On June 21, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported the National Comprehensive Cancer Network (NCCN) has elevated FOTIVDA (tivozanib) to Category 1 status as a subsequent therapy for RCC patients who have received two or more prior therapies in the latest Kidney Cancer Treatment Guidelines released on June 17, 2022 (Press release, AVEO, JUN 21, 2022, View Source [SID1234616134]).

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"Category 1 is the highest Category recommendation offered by NCCN, which is based on strong clinical evidence and perception of the product among the NCCN Panel Members. The NCCN guidelines are recognized and followed by both academic and community oncologists when selecting appropriate therapeutic options for their patients," said Michael Bailey, president and chief executive officer of AVEO. "This year we presented encouraging long-term, progression free survival (PFS) and overall survival (OS) follow-up data from the Phase 3 TIVO-3 study. These new data demonstrate the durability of FOTIVDA’s anti-tumor activity which has translated into an improving OS hazard ratio."

The NCCN Clinical Practice Guidelines are the recognized standard for clinical policy in cancer care and are developed through review of evidence and recommendations from physicians and oncology researchers. The current NCCN RCC guidelines make treatment recommendations for first-line or subsequent therapy options for RCC patients and are referenced in the development of other clinical pathways.

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.

On June 21, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for the company’s anti-PD-1 inhibitor, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Press release, BeiGene, JUN 21, 2022, View Source [SID1234616150]).

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The sBLA is supported by data from an interim analysis from the global RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. In China, gastric cancer (GC) has become the third most common canceri and adenocarcinoma represents the major histologic subtype of GC, over 90% of reported cases across the worldii.

Lai Wang, Ph.D., Global Head of R&D at BeiGene said, "Gastric cancer is the second leading cause of cancer-related deaths in China and there are few options to treat metastatic disease. We are pleased that our rigorous clinical development program has demonstrated a survival benefit with tislelizumab and chemotherapy treatment in patients whose tumors express PD-L1 and look forward to working with regulators to bring forward this potential new treatment option."

Tislelizumab is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. The EMA is also reviewing tislelizumab for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC. In January 2021, BeiGene announced a collaboration with Novartis to accelerate the clinical development and marketing of tislelizumab in North America, Europe, and Japan. Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for nine indications and this sBLA is the 10th regulatory submission for tislelizumab in China. Tislelizumab is not approved for use outside of China.

About RATIONALE 305 (NCT03777657)
RATIONALE 305 is a randomized, double-blind, placebo-controlled, global Phase 3 trial comparing the efficacy and safety of tislelizumab combined with platinum and fluoropyrimidine chemotherapy and placebo combined with platinum and fluoropyrimidine chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic G/GEJ adenocarcinoma. The primary endpoint of the trial is overall survival (OS). Secondary endpoints include progression-free survival (PFS), overall response rate (ORR), duration of response (DoR), and safety. A total of 997 patients from 13 countries and regions across the world were enrolled and randomized 1:1 to receive either tislelizumab and chemotherapy or placebo and chemotherapy.

About Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. In January 2021, BeiGene announced a collaboration with Novartis to accelerate the clinical development and marketing of tislelizumab in North America, Europe, and Japan.

BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials. More information on the clinical trial program for tislelizumab can be found at: View Source

BeiGene Oncology
BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S. Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor, ociperlimab, that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On June 21, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported a new collaboration with HealthVerity, Inc., the leader in Identity, Privacy, Governance, and Exchange (IPGE) for real-world data (RWD), that will expand Labcorp’s comprehensive, end-to-end drug development and clinical trial programs (Press release, LabCorp, JUN 21, 2022, View Source [SID1234616118]).

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HealthVerity’s IPGE platform, an integrated technology and RWD infrastructure, enables Labcorp Drug Development and other participating companies to access fully interoperable, HIPAA-compliant data from the U.S.’s largest ecosystem1 of health care and consumer data.

"This collaboration allows Labcorp to expand existing end-to-end solutions for drug and diagnostics development, commercialization and clinical trial efforts to include large-scale access to real-world data for research applications," said Dr. Paul Kirchgraber, CEO of Labcorp Drug Development. "By applying advanced analytics, Labcorp can help its clients improve their processes and reach better outcomes. Our substantial repository of test results can also help study sponsors more quickly and accurately assess patient eligibility for clinical trials, enroll patients faster and accelerate the availability of new medicines."

Now more than ever, study sponsors are seeing the potential of RWD to yield longitudinal patient insights before, during and after trials. With more predictive analytics and artificial intelligence applications requiring comprehensive and fully interoperable RWD, Labcorp can align de-identified patient data with ten times greater accuracy2 than industry alternatives by using the HealthVerity IPGE platform. In addition, access to HealthVerity’s RWD with on-demand de-identification and data linkage capabilities reinforces Labcorp’s ability to be a trusted source of information for its clients.

"Fragmentation of patient data is at an all-time high, and the goal is no longer just connecting this data," said Andrew Kress, CEO of HealthVerity. "Rather, the goal is making data more accessible and useful for gaining a detailed understanding of patient journeys. With analytics and applications requiring more frictionless access to the data itself, the HealthVerity IPGE platform stands alone in offering the ability to combine transaction-level patient data in a de-identified, fully interoperable manner, and delivering it directly into the client’s applications of choice."

Labcorp is an investor in HealthVerity through the Labcorp Venture Fund.

On June 21, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP), a clinical-stage biotherapeutics company using its proprietary DIAMOND AI (artificial intelligence) and data mining platform to discover and develop cell therapies with a focus on immuno-oncology, reported a strategic pipeline shift to prioritize its allogeneic, non-engineered off-the-shelf product candidate, Deltacel/KB-GDT (Press release, Kiromic, JUN 21, 2022, View Source [SID1234616135]).

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Kiromic expects to submit its first new investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in the second half of 2022. The IND will seek to evaluate Deltacel in combination with a standard antitumor modality, with the expected beginning of trial activation by year-end. Deltacel consists of Gamma Delta T-cells (GDT) that are expanded, enriched, and activated through a proprietary method. Kiromic will also pursue INDs for its Procel and Isocel product candidates in combination with a standard antitumor modality in 2023.

These three additional IND filings will expand the Company’s pipeline to five allogeneic GDT clinical trials and three product candidates.

This reprioritization and expansion of Kiromic’s pipeline follows a recently announced sponsored research agreement to generate in vivo preclinical data. The Company believes that, through this agreement, we will be able to efficiently generate data for our GDT allogeneic therapies and other pre-clinical assets to support our anticipated IND filings.

"We are well positioned to prioritize Deltacel/KB-GDT in combination with a standard antitumor modality as our first IND, which we intend to submit to the FDA during the second half of this year with the expected beginning of trial activation by year-end. We believe that this shift both de-risks and accelerates our immediate path forward, enabling us to advance our non-viral, non-engineered product candidate while also reducing costs and mitigating current supply chain headwinds associated with a virus-based approach," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

"Against the backdrop of a global cancer cell therapy market that’s expected to exceed $33 billion by 2027, Kiromic’s product pipeline now encompasses three additional Gamma Delta T-cell therapeutic candidates, Deltacel, Procel, and Isocel. Each is being developed to target solid tumors – which represent 90% of all cancers – and each is ideally positioned to address unmet medical needs. We look forward to advancing these candidates into the clinic with the goal of providing new treatment options to patients with cancer," added Mr. Bersani.

These three IND applications will expand Kiromic’s therapeutic pipeline to five allogeneic GDT clinical trials (see accompanying graphic), including:

New IND #1: Deltacel in combination with a standard antitumor modality, with clinical activation expected to begin by the end of the fourth quarter of 2022
New IND #2: Procel in combination with a standard antitumor modality, with clinical activation expected to begin by the end of the second quarter of 2023
ALEXIS – PRO-1 Procel as a monotherapy, with clinical activation expected to begin by the end of second quarter 2023
New IND #3: Isocel in combination with a standard antitumor modality, targeting clinical activation to begin by the end of the fourth quarter of 2023
ALEXIS – ISO-1 Isocel as a monotherapy, targeting clinical activation to begin by the end of the fourth quarter of 2023

On June 21, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early, when it can be cured, and Fountain Health Insurance ("Fountain Health") reported a partnership that will offer Galleri, GRAIL’s multi-cancer early detection (MCED) blood test, to Fountain Health customers at 100% coverage as part of its annual wellness benefits (Press release, Grail, JUN 21, 2022, View Source [SID1234616151]).

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"Our partnership with GRAIL is an outstanding opportunity to change the health story for thousands of people by finding cancer early so we can improve outcomes. However, saving the life of an employee or loved one is what truly will make this transformative. What better gift could you give to your employees?" says Robert J. Rossiter, chief executive officer at Fountain Health.

The Galleri test is a first-of-its-kind MCED blood test. In a clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancers, over 45 of which lack recommended screening tests today. Using advanced genomics and machine learning, the test also determines the origin of the cancer signal, which can then guide diagnostic workup. Early detection of cancer has been demonstrated to improve cancer outcomes, yet today, the majority of cancers are detected in late stages because only five cancer types have recommended screenings – breast, cervical, colon, lung and prostate cancers.

"We applaud Fountain Health for its commitment to proactive care and finding cancer earlier, when treatment is more likely to be successful," said Bob Ragusa, chief executive officer at GRAIL. "By offering the Galleri test and covering it at 100%, Fountain Health is helping ensure more people have access to critical health information that could give a better chance of surviving cancer, which still claims the lives of more than 600,000 people annually in the U.S."