On November 12, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported updated results from its Phase 1/1b clinical trial of mupadolimab (formerly CPI-006), a humanized monoclonal antibody directed against CD73 with a proposed unique mechanism of activating B cells to generate immune responses to tumor antigens and viruses, and inhibiting the production of immunosuppressive adenosine in the tumor microenvironment (Press release, Corvus Pharmaceuticals, NOV 12, 2021, View Source [SID1234595334]). The clinical data, along with pre-clinical data, further strengthen mupadolimab’s mechanism of action and demonstrate its potential anti-tumor activity in cancer patients.

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The data were made available today in an on-demand, electronic poster format for registered participants of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, which is taking place from November 10 to 14, 2021. The poster is also being presented in-person at SITC (Free SITC Whitepaper) by Jason J. Luke, M.D., principal investigator of the trial and Director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center and Associate Professor of Medicine at the University of Pittsburgh School of Medicine.

"We continue to broaden our understanding of mupadolimab’s unique characteristics as an anti-CD73 antibody that exhibits potent blockade of adenosine production as well as powerful adenosine-independent effects on the immune system that result in enhanced B cell and T cell function," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Recent research has demonstrated that B cells have a vital role in the immune response to tumors from non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers (HNSCC) each frequently containing high numbers of B cells in the tumor and tumor microenvironment. In our Phase 1/1b clinical trial, treatment with mupadolimab in these cancers resulted in tumor regression in patients that failed to respond to, and progressed through prior treatment with anti-PD(L)-1 therapy. This suggests that, in some patients, mupadolimab’s novel mechanism of action may overcome resistance to anti-PD(L)1 therapies."

Dr. Miller added, "In addition, the results presented at SITC (Free SITC Whitepaper) provide important data on the immunologic effects of mupadolimab, as well as pharmacokinetic, pharmacodynamic and safety data for monotherapy and combination therapy. Looking forward, we are now enrolling additional patients with HNSCC and NSCLC in expansion cohorts. These patients will receive the combination of mupadolimab and pembrolizumab and we anticipate reporting results from these expansion cohorts in early 2022. We believe that the data presented at SITC (Free SITC Whitepaper) and data obtained from ongoing expansion cohorts may provide the rationale for a randomized controlled study of mupadolimab, which we expect could begin in 2022."

Mupadolimab Phase 1/1b Clinical Trial Key Results Presented at SITC (Free SITC Whitepaper) 2021
Mupadolimab is being studied in a Phase 1/1b clinical trial in patients with a variety of advanced, refractory cancers, including NSCLC and HNSCC that have failed previous treatment with anti-PD-1 therapy and chemotherapy. The study design included mupadolimab dose escalation from 1 mg/kg to 24 mg/kg intravenous infusion every 3 weeks until disease progression or dose limiting toxicities were reached. Cohorts of patients were treated with mupadolimab monotherapy; combination with ciforadenant, Corvus’ small molecule inhibitor of the A2A receptor; combination with pembrolizumab; or triplet combination with ciforadenant and pembrolizumab.

The data presented at SITC (Free SITC Whitepaper) showed that mupadolimab doses of 12mg/kg are optimal, resulting in complete occupancy of the CD73 target and maximal effects on B cell activation. In the assessment of anti- tumor activity in patients receiving optimal doses of mupadolimab, tumor regression (not meeting the threshold for partial response by RECIST) was seen in five patients who had progressive disease as best response to most recent therapy, which included anti-PD(L)1 therapy (see waterfall plot below). This indicates that tumor regression could occur in patients with tumors refractory to anti-PD(L)1 that are treated with mupadolimab.

A figure accompanying this announcement is available at View Source

"The findings of tumor regression with mupadolimab in patients who had grown through their most recent prior therapy with an anti-PD(L)1 is noteworthy. This supports the possibility that mupadolimab’s mechanism of action could serve to add to effectiveness or overcome limitations of current anti-PD(L)1 therapies. This activity would be expected to be more impactful in patients treated earlier in their disease, with less prior therapies," said Dr. Luke. "We look forward to expanding our experience with mupadolimab in combination with anti-PD(L)-1 in earlier lines of therapy."

Additional mupadolimab oncology program highlights from the SITC (Free SITC Whitepaper) poster presentation include:

Pharmacokinetic (PK) and pharmacodynamic (PD) results showed complete CD73 target occupancy with mupadolimab at doses of 12 mg/kg and higher. Doses up to 18 mg/kg were tolerated without dose limiting toxicities.
Within 30 minutes of mupadolimab intravenous infusion, a reduction in B cells in blood was seen, consistent with redistribution of B cells to lymphoid tissues.
Corvus presented updated preclinical data characterizing mupadolimab’s dual mechanism of action: Mupadolimab is an IgG1 humanized antibody that has been engineered to be Fc gamma receptor binding deficient. Lab data demonstrated that it completely blocks adenosine production from AMP without a hook effect, which is a reduction in binding with higher concentrations of antibody that may limit efficacy to a narrow range of concentrations. In vitro studies showed that binding of mupadolimab to B cells stimulates activation and differentiation into plasmablasts (antibody producing cells) in a mechanism that is independent of adenosine. In vitro studies showed that T cell functions are inhibited by adenosine monophosphate (AMP) and restored by the addition of mupadolimab.
Corvus analyzed CD73 expression in tumor biopsies, obtained from outside sources, using immunohistochemistry from 75 patients with NSCLC and 31 patients with HNSCC. High CD73 expression was seen in tumor cells and/or stroma in all patients. In HNSCC, CD73 expression is predominantly stromal.
Corvus is also developing mupadolimab as a therapeutic for infectious disease, starting with COVID-19. Preclinical data with humanized mice (mice with human immune system) inoculated with SARS-CoV-2 and influenza viral antigens showed that treatment with mupadolimab enhanced antibody responses that were viral specific, demonstrating its potential to be a universal therapy or adjuvant for viral diseases. In September, Corvus announced results from its Phase 3 clinical trial of mupadolimab for COVID-19, which have been published online at medRxiv.org. The results, which cover 40 patients that were enrolled in the trial prior to its voluntary discontinuation, suggest improvement in the primary and key secondary endpoints in patients treated with single doses of mupadolimab at 2mg/kg and 1mg/kg compared to placebo. Due to the small sample size, the results did not reach statistical significance. No drug related adverse events were reported in the trial.

Conference Call, Webcast and Presentation Slides
Corvus will host a conference call and webcast today, November 12, 2021, at 9:00 a.m. ET (6:00 a.m. PT), to discuss the update on mupadolimab and other topics. The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) and using the conference ID 13724618. The live webcast, which will include presentation slides, may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

On November 12, 2021 Greenwich LifeSciences Presented the Corporate Presentation (Presentation, Greenwich LifeSciences, NOV 12, 2021, View Source [SID1234595326]).

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On November 12, 2021 Anaveon, a clinical stage, immuno-oncology company, reported that it will present a poster on its lead program ANV419 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held from Wednesday, November 10, 2021 to Sunday, November 14, 2021 (Press release, Anaveon, NOV 12, 2021, View Source [SID1234595325]).

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Non-Human Primate (NHP) data presented demonstrate that ANV419 has excellent safety and tolerability and selectively proliferates CD8 T cells and natural killer cells. Despite rapid intravenous injection over 1 minute, there were no signs of vascular leak syndrome, cytokine release syndrome or eosinophilia that are normally associated with recombinant IL-2 (aldesleukin) treatment up to the highest treated dose, with the highest dose of 0.3mg/kg considered the No Observed Adverse Effect Level (NOAEL). This favorable pharmacokinetic (PK)/pharmacodynamic (PD) and safety profile of ANV419 in NHPs supports a clinical dosing interval of every two weeks or greater at therapeutically relevant doses.

Based on the safety and the strong pharmacodynamic effects demonstrated in NHPs, Anaveon is conducting a Phase I ascending dose study of ANV419 monotherapy in patients with advanced solid tumors to determine safety and identify a Recommended Phase II Dose (RP2D) for ANV419 treatment. Early clinical data of ANV419 are consistent with the NHP results and suggest an attractive safety/PD relationship, warranting further development in patients with malignant tumors. ANV419, a powerful and selective interleukin-2 (IL-2) agonist, has been designed to overcome known challenges with tolerability and selectivity of recombinant human IL-2.

The abstract is available on the SITC (Free SITC Whitepaper) website and the accompanying poster will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform and also available on Anaveon’s website.

"We are highly encouraged by the data presented at SITC (Free SITC Whitepaper)," said Christoph Huber, Chief Scientific Officer of Anaveon. "ANV149 has shown a class leading safety profile and we look forward to presenting the first clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting in April 2022 and to exploring the drug’s efficacy in a range of cancer indications, as well as in combination with other therapeutics."

Details of the poster presentation:

Title: Favorable pre-clinical safety profile of the novel not-alpha IL-2 agonist ANV419 supports first in human clinical development

Poster Presentation: Poster #703 – The ePoster will be on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform from 7:00 am ET on Friday, November 12, 2021 and will be presented on both Friday, November 12, 2021 and Saturday November 13, 2021 between 7.00 am and 8.30 am ET.

Anaveon was founded in December 2017. The Company is developing selective IL-2 Receptor Agonists, which have the potential to therapeutically enhance a patient’s immune system to respond to tumors. In the body, human IL-2 stimulates a type of immune cell, called a T-cell, to multiply and become activated. Activated T-cells are able to attack tumors and, consistent with this approach, human IL-2 is already approved as a therapeutic for the treatment of metastatic melanoma and renal cancer; however, due to lack of specificity, human IL-2 has severe, dose-limiting side effects and a short half-life that requires frequent infusions. The lead compound, ANV419, is designed to preferentially signal through the IL-2 beta/gamma receptor and therefore overcome known challenges of human IL-2. This novel type of therapeutic, if approved, could potentially have a wide utility in oncology, including in combination with cell therapies, vaccines, checkpoint inhibitors and radiotherapy.

On November 12, 2021 Amgen (NASDAQ: AMGN) reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of LUMYKRAS (sotorasib), known as LUMAKRAS in the U.S., for the treatment of adults with advanced non-small-cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy (Press release, Amgen, NOV 12, 2021, View Source [SID1234595324]). If the European Commission follows the recommendation for approval, LUMYKRAS will be the first targeted therapy available in the European Union (EU) for the KRAS G12C mutation, one of the most prevalent biomarkers in NSCLC.

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"After 40 years of cancer research to target the KRAS mutation, many in the scientific community believed that KRAS was ‘undruggable’ leaving patients with this mutation with limited treatment options," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "The LUMYKRAS development program was designed to bring this targeted therapy to patients with KRAS G12C-mutated non-small cell lung cancer as quickly as possible. The EMA CHMP positive opinion brings patients in the EU closer to this transformative therapy and highlights our commitment to improving patient outcomes in difficult-to-treat cancers."

The CHMP based its positive opinion on results from the Phase 2 CodeBreaK 100 clinical trial, the largest trial conducted to date exclusively for patients with the KRAS G12C mutation. CodeBreaK 100 enrolled 126 patients, 124 of whom had centrally evaluable lesions at baseline. In the trial, LUMYKRAS demonstrated favorable efficacy and tolerability in these 124 patients with KRAS G12C mutation-positive NSCLC who had disease progression after receiving an immunotherapy and/or chemotherapy. LUMYKRAS 960 mg, administered orally once-daily, demonstrated an objective response rate (a proportion of patients with ≥ 30% decrease in the sum of the longest diameter of the target lesions compared with baseline) of 37.1% (95% CI: 28.6-46.2) a median duration of response (DoR) of 11.1 months, disease control rate (DCR) of 80.6% and median overall survival (OS) of 12.5 months.3

The most common treatment-related adverse reactions were diarrhea (32%), nausea (19%), increase in aminotransferase level (ALT) and increase in the aspartate aminotransferase level (AST) (15% each). The most common severe (grade ≥ 3) treatment-related adverse reactions were increased alanine aminotransferase (ALT; 6%), increased aspartate aminotransferase (AST; 6%), and diarrhea (4%). Only 7% of patients discontinued treatment due to treatment-related adverse events.3

The detailed CodeBreaK 100 Phase 2 data in NSCLC were presented at the 2020 World Conference on Lung Cancer (WCLC) and published in the New England Journal of Medicine (NEJM).

"Patients with KRAS G12C-mutated NSCLC face poor prognosis and usually do not respond to currently available treatments," said Prof. Fabrice Barlesi, general director of Gustave Roussy, Villejuif, France. "The introduction of sotorasib in the EU as a novel treatment option would be a welcome development as a potentially new standard of care for the tens of thousands of patients with NSCLC living with this common mutation."

"The rapid tumor shrinkage and durable responses observed in the large-scale CodeBreaK 100 clinical trial that support this positive opinion are impressive and demonstrate the potential benefit sotorasib can offer our patients who have the KRAS G12C mutation," said Prof. Jürgen Wolf, M.D., medical director, Center for Integrated Oncology, University Hospital of Cologne, Germany. "As we move closer to a potential EMA approval, it is critical that we continue to increase the implementation of biomarker testing so we can match the right patients who may benefit from this first-in-class targeted therapy as quickly as possible."

NSCLC accounts for approximately 84% of the 2.2 million new lung cancer diagnoses each year worldwide, including approximately 400,000 new cases in Europe.4,5 KRAS G12C is one of the most prevalent driver mutations in NSCLC, with about 13-15% of patients with non-squamous NSCLC having the KRASG12C mutation.6,7 LUMYKRAS, which is administered orally in a tablet formulation, binds with the mutated KRAS G12C protein keeping the mutated protein in an inactive state, thus preventing it from switching to its favored active state that supports cancer cell growth. LUMYKRAS has been shown to irreversibly bind to the inactive KRAS G12C protein, permanently locking it in an inactive state, inhibiting oncogenic signaling and tumorigenesis.3,8

The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use throughout the European Union. A European Commission decision is expected by mid-January 2022.

In May 2021, LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S., under accelerated approval. Regulatory approvals have also been received in the United Arab Emirates (LUMAKRAS), and under Project Orbis in Canada (LUMAKRAS) and Great Britain (LUMYKRAS). In addition to our EMA MAA, there are 16 regulatory applications pending review around the world.

About LUMAKRAS/LUMYKRAS (sotorasib)
Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS/LUMYKRAS, a KRASG12C inhibitor.8 LUMAKRAS/LUMYKRAS has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation.9

Amgen is progressing the largest and broadest global KRASG12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, including triplets, with clinical trial sites spanning five continents. To date, LUMAKRAS/LUMYKRAS has treated over 3,000 patients around the world through the clinical development program and commercial use.

In the U.S., LUMAKRAS was reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen is participating in the FDA’s Project Orbis initiative and through the initiative, has Marketing Authorization Applications (MAAs) for sotorasib in review in Australia and Brazil. Additionally, Amgen has submitted MAAs in the Japan, Switzerland, South Korea, Singapore, Israel, Turkey, Taiwan, Colombia, Thailand, Mexico, Hong Kong, Saudi Arabia, Argentina and Kuwait.

LUMAKRAS/LUMYKRAS is also being studied in multiple other solid tumors.10

About Non-Small Cell Lung Cancer and the KRAS G12C Mutation
Lung cancer is the leading cause of cancer-related deaths worldwide, and it accounts for more deaths worldwide than colon cancer, breast cancer and prostate cancer combined.11 Overall survival rates for NSCLC are improving but remain poor for patients with advanced disease and 5-year survival is only 7% for those with metastatic disease.12

KRAS G12C is the most common KRAS mutation in NSCLC.13 About 13% of patients with non-squamous NSCLC harbor the KRAS G12C mutation.1 Unmet medical need remains high and treatment options are limited for NSCLC patients with the KRAS G12C mutation whose first-line treatment has failed to work or has stopped working. The outcomes with current therapies are suboptimal with a median progression-free survival of approximately 4 months following second-line treatment of KRAS G12C-mutated NSCLC.14

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors.11 Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline3. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and results have been submitted for publication.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. A Phase 2 randomized study will evaluate sotorasib in patients with stage IV KRAS G12C-mutated NSCLC in need of first-line treatment (CodeBreaK 201).

For information, please visit www.hcp.codebreaktrials.com.

LUMAKRAS (sotorasib) U.S. Indication

LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

LUMAKRAS (sotorasib) Important U.S. Safety Information

Hepatotoxicity

LUMAKRAS can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
Among 357 patients who received LUMAKRAS in CodeBreaK 100, hepatotoxicity occurred in 1.7% (all grades) and 1.4% (Grade 3). A total of 18% of patients who received LUMAKRAS had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity.
Monitor liver function tests (ALT, AST and total bilirubin) prior to the start of LUMAKRAS every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations.
Withhold, dose reduce or permanently discontinue LUMAKRAS based on severity of adverse reaction.
Interstitial Lung Disease (ILD)/Pneumonitis

LUMAKRAS can cause ILD/pneumonitis that can be fatal. Among 357 patients who received LUMAKRAS in CodeBreaK 100, ILD/pneumonitis occurred in 0.8% of patients, all cases were Grade 3 or 4 at onset, and 1 case was fatal. LUMAKRAS was discontinued due to ILD/pneumonitis in 0.6% of patients.
Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS if no other potential causes of ILD/pneumonitis are identified.
Most Common Adverse Reactions

The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough.
Drug Interactions

Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS.
If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS 4 hours before or 10 hours after a locally acting antacid.

On November 12, 2021 Alligator Bioscience AB ("Alligator" or the "Company") reported new preclinical data highlighting the 4-1BB (CD137) antibody ATOR-1017 including an update on the ongoing phase 1 study (Press release, Alligator Bioscience, NOV 12, 2021, View Source [SID1234595323]). ATOR-1017, a promising candidate for immunotherapy with enormous potential for combination with other immunomodulatory antibodies, will be presented at the Society for Immunotherapy Cancer’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting & Pre-Conference Programs virtually on November 10th – 14th, 2021.

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"By combining ATOR-1017 with antibodies blocking PD-1, tumor infiltrating T cells, in particular exhausted tumor specific T cells, can be more effectively activated and potentially increase the response rate in multiple types of cancer," stated Karin Enell Smith, PhD, MS, Principal Scientist at Alligator Bioscience. "The functional activation profile of ATOR-1017 is expected to minimize the risk of systemic immune activation and toxicity, by directing a potent immune response to immune cells in tumor tissue and tumor draining lymph nodes. This is supported by early data from the ongoing first-in human phase I study where ATOR-1017 has been shown to be safe and tolerable. These results support further clinical development of ATOR-1017 in combination with PD-1 blocking antibodies"

In addition, the poster includes data from the 360 mg cohort of the ongoing ATOR-1017 phase 1 study.

Title: ATOR-1017, a second generation 4-1BB antibody with potential to

enhance efficacy of PD-1 therapies

Presenter: Karin Enell Smith, PhD, MS

Virtual Meeting: E-Posters Session: Poster

The above poster presentations will be available online at www. View Source on Saturday, November 13, 2021.