On January 5, 2024 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported unaudited preliminary revenue for the fourth quarter and full year ended December 31, 2023 (Press release, Personalis, JAN 5, 2024, View Source [SID1234639019]).

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Preliminary Fourth Quarter Revenue and Cash Balance

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Preliminary total company revenue is estimated to be $19.7 million in the fourth quarter of 2023, an increase of 18% compared with $16.7 million in the fourth quarter of 2022

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Preliminary revenue from pharma tests, enterprise sales, and other customers is estimated to be $18.7 million in the fourth quarter of 2023 compared with $15.8 million in the fourth quarter of 2022; revenue from enterprise customers includes revenue from Natera which is estimated to be $7.1 million in the fourth quarter of 2023, compared with $8.2 million from Natera in the fourth quarter of 2022

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Preliminary revenue from the Veteran’s Administration Million Veteran’s Program (VA MVP) is estimated to be $1.0 million in the fourth quarter of 2023, compared with $0.9 million in the fourth quarter of 2022

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Preliminary cash, cash equivalents, and short-term investments is estimated to be $114.0 million as of December 31, 2023, and is expected to last through the first quarter of 2026, as a result of 2023 cost-cutting measures which reduced expenses by approximately $35 million annually

Preliminary Full Year 2023 Revenue and Cash Usage

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Preliminary total company revenue is estimated to be $73.5 million in the full year of 2023, an increase of 13% compared with $65.0 million in the full year of 2022

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Preliminary revenue from pharma tests, enterprise sales, and other customers is estimated to be $64.1 million in the full year of 2023 compared with $56.6 million in the full year of 2022; revenue from enterprise customers includes revenue from Natera which is estimated to be $31.7 million in the full year of 2023, compared with $26.6 million from Natera in the full year of 2022

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Preliminary revenue from the VA MVP is estimated to be $9.4 million in the full year of 2023, compared with $8.4 million in the full year of 2022

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Cash usage is expected to be approximately $54 million in the full year of 2023, reduced from $119 million in 2022

"Our strong fourth quarter performance caps off a remarkable year where we delivered on our commitments to investors," stated Chris Hall, President and CEO of Personalis. "To touch on a few highlights, over this past year we launched our NeXT Personal Dx ultrasensitive MRD product, deepened clinical evidence to support obtaining reimbursement, presented unprecedented clinical evidence for early-stage lung cancer detection at medical conferences, expanded our relationships with research collaborators, and forged a new strategic commercial partnership with Tempus to commercialize and ramp our MRD product, all while reducing our annualized expenses by $35 million. I’m very proud of our progress and we expect to further leverage our clinical and commercial strength to drive more success in 2024."

The above information is preliminary and subject to Personalis’ normal quarter and year-end accounting procedures and external audit by the company’s independent registered public accounting firm. In addition, these preliminary unaudited results are not a comprehensive statement of the company’s financial results for the year ended December 31, 2023, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the company’s results for any future period.

On January 4, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported corporate updates on its research and development programs and upcoming milestones (Press release, Sensei Biotherapeutics, JAN 4, 2024, View Source [SID1234638984]).

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"In 2023, we significantly advanced our lead clinical asset while prudently maintaining our strong balance sheet," said John Celebi, President and Chief Executive Officer. "We believe SNS-101, which has demonstrated potentially best-in-class pharmacokinetics and tolerability at clinical doses far beyond other VISTA-targeted immunotherapies, has strong potential as a transformative option in multiple cancer indications. Given the favorable data thus far, we are expanding the SNS-101 Phase 1/2 clinical trial to include additional patients in a more focused set of indications as an intermediate stage to further optimize the Phase 2 study design with additional patient data while we prepare for an anticipated end of Phase 1 meeting with FDA by Q4 2024. As a result, we are dedicating additional resources to support this expanded clinical program while pausing the IND-enabling studies originally planned for our next TMAb product candidate. We expect these adjustments to extend our cash runway into the fourth quarter of 2025."

Highlights and Milestones

SNS-101

SNS-101 is a conditionally active antibody harnessing the acidic tumor microenvironment to target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation). VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates. Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors. Recent updates include:

As of January 2, 2024:
A total of 25 patients have been treated with SNS-101 across various dose levels, with 16 patients in the monotherapy arm and nine patients in the combination arm. There have been no dose limiting toxicities (DLT) observed across both the monotherapy arm and the combination arm.
In the monotherapy dose escalation arm, patients have cleared all planned dosing cohorts of 0.3, 1, 3, 10 and 15 mg/kg.
In the combination dose escalation arm, six patients have been enrolled in the first cohort and have cleared the DLT period at a dose level of 3.0 mg/kg SNS-101 + Libtayo. The second cohort at a dose level of 10.0 mg/kg SNS-101 + Libtayo has been enrolled and is pending clearance of the DLT period as determined by the study safety monitoring committee.
Following completion of dose escalation and prior to initiating the Phase 2 portion, the Company plans to enroll up to 40 additional patients in both monotherapy and in combination with Libtayo in specific tumor types to further optimize the design of the Phase 2 trial.
In the monotherapy dose expansion arm, Sensei plans to enroll up to 10 patients with microsatellite stable (MSS) colorectal cancer (CRC) at a dose level of 15 mg/kg.
In the combination dose expansion arm, Sensei plans to enroll up to 30 patients with MSS CRC, head and neck cancer (H&N), non-small cell lung cancer (NSCLC), and melanoma. The dose level will be determined following completion of the combination dose escalation phase of the study.
The solid tumor types were selected to focus the cancer indications on a basket of more commonly occurring histologies, including both "hot" (NSCLC, H&N, Melanoma) and "cold" (CRC) tumors where we believe SNS-101 has potential to provide clinical benefit based on VISTA biology and supporting preclinical data. All patients with "hot" tumors enrolling into the expansion arm are expected to have been previously treated with a PD1/L1 checkpoint inhibitor. Additional tumor types and doses may be considered for both the monotherapy and combination expansion arms.
Sensei expects to open enrollment in the monotherapy expansion arm later this month. The combination expansion arm will begin following completion of the combination dose escalation phase of this study.
Anticipated milestones for the SNS-101 Phase 1/2 clinical trial include:

Initial safety and pharmacokinetic data for the combination dose escalation arm of SNS-101 and Libtayo in Q1 2024
Topline data for the SNS-101 monotherapy dose escalation arm in Q2 2024
Topline data for the combination dose escalation arm of SNS-101 and Libtayo in Q3 2024
Initial data for the SNS-101 dose expansion cohorts by the end of 2024
Additional Corporate Updates

Sensei announces that Ron Weitzman, M.D., F.A.C.P., has joined Sensei as part-time Chief Medical Officer. Dr. Weitzman joined Sensei as a consultant in August 2022 and has been instrumental in the design and implementation of the ongoing Phase 1/2 clinical trial. Dr. Weitzman brings over 25 years experience leading oncology clinical studies ranging from early to late-stage clinical development, including a pivotal study for cabozantanib that led to its FDA approval. Dr. Weitzman has held leadership roles at various global biopharmaceutical companies, including Exelixis, Genentech and Novartis, and has served as a consulting CMO to various biotechnology companies for nearly a decade. Dr Weitzman is board-certified by the American Board of Internal Medicine in Medical Oncology and is an active member of the American College of Physicians.
Sensei has decided to realign its resources to fully support the Phase 1/2 clinical trial of SNS-101. As a result, Sensei will pause IND-enabling work on its preclinical-stage TMAb programs, including SNS-102 (VSIG4), SNS-103 (CD39) and SNS-201 (VISTAxCD28). During this time, preclinical work to characterize selected lead antibodies, including their mechanisms of action, and target biology is expected continue.
In 2023, Sensei selected lead candidates for both SNS-102 and SNS-201. SNS-102 is a conditionally active antibody targeting VSIG4 that is 585-fold more selective for VSIG4 at low pH conditions. SNS-201 is a bispecific antibody incorporating a CD28 agonist arm and a pH-sensitive anti-VISTA arm designed to conditionally activate CD28 under low pH conditions, such as those found in the tumor microenvironment, leading to T cell activation in the tumor while minimizing off-tumor toxicity.
This realignment of resources is expected to extend cash runway into the fourth quarter of 2025.

On January 4, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported its 2024 company priorities and anticipated milestones for its wholly-owned and partnered pipeline (Press release, CytomX Therapeutics, JAN 4, 2024, View Source [SID1234638969]).

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"With INDs recently filed for wholly-owned programs, CX-2051 and CX-801, and continued progress in dose escalation with our Probody T-Cell engager, CX-904, CytomX is well positioned as we enter 2024. Our current lead programs build on more than a decade of Probody platform experience at CytomX and integrate key design elements that leverage previously validated oncology targets, potent effector mechanisms and tailored masking strategies," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics. "We believe our multi-modality Probody therapeutic pipeline will address major unmet medical needs in the treatment of cancer. CytomX is entering a potentially milestone-rich period in 2024 and 2025 during which we aim to generate proof of concept clinical data across our lead programs that point the way to future registrational studies."

"CytomX’s multi-modality pipeline is highly relevant at this moment in time in oncology R&D. CX-904 is a potentially differentiated EGFR-CD3 T-cell engager in an ongoing Phase 1 clinical trial and, with both CX-2051 and CX-801 also expected to enter the clinic in 2024, we have a broad opportunity to make a meaningful difference in the treatment of cancer," said Wayne Chu, M.D., chief medical officer of CytomX Therapeutics. Continued Dr. Chu, "CX-2051 is an ADC designed to truly unlock EpCAM as an anti-cancer target and we believe the topoisomerase-1 inhibitor payload may be an ideal effector mechanism for multiple EpCAM expressing tumors. CX-801 is a powerful immune-stimulating agent with potential to mitigate historical clinical limitations of cytokine therapies due to toxicity. Our vision is for CX-801 to become a cornerstone of combination regimens for a wide range of tumor types including those that have either stopped responding to, or have failed to respond to, prior immunotherapy. CytomX’s lead therapeutic candidates have the potential for significant impact and we will be working tirelessly to bring these therapies forward for the benefit of patients."

CX-904, EGFRxCD3 T-cell Engager

CX-904 is a conditionally activated Probody T-cell engager designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment. CX-904 is partnered with Amgen in a global co-development alliance and is being evaluated in an ongoing Phase 1 study in patients with advanced solid tumors that have known EGFR expression. Backfilling of certain dose escalation cohorts has been initiated and dose ranging continues. Initial Phase 1a dose escalation data is anticipated in the second half of 2024. The Phase 1a data will inform a potential decision during 2024 to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types. The decision to potentially initiate Phase 1b expansion cohorts will be taken in conjunction with Amgen.

CX-2051, Antibody Drug Conjugate (ADC) targeting EpCAM

EpCAM is a high potential oncology target that has been clinically validated by locally administered, previously approved cancer therapies. However, efforts to generate systemically administered anti-EpCAM therapeutics have, to date, not been successful due to toxicities in certain epithelial tissues, notably in the gastrointestinal tract. CX-2051, a conditionally activated ADC, is tailored to optimize the therapeutic index for EpCAM-expressing epithelial cancers. The cytotoxic payload utilized in CX-2051 is a derivative of camptothecin, a topoisomerase-1 inhibitor, a class of drug that has shown potent clinical anti-cancer activity in the ADC context for multiple targets. CX-2051 has demonstrated a wide predicted therapeutic index and strong preclinical activity and tolerability in multiple preclinical models, including colorectal cancer. An IND application has been filed for this program and clinical initiation in EpCAM expressing solid tumors is expected in the first half of 2024.

CX-801, Interferon-alpha 2b (IFNα2b)

Interferon-alpha 2b is an immunotherapeutic cytokine that has demonstrated clinical activity and gained regulatory approval previously in multiple cancer types, including metastatic melanoma, renal cancer and bladder cancer. IFNα2b provides a potentially superior approach to activating anti-tumor immune responses compared to other cytokines. CX-801 is a dually masked, conditionally activated version of IFNα2b that has the potential to become a cornerstone of combination therapy for a wide range of tumor types. An IND application has been filed for this program. Phase 1 initiation for CX-801 as a monotherapy and in combination with checkpoint inhibition is expected in the first half of 2024.

BMS-986288, Non-fucosylated CTLA-4-targeting Probody Therapeutic

Bristol Myers Squibb continues to make progress evaluating the next-generation CTLA-4 program, BMS-986288, a non-fucosylated CTLA-4 targeting Probody therapeutic. In 2023, Bristol Myers Squibb prioritized the BMS-986288 Probody therapeutic program as its lead next-generation CTLA-4 program and advanced the program to Phase 2 clinical studies. BMS-986288 is designed to be more potent than ipilimumab (YERVOY) and to leverage CytomX’s Probody therapeutic technology to potentially localize clinical activity to tumors while reducing systemic toxicity. The ongoing Phase 2 clinical evaluation of BMS-986288 includes proof of concept studies for microsatellite stable (MSS) colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). Bristol Myers Squibb anticipates data from the study will be available in 20241. CytomX and Bristol Myers Squibb also continue to collaborate on multiple preclinical research programs.

Research and Development Partnerships

CytomX has multiple active research and development partnerships with major biotechnology and pharmaceutical companies (Amgen, Astellas, Bristol Myers Squibb, Moderna, Regeneron). Throughout 2023, CytomX made substantial progress across its research partnerships including the commencement of programs under its new alliances with Regeneron and Moderna. In January 2023, CytomX earned a $5 million milestone for the first T-cell engager clinical candidate nominated in the Astellas collaboration. CytomX has a consistent track record of forming new strategic research and development alliances and achieving preclinical research and clinical milestones. Partnering is expected to remain an important part of the Company’s strategy in 2024 and beyond.

2024 PRIORITIES AND KEY MILESTONES

CytomX enters 2024 in a strong strategic position and with significant momentum in its pipeline. The company’s key pipeline programs are progressing towards clinical proof of concept and key milestones in 2024 including:

CX-904 (EGFRxCD3): Continued enrollment into Phase 1a dose escalation. Phase 1a initial dose escalation data are expected in the second half of 2024. These data are expected to inform a potential decision, to be taken with Amgen, to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types in 2024.
CX-2051 (EpCAM): Initiation of Phase 1 dose escalation in solid tumors with known EpCAM expression including metastatic colorectal cancer as one priority indication is expected in the first half of 2024.
CX-801 (IFNα2b): Initiation of Phase 1 dose escalation in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma is expected in the first half of 2024.
Next-Generation CTLA-4 Program: Continued clinical progress for BMS-986288 including proof-of-concept studies in MSS CRC and NSCLC. Bristol Myers Squibb anticipates data from the study will be available in 2024.
Collaborations: Continuation of drug discovery and development activities with Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna with potential pre-clinical and clinical milestones possible in 2024 and and beyond.
Financial: CytomX ended the third quarter of 2023 with $194 million of cash and cash equivalents. Cash runway is projected to the second half of 2025, excluding any potential milestones from existing collaborations or new business development.

On January 4, 2024 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported a clinical update, including its roadmap for advancing Nana-val’s clinical development in 2024 (Press release, Viracta Therapeutics, JAN 4, 2024, View Source [SID1234638985]). Nana-val (nanatinostat in combination with valganciclovir), is the company’s all-oral investigational therapy targeting Epstein-Barr virus-associated cancers.

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Anticipated Key 2024 Milestones
Pivotal NAVAL-1 study of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphomas

Complete enrollment of Stage 2 in the R/R EBV+ peripheral T-cell lymphoma (PTCL) cohort of patients treated with Nana-val (n=11) in the first quarter of 2024.
Report Stage 1 data from both arms of the R/R EBV+ PTCL cohort (in patients treated with nanatinostat, with [n=10] or without [n=10] valganciclovir) in the first half of 2024.
Meet with the U.S. Food and Drug Administration (FDA) to discuss additional requirements for accelerated approval by mid-2024.
Enroll patients with R/R EBV+ PTCL into the post-Phase 2 expansion cohort to support potential accelerated approval.
Present Stage 2 data from patients with R/R EBV+ PTCL in the second half of 2024.
Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) and R/R EBV+ post-transplant lymphoproliferative disorder (PTLD) by year-end 2024.
Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors (Study 301)

Determine the recommended Phase 2 dose (RP2D) by investigating the novel split daily dosing (SDD) regimen at higher dose levels of Nana-val in the second half of 2024.
Initiate a dose-optimization cohort to confirm the RP2D as part of the study’s Phase 2 expansion by year-end 2024.
"Our primary focus in 2024 is the speed to market strategy for Nana-val in patients with relapsed or refractory EBV-positive PTCL, supported by its accelerating pace of enrollment into Stage 2 and plans to engage with the FDA to discuss Nana-val’s potential accelerated approval pathway in mid-2024," said Mark Rothera, President and Chief Executive Officer of Viracta. "Additionally, we are encouraged by the progress of the Phase 1b/2 trial of Nana-val in patients with advanced EBV-positive solid tumors, which is now enrolling and treating patients with the novel split daily dosing regimen, and we remain on track to expand the study into Phase 2 in 2024. The growing clinical data together with the recent orphan drug designation granted by FDA for the treatment of nasopharyngeal carcinoma further positions Nana-val as a tumor-agnostic approach to address the high unmet medical need for patients with EBV-associated cancers, including both lymphomas and solid tumors. With an anticipated cash runway into 2025, we are well-positioned for a successful 2024."

Recent Clinical Trial Updates
Pivotal NAVAL-1 study of Nana-val in patients with R/R EBV+ lymphomas

Completed enrollment of Stage 1 in the R/R EBV+ PTCL cohort of patients, and enrollment into Stage 2 continues to accelerate, as nearly half of the Stage 2 patients have been enrolled.
The protocol was amended to additionally enable enrollment of second-line R/R EBV+ DLBCL patients and R/R EBV+ PTLD patients, including pediatric EBV+ PTLD patients ≥ 12 years of age.
Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors (Study 301)

Initiated enrollment of the sixth dose cohort of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) evaluating the new SDD regimen.
In December 2023, the FDA granted an orphan drug designation (ODD) to Nana-val for the treatment of NPC, the fifth ODD granted to Nana-val by the FDA and the seventh ODD for Nana-val globally.
Confirmed partial responses without dose-limiting toxicities through the initial five dose cohorts. Further, new preclinical data presented at ESMO (Free ESMO Whitepaper) Asia Congress 2023 support continued dose-escalation to enhance Nana-val’s antitumor activity.
Best responses through the fifth dose cohort included two confirmed partial responses and five stable diseases out of 17 patients.
About NAVAL-1
NAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of three indication cohorts based on EBV+ lymphoma subtype. If two objective responses are achieved within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration.

About the Phase 1b/2 Study of Nana-val in Patients with Advanced EBV+ Solid Tumors (Study 301)
This Phase 1b/2 trial (NCT05166577) is an open-label, multinational clinical trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation part is designed to evaluate safety and to select the recommended Phase 2 dose (RP2D) of Nana-val in patients with recurrent or metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC). Along with the U.S. Food and Drug Administration’s Project Optimus initiative, at the start of Phase 2, up to 40 patients with R/M EBV+ NPC will be randomized to receive either the RP2D or a dose level below the RP2D in a dose-optimization cohort. Once the RP2D has been confirmed, up to 60 patients with R/M EBV+ NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to further evaluate antitumor activity, safety and tolerability, pharmacokinetics, and potential pharmacodynamic biomarkers. Additionally, patients with other advanced EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort.

About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other advanced EBV+ solid tumors.

About EBV-Associated Cancers
Approximately 90% of the world’s adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer.

On January 4, 2024 FibroBiologics, Inc., a clinical-stage biotechnology company focused on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported that it will attend the Biotech Showcase in San Francisco, CA from January 8-10, 2024 (Press release, FibroBiologics, JAN 4, 2024, View Source [SID1234638970]). Biotech Showcase is a premier event for private and mid-cap biotechnology companies to highlight their innovation by connecting with global investors and engaging with executives from prominent biopharmaceutical interests.

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FibroBiologics will be represented by Chairman, Founder, and Chief Executive Officer Pete O’Heeron and Chief Scientific Officer Hamid Khoja, Ph.D., who will be presenting on FibroBiologics’ recent corporate milestones and research advances using fibroblasts in indications as diverse as multiple sclerosis, degenerative disc disease, and wound healing.

Details of the event are as follows:
Event: Biotech Showcase 2024
Date: January 9, 2024, at 11:30 a.m. Pacific Standard Time
Location: Hilton San Francisco – Union Square, San Francisco, CA
Track: Yosemite C (Ballroom Level)

"We believe fibroblast-based therapies have been overlooked as a compelling alternative to stem cells and anticipate our presentation at Biotech Showcase will be an opportunity to connect with fellow experts in the field, sharing our latest discoveries about our innovative therapies and initiating dialogue within the community," said Mr. O’Heeron.