On June 17, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that updated efficacy and safety results from the dose-escalation part of the Phase 1/2 study with SAR443579/IPH6101 (SAR’579), an investigational CD123 targeting NKp46/CD16-based Natural Killer Cell Engager (NKCE), from a joint research collaboration between Innate Pharma and Sanofi and ANKET platform lead asset, were shared in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Congress in Madrid, Spain on Sunday, June 16 at 11:45 CEST (Press release, Innate Pharma, JUN 17, 2024, View Source [SID1234644389]).

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The study, led by Sanofi, tests SAR’579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B cell acute lymphoblastic leukemia (B-ALL) and high-risk myelodysplasia (HR-MDS). SAR’579 has FDA Fast Track Designation for the treatment of acute myeloid leukemia.

"We are pleased to see that SAR’579 continues to show promising and durable clinical efficacy along with a favorable safety profile. The ongoing Phase 1/2 study has recently progressed to the Phase 2 stage, marking a significant milestone in its development. We look forward to the continued progress of this multi-specific NK Cell Engager which holds great potential to benefit patients suffering from various blood cancers," says Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma.
Fifty-nine patients (58 R/R AML and 1 HR-MDS) across 11 dose levels (0.01 – 6mg/kg) were treated. Patients had received a median of 2 (1 – 10) prior lines of treatment. A maximum response rate was observed at a final target dose of 1 mg/kg every week with 5 AML patients achieving a CR (4 CR/1 CRi)1. The median treatment duration was 7.9 weeks, with durable CR (>10 months) observed in 3 patients with 2 remaining on maintenance therapy as of the data cutoff. SAR’579 was well tolerated up to doses of 6 mg/kg every week. These data will form the basis for selection of recommended doses for development in the Phase 2 portion of the trial.

"We are excited about the emerging results from our development of SAR’579. Ongoing studies are focused on further demonstrating the potential of the NK cell engager in patients with leukemia. We look forward to sharing data from these trials at future scientific meetings," says Peter Adamson, Global Development Head, Oncology, Sanofi.

About ANKET

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.
About the Innate-Sanofi research collaboration and licensing agreements

The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes SAR443579/IPH6101 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and SAR445514/IPH6401 (Trifunctional anti-BCMA
1 CR: complete remission; CRi: CR with incomplete hematological recovery

NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma is eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

As part of the license agreement entered in December 2022, Sanofi licensed IPH62 and IPH67 and has the option for one additional target. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to €1.35bn in development and commercial milestone payments as well as royalties on net sales.

On June 17, 2024, Illumina, Inc. ("Illumina" or the "Company") reported to have entered into a 364-day delayed draw credit agreement (the "Credit Agreement") among the Company, as the borrower, the lenders from time to time party thereto and JPMorgan Chase Bank, N.A., as administrative agent (in such capacity, the "Administrative Agent") (Filing, 8-K, Illumina, JUN 17, 2024, View Source [SID1234644385]).

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The Credit Agreement provides for a senior unsecured term loan credit facility in an aggregate principal amount of up to $750 million (the "Credit Facility") which can be drawn on a delayed draw basis at any time prior to the earliest of (i) the termination of the definitive agreement in respect of the GRAIL Transactions (as defined below), (ii) the consummation of the GRAIL Transactions without the funding of the Credit Facility, (iii) May 5, 2025, if the GRAIL Transactions have not occurred prior to such date, and (iv) the date on which the Company notifies the Administrative Agent that it is terminating the commitments under the Credit Facility, for a 364-day term. Any loans under the Credit Facility will have a variable interest rate based on either the term secured overnight financing rate or the alternate base rate, plus an applicable rate that varies with the Company’s debt rating and, in the case of loans bearing interest based on the term secured overnight financing rate, a credit spread adjustment equal to 0.10% per annum. The current borrowing rate under the Credit Facility is approximately 6.70%.

The proceeds of the loans under the Credit Facility may be used to fund cash to the balance sheet of GRAIL, LLC ("GRAIL"), in connection with the Company’s planned divestment of GRAIL (the "GRAIL Transactions").

The Credit Agreement contains financial and operating covenants. The financial covenant provides for a maximum total leverage ratio. Operating covenants include, among other things, limitations on (i) the incurrence of indebtedness by the Company’s subsidiaries, (ii) liens on assets of the Company and its subsidiaries and (iii) certain fundamental changes and the disposition of assets by the Company and its subsidiaries. The Credit Agreement contains other customary covenants, representations and warranties, and events of default.

Amounts borrowed under the Credit Facility may be prepaid, and the commitments under the Credit Facility may be terminated by the Company, at any time without premium or penalty (other than customary breakage costs). As of the date of this report, no borrowings were outstanding under the Credit Facility. The Credit Facility is expected to be drawn in full on June 20, 2024, and therefore the Credit Facility is expected to mature, and all amounts outstanding thereunder would become due and payable in full, on June 19, 2025.

The foregoing summary of the Credit Agreement is qualified in its entirety by the full text of the Credit Agreement, which is attached as Exhibit 10.1 hereto and is incorporated herein by reference.

On June 17, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported publication of data from its Phase 1 dose escalation study of its lead personalized cancer vaccine candidate, EVX-01, for metastatic melanoma (Press release, Evaxion Biotech, JUN 17, 2024, View Source [SID1234644383]). The study results, published in the Journal for ImmunoTherapy of Cancer, demonstrated that eight out of 12 patients (67%) experienced objective clinical responses (ORR) with six partial and two complete responses. Further, EVX-01 immunization did not induce vaccine-related serious adverse events in patients co-administered with anti-PD1 therapy.

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The EVX-01 cancer vaccine is designed to target neoantigens – antigenic sequences derived from cancer mutations – that are displayed on the surface of cancer cells, allowing the immune system to recognize, attack and eliminate the malignant cells. Since the neoantigen tumor profiles vary from one cancer patient to another, the EVX-01 cancer vaccine is truly personalized and tailored to the unique characteristics of each patient’s tumor and immune system profile. This represents a novel treatment paradigm with potential broad application in cancer therapy.

At this year’s ASCO (Free ASCO Whitepaper) annual meeting, the Company presented comprehensive immune data from its ongoing EVX-01 Phase 2 study, with 71% of the administered neoantigens inducing a specific T-cell response. Furthermore, a positive correlation between the neoantigen prediction score assigned by AI-Immunology and the reported induced immune response confirmed the Phase 1 study findings and further substantiated the predictive power of Evaxion’s AI platform.

"This publication provides a clear conclusion to our Phase 1 study, with peer-reviewed validation of our reported outcomes. We are very impressed with EVX-01 achieving a 67% objective response rate in the trial. This is encouraging as it verifies a true reduction in tumor burden following dosing and compares favorably with historical data from anti-PD-1 monotherapy trials. With the encouraging data from our ongoing Phase 2 study of EVX-01 presented at this year’s annual ASCO (Free ASCO Whitepaper) meeting, we are on track to report our one-year readout in the third quarter of this year," said Christian Kanstrup, CEO of Evaxion.

For more information about the recent EVX-01 Phase 2 immune data presented at ASCO (Free ASCO Whitepaper), please visit our recent press release.

About EVX-01 Phase 2 Clinical Trial

EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The ongoing Phase 2 clinical study is a self-sponsored, open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, together with leading principal investigators and research centers from Italy and Australia. It aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with the anti-PD1 treatment pembrolizumab (more commonly known as KEYTRUDA) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.

On June 17, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported the promotion of Chris Ogden to Chief Financial Officer effective June 15, 2024 (Press release, CytomX Therapeutics, JUN 17, 2024, View Source [SID1234644382]).

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"Chris has made broad contributions as a member of the CytomX executive team and is a proven cross-functional leader within the organization," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX. "We are excited to announce this promotion, which is a reflection of Chris’ financial acumen, strategic leadership and deep commitment to CytomX’s mission."

Mr. Ogden joined CytomX in August of 2021 as Vice President, Finance and Accounting and has since served in roles of increasing responsibility spanning finance, accounting, investor relations, capital raising, information technology, and facilities, most recently as Senior Vice President, Finance and Accounting. Mr. Ogden joined CytomX after a 16-year tenure at Eli Lilly and Company, where he held senior financial leadership positions, including most recently as chief financial officer of Lilly Diabetes. Prior to his role in Lilly Diabetes, Mr. Ogden was the chief financial officer and treasurer of Lilly del Caribe in Puerto Rico. Over the course of his career at Eli Lilly, Mr. Ogden held financial leadership roles that included drug development, manufacturing, commercial operations, and investor relations. Mr. Ogden received his M.B.A. from Harvard Business School and his B.A. in economics from Wabash College.

"It is a privilege to work with the incredibly talented team at CytomX, and I am thrilled to assume the CFO role and to continue to help lead the company through this next chapter, as we pursue our vision to transform lives with safer, more effective cancer therapies," said Chris Ogden. "CytomX’s pipeline is positioned in some of the most exciting areas of oncology research and development including T-cell engagers and antibody drug conjugates, and our PROBODY platform and business model provides a strong foundation to build significant long-term shareholder value through sustained innovation."

On June 17, 2024 AstraZeneca reported that Imfinzi (durvalumab) in combination with carboplatin and paclitaxel followed by Imfinzi monotherapy has been approved in the US as treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) (Press release, AstraZeneca, JUN 17, 2024, View Source [SID1234644379]).

The approval by the Food and Drug Administration (FDA) was based on the results of a prespecified exploratory subgroup analysis by MMR status in the DUO-E Phase III trial. Results from DUO-E were published in the Journal of Clinical Oncology.

In the trial, Imfinzi plus carboplatin and paclitaxel followed by Imfinzi monotherapy (Imfinzi arm) reduced the risk of disease progression or death by 58% in patients with dMMR endometrial cancer versus chemotherapy alone (hazard ratio 0.42; 95% confidence interval 0.22-0.80).2

In the US, endometrial cancer is the fourth most common cancer in women, with more than 66,000 patients diagnosed and almost 12,000 deaths in 2022.3,4 Patients diagnosed at an early stage of disease have a five-year survival rate of approximately 80-90%, but there is a significant need for new treatment options for people with advanced disease, where the survival rate falls to less than 20%.5,6

Shannon N. Westin, Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, and principal investigator of the trial, said, "With the incidence and mortality of endometrial cancer expected to continue to increase significantly in the coming decades, it is more important than ever that we bring new treatment options to patients at the earliest possible moment in their care. This approval underlines clear evidence that durvalumab plus chemotherapy followed by durvalumab monotherapy delivers important clinical benefits for patients with mismatch repair deficient endometrial cancer."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "There have been limited advances in the treatment of endometrial cancer in the last few decades, and continued innovation is critical as the burden of this cancer is expected to grow in the future. Immunotherapy in combination with chemotherapy is emerging as a new standard of care in this setting, and the approval of Imfinzi offers an important new option for patients with mismatch repair deficient disease."

The safety and tolerability profile of the Imfinzi and chemotherapy regimen was generally manageable, well tolerated and broadly consistent with prior clinical trials with no new safety signals.1,2

The Lynparza (olaparib) and Imfinzi arm, which investigated Imfinzi plus chemotherapy followed by Imfinzi plus Lynparza as maintenance therapy, also met the primary endpoint of progression-free survival (PFS). The trial continues to assess OS as a key secondary endpoint for both arms. Regulatory applications for both Imfinzi as well as Imfinzi and Lynparza regimens are currently under review in the EU, Japan and several other countries based on the DUO-E results.

Notes

Endometrial cancer
Endometrial cancer is a highly heterogeneous disease that originates in the tissue lining of the uterus and is most common in women who have already been through menopause, with the average age at diagnosis being over 60 years old.7-10 It is the sixth most common cancer in women worldwide.11,12 Incidence and mortality of endometrial cancer are expected to increase by approximately 61% and 87% respectively (from 420,400 cases and 97,700 deaths in 2022 to 676,300 cases and 183,100 deaths) in 2050.13

The majority of patients with endometrial cancer are diagnosed at an early stage of disease, where the cancer is confined to the uterus.9,10 They are typically treated with surgery and/or radiation, and the five-year survival rate is high (approximately 80-90%).5,6 Patients with advanced disease (Stage III-IV) usually have a much poorer prognosis, with the five-year survival rate falling to less than 20%.5,6 Immunotherapy combined with chemotherapy is emerging as a new standard of care for advanced endometrial cancer, particularly for patients with dMMR disease, who make up approximately 20-30% of all patients with this type of cancer.6,14,15,16 There remains a high unmet need for treatments for the remaining 70-80% of endometrial cancer patients with pMMR disease.15,16

DUO-E
The DUO-E trial (GOG 3041/ENGOT-EN10) is a three-arm, randomised, double-blind, placebo-controlled, multicentre Phase III trial of 1st-line Imfinzi (durvalumab) plus platinum-based chemotherapy (carboplatin and paclitaxel) followed by either Imfinzi monotherapy or Imfinzi plus Lynparza (olaparib) as maintenance therapy versus platinum-based chemotherapy alone as a treatment for patients with newly diagnosed advanced or recurrent endometrial cancer.

The DUO-E trial randomised 699 patients with newly diagnosed advanced or recurrent epithelial endometrial carcinoma to receive either Imfinzi (1120mg) or placebo, given every three weeks in addition to standard-of-care platinum-based chemotherapy. After 4-6 cycles of chemotherapy, patients (whose disease had not progressed) then received either Imfinzi (1500mg) or placebo every four weeks as maintenance, plus 300mg Lynparza (300mg BID [2x150mg tablets, twice a day]) or placebo until disease progression.

The dual primary endpoint was PFS of each treatment arm versus standard of care. Key secondary endpoints included overall survival (OS), safety and tolerability. The trial continues to assess OS for both Imfinzi monotherapy and Imfinzi plus Lynparza as maintenance therapy in the overall trial population. Mismatch repair (MMR) status, recurrence status and geographic location were stratification factors. The trial was sponsored independently by AstraZeneca and conducted in 253 study locations across 22 countries including the US, Europe, South America and Asia.

For more information about the trial, please visit ClinicalTrials.gov.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to its indications in unresectable, Stage III NSCLC and ES-SCLC, Imfinzi is currently approved in a number of countries in combination with a short course of tremelimumab (Imjudo) and chemotherapy for the treatment of metastatic NSCLC.

Imfinzi is also approved in a number of countries in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU.

Since the first approval in May 2017, more than 220,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal cancers and other solid tumours.

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