory diseases.

On March 28, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that PRP suppresses the TGF-β pathway and the tumor microenvironment in pancreatic cancer, elucidated by one of the Company’s joint researchers, Mrs. Belén Toledo Cutillas MSc, at the laboratory of Professor Macarena Perán, PhD, University of Jaén, Granada, Spain (Press release, Propanc, MAR 28, 2023, View Source;pathway-tumor-microenvironment-in-pancreatic-cancer [SID1234629447]). The experiments were conducted with a well-known small molecule inhibitor of the same pathway, comparing it against the effects of PRP, with results showing an even greater suppression by Propanc’s novel cancer therapy. TGF-β is a growth factor molecule involved in cell proliferation, migration and survival, and death that influences tumor growth in advanced forms of cancer.

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In addition, Mrs. Cutillas also analyzed the same pathway comparing (i) a pancreatic tumor cell line along with a chemoresistant pancreatic tumor cell line with (ii) the same line treated with PRP. It was observed the TGF-β pathway, which is overexpressed in the chemoresistant cell line, decreased drastically when treated with PRP. Mrs. Cutillas concluded that the results appear to confirm that PRP can suppress not only the tumor microenvironment, but also chemoresistant tumor cells, which also plays a key role in how a malignant tumor grows and spreads. Further experiments will be conducted by developing a series of immunofluorescence and western blot studies that complement these results with other biomarkers.

Dr Julian Kenyon, MD, MB, ChB, Propanc’s Chief Scientific Officer said, "These results confirm that PRP exerts significant effects on the tumor microenvironment and the TGF-β pathway, which is a key biomarker for the way tumors become malignant, grow and spread, and develop resistance to standard treatments over time. I am convinced that PRP has the potential to act as an effective chemosensitizing agent against resistant solid tumors to standard treatment regimens, which often leads to a poor prognosis for cancer sufferers. We continue to generate convincing scientific evidence supporting PRP as a novel cancer therapy for the treatment of solid tumors, but without the side effects normally associated with standard treatment approaches. Our joint research team will continue to explore these opportunities with great interest as we advance to early-stage clinical development for PRP."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers.

On March 28, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that Dr. Matt Coffey, President and Chief Executive Officer, will participate in the Novel Mechanisms with Important Readouts panel at Cantor Fitzgerald’s The Future of Oncology Virtual Symposium, which is taking place April 3-5, 2023 in a virtual format (Press release, Oncolytics Biotech, MAR 28, 2023, View Source [SID1234629446]). Additional details on the panel presentation can be found below.

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Date: Monday, April 3, 2023

Time: 11:00 a.m. ET

Panel Title: Novel Mechanisms with Important Readouts

A live webcast and archived replay of the panel presentation will be available to registered attendees of the symposium through the symposium website. Company management will also be participating in virtual one-on-one investor meetings at the symposium. To schedule a meeting, contact your Cantor Fitzgerald representative or email [email protected].

On March 28, 2023 NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells for liquid and solid malignancies, reported financial results for the fourth quarter and full year 2022 (Press release, NexImmune, MAR 28, 2023, View Source [SID1234629445]).

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"We remain confident in the potential therapeutic benefit of our AIM platform-based products amd their ability to significantly impact the emerging field of antigen specific immune-oncology therapies, novel IO combinations, autoimmune treatments and potential approaches for viral-driven diseases. While we are still observing patients in our ongoing cell therapy program, we are focused on advancing our AIM INJ ‘off-the-shelf’ modality," said Kristi Jones, Chief Executive Officer. "The combined data from our clinical cell therapy programs and INJ pre-clinical experiments are consistent, and we believe validate the AIM nanoparticles MOA regardless of modality. In addition, recent pre-clinical data combining AIM nanoparticle expanded multi-antigen specific T cells with a T cell bispecific engager demonstrated superior potency as well as enhanced persistence and durability supporting novel antigen specific IO combinations."

We believe that the AIM INJ therapeutic modality offers the most disruptive potential to benefit patients, as well as the greatest potential to create long-term value for our shareholders. The unique benefits of our "off the shelf" T cell targeted therapies include scalability and access to broader patient populations to address unmet need. We will provide an update on these programs over the coming months."

Jones continued, "Our AIM ACT cell therapy product candidates currently in clinical trials continue to show clinical activity in early dose escalation and are well-tolerated in patients. While paused, these clinical programs have demonstrated evidence of activity such as reduction in tumor burden, and a tolerability profile to support potential c novel IO combinations and to shift into patients with lower tumor burden. We are exploring external opportunities, including with academic centers and corporate collaborators, to advance these programs."

Select Fourth Quarter and Full Year 2022 Clinical and Business Highlights

Business and Strategy Update

Jerry Zeldis, MD, PhD, will retire from his position of Executive Vice President, R&D, effective March 31, 2023. Also, as part of the Company’s previous announced realignment of resources to focus on the AIM INJ platform and pause our cell therapy clinical programs, Bob Knight, MD, will step down from the position of Chief Medical Officer. Dr. Knight and Dr. Zeldis will transition to advisory roles and continue to provide both strategic counsel and fulfill operating responsibilities at NexImmune. Dr. Zeldis will also continue to be an active member on NexImmune’s Scientific Advisory Board.

"On behalf of the BOD, I want to thank Jerry and Bob for their leadership and contribution in bringing NexImmune’s revolutionary technology to the clinic and into patients. We are grateful for the continued support we will receive as both will remain involved with NexImmune in an active advisory capacity," said Sol Barer, NexImmune’s Chairman of the Board.

Clinical and Preclinical Updates

AIM INJ, Injectable "Off-the-shelf" Antigen-Specific Immunotherapy, and Other Preclinical Research

•Initiated multiple pre-clinical studies to evaluate monotherapy and in combination with a checkpoint inhibitor to support our oncology program

•Continued to evaluate AIM INJ nanoparticles as a therapeutic for type 1 diabetes as well as other autoimmune diseases with Yale University Professor Kevan Harold in partnership with JDRF

•Poster presented at 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR demonstrated evidence that AIM multi-antigen specific cells combined with a BCMA bispecific results in superior potency, enhanced persistence and durability in multiple myeloma models

•Publication in Frontiers in Medicine highlighting the ability of NexImmune’s AIM Platform to treat viral diseases

•Announced research collaboration with National Institute of Neurological Disorders and Stroke of the National Institutes of Health with initial focus on multiple sclerosis

•Announced neo-antigen melanoma research collaboration with NYU Langone’s Perlmutter Cancer Center
NEXI-001 Relapsed Refractory AML Post Allo-HSCT

•Full enrollment and dosing in the final safety cohort of NEXI-001 completed

•Plan to announce data for currently enrolled patients at or around an upcoming conference in mid-2023

•Continue to explore opportunities to advance NEXI-001 with potential collaborators and investigators

NEXI-003 HPV-Related Cancers

•Announced clearance of IND by the FDA for NEXI-003 for treatment of HPV-related cancers

•Continue to explore opportunities to develop this adoptive cell therapy with external partners and collaborators and develop a corporate HPV strategy that utilizes the AIM INJ modality.

Select 4Q and Full 2022 Financial Highlights

Cash, cash equivalents and marketable securities for the company as of December 31, 2022 were $34.6 million compared to $81.8 million at December 31, 2021. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its operating and capital expenditure requirements into the fourth quarter of 2023.

Research and development expenses were $13.7 million in the fourth quarter ended December 31, 2022, compared to $12.0 million for the same period in the prior year. Research and development expenses were $47.1 million for the full year period ended December 31, 2022, an increase of $9.6 million compared to $37.5 million for the full year ended December 31, 2021. The increase in R&D expenses was mainly attributable to costs for research related to preclinical manufacturing and the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $3.5 million for the fourth quarter ended December 31, 2022, which represent effectively no change for the same period in the prior year. General and administrative expenses were $15.9 million for the full year period ended December 31, 2022, an increase of $0.1 million compared to $15.8 million for the full year ended December 31, 2021. The increase was due primarily to an increase in fees related to professional and consulting services offset by decrease in headcount and stock compensation expense.
Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $16.9 million for the quarter and $62.5 million for the full year 2022, or a basic and diluted GAAP loss per share of $0.65 and $2.60 respectively. This compared to a net loss of $50.9 million, or a basic and diluted GAAP loss per share of $2.54, for the same period the prior year.