On August 2, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and reported financial results for the second quarter ended June 30, 2021 (Press release, Corvus Pharmaceuticals, AUG 2, 2021, View Source [SID1234585530]).

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"We continue to advance mupadolimab, our anti-CD73 antibody, with a focus on HPV positive (human papilloma virus) head and neck cancer and other viral associated cancers," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We believe mupadolimab is well positioned to improve patient outcomes based on its dual mechanism of inhibiting immunosuppressive adenosine and enhancing antibody responses to viruses, which have been shown to cause certain cancers. This is based on the known B cell stimulating properties of mupadolimab and data we have generated in cancer and viral diseases such as COVID-19. We also continue to advance our other oncology programs, including with our Chinese partner, Angel Pharmaceuticals, who recently filed an IND in China to initiate Phase 1/2 clinical development of CPI-818 for the treatment of T cell lymphomas."

2021 Key Areas of Focus
The Company is efficiently advancing its clinical programs – mupadolimab, CPI-818 and ciforadenant – along with pre-clinical programs in its pipeline. The highlights from the Company’s clinical pipeline include:

Mupadolimab Expansion Clinical Trial for HPV+ Oropharyngeal Cancer

The Company began enrollment of a Phase1b/2 clinical trial in patients with HPV+ oropharyngeal cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy. Up to 15 patients will be enrolled in this clinical trial and will receive mupadolimab in combination with pembrolizumab. The endpoint of the clinical trial is response rate and results are anticipated by year end 2021. HPV is a transmissible DNA virus that causes approximately 75% of head and neck cancers. The incidence of this disease has been increasing in the United States and elsewhere.
Mupadolimab Focus on Viral Associated Cancers

The Company plans to evaluate mupadolimab in other viral associated tumors such as cancer of the cervix and head and neck cancers caused by Epstein Barr virus (EBV), which is a member of the herpes virus family and one of the most common human viruses.
In July 2021, the Company discontinued its Phase 3 clinical trial of mupadolimab in COVID-19 due to positive trends exhibited by COVID-19 vaccines in lowering serious infection and hospitalizations. The discontinuation was not related to any safety or efficacy issues observed in trial patients. As a result, the Company’s projected 2021 net cash used in operating activities decreased by an estimated $11 million.
CPI-818 Phase 2 Clinical Trial for T cell Lymphoma in Partnership with Angel Pharmaceuticals

Angel Pharmaceuticals has filed an investigational new drug application (IND) for CPI-818 with the Center for Drug Evaluation (CDE) in China. If approved, Angel plans to initiate a Phase 2 clinical trial of CPI-818 for the treatment of refractory T cell lymphomas in late 2021, with the potential to expand into autoimmune diseases over time.
Ciforadenant Phase 2 Clinical Trial for Front Line RCC

Corvus is a leader in the development of precisely targeted therapies targeting the adenosine pathway. Ciforadenant is small molecule antagonist of the adenosine A2A receptor. It is designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. The Company also discovered the Adenosine Gene Signature, which has demonstrated the potential to serve as a biomarker to identify patients most likely to respond to treatment with ciforadenant.
The Company plans to collaborate with the Kidney Cancer Consortium to initiate a Phase 2 clinical trial of ciforadenant in first-line therapy for metastatic renal cell cancer (RCC) in combination with pembrolizumab and a tyrosine kinase inhibitor. The clinical trial is expected to enroll up to 60 patients and is intended to increase complete responses and deep responses in the front-line setting. Preclinical studies and data from earlier clinical trials with ciforadenant indicate adenosine may be a cause of resistance to current therapies with anti-PD(L)-1 and tyrosine kinase inhibitors. Tumor biopsies will be evaluated for expression of the Adenosine Gene Signature.
Financial Results

As of June 30, 2021, Corvus had cash, cash equivalents and marketable securities totaling $66.5 million. This compared to cash, cash equivalents and marketable securities of $44.3 million as of December 31, 2020. The increase in cash of $22.2 million resulted from the receipt of approximately $43.8 million in net proceeds from the sale of common stock through an underwritten offering and the Company’s at the market equity offering program, and was reduced by $21.4 million of cash used in operating activities in the six months ended June 30, 2021. With the discontinuation of the mupadolimab Phase 3 clinical trial in COVID-19, Corvus now expects full year 2021 net cash used in operating activities to be between $35 million and $37 million, a decrease of an estimated $11 million compared to the previously expected range of $46 million and $48 million and resulting in a projected balance of cash, cash equivalents and marketable securities of between $51.1 million to $53.1 million at December 31, 2021.

Research and development expenses for the three months ended June 30, 2021 totaled $9.1 million compared to $7.9 million for the same period in 2020. The increase of $1.2 million was primarily due to an increase in clinical trial costs for the Company’s mupadolimab Phase 3 COVID-19 clinical trial, which was partially offset by lower clinical trial costs for CPI-818 and ciforadenant.

The net loss for the three months ended June 30, 2021 was $11.8 million compared to a net loss of $10.6 million for the same period in 2020. Total stock compensation expense for the three months ended June 30, 2021 was $1.2 million compared to $1.4 million for the same period in 2020.

On August 2, 2021 Cardinal Health (NYSE: CAH) and Hellman & Friedman (H&F) reported the completion of the previously announced sale of Cardinal Health’s Cordis business to H&F (Press release, Cardinal Health, AUG 2, 2021, View Source;Friedman/default.aspx [SID1234585529]). The sale price of approximately $1 billion includes the buyer’s assumption of certain liabilities and the seller’s retention of certain working capital accounts.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide.

"We appreciate H&F’s partnership throughout the transaction, and we are excited about Cordis’s future under H&F’s ownership," said Mike Kaufmann, CEO of Cardinal Health. "As we shared previously, this divestiture demonstrates our disciplined portfolio evaluation approach, and we remain committed to investing in our strategic growth areas."

"We are thrilled to begin this next chapter for Cordis and value the partnership with Cardinal Health through the transition," said Shar Matin, CEO of Cordis. "We believe that an independent Cordis company, combined with an innovative approach to bring differentiated products to market, will allow us to create incremental value for teammates, customers and investors."

Cardinal Health plans to release its fourth-quarter and year-end financial results for its fiscal year 2021 on August 5 prior to the opening of trading on the New York Stock Exchange. The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

On August 2, 2021 Celgene Corporation, now a wholly owned subsidiary of Bristol Myers Squibb, reported that it received accelerated approval by the U.S. Food & Drug Administration (FDA) for Istodax (romidepsin), a histone deacetylase (HDAC) inhibitor, as monotherapy for the treatment of peripheral T-cell lymphoma (PTCL) in adult patients who have received at least one prior therapy (Press release, Bristol-Myers Squibb, AUG 2, 2021, View Source [SID1234585528]). This accelerated approval was based upon results from two clinical studies, assessing the effect of Istodax on the surrogate endpoint of overall response rate. Bristol Myers Squibb conducted a subsequent confirmatory Phase 3 study evaluating romidepsin plus CHOP (Ro-CHOP) versus CHOP in first-line PTCL patients, but the trial did not meet the primary efficacy endpoint of progression free survival.

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Based on this outcome, Bristol Myers Squibb made the decision to withdraw the PTCL indication from the U.S. market. The company took this action in accordance with the FDA’s requirements for evaluating accelerated approvals that have not demonstrated sufficient clinical benefit.

Bristol Myers Squibb is notifying healthcare professionals about the withdrawal. Istodax remains on the market for treatment of patients with cutaneous T-cell lymphoma (CTCL) who have received at least one prior systemic therapy. Patients who are being treated with Istodax for PTCL should consult with their healthcare provider in all aspects of their medical care and may remain on treatment if deemed clinically appropriate by the treating physician. For patients who are currently being treated with Istodax for PTCL, and who have questions about access and reimbursement support, please contact BMS Access Support at 1-800-861-0048 or visit www.bmsaccesssupport.com.

"While the outcome of the confirmatory study in peripheral T-cell lymphoma is disappointing, Bristol Myers Squibb will continue to provide Istodax for patients with cutaneous T-cell lymphoma, where it remains an approved and important treatment option," said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. "As always, our efforts across blood cancer research and development remain centered on delivering better outcomes for patients in need."

Since the initial approval of Istodax, nearly a decade ago, more options have been made available for patients, many of which have redefined treatment across PTCL and other hematologic conditions.

Bristol Myers Squibb continues to evaluate the potential of its therapies for people with blood cancers and disorders who may benefit, while pursuing the next breakthroughs for patients.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Istodax

Istodax (romidepsin) for injection is an epigenetic therapy and a member of a class of cancer drugs known as histone deacetylase (HDAC) inhibitors. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. HDACs also deacetylate non-histone proteins, such as transcription factors. In vitro, Istodax causes the accumulation of acetylated histones, and induces cell cycle arrest and apoptosis of some cancer cell lines. The mechanism of the antineoplastic effect of romidepsin observed in nonclinical and clinical studies has not been fully characterized. For full prescribing information, visit www.ISTODAX.com.

Indication

ISTODAX (romidepsin) for injection is indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

This indication is based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.

Important Safety Information

WARNINGS AND PRECAUTIONS

Myelosuppression: ISTODAX (romidepsin) for injection can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; monitor blood counts regularly during treatment with ISTODAX; interrupt and/or modify the dose as necessary
Infections: fatal and serious infections, including pneumonia, sepsis and viral reactivation, including reactivation of Epstein Barr and hepatitis B viruses, have been reported during and after treatment with ISTODAX in clinical trials. The risk of life-threatening infections may be greater in patients with a history of prior treatment with monoclonal antibodies directed against lymphocyte antigens and in patients with disease involvement of the bone marrow. Reactivation of hepatitis B virus infection was reported in 1% of patients in clinical trials. Reactivation of Epstein Barr viral infection leading to liver failure has occurred, including after ganciclovir prophylaxis. Consider monitoring for reactivation and antiviral prophylaxis in patients with evidence of prior hepatitis B infection.
Electrocardiographic (ECG) changes: ECG changes have been observed with ISTODAX. In patients with congenital long QT syndrome, patients with a history taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, consider cardiovascular monitoring of ECGs at baseline and periodically during treatment. Confirm that potassium and magnesium levels are within the normal range before administration of ISODAX
Tumor lysis syndrome (TLS): TLS has been reported during treatment with ISTODAX. Patients with advanced stage disease and/or high tumor burden are at greater risk and should be closely monitored and managed as appropriate
Embryo-fetal toxicity: ISTODAX can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

Cutaneous T-Cell Lymphoma

The most common adverse reactions (≥30%), excluding laboratory abnormalities, are nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST-T wave changes, dysgeusia, constipation and pruritis. Grade 3‐4 laboratory abnormalities (≥10%) include lymphopenia, neutropenia, anemia and thrombocytopenia.

DRUG INTERACTIONS

Monitor more frequently prothrombin time and international Normalized Ratio in patients concurrently administered ISTODAX and warfarin or coumarin derivatives
Romidepsin is metabolized by CYP3A4
>> Monitor patients for toxicity related to increased romidepsin exposure and follow dose modifications for toxicity when ISTODAX is initially co-administered with strong CYP3A4 inhibitors

>> Avoid co-administration of ISTODAX (romidepsin) with rifampin and other potent inducers of CYP3A4

Exercise caution with concomitant use of ISTODAX and P-glycoprotein (P-gp, ABCB1) inhibitors
USE IN SPECIFIC POPULATIONS

Pregnancy Category D:If this drug is used during pregnancy, of if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus
Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ISTODAX, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
Patients with moderate and sever hepatic impairment and/or patients with the end-stage renal disease should be treated with caution

On August 2, 2021 InterVenn Biosciences reported the completion of a $201 million Series C financing (Press release, InterVenn Biosciences, AUG 2, 2021, View Source [SID1234585527]).

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The funding round was led by new investors SoftBank Group, Heritage Provider Network, Irving Investors, Highside Capital Management, and backed by existing investors Amplify Partners, Anzu Partners, Genoa Ventures and True Ventures. The proceeds from the financing will be used to accelerate development and commercialization of Dawn, the company’s liquid biopsy assay for immune checkpoint inhibitor response prediction, and to expand the network of partners on the company’s AI-driven glycoproteomics platform.

To date, the InterVenn glycoproteomics platform has been used to develop 16 clinical use cases across oncology and other indications. Dawn is currently under development and is planned to be commercialized in 2022. Bolstered by encouraging early results and promising performance, InterVenn will invest in the development of glycoproteomics-based liquid biopsy solutions across the oncology spectrum of care (screening through therapy response monitoring), as well as non-oncology applications. Additionally, the financing will enable InterVenn to expand investment in a partnership ecosystem to accelerate development and commercialization of new clinical solutions, and broaden insights into new biomarkers and therapies.

"We are thrilled to have such strong support from this global investor group to support the next phase of our evolution," said Aldo Carrascoso, Co-Founder and Chief Executive Officer of InterVenn Biosciences. "Our new investors, as well as our existing investors, recognize the transformative potential of our technology and bring strong industry knowledge that will result in a positive partnership for InterVenn. With this fundraising, we believe InterVenn is ideally positioned to unlock the glycoproteome as a novel and fundamental layer in biology, which will reveal a myriad of new insights on how to diagnose and treat disease."

Cowen served as sole placement agent to InterVenn for the private placement.

On August 2, 2021 Alkermes plc (Nasdaq: ALKS) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma (Press release, Alkermes, AUG 2, 2021, View Source [SID1234585525]). Earlier this year, the FDA also granted orphan drug designation to nemvaleukin for the treatment of mucosal melanoma. The company recently initiated enrollment in ARTISTRY-6, a global phase 2 trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy. The study is evaluating intravenously administered nemvaleukin in patients with mucosal melanoma and subcutaneously administered nemvaleukin in patients with advanced cutaneous melanoma.

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"Receiving Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma is an important milestone for the nemvaleukin development program and underscores nemvaleukin’s potential clinical utility to address an unmet medical need in this difficult-to-treat tumor type," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We are committed to advancing this important research in mucosal melanoma, a rare and aggressive form of melanoma for which there are very limited treatment options, particularly for those patients previously treated with checkpoint inhibitors."

Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met. For more information on Fast Track designation, please visit the FDA’s website, available at View Source

More information on the ARTISTRY-6 study can be found at www.clinicaltrials.gov, identifier: NCT04830124.

About Nemvaleukin Alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high-affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.