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Replimune and Incyte Enter into Clinical Trial Collaboration and Supply Agreement to Evaluate RP1 and INCB99280 in Patients with Cutaneous Squamous Cell Carcinoma

On July 31, 2023 Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, and Incyte (NASDAQ:INCY), a global biopharmaceutical company, reported a clinical trial collaboration and supply agreement to study RP1, Replimune’s lead product candidate, in combination with INCB99280, Incyte’s small molecule oral PD-L1 inhibitor (Press release, Replimune, JUL 31, 2023, View Source [SID1234633547]).

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"We are excited to enter into this collaboration with Incyte to explore the use of RP1 prior to surgery as we believe that our tumor-directed oncolytic immunotherapies could have a great impact in the neoadjuvant setting both in cutaneous squamous cell carcinoma (CSCC) and in other cancer types, given the high rates of complete responses we’ve seen to date, and data indicating RP1 is generally very well tolerated," said Robert Coffin, Chief Research and Development Officer of Replimune. "The unique potential of the RPx platform to induce a patient-specific anti-tumor immune response with an off-the-shelf treatment speaks to the practicality and broad potential utility of the approach, and exploring its use with Incyte’s oral PD-L1 inhibitor has the potential to improve the patient experience further."

"We look forward to collaborating with Replimune on this study evaluating INCB99280 and RP1 in patients with CSCC. Our oral PD-L1 program has shown promising safety and efficacy in early studies thus far, and we look forward to adding to the growing body of evidence for INCB99280 and learning more about its potential to improve clinical outcomes," said Lance Leopold, M.D., Group Vice President, Clinical Development Hematology and Oncology, Incyte.

Under the terms of the agreement, Incyte will initiate and sponsor the clinical trial of INCB99280 and RP1 in patients with high risk, resectable cutaneous squamous cell carcinoma (CSCC), with the clinical trial expected to initiate in early 2024. Replimune will supply Incyte with RP1 for the study and share equally in the costs of the study.

About RP1

RP1 is Replimune’s lead oncolytic immunotherapy product candidate and is based on a proprietary new strain of herpes simplex virus engineered for robust tumor selective replication and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About INCB99280

INCB99280 is a potent and selective small molecule oral PD-L1 inhibitor, which has demonstrated promising clinical activity and safety in patients with solid tumors. INCB99280 is being evaluated in multiple Phase 2 studies as monotherapy and in combination with other antitumor agents.

Mustang Bio Announces Amendment and Closing of Strategic Manufacturing Partnership Transaction with uBriGene (Boston) Biosciences

On July 31, 2023 Mustang Bio, Inc. ("Mustang" or the "Company") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, reported that, on July 28, 2023, it amended its previously announced asset purchase agreement with uBriGene (Boston) Biosciences Inc. ("uBriGene"), the U.S. subsidiary of uBriGene Group, a leading cell and gene therapy contract development and manufacturing organization ("CDMO") and closed the transaction under the terms of the amended asset purchase agreement (Press release, Mustang Bio, JUL 31, 2023, View Source [SID1234633546]).

Per the terms of the amended agreement, at closing, uBriGene acquired all of Mustang’s assets primarily relating to the manufacturing and production of cell and gene therapies for upfront consideration of $6 million in cash. Mustang’s lease to the premises in Worcester, Massachusetts where its state-of-the-art clinical- and commercial-scale cell and gene therapy manufacturing facility is located (and related contracts and manufacturing personnel) did not transfer at closing because such transfer requires the consent of the landlord, which has requested additional time to consider the proposed transfer. An additional $5 million contingent payment (less any outstanding liabilities relating to transferred contracts and employees) will be payable to Mustang upon (i) Mustang’s raising $10 million in gross proceeds from equity raises following the closing of the transaction and (ii) completion of the assignment of Mustang’s lease to uBriGene, which remains subject to landlord’s approval. Unless and until the lease is transferred to uBriGene, Mustang will retain its facility lease and facility personnel, and will continue to occupy the leasehold premises and manufacture there its lead product candidate, MB-106.

The amended asset purchase agreement provides that Mustang will continue to work with uBriGene to secure the assignment of its manufacturing facility lease, which would complete the transfer of its facility to uBriGene as originally planned. The Company and uBriGene expect to complete their filing of a joint voluntary notice to obtain clearance for the transaction from the U.S. Committee on Foreign Investment in the United States ("CFIUS") no later than August 31, 2023. It is expected that CFIUS may take up to 90 days to complete its review, after which Mustang’s landlord has informed the Company that it will require an additional 30 days to review the request for consent to assign the lease. If, after 120 days from the date of closing, the lease has not transferred to uBriGene, uBriGene may request the parties use their best commercial efforts to negotiate in good faith a repurchase by Mustang of the transferred assets and assumed liabilities acquired on the date of closing.

Under the terms of the amended asset purchase agreement, the lease of the facility and related contracts are to be transferred to uBriGene within three business days following receipt of the landlord’s consent to the proposed lease transfer, and Mustang employees who support the transferred operations and have accepted offers of employment with uBriGene will become employees of uBriGene effective on the date that is 30 days following the completion of the lease transfer.

At closing, Mustang and uBriGene also entered into a manufacturing services agreement, under which Mustang contracted uBriGene to manufacture Mustang’s lead product candidates. This includes the manufacturing of MB-106, the Company’s first-in-class CD20-targeted autologous CAR T therapy, for the ongoing multi-center Phase 1/2 trial in patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia. Pending the landlord’s determination regarding transfer of the facility lease to uBriGene, Mustang and uBriGene also have entered into a second manufacturing services agreement, under which Mustang will serve as uBriGene’s contract development and manufacturing provider and will continue to manufacture MB-106, as well as potentially other cell and gene therapies, in exchange for compensation to be equal to Mustang’s operating costs associated with the performance of such services.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, commented, "We are very pleased to have closed this strategic transaction with uBriGene. This transaction will allow Mustang to optimize its resources and focus on advancing our lead clinical-stage programs in order to achieve multiple near-term milestones, while significantly reducing our operating expenses and enhancing our cash position. We look forward to reporting initial clinical data from our MB-106 multicenter program soon."

The upfront proceeds from the transaction and recent reductions in operating expenses relating to Mustang’s portfolio along with resource optimization are expected to extend the Company’s cash runway into early 2024.

The Worcester facility is a 27,000 square foot, cutting-edge cGMP facility supporting process development, manufacturing and analytical testing, designed with the flexibility to expand and support various cell and gene therapy production requirements and capacities.

"Our transaction with Mustang will permit the expansion of the Worcester site’s capabilities while leveraging Mustang’s experienced staff and robust quality and operating systems to manufacture a broader portfolio of advanced modalities," said Alex Chen, President of uBriGene. "uBriGene will also offer its expertise in preclinical research services and late-stage and commercial manufacturing of advanced therapy products with respect to product and process characterization, and regulatory inspections."

Upon transfer of the lease to uBriGene, Mustang’s headquarters will relocate to 1 Mercantile Street, in Worcester, MA.

Mustang has filed a Current Report on Form 8-K, dated July 31, 2023 (the "Form 8-K"), with the U.S. Securities and Exchange Commission (the "SEC"), relating to the amended asset purchase agreement and closing of the transaction described in this press release. You are encouraged to refer to the Form 8-K for a more complete description of the material terms of the amended asset purchase agreement, the manufacturing services agreements, the transaction, the closing, and related matters.

Labcorp to Host Investor Day on September 14, 2023

On July 31, 2023 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported that it will host an Investor Day on Thursday, September 14, 2023, in New York City, beginning at 1:00 p.m. ET and is expected to conclude by approximately 4:00 p.m. ET (Press release, LabCorp, JUL 31, 2023, View Source [SID1234633545]).

This event will highlight Labcorp’s go-forward strategy from Labcorp Chairman & CEO Adam Schechter, followed by business overviews and a longer-term financial outlook. Presentations will be followed by a Q&A session.

A live webcast of the event will be available through the Labcorp Investor Relations website beginning at 1:00 p.m. ET. A replay of the webcast and supporting materials will be available after the conclusion of the event.

FDA Grants Fast Track designation to IVS-3001, Invectys’ CAR-T Cell Therapy in the Treatment of Renal Cell Carcinoma

On July 31, 2023 Invectys, Inc., a clinical-stage immuno-oncology company focused on developing novel therapies for advanced cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its revolutionary product, IVS-3001 (Press release, Invectys, JUL 31, 2023, View Source [SID1234633544]). This significant milestone marks a crucial step forward in advancing cancer treatment options and improving patient outcomes.

IVS-3001 is a cutting-edge CAR-T cell immunotherapy that targets the rarely exploited immune checkpoint and tumor-specific antigen known as HLA-G. This molecule, typically expressed only during pregnancy, protects the fetus from the mother’s immune system. However, in cancer, HLA-G can be utilized by tumors to create a protective microenvironment, evading the immune system, and promoting tumor growth. By targeting this mechanism, IVS-3001 aims to reinvigorate the body’s natural defense to combat cancer effectively.

The Fast Track designation to IVS-3001 was based on the compelling data from the Investigational New Drug Application (IND) submission, and the potential for addressing the unmet need in patients with HLA-G positive locally advanced or metastatic clear cell renal cell carcinoma (RCC) who have failed or are intolerant to standard RCC therapies.

Fast Track designation is a critical regulatory designation designed to expedite the development and review process for therapies that address unmet medical needs in serious conditions.

« We are thrilled to receive the FDA’s Fast Track designation for IVS-3001, » said Dr. Jake Kushner, CEO of Invectys. « This recognition further validates the potential of our CAR-T cell therapy in revolutionizing cancer treatment for patients with solid tumors. The dedicated team at Invectys, as well as our partners, are committed to bringing this innovative therapy to the clinic and making a meaningful difference in the lives of cancer patients. »

For more information on Invectys, Inc. and its revolutionary CAR-T cell immunotherapy, please visit www.invectys.com.

ImmunoGen Reports Recent Progress and Second Quarter 2023 Financial Results

On July 31, 2023 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported recent progress in the business and reported financial results for the quarter ended June 30, 2023 (Press release, ImmunoGen, JUL 31, 2023, View Source [SID1234633543]).

"This quarter we achieved a significant milestone for patients and our organization. With positive data from our confirmatory MIRASOL trial, ELAHERE is the first therapy to demonstrate an overall survival benefit versus chemotherapy in a Phase 3 trial in platinum-resistant ovarian cancer. These data further support the potential of ELAHERE to become the new standard of care for FRα-positive platinum-resistant disease," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "In parallel, through strong execution by our commercial team supported by robust engagement from medical affairs, we have accelerated the ELAHERE launch, more than doubling our Q1 results with increasing breadth and depth of adoption driven by recognition of the benefits this novel treatment brings to patients with advanced ovarian cancer."

Enyedy continued, "We also progressed our broader development program to move ELAHERE into platinum-sensitive disease and position it as the combination agent of choice in ovarian cancer. Turning to our second pivotal program, PVEK, we presented an interim analysis from our CADENZA trial showing encouraging anti-tumor activity and durable responses in BPDCN and are pleased to share that we enrolled our last patient in the pivotal de novo frontline cohort at the end of the second quarter. We also advanced development with IMGC936 and IMGN151, our second-generation ADC targeting FRα. Looking ahead, we see continued momentum through the second half of the year with multiple data readouts and regulatory milestones, including efficacy results from PICCOLO with ELAHERE monotherapy in platinum-sensitive ovarian cancer and from the expansion cohorts with the PVEK/VEN/AZA triplet in frontline AML as well as the submissions of the MAA and sBLA for ELAHERE."

RECENT PROGRESS

Generated $77.4 million in ELAHERE (mirvetuximab soravtansine-gynx) net sales for the quarter ended June 30, 2023.
Announced positive data from the confirmatory Phase 3 MIRASOL trial in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) and presented the results in a late-breaking oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting.
Presented an interim analysis from the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 Congress.
Completed enrollment in the pivotal frontline de novo BPDCN cohort in the Phase 2 CADENZA trial.
Our partner, Neopharm Israel, submitted the Marketing Authorization Application (MAA) to the Israeli Ministry of Health (MoH) for ELAHERE in FRα-positive PROC to support potential approval in mid-2024.
ANTICIPATED UPCOMING EVENTS

Submit MAA to the European Medicines Agency (EMA) for ELAHERE in FRα-positive PROC in the fourth quarter of 2023 to support approval and launch in Europe.
Submit supplemental Biologics License Application (sBLA) to the Food & Drug Administration (FDA) in the fourth quarter of 2023 to support the conversion of the accelerated approval of ELAHERE to full approval.
Our partner, Huadong Medicine, expects to submit the MAA to the National Medical Products Administration (NMPA) of China for ELAHERE in FRα-positive PROC by the end of 2023 to support potential approval and launch.
Present additional subset analyses from the Phase 3 MIRASOL trial in an oral session at the European Society of Gynaecological Oncology (ESGO) Congress in September.
Report on the primary endpoint of objective response rate (ORR) for PICCOLO, a single-arm Phase 2 trial of mirvetuximab in FRα-high platinum-sensitive ovarian cancer (PSOC), before the end of 2023.
Report data from two cohorts evaluating the pivekimab triplet with Venclexta (venetoclax) and Vidaza (azacitidine) in frontline acute myeloid leukemia (AML) at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Provide an update on the IMGC936 non-small cell lung cancer (NSCLC) cohort following a prespecified interim analysis.
FINANCIAL RESULTS

Total revenues were $83.2 million for the quarter ended June 30, 2023, including $77.4 million of net product revenues from sales of ELAHERE, compared to $14.2 million in total revenues for the quarter ended June 30, 2022. The increase was primarily driven by ELAHERE net sales, partially offset by $6.9 million of license fees recorded as revenue in the prior year period pursuant to the Company’s collaboration agreement with Huadong Medicine Co., Ltd (Huadong Medicine).

Research and development expenses were $50.1 million for the quarter ended June 30, 2023 compared to $51.4 million for the quarter ended June 30, 2022. The decrease was primarily driven by a $7.5 million one-time upfront fee recorded in the prior period related to our research collaboration with Oxford Biotherapeutics Ltd. and ELAHERE supply costs expensed in the prior quarter versus capitalized in the current period. Partially offsetting these decreases, third-party service fees and personnel costs increased driven largely by the expansion of our medical affairs organization, as well as an increase in clinical trial expenses in the current quarter.

Selling, general and administrative expenses were $36.4 million for the quarter ended June 30, 2023 compared to $23.8 million for the quarter ended June 30, 2022. The increase was due primarily to greater expenses in support of the US launch of ELAHERE, including costs related to the addition of our commercial organization and sales and marketing activities.

Net loss for the second quarter of 2023 was $4.2 million, or $0.02 per share, compared to a net loss of $62.0 million, or $0.24 per share, for the second quarter of 2022.

In May 2023, pursuant to a public equity offering, the Company sold an aggregate of 29,900,000 shares of its common stock, with net proceeds of $350.8 million.

ImmunoGen had $572.0 million in cash and cash equivalents and $75.4 million in accounts receivable as of June 30, 2023, compared with $275.1 million in cash and cash equivalents and $12.6 million in accounts receivable as of December 31, 2022. Cash used in operations was $140.5 million for the first six months of 2023 compared with cash used in operations of $105.4 million for the same period in 2022. Capital expenditures were $0.3 million and $0.5 million for the first six months of 2023 and 2022, respectively.

FINANCIAL GUIDANCE

ImmunoGen has updated its financial guidance for 2023 and now expects operating expenses of between $350 million and $365 million; this increase reflects greater spending in support of ELAHERE, including preparations for a launch in Europe, and to expand the Company’s research capabilities and pipeline. Revenue guidance, excluding ELAHERE sales, remains unchanged at between $45 million and $50 million.

The Company expects that its existing cash and cash equivalents, together with anticipated future product and collaboration revenues, will fund operations for more than two years.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

ABOUT ELAHERE

ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Eye problems are common with ELAHERE and can be severe. ELAHERE also can cause severe or life-threatening inflammation of the lungs that may lead to death and patients may develop nerve problems called peripheral neuropathy during treatment. Please see full Prescribing Information, including Boxed Warning, and Medication Guide for ELAHERE.