On June 6, 2022 2seventy bio, Inc. (Nasdaq: TSVT) reported that it will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference in Rancho Palos Verdes, CA on Tuesday, June 14, 2022 at 3:20pm PT (Press release, 2seventy bio, JUN 6, 2022, View Source [SID1234615629]).

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A live webcast will be available via the Investors and Media section of 2seventy bio’s website at View Source A replay will be archived on 2seventy bio’s site for 30 days following the event.

On June 6, 2022 Vizgen, the life science company dedicated to improving human health by visualizing single-cell spatial genomics information, reported an expansion of its product roadmap and the availability of the Formalin-Fixed Paraffin-Embedded (FFPE) Human Immuno-oncology data release (Press release, Vizgen, JUN 6, 2022, View Source [SID1234615646]). Vizgen’s product updates will expand sample input flexibility, propel new applications, and empower greater data insights. These updates demonstrate the company’s continued commitment to exposing the research community to the power of spatial genomics. The updates will be presented as oral and poster presentations at the Advances in Genome Biology and Technology (AGBT) 2022 General Meeting, occurring June 6-9, 2022.

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Product roadmap updates for 2H 2022:

Formalin-Fixed Paraffin-Embedded Sample Preparation Solution enabling MERFISH measurements on FFPE tissue samples.
Protein Co-detection Kit for the simultaneous detection of RNA and proteins during a standard MERFISH experiment, enabling multi-omics measurements.
1,000 Plex Gene Panels for the detection of up to 1,000 gene targets within a single MERFISH experiment, resulting in higher gene target coverage which is crucial when performing initial discovery experiments.
The new publicly available FFPE Human Immuno-oncology dataset, generated with Vizgen’s MERSCOPE platform, represents the largest public data set for single-cell spatial genomics ever released. This data was generated using Vizgen’s forthcoming FFPE Sample Preparation Kit. The dataset contains 16 total datasets from 8 FFPE tumor tissue types including breast, colon, lung, liver, skin, prostate, uterine and ovarian, each measuring 500 genes totaling over 4 billion transcripts and 9 million cells cumulatively. The dataset is freely available to participants in the company’s Data Release Program to use in any way and can be downloaded at View Source

"We announced MERSCOPE, the industry’s first solution to combine single-cell and spatial transcriptomics in one turnkey system, and the only commercial platform solution for MERFISH technology, last year at AGBT. Customer adoption from academic research institutions and pharmaceutical companies has been tremendous and our platform continues to lead spatial genomics innovation in the industry," said Terry Lo, President and CEO of Vizgen. "With this first of its kind data release, the research community now has access to an unprecedented scale and quality of single-cell spatial genomics data from cancer samples. As we look to establish new standards in the field, we are excited about our upcoming roadmap of new capabilities that further our mission to improve human health."

For additional information about Vizgen’s Human FFPE Immuno-oncology Data Release, visit: View Source

On June 6, 2022 The US Oncology Network (The Network), US Oncology Research and Ontada reported that Results from the second phase of the broad, collaborative MYLUNG ConsortiumTM research study in non-small cell lung cancer (NSCLC) were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, US Oncology, JUN 6, 2022, View Source [SID1234615662]). The findings show that the incorporation of a remote oncology pharmacist in clinical research teams significantly enhanced patient enrollment for Protocol 2 of the MYLUNG Consortium.

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"Advances in science are quickly enabling new treatment opportunities, but timely enrollment into clinical trials continues to be a challenge," said Elizabeth Koselke, PharmD, senior clinical pharmacist for The Network. "Our study showed that by incorporating an oncology-trained clinical pharmacist to remotely review chemotherapy regimens and a customized recruitment report, we were able to more efficiently screen patients and significantly enhance Protocol 2 enrollment."

Koselke presented the findings during an oral presentation at ASCO (Free ASCO Whitepaper) titled, "Impact of oncology clinical pharmacist intervention on clinical trial enrollment in The US Oncology Network ’s MYLUNG Consortium."

In the study, oncology-trained clinical pharmacists reviewed over an eight-month period 506 newly diagnosed and untreated NSCLC patients from six practices in The Network. Working remotely, the pharmacist reviewed chemotherapy regimen orders and identified, screened and assisted with recruitment of eligible patients for enrollment in MYLUNG Consortium Protocol 2. Working remotely enabled the pharmacists to identify patients quickly across the country who were potential candidates for the study. Enrollments and intervention data were then tracked to monitor the impact of the pharmacist intervention. The study showed that average monthly enrollment was significantly greater after pharmacist intervention (6.6 patients a month per practice) when compared to monthly enrollment before pharmacist intervention (3.4 patients a month per practice).

"These data show that using an interdisciplinary approach to trial enrollment can be an effective method to increase speed and efficiency in real-world clinical research," noted Robert L. Coleman, MD, FACOG, FACS, chief scientific officer of US Oncology Research and the MYLUNG Consortium Principal Investigator. "As we move into Protocol 3 of the MYLUNG Consortium study, we look forward to continuing to validate pharmacist intervention across a wider spectrum of practices across The Network."

An additional study at ASCO (Free ASCO Whitepaper) 2022 took a further look at the MYLUNG Consortium Protocol 1 results that were first presented at ASCO (Free ASCO Whitepaper) 2021. These initial findings reported that fewer than 50 percent of metastatic non-small cell lung cancer patients had the recommended biomarker tests.

In a poster presentation titled, "Predictors of biomarker testing among patients (pts) with metastatic non-small cell lung cancer (mNSCLC)," MYLUNG Consortium researchers examined the social and economic factors associated with biomarker undertesting. The research found that lower comprehensive biomarker testing rates were associated with patients who were of the African American race, seen in a smaller practice size or in a practice in the southern part of the United States, or had squamous cell histology.

"This retrospective analysis took the previously reported research from Protocol 1 and further examined the patient factors that are associated with a lack of biomarker testing," said Dr. Nicholas Robert, chief medical officer of Ontada. "Understanding these clinical and social determinants of health will be important interventions to improve testing rates as we enter into the prospective phases of the MYLUNG Consortium study."

The MYLUNG Consortium is a collaborative and innovative research study comprised of three protocols over a five-year period, enabled through a unique collaboration of various organizations and stakeholders working together across the spectrum of NSCLC drug development, therapy and care. The number of consortium participants continues to grow, all bringing unique perspectives to this innovative study. The MYLUNG Consortium brings together providers and researchers in The Network, US Oncology Research and Ontada with life sciences companies Amgen, AstraZeneca, Eli Lilly and Company, Genentech (a member of the Roche Group), and Mirati Therapeutics, Inc. Patient advocacy groups LUNGevity and GO2 Foundation for Lung Cancer are also participating, playing a key role in the study by keeping the focus on patients. Participating practices in The Network include Illinois Cancer Specialists, Maryland Oncology Hematology, Minnesota Oncology, New York Oncology Hematology, Oncology Hematology Care, Rocky Mountain Cancer Centers, Texas Oncology, Southern Cancer Center, Virginia Cancer Specialists, Virginia Oncology Associates, Willamette Valley Cancer Institute and Research Center and Woodlands Medical Specialists.

Read more about the MYLUNG Consortium here. To schedule a media interview with one of the study investigators, contact Claire Crye at [email protected].

On June 6, 2022 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vectored immunotherapies, reported first data from the completed Phase 1 trial evaluating NOUS-209 in combination with anti-PD-1 checkpoint inhibitor (pembrolizumab) (Press release, NousCom, JUN 6, 2022, View Source [SID1234615678]). The data, presented yesterday in a poster discussion session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrated NOUS-209 to be safe, highly immunogenic and with promising signs of clinical efficacy.

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NOUS-209, Nouscom’s lead product, is an off-the-shelf cancer vaccine targeting 209 shared neoantigens. It has been investigated in a Phase 1 clinical trial, administered in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, for the treatment of deficiency in Mismatch Repair/Microsatellite Instable High (dMMR/MSI-H) unresectable or metastatic gastric, colorectal and gastro-esophageal junction tumors.

The key findings from the study are as follows:

NOUS-209 continues to be safe and well tolerated
NOUS-209 immunogenicity was demonstrated by ex-vivo IFN-ɣ ELISpot assay in 83% of evaluable patients; vaccine induced immune responses were potent and broad
Early signs of clinical efficacy with 10 durable confirmed partial responses (PR), 4 durable stable disease (SD) and 6 progressive disease (PD)
Previously presented interim clinical and translational data of the combination indicated that neoantigen-specific CD8+ T cells expand and diversify only upon treatment with NOUS-209, and successfully infiltrate the tumor microenvironment to exert anti-tumor activity (presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)1 in April 2022).

Professor Marwan G. Fakih, M.D., Medical Oncology Specialist at City of Hope’s Duarte California, and Study investigator said: "With clinical and translational data now available from all patients enrolled in this trial, it is encouraging to see NOUS-209 continuing to be safe, highly immunogenic and have signs of clinical efficacy. Durability of response in all PR and SD patients is particularly encouraging and provides hope for this patient group where there is still a significant unmet need. I look forward to seeing further clinical development of this compound in MSI-H patients."

Dr. Marina Udier, Chief Executive Officer of Nouscom, said: "These new data with all patients enrolled continues to reinforce our compelling and differentiating data for NOUS-209. This is a significant step for the company, validating the potency of our platform in inducing neoantigen specific CD8+ T cells, which are also able to successfully infiltrate tumors of metastatic cancer patients, exerting anti-tumor efficacy. We are actively working on the next stages of NOUS-209’s clinical development plan and look forward to announcing the start of the Phase 2 study in the second half of 2022."

Poster Presentation Details:

Title: First clinical and immunogenicity results including all subjects enrolled in a phase I study of NOUS-209, an off-the-shelf immunotherapy, with pembrolizumab, for the treatment of tumors with a deficiency in mismatch repair/microsatellite instability (dMMR)
The abstract is available here

References

AACR Presentation: Characterization of immune correlates of clinical activity for NOUS-209, an Off-the-Shelf immunotherapy, with Pembrolizumab for treatment of tumors characterized by Microsatellite Instability (MSI), Professor Marwan G. Fakih, M.D.
About NOUS-209

NOUS-209 is an off-the-shelf immunotherapy for Microsatellite Instable High (MSI-H) tumors. MSI-H tumors are characterized by a defective DNA mismatch repair system, which generates highly immunogenic frame shift peptides (frameshift mutations, FSPs) that are not found on healthy tissue.

NOUS-209 is designed to comprise 209 shared FSP neoantigens, selected by Nouscom’s proprietary GENESIS (GE(netic)NE(oantigen)S(election)I(n)S(ilico)) algorithm, on the basis that an average of 50 neoantigens on any patient’s tumor will be shared with those in NOUS-209. Nouscom’s heterologous prime/boost platform clones these FSPs into Great Ape Adenoviral (GAd) and Modified Vaccinia Ankara (MVA) vectors, to generate the viral-vectored vaccine, combined with other immunomodulators to harness the full power of the immune response by generating neoantigen specific CD8+ T cells, which successfully infiltrate tumor to exert anti-tumor activity.

NOUS-209 is in Phase 1 clinical trial (NCT04041310), a multicenter, open label, multiple cohorts, first-in-human clinical study of NOUS-209 in combination with pembrolizumab, designed to evaluate safety, tolerability and immunogenicity and to detect preliminary evidence of anti-tumor activity.

On June 6, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology focused biopharmaceutical company, reported that three posters during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting highlighting data for tivozanib, the Company’s oral, once-daily next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) designed to block the VEGF pathway by potently and selectively inhibiting all three VEGF receptors (Press release, AVEO, JUN 6, 2022, View Source [SID1234615613]).

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Michael Bailey, president and chief executive officer of AVEO, stated, "We are pleased to present these three posters at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, which we believe further showcase the profile of tivozanib as an effective therapy for relapsed or refractory advanced (R/R) renal cell carcinoma (RCC) patients. The overall survival (OS) data from TIVO-3 continue to improve with long-term follow up, including a significant 55% reduction in death with the subset of patients with greater than one year progression free survival (PFS). In addition, we’ve highlighted an analysis of a Phase 2 study which shows tivozanib demonstrated promising activity in non-clear cell renal cell carcinoma (nccRCC) patients, a difficult to treat patient population. A third poster presented at the ASCO (Free ASCO Whitepaper) Annual Meeting showcases our most advanced clinical combination initiative — our ongoing Phase 3 TiNivo-2 clinical trial evaluating tivozanib in combination with nivolumab — which is designed to generate data to support regulatory approval of tivozanib combined with nivolumab in the larger second-line R/R RCC market following prior immune checkpoint inhibitor therapy."

Poster title: "Maturation of overall survival (OS) in TIVO-3 with long-term follow-up." – (Abstract: 4557; Poster: 48)

AVEO presented a poster evaluating OS with extended mean follow-up. As previously announced, at two years following the last patient in the TIVO-3 study, the mean follow-up was 17.9 months (data cutoff was August 2019) and 65% of patients experienced an event, with an OS hazard ratio (HR) of 0.99 (95% CI 0.76–1.29). With subsequent OS analyses and mean follow-up extended to 22.8 months, the data show that 80% of patients ultimately experienced events and the hazard ratio of OS lowered to 0.89 (95% CI 0.70–1.14), trending in favor of tivozanib.

A conditional survival analysis was also performed which looked at OS for patients whose disease was progression free at the 12 month landmark, showing a statistically significant 55% relative reduction in the risk of death with tivozanib over sorafenib in this population (HR 0.45; 95% CI 0.22–0.91). The median OS for those patients achieving 12 month PFS was 48.3 months (tivozanib) as compared to 32.8 months (sorafenib), once again demonstrating the long-term benefit of tivozanib.

Poster title: "Activity of tivozanib in non-clear cell renal cell carcinoma (nccRCC): Subgroup analysis from a phase 2 randomized discontinuation trial." – (Abstract: 4542; Poster: 33)

AVEO presented data from a subgroup analysis of patients with nccRCC who had no prior VEGF targeted treatment in its Phase 2 randomized discontinuation trial evaluating tivozanib. These data showed that the overall response rate (ORR) at 16 weeks in all treated patients with nccRCC was 15.2% by independent radiology review. The best unconfirmed overall response rate (ORR) and confirmed ORR (at any time point) was 31.6% and 21.1%, respectively. The disease control rate was 74%. The median PFS was 6.7 months (204 days). Safety was not analyzed by histology but there were no new safety signals and this was consistent with tivozanib labelling in the intent to treat population.

The analysis concluded that tivozanib demonstrated activity and a favorable safety profile in patients with nccRCC. These data add to the body of evidence supporting VEGFR TKI use in advanced RCC, including in non-clear cell histologies.

Trials in Progress Poster Presentation "TiNivo-2: A phase 3, randomized, controlled, multicenter, open-label study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma who have progressed following one or two lines of therapy where one line was an immune checkpoint inhibitor." – (Abstract: TPS4605; Poster: 92b)

The Company presented a trial in progress poster for the Phase 3 TiNivo-2 trial, which is evaluating the combination of tivozanib and Bristol-Myers Squibb’s OPDIVO (nivolumab), an antibody directed against programmed death-1 (PD-1), versus tivozanib monotherapy for the treatment of RCC patients progressing following prior immune checkpoint inhibitor therapy. Subjects will receive tivozanib 1.34 mg orally once daily for 21 consecutive days followed by seven days off, on the monotherapy arm, and tivozanib 0.89 mg at the same schedule in addition to nivolumab 480 mg intravenously every four weeks on the combination arm.

The primary objective of the study is to compare the PFS of tivozanib in combination with nivolumab to monotherapy tivozanib. A sample size of 326 subjects, with 191 events will provide at least 80% power to detect a 50% improvement in PFS as assessed by IRR. Secondary endpoints include assessment of OS, ORR and duration of response, as well as safety and tolerability. Exploratory endpoints are to assess the quality of life and to investigate the pharmacokinetics of tivozanib.

TiNivo-2 opened for enrollment during the third quarter of 2021 and currently expects to complete enrollment in the first half of 2023.

About FOTIVDA (tivozanib)

FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.1 FOTIVDA was discovered by Kyowa Kirin.

INDICATIONS

FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS
The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.
Females and Males of Reproductive Potential: Can impair fertility.
Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.

About Advanced Renal Cell Carcinoma

According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.2 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,3 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.