On November 6, 2024 Bio-Techne Corporation (NASDAQ: TECH) reported it will showcase its market-leading portfolio to advance cancer research from target discovery to personalized medicine and cell therapy development at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, taking place November 6-10, 2024, in Houston, Texas (Press release, Bio-Techne, NOV 6, 2024, View Source [SID1234647804]).

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Bio-Techne’s spatial biology brands, Advanced Cell Diagnostics (ACD) and Lunaphore, are revolutionizing spatial biology research with their pioneering innovations that are advancing the development of tailored immunotherapies to improve patient outcomes.

At booth #613, ACD will present its wide range of spatial multiomics products. These products leverage the precise RNAscope technology and an advanced protease-free workflow for same-section RNA and protein detection assays. In combination, these capabilities empower drug discovery research, accelerate cell and gene therapy workflows, enable the characterization of key soluble factors and the immune landscape, and support the development of improved diagnostic tools for an accelerated path from translational research to clinical applications.

At booth #701, Lunaphore will showcase its fully-automated, end-to-end COMET suite, designed to provide innovative solutions in spatial biology for the translational research community. The complete portfolio will be showcased through product demonstrations. Furthermore, attendees can test the HORIZON image analysis software, tailored for COMET hyperplex images, offering new features for intuitive multiomics data and neighborhood analysis.

"Bio-Techne’s spatial biology solutions lead the way in developing groundbreaking innovations, shaping the future of scientific discovery," said Dr. Matt McManus, President of Bio-Techne’s Diagnostics & Spatial Biology Segment. "Our mission is to empower scientists with cutting-edge technologies to accelerate research and develop the next-generation therapies. We are excited to feature our spatial portfolio at this prestigious conference."

Several scientists from the company and its partners will present posters at the conference highlighting how the industry-leading capabilities of Bio-Techne’s solutions enable key research and clinical applications.

Bio-Techne poster presentations:

Multiomic mapping of the brain: same-section, fully-automated spatial RNA and protein detection on mouse frozen tissues
Friday, November 8 at 12:15 – 13:45 & 17:30 – 19:00
Presenter: Alice Comberlato, Ph.D., Lunaphore, a Bio-Techne Brand
Poster number: #81

Novel fully-automated multiomics assay for profiling immune cell landscape and activation states
Friday, November 8 at 12:15 – 13:45 & 17:30 – 19:00
Presenter: Anushka Dikshit, Ph.D, Advanced Cell Diagnostics, a Bio-Techne Brand
Poster number: #85

Qualification of immune checkpoint biomarker antibodies in glioblastoma with multiplex immunofluorescence
Friday, November 8 at 12:15 – 13:45 & 17:30 – 19:00
Presenter: Ruha Adelkar, Bio-Techne
Poster number: #69

High throughput spatial mulitomic assay for assessing immune cell phenotype and function in the tumor microenvironment
Saturday, November 9 at 12:15- 13:45 & 19:00 – 20:30
Presenter: Anushka Dikshit, Ph.D., Advanced Cell Diagnostics, a Bio-Techne Brand
Poster number: #86

Fully automated, novel protease-free workflow for co-detection of protein-protein interaction, individual proteins and mRNA using RNAscope Multiomic LS assay
Saturday, November 9 at 12:15 -13:45 & 19:10 – 20:30
Presenters: Ge-Ah Kim, Advanced Cell Diagnostics, a Bio-Techne Brand
Poster number: #106

A new automated RNAscopeTM assay for the fluorescent co-detection of multiple RNA and protein biomarkers on Roche DISCOVERY ULTRA
Saturday, November 9 at 12:15- 13:45 & 19:10 – 20:30
Presenters: Renzo Adilardi, Advanced Cell Diagnostics, a Bio-Techne Brand
Poster number: #206

Poster presentations, in collaboration

Application of a novel multiplex imaging-based immunotherapy panel and AI-powered analysis solution for spatial biomarker identification on immunotherapy-treated melanoma patients [research conducted in collaboration with Prof. Paolo Ascierto, National Tumor Institute Fondazione G. Pascale and Nucleai]
Friday, November 8 at 12:15 – 13:45 & 17:30 – 19:00
Presenter: Ettai Markovits, Ph.D., Nucleai
Poster number: #117

Enhanced analysis of tumor microenvironment and immune regulation via an automated adjustable signal amplification technique for multiplex immunofluorescence [research conducted in collaboration with Prof. Janis Taube, Johns Hopkins University School of Medicine]
Saturday, November 9 at13:45 & 19:10 – 20:30
Presenter: François Rivest, Ph.D., Lunaphore, a Bio-Techne Brand
Poster number: #124

On November 6, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported it will participate in the Jefferies London Healthcare Conference on November 20, 2024, with a fireside chat at 2:30 p.m. GMT (Press release, BeiGene, NOV 6, 2024, View Source [SID1234647803]).

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The live webcast of this event can be accessed from the investors section of BeiGene’s website at View Source, View Source, View Source An archived replay will be available for 90 days following the event.

On November 6, 2024 Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease, reported an overview of business updates and announced financial results for the third quarter of 2024 (Press release, Barinthus Biotherapeutics, NOV 6, 2024, View Source [SID1234647802]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We continue our strong execution on our clinical trials, completing enrollment in the HBV003 trial of VTP-300 in chronic hepatitis B, and advancing VTP-1000 in celiac disease into the clinic with the first in human study of the novel SNAP-TI platform," said Dr. Leon Hooftman, Chief Medical Officer of Barinthus Bio. "We expect a data rich fourth quarter from the VTP-300 chronic hepatitis B program, with updated interim readouts from both the HBV003 and IM-PROVE II trials accepted as late-breaking abstracts at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2024. These updates will provide more mature data than previously disclosed as participants progress and move towards a potential functional cure."

Third Quarter 2024 and Recent Corporate Developments

VTP-300 (Chronic hepatitis B)
In September 2024, enrollment was completed in the HBV003 trial of VTP-300 in 121 adult participants with chronic hepatitis B. The Phase 2b trial is designed to obtain critical dosing information for a potential functional cure regimen for chronic hepatitis B, with participants receiving VTP-300 and low-dose (LD) nivolumab.
Earlier this year, interim data from the HBV003 trial was presented at the European Association for the Study of the Liver (EASL) Congress and demonstrated that treatment with VTP-300 and LD nivolumab was generally well-tolerated and led to a sustained decline in Hepatitis B surface antigen (HBsAg) levels. Seventy-six percent of participants (n=16/21) assessed for nucleos(t)ide analogue (NUC) therapy discontinuation met the criteria. Sixty-seven percent of participants (n=14/21) assessed for NUC discontinuation had HBsAg <10 IU/mL at Week 24 or later. Nineteen percent of the eligible participants (n=4/21) reached undetectable levels of HBsAg, with 2 of these patients maintaining undetectable levels for over 16 weeks.

VTP-1000 (Celiac Disease)
In September 2024, we initiated the first-in-human Phase 1 AVALON trial of VTP-1000 in adults with celiac disease. The randomized, placebo-controlled clinical trial, which includes a controlled gluten challenge, will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000.

VTP-850 (Prostate Cancer)
In October 2024, we announced that the PCA001 trial of VTP-850 in men with rising prostate-specific antigen (PSA) after definitive local therapy for prostate cancer (i.e., biochemical recurrence) had completed patient enrollment of 22 participants. The Phase 1 trial is designed to evaluate safety and efficacy, as measured by PSA and T cell response. We expect to have data from the Phase 1 trial in the first half of 2025.

Financial Update
In October 2024, we were informed that an additional $15.0 million of revenue was due to the Company from Oxford University Innovation (OUI) in relation to the Company’s share of royalties received by OUI, as a result of prior commercial sales of Vaxzevria by AstraZeneca. We expect that this additional cash, when received, will enable us to fund our research and development plans further into the second quarter of 2026.

Upcoming Milestones
VTP-300 (Chronic hepatitis B)
In the fourth quarter of 2024, we expect to announce updated data from the VTP-300 program in ongoing clinical trials in chronic hepatitis B at AASLD – The Liver Meeting 2024 scheduled from November 15-19, 2024 in San Diego, CA:
•Updated interim data from HBV003, the Phase 2b trial evaluating additional dosing of VTP-300 and timing of PD-1 inhibition, accepted as a late-breaking oral presentation.
•Updated interim data from the Phase 2a IM-PROVE II clinical trial evaluating the combination of VTP-300 and Arbutus Biopharma’s imdusiran, accepted as a late-breaking poster.

VTP-1000 (Celiac Disease)
In the first half of 2025, we expect to announce data from the single ascending dose part of the Phase 1 AVALON trial of VTP-1000 in adults with celiac disease.

VTP-850 (Prostate Cancer)

In the first half of 2025, we expect to announce results of the Phase 1 PCA001 trial of VTP-850 in men with rising PSA after definitive local therapy for prostate cancer (i.e., biochemical recurrence).

Third Quarter 2024 Financial Highlights

•Cash position: As of September 30, 2024, cash, cash equivalents and restricted cash were $106.1 million, compared to $117.8 million as of June 30, 2024. The net cash used in operating activities was $18.2 million in the third quarter of 2024, primarily resulting from the development of our pipeline and ongoing clinical trials, offset by $6.2 million due to the effect of foreign exchange rates on cash balances. Based on our current operating plans, we expect our available resources to fund operating expenses and capital expenditure requirements into the second quarter of 2026.

•Revenue: Revenue consisted of $15.0 million in the third quarter of 2024 compared to nil in the second quarter of 2024. Revenue was comprised of the Company’s share of royalties received by OUI as a result of prior commercial sales of Vaxzevria by AstraZeneca.There is no expectation of additional payments or that we will be notified of such payments in a timely manner.
•Research and development expenses: Research and development expenses were $11.1 million in the third quarter of 2024 compared to $11.7 million in the second quarter of 2024, with the decrease mainly attributable to a reduction in personnel-related costs as a result of the pipeline prioritization earlier in the year. The quarter-on-quarter R&D expense per program is outlined in the following table.

Period ended Three months ended September 30, 2024
Three months ended June 30, 2024
Change
$000 $000 $000
Direct research and development expenses by program:
VTP-200 HPV $ 246 $ 383 $ (137)
VTP-300 HBV 2,748 3,034 (286)
VTP-500 MERS1
40 304 (264)
VTP-600 NSCLC/ESCC2
108 24 84
VTP-850 Prostate cancer 914 414 500
VTP-1000 Celiac
1,751 1,371 380
Other and earlier stage programs 707 908 (201)
Total direct research and development expenses $ 6,514 $ 6,438 $ 76
Indirect research and development expenses:
Personnel-related (including share-based compensation)3
3,871 4,763 (892)
Facility related 214 342 (128)
Other indirect costs 540 119 421
Total indirect research and development expenses 4,625 5,224 (599)
Total research and development expense $ 11,139 $ 11,662 $ (523)

1The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
2The VTP-600 NSCLC/Esophageal Squamous-Cell Carcinoma (ESCC) Phase 1/2a trial is sponsored by Cancer Research UK.
3This includes $0.6 million of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program funded by CEPI.
•General and administrative expenses: General and administrative expenses were $13.4 million in the third quarter of 2024, compared to $7.2 million in the second quarter of 2024. The increase of $6.2 million relates primarily to a loss of $7.7 million on foreign exchange in the third quarter of 2024, compared to a loss of $0.1 million in the second quarter of 2024.
•Net loss: For the third quarter of 2024, we generated a net loss attributable to shareholders of $8.1 million, or $(0.21) per share on both basic and fully diluted bases, compared to a net loss attributable to shareholders of $16.9 million, or $(0.43) per share on both basic and fully diluted bases in the second quarter of 2024.

On November 6, 2024 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported financial results for the third quarter ended September 30, 2024, and provided a pipeline update on its clinical-stage investigational molecules – targeting TIGIT, HIF-2a, CD73, the A2a/A2b receptors, CD-39, AXL and PD-1 – across multiple common cancers (Press release, Arcus Biosciences, NOV 6, 2024, View Source [SID1234647801]).

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"Through the course of this year, we have presented multiple compelling datasets at medical conferences that we believe have de-risked several programs and support potential best-in-class profiles for our molecules, including our HIF-2a inhibitor casdatifan in ccRCC and our Fc-silent anti-TIGIT antibody domvanalimab in lung and upper gastrointestinal cancers," said Terry Rosen, Ph.D., chief executive officer of Arcus. "Meanwhile, in addition to our rapidly approaching first Phase 3 readout for domvanalimab in gastric cancer, we are aggressively pursuing our development plan for casdatifan, including in the IO-naive ccRCC setting in collaboration with AstraZeneca, and in the post-IO setting with the initiation of our Phase 3 PEAK-1 study in the first half of next year."
Corporate Updates:

•In October 2024, Arcus announced a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with volrustomig, AstraZeneca’s investigational PD-1/CTLA-4 bispecific antibody, in IO-naive patients with ccRCC. AstraZeneca will operationalize the study. This is the second clinical collaboration between Arcus and AstraZeneca. Gilead retains the right to opt in to the development and commercialization for casdatifan after delivery of a qualifying data package.
Pipeline Highlights:

Casdatifan (HIF-2a inhibitor)
Casdatifan Updates:
•First clinical data from the casdatifan 100mg and 50mg expansion cohorts of ARC-20, a Phase 1/1b study in metastatic ccRCC, were presented in an oral plenary session at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in October. Observations from the 100mg daily expansion cohort included:
◦An objective response rate (ORR) of 34% (2 responses are pending confirmation; 25% confirmed ORR), a low rate of primary progression of 19% and a high disease control rate of 81%.
◦The median progression-free survival (PFS) had not been reached at the time of the data cutoff.

◦Together, these data support the potential for casdatifan to be a best-in-class HIF-2a inhibitor for the treatment of ccRCC.
•In the third quarter, Arcus had a successful Type B meeting with the U.S. Federal Drug Administration (FDA) to discuss its first Phase 3 study for casdatifan, PEAK-1, which will evaluate casdatifan in combination with cabozantinib versus cabozantinib in post-IO patients with ccRCC. Arcus is moving rapidly toward the initiation of PEAK-1 in the first half of 2025.
Upcoming Casdatifan Milestones:
•Multiple expansion cohorts of ARC-20 evaluating casdatifan in ccRCC as a monotherapy and in combination with cabozantinib in ccRCC are underway with additional data presentations expected in the next 12 months.
◦100mg (50mg twice daily (BID), capsules) and 50mg expansion cohorts: Updated data, including median PFS, are expected to be presented in the first quarter of 2025.
◦150mg and 100mg (once daily (QD), tablets) expansion cohorts: Initial data are expected to be presented in 2025.
◦100mg of casdatifan plus cabozantinib: Safety data are expected to be presented in 2025.
Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)
Domvanalimab-Zimberelimab Updates:
•Data from Part 1 of ARC-10, a randomized study evaluating domvanalimab plus zimberelimab in PD-L-1 high NSCLC are being presented at the SITC (Free SITC Whitepaper) Annual Meeting in November.
•Domvanalimab plus zimberelimab was associated with greater PFS, overall survival, and objective response rate compared with zimberelimab or chemotherapy.
◦A 36% reduction in risk of death (hazard ratio [HR]=0.64) was observed for domvanalimab plus zimberelimab compared to that of zimberelimab alone.
◦Zimberelimab reached a median overall survival of 2 years, and the median overall survival for domvanalimab plus zimberelimab was not reached.
◦Treatment-related adverse events leading to treatment discontinuation were low (10.5%) for the combination of domvanalimab and zimberelimab.
•Data from an investigator-sponsored trial evaluating domvanalimab plus zimberelimab in anti-PD-(L)1 refractory hepatocellular carcinoma will be presented in an oral session at the SITC (Free SITC Whitepaper) Annual Meeting.
Upcoming Domvanalimab-Zimberelimab Milestones:
•Overall survival data from the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) adenocarcinomas, are expected to be presented in 2025.

CD73-Adenosine Axis: Quemliclustat (small-molecule CD73 inhibitor) and Etrumadenant (A2a/A2b receptor antagonist)

Quemliclustat
•Arcus has initiated PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in pancreatic cancer.
Etrumadenant
•Biomarker data from cohort B of ARC-9, a randomized Phase 1b/2 study evaluating etrumadenant plus zimberelimab, FOLFOX chemotherapy and bevacizumab (EZFB) versus regorafenib in third-line metastatic colorectal cancer (mCRC), are being presented at SITC (Free SITC Whitepaper) in November.

Early Clinical Programs

•Evaluation of AB801, a potent and highly selective small-molecule AXL inhibitor, in the dose-escalation phase of a Phase 1/1b study in patients is ongoing. Arcus anticipates advancing this molecule into expansion cohorts in NSCLC in early 2025.
Financial Results for Third Quarter 2024:
•Cash, Cash Equivalents and Marketable Securities were $1.1 billion as of September 30, 2024, compared to $866 million as of December 31, 2023. The increase during the period is primarily due to the receipt of $320 million in cash from Gilead for their January 2024 equity investment, the receipt of the $100 million option continuation payment from Gilead in July 2024 and proceeds from our $50 million term loan, partially offset by the use of cash in research and development activities. We believe our cash, cash equivalents and marketable securities on-hand will be sufficient to fund operations into mid-2027. Cash, cash equivalents and marketable securities are expected to be between $950 million and $985 million at the end of 2024.
•Revenues were $48 million for the third quarter 2024, compared to $32 million for the same period in 2023. In the third quarter 2024, Arcus recognized $41 million in license and development services revenue related to the advancement of programs and Taiho’s exercise of its option for the license of quemliclustat for the Taiho Territory of $15 million, as well as $7 million in other collaboration revenue primarily related to Gilead’s ongoing rights to access Arcus’s research and development pipeline in accordance with the Gilead collaboration agreement.
•Research and Development (R&D) Expenses were $123 million for the third quarter 2024, compared to $82 million for the same period in 2023. The net increase of $41 million was primarily driven by higher clinical trial and headcount-related costs associated with our late-stage development program activities. Non-cash stock-based compensation expense was $9 million for the third quarter 2024, compared to $8 million for the same period in 2023. For the third quarter 2024 and 2023, Arcus recognized gross reimbursements of $37 million and $33 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration. R&D expense by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.
•General and Administrative (G&A) Expenses were flat for the third quarter 2024, compared to the same period in 2023. Non-cash stock-based compensation expense was $10 million for each of the third quarter 2024 and 2023.
•Net Loss was $92 million for the third quarter 2024, compared to $71 million for the same period in 2023.
Conference Call Information:
Arcus will host a conference call and webcast today, November 6, at 2:00 PM PT / 5:00 PM ET to discuss its third-quarter 2024 financial results and pipeline updates. To access the call, please dial +1 (404) 975-4839 (local) or +1 (833) 470-1428 (toll-free), using Access Code: 940081. Participants may also register for the call online using the following link: View Source;confId=72838. To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcast will be available following the live event.
Arcus Ongoing and Announced Clinical Studies:
Trial Name Arms Setting Status NCT No.
Lung Cancer
STAR-121 dom + zim + chemo vs. pembro + chemo 1L NSCLC (PD-L1 all-comers) Ongoing Registrational Phase 3
NCT05502237
PACIFIC-8 dom + durva vs. durva Unresectable Stage 3 NSCLC Ongoing Registrational Phase 3
NCT05211895
ARC-7 zim vs. dom + zim vs. etruma + dom + zim 1L NSCLC (PD-L1 ≥ 50%) Ongoing Randomized Phase 2
NCT04262856
EDGE-Lung dom +/- zim +/- quemli +/- chemo 1L/2L NSCLC (lung cancer platform study) Ongoing Randomized Phase 2
NCT05676931
VELOCITY-Lung
dom +/- zim +/- etruma +/- sacituzumab govitecan-hziy or other combos
1L/2L NSCLC (lung cancer platform study) Ongoing Randomized Phase 2
NCT05633667
Upper Gastrointestinal Cancers
STAR-221 dom + zim + chemo vs. nivo + chemo 1L Gastric, GEJ and EAC Ongoing Registrational Phase 3
NCT05568095
EDGE-Gastric (ARC-21) dom +/- zim +/- quemli +/- chemo 1L/2L Upper GI Malignancies
Ongoing
Randomized Phase 2
NCT05329766
Colorectal Cancer

ARC-9 etruma + zim + mFOLFOX vs. SOC 2L/3L/3L+ CRC
Ongoing
Randomized Phase 2
NCT04660812
Pancreatic Cancer
PRISM-1 quemli + gem/nab-pac vs. gem/nab-pac 1L PDAC Ongoing Phase 3
NCT06608927
ARC-8 quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac 1L, 2L PDAC Ongoing Randomized Phase 1/1b
NCT04104672
Kidney Cancer
PEAK-1 cas + cabo vs. cabo Post-IO ccRCC Planned Phase 3 TBD
ARC-20 cas, cas + cabo Cancer Patients / ccRCC Ongoing Phase 1/1b
NCT05536141
Other
ARC-25 AB598 Advanced Malignancies Ongoing
NCT05891171
ARC-27 AB801 Advanced Malignancies Ongoing
NCT06120075

cabo: cabozantinib; cas: casdatifan; dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard of care; zim: zimberelimab; ccRCC: clear cell renal cell carcinoma; CRC: colorectal cancer; EAC: esophageal adenocarcinoma; GEJ: gastroesophageal junction; GI: gastrointestinal; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma.

On November 6, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the presentation of additional data from the Phase 1 clinical trial of its breast cancer vaccine at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, will be made publicly available on the Company’s website at 12:15pm CT on November 8, 2024 (Press release, Anixa Biosciences, NOV 6, 2024, View Source [SID1234647800]). Concurrently, the Company will issue a press release providing an analysis of the data.

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As previously announced, the presentation, titled "Phase I Trial of alpha-lactalbumin vaccine in high risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC," will be presented at 12:15pm CT on November 8, 2024 at the SITC (Free SITC Whitepaper) 39th Annual Meeting.

The poster presentation can be viewed starting at 12:15pm CT on November 8, 2024 at View Source