On April 29, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that AstraZeneca (LSE/STO/Nasdaq: AZN) has now dosed the first patient in its Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab (PD-L1) in combination with monalizumab (NKG2A) or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) (Press release, Innate Pharma, APR 29, 2022, View Source [SID1234613181]).

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The purpose of the study, which is sponsored by AstraZeneca, is to determine if the addition of monalizumab or oleclumab to standard-of-care durvalumab improves outcomes for patients in this setting.

Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells.

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

"We are very pleased that our key late-stage asset, monalizumab, has progressed into a second Phase 3 trial with our partner, AstraZeneca. The launch of PACIFIC-9 represents an important financial milestone for Innate, as it triggers a $50 million milestone payment that reinforces our cash position," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Based on the recent COAST clinical trial results, we are excited about the potential of extending the clinical benefit of durvalumab with the addition of monalizumab in patients with unresectable, Stage III NSCLC."

Detailed results from the randomized COAST Phase 2 trial were published in the Journal of Clinical Oncology on April 22, 2022. AstraZeneca initially presented the results during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 in September 2021 (see AstraZeneca press release). The results of the interim analysis showed monalizumab in combination with durvalumab increased objective response rate (ORR) and prolonged progression-free survival (PFS) versus durvalumab alone in patients with unresectable, Stage III NSCLC who had not progressed after CRT. The Journal of Clinical Oncology publication now includes exploratory subgroup analysis.

"Durvalumab has transformed the treatment of patients with unresectable, Stage III NSCLC, and we’re excited by the promise of extending its benefit through novel combinations with two potential first-in-class monoclonal antibodies demonstrating strong clinical activity. Based on the stand-out results from COAST, we are pleased that the Phase 3 trial is underway, which we hope will bring new treatment options to patients and further increase the potential for long-term survival benefit in this setting," said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca.

About PACIFIC-9:

PACIFIC-9 is a Phase 3, randomised, double-blind, multicenter global study to determine the efficacy and safety of durvalumab alone or in combination with oleclumab or monalizumab+ in patients with unresectable, Stage III NSCLC who have not progressed on definitive, platinum-based CRT.​

The first patient has been dosed in April 2022. The PACIFIC-9 Phase 3 trial is now looking to recruit patients across more than 200 centers in the coming months. ​

Stage III NSCLC:

In 2020, an estimated 2.2 million people were diagnosed with lung cancer worldwide1. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2,3,4 Stage III NSCLC represents approximately one quarter of NSCLC incidence5.

Stage III (locally advanced) NSCLC is commonly divided into three subcategories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally. In contrast to Stage IV, when cancer has spread (metastasised), the majority of Stage III patients are currently treated with curative intent2,6.

The majority of Stage III NSCLC patients are diagnosed with unresectable tumours2,5.

About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies7.

The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies, including the Phase 2 NeoCOAST trial in the neoadjuvant early-stage setting.

About the Innate-AstraZeneca monalizumab agreement:

In October 2018, AstraZeneca obtained full oncology rights to monalizumab by exercising its option under the co-development and commercialization agreement initiated in 2015.

The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma. Including the $50 million payment triggered by dosing the first patient in the Phase 3 PACIFIC-9 clinical trial, Innate Pharma has received $450 million to date.

For any commercialized oncology indication, AstraZeneca will book all sales revenue and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate will co-fund 30% of the costs of the Phase 3 development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.

On April 29, 2022 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported its full year 2021 financial results, the completion of development of a frozen formulation of Allocetra twelve months ahead of schedule, and provided strategic updates on its clinical programs (Press release, Enlivex Therapeutics, APR 29, 2022, View Source [SID1234613226]).

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Frozen Formulation of Allocetra Completed Twelve Months Ahead of Schedule:

Development of a frozen formulation Allocetra, a cornerstone of Enlivex’s recent R&D efforts, was completed in Q1 2022, twelve months ahead of Enlivex’s schedule. While the liquid formulation of Allocetra has a shelf life of 96 hours, the frozen formulation is expected to have a shelf life spanning multiple years. This is expected to substantially improve the product candidate’s scalability and shipping logistics, lower its production costs, and increase profitability upon potential commercialization. Due to the early completion of the development of frozen formulation Allocetra, Enlivex intends to utilize it in its ongoing Phase II sepsis trial going forward, rather than introducing it only at the start of a Phase III study. In addition, Enlivex plans to utilize the frozen formulation of Allocetra in its upcoming solid tumor trials that are expected to begin in late 2022 and onwards and in all subsequent clinical studies moving forward. Use of frozen formulation Allocetra in clinical trials is subject to the approval of the relevant regulatory authorities.

Sepsis: Integrating Frozen Formulation Allocetra into Phase II Trial, Expanding Study Population

In 2021, Enlivex initiated a placebo-controlled, randomized, dose-finding, multi-center, Phase II trial evaluating liquid Allocetra in patients with pneumonia-associated sepsis. The Company is now working to amend the protocol of this clinical trial to treat newly recruited patients with frozen formulation Allocetra and expand the study population to include patients whose septic condition stems from biliary, urinary tract, or peritoneal infections. Enlivex expects to submit the proposed protocol amendments to regulators in Q2 2022. Due to the anticipated time needed by regulators to review and approve these amendments, this is expected to briefly defer completion of the trial by approximately six to eight months, but Enlivex expects that it will significantly shorten the overall timeline for a potential regulatory approval of frozen formulation Allocetra in sepsis and the associated commercial launch.

Enlivex’s Phase II sepsis trial is supported by previously reported positive results from a Phase Ib trial that demonstrated Allocetra’s favorable safety profile and showed vastly improved clinical outcomes, including SOFA (sequential organ failure assessment) scores, duration of hospitalization, and mortality, in Allocetra-treated sepsis patients compared to a group of matched historical controls who received standard-of-care therapy. Sepsis is a life-threatening disease with no FDA approved therapies and a high unmet need. Each year, more than 1.7 million adults in the United States develop sepsis, with more than 270,000 dying of the disease.

COVID-19 De-Prioritization:

Due to (a) the emergence of variants that may be associated with less severe disease, (b) a more stringent regulatory environment, and (c) increased volatility of the potential business segment, Enlivex is de-prioritizing Allocetra’s clinical development in COVID-19 and re-allocating the program’s cash resources to the Company’s primary development priorities, sepsis and oncology.

Though Enlivex commenced its ongoing Phase IIb COVID-19 trial just prior to the Omicron-driven surge in COVID-19 infections, the majority of Omicron-infected severe/critical patients were not eligible for recruitment into the trial, either because COVID-19 was not the reason for their severe/critical condition (i.e., while they had COVID-19, they were in severe or critical condition for reasons that were not necessarily because of COVID-19), or because they had significant co-morbidities (e.g., renal insufficiency, cancer) that were the drivers of their condition. Those patients that did meet the trial’s inclusion criteria (age < 90, no significant co-morbidities, severe/critical condition driven by COVID-19) were found to be overwhelmingly unvaccinated against COVID-19 and unwilling to participate in a clinical trial of an investigational drug candidate. In conjunction with the decision to de-prioritize its COVID-19 program, the Company plans to cease recruitment of patients into the Phase II trial. Given the slow recruitment, the total patients enrolled in the trial (11, of which 8 were recruited into the placebo arm) has not been sufficient to make any meaningful assessments of Allocetra’s efficacy. Patients already enrolled in Enlivex’s Phase IIb COVID-19 trial will continued to be followed for assessments of safety.

Solid Tumors: Planned Clinical Trials Evaluating Allocetra in Patients with Solid Tumors in 2022

A major shortcoming of immunotherapeutic cancer treatments is limited efficacy against solid tumors, which represent approximately 90% of all cancer cases. Enlivex believes that this is due in large part to the negative reprogramming of macrophages in the tumor microenvironment, which results in the proliferation of pro-tumor macrophages that contribute to drug resistance, prevent disease resolution, and promote disease severity. Previously reported preclinical data from solid tumor models suggest that Allocetra has the potential to reprogram pro-tumor macrophages back to their homeostatic state, and thereby may promote disease resolution and provide patients that do not respond well to existing FDA-approved immunotherapies with an effective treatment option. Based on these and other data, Enlivex plans to initiate a Phase Ib trial evaluating Allocetra in combination with chemotherapy in solid peritoneal tumors in Q3 2022, (one quarter deferral from previous expectations), and a Phase I/II trial evaluating Allocetra in combination with an immune checkpoint inhibitor in late 2022.

Manufacturing: Positive Regulatory Interaction, Buildup of Plant & Supply Chain Infrastructure On Schedule

Construction of Enlivex’s new cGMP Allocetra manufacturing plant in Israel has continued to proceed as planned following a positive interaction with regulators. The facility will initially be approximately 17,000 square feet, and will have the ability to be expanded to approximately 21,500 square feet in the future. Additional manufacturing capacity provided by the facility is intended to support ongoing clinical trials, future clinical trials, and initial commercial production of Allocetra that may occur if it receives applicable regulatory approvals. The Company’s efforts to establish supply chain infrastructure to support potential commercialization in the future are also advancing on-schedule.

Corporate: Extend Expected Cash Runway to Q3 2024

Enlivex currently expects that its re-prioritization of resources from COVID-19 to its sepsis, oncology, and manufacturing programs will have extended its cash runway by approximately three quarters. The Company expects its existing cash, cash equivalents, and marketable securities to be sufficient to fund its operating expenses into Q3 2024.

"Planned amendments to our sepsis trial are expected to accelerate the program’s projected timeline to regulatory approval while expanding its commercial opportunity and potential therapeutic impact," said Oren Hershkovitz, Ph.D., CEO of Enlivex. "In addition to broadening the trial to include patients with sepsis stemming from biliary, urinary tract, or peritoneal infections, we are planning to utilize Allocetra’s frozen formulation in the study. Given this formulation’s prolonged shelf-life, we expect its use to dramatically reduce our future manufacturing costs and enable the geographic expansion of our clinical programs."

Dr. Hershkovitz continued, "We have also made the decision to de-prioritize Allocetra’s development in COVID-19. Effective treatments for patients with mild-to-moderate disease have proven to be powerful tools that have reduced the need for therapies designed for those in severe or critical condition. In addition, the recent emergence of variants that may be associated with less severe disease and a more stringent regulatory environment have collectively led to a sharp increase in the volatility of this potential business segment. We thus will be focusing our resources on our sepsis and oncology programs. This is expected to extend our cash runway into Q3 2024 and leave us better positioned to execute on our stated clinical objectives."

Full Year 2021 Financial Results:

Research and development expenses were $12.8 million for the year ended December 31, 2021, as compared to $6.0 million for 2020. This increase was primarily attributable to increases in salaries, expenses for preclinical studies and R&D activities, clinical studies and consumption of materials and stock-based compensation to employees and consultants General and administrative expenses were $6.4 million for the year ended December 31, 2021, as compared to $ 3.7 million for 2020. This increase was primarily attributable to increases in stock-based compensation to employees and directors and insurance expenses Net loss for the year ended December 31, 2021 was $14.4 million, as compared to a net loss of $11.8 million for the year ended December 31, 2020.

As of December 31, 2021, Enlivex had cash, cash equivalents, short term deposits , and marketable securities of $84.1 million.

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On April 29, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that its current U.S. Federal Supply Schedule (FSS) contract with the Veterans Health Administration (VHA) has been expanded to include coverage for the Company’s entire skin cancer test portfolio, effective as of April 15, 2022 (Press release, Castle Biosciences, APR 29, 2022, View Source [SID1234613241]).

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"Castle’s innovative tests for skin cancer provide precise, personalized information based on each patient’s tissue biology and are designed to meaningfully impact how skin cancers are diagnosed and managed," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We are proud that veterans and their families treated at VHA and Military Health System (MHS) medical centers will now have greater access to our skin cancer tests and the clinically actionable information they provide, which can help guide and improve the management of their disease."

One in five Americans will be diagnosed with skin cancer during their lifetime, making it the most common form of cancer in the U.S.1 U.S. military personnel have higher rates of skin cancer than civilians, due in part to occupational sun exposure and other work conditions, compounded by certain demographic characteristics associated with higher rates of melanoma.2

The VHA is a component of and implements the healthcare program for U.S. veterans through the U.S. Department of Veterans Affairs (VA). Castle’s current five-year FSS contract went into effect on Aug. 15, 2021, and included coverage for the Company’s DecisionDx-Melanoma gene expression profile test. Effective April 15, 2022, the expanded contract includes coverage for the remaining four tests in Castle’s dermatologic cancer test portfolio: DecisionDx-SCC, DecisionDx DiffDx-Melanoma, myPath Melanoma and DecisionDx-CMSeq. Castle’s expanded FSS contract provides greater access to the aforementioned tests for veterans being treated through the VHA, the largest integrated health care system in the U.S., as well as active-duty service members and their families seeking medical treatment through the MHS.

More information about Castle’s tests can be found at www.CastleTestInfo.com.

On April 29, 2022 AstraZeneca reported that First quarter 2022 results (Press release, AstraZeneca, APR 29, 2022, View Source [SID1234613203])

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Financial performance (growth numbers at CER)
‒ Total Revenue increased 60% to $11,390m, reflecting growth across the Company, the contribution of the Alexion medicines and several Vaxzevria contracts that are expected to complete delivery by half year 2022
‒ Total Revenue from Oncology increased 25%7, including a milestone payment; Product Sales from Oncology increased 18%. Total Revenue from CVRM8 increased 18%, R&I9 increased 4% and Rare Disease increased 7%10 ‒ Operating Margin in the quarter benefitted from phasing of costs
‒ Core EPS increased 20% to $1.89
‒ FY 2022 guidance at CER reiterated Key milestones achieved since the prior results
‒ Key data: Enhertu11 in HER212-low breast cancer (DESTINY-Breast04), AZD8233 in hypercholesterolaemia (ETESIAN, Phase IIb) and publication of data for Lynparza in prostate cancer (PROpel) and nirsevimab in RSV13 (MELODY/MEDLEY)
‒ Key approvals: Saphnelo and Evusheld in the EU, Ondexxya in Japan, and in the US, approvals of Ultomiris for gMG14 and Lynparza15 for early breast cancer (OlympiA)
‒ Other key milestones: US FDA16 Breakthrough Therapy Designation for Enhertu in HER2-low breast cancer (DESTINY-Breast04), Priority Reviews for Enhertu in HER2-mutant metastatic non-small cell lung cancer (DESTINY-Lung01), and Imfinzi and tremelimumab in advanced liver cancer (HIMALAYA), and EMA17 accelerated assessment for nirsevimab in RSV (MELODY/MEDLEY) Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "2022 has started strongly for AstraZeneca.

Farxiga achieved $1bn revenue in the quarter and our Oncology medicines delivered Product Sales growth of 18%, despite COVID-19 continuing to impact cancer diagnosis and treatment. High-level results from the DESTINY-Breast04 trial pointed to Enhertu’s potential to redefine treatment of HER2-low metastatic breast cancer, and Ultomiris became the first and only long-acting C5 inhibitor approved for generalised myasthenia gravis in the US. Today we have unveiled plans for a new strategic research and development centre in the heart of Cambridge, Massachusetts’ scientific hub. In line with our sustainability commitments, it will be designed to the highest environmental standards.

Our investments in pioneering science give us confidence of further advances in the years to come." 2 Guidance The Company reiterates FY 2022 guidance at CER. Total Revenue is expected to increase by a high teens percentage Core EPS is expected to increase by a mid-to-high twenties percentage

‒ The CER growth rates include the full-year contribution of Vaxzevria in both FY 2021 and FY 2022
‒ Total Revenue from COVID-19 medicines is anticipated to decline by a low-to-mid twenties percentage, with an expected decline in sales of Vaxzevria being partially offset by growth in Evusheld sales. The majority of Vaxzevria revenue in 2022 is expected to come from initial contracts. The Gross Margin from the COVID19 medicines is expected to be lower than the Company average
‒ Core Operating Expenses are expected to increase by a low-to-mid teens percentage, driven in substantial part by the full year integration of Alexion expenses
‒ Emerging Markets Total Revenue, including China, is expected to grow mid-single-digits in FY 2022. China Total Revenue is expected to decline by a mid-single-digit percentage in FY 2022, primarily due to continued NRDL and VBP programme impacting various medicines.

The Company remains confident in the longer term outlook for Emerging Markets, driven by a large market opportunity, broader patient access and an increased mix of new medicines

‒ A Core Tax Rate between 18-22% AstraZeneca continues to recognise and actively manage the heightened risks from COVID-19 and geopolitical and supply chain uncertainties on overall business performance. Variations in performance between quarters can be expected to continue.

The Company is unable to provide guidance on a Reported basis because AstraZeneca cannot reliably forecast material elements of the Reported result, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal-settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement. Currency impact If foreign-exchange rates for April to December 2022 were to remain at the average of rates seen in Q1 2022, it is anticipated that there would be a low single-digit adverse impact on Total Revenue and a mid single-digit adverse impact on Core EPS versus the financials at CER.

The Company’s foreign-exchange rate sensitivity analysis is contained in Table 15. Corporate and business development In April 2022, AstraZeneca and Harbour BioMed (HBM) committed to a global out-license agreement for HBM7022, a pre-clinical bispecific antibody targeting Claudin18.2 and CD3. AstraZeneca will be granted an exclusive global license for research, development, registration, manufacturing, and commercialisation of HBM7022. HBM shall receive an upfront payment of $25m with the potential for additional payments up to $325m pending achievement of certain development, regulatory and commercial milestones. HBM is also eligible to receive tiered royalties on net sales. Sustainability summary AstraZeneca published its eighth annual Sustainability Report and Sustainability Data summary, released in conjunction with the 2021 Annual Report. The report outlines progress on strategic priorities, material focus areas, challenges and aims for the future.

AstraZeneca continues to provide urgent humanitarian support in Ukraine and neighbouring countries. To date, AstraZeneca has committed over $7m to response efforts, including donations of:

‒ Medicines to the Company’s humanitarian relief partner Direct Relief, which is working directly with the Ukrainian Ministry of Health
‒ Medicines via The Red Cross affiliates in neighbouring countries
‒ $2m to support relief agencies working in Ukraine, Poland and surrounding areas with a focus on providing healthcare and humanitarian assistance.

Funding is being provided to Project HOPE, working with and through the World Health Organization, and International Medical Corps
‒ More than $1m to UNICEF and The Red Cross Reporting changes for Q1 2022 AstraZeneca’s Total Revenue and Product Sales tables in FY 2022 include a new disease area: BioPharmaceuticals: Vaccines & Immune Therapies (V&I). This incorporates revenues from Vaxzevria, Evusheld, FluMist, Synagis and nirsevimab.

In the FY 2021 quarterly and annual reports, Vaxzevria and Evusheld revenues were shown under COVID-19, and FluMist, Synagis and nirsevimab revenues were shown under Other Medicines. In addition, revenue from Koselugo have moved from Oncology to Rare Disease, and revenue from Andexxa has moved from Rare Disease to BioPharmaceuticals: CVRM.

The growth rate for each disease area has been calculated as though these changes had been implemented in FY 2021. Conference call A conference call and webcast for investors and analysts will begin today (29 April 2022) at 11:45 BST. Details can be accessed via astrazeneca.com.

On April 29, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that final data from its phase II study of paxalisib in patients with newly diagnosed glioblastoma will be the subject of a poster presentation at the upcoming Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Kazia Therapeutics, APR 29, 2022, View Source [SID1234613242]).

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The ASCO (Free ASCO Whitepaper) Annual Meeting will take place virtually and in person from 3-7 June 2022 and will be held in Chicago, IL.

Abstracts from the meeting are expected to be released from 5pm, ET, on 26 May 2022, and the poster will be made available by ASCO (Free ASCO Whitepaper) and via the Kazia website shortly after presentation.

POSTER PRESENTATION

Title: Paxalisib in patients with newly diagnosed glioblastoma with unmethylated MGMT promoter status: Final phase 2 study results.
Date and Time: Sunday, 5 June 2022 – 8am – 11am, CDT
Session: Central Nervous System Tumors
Abstract ID: 2047