On May 19, 2021 Photocure ASA (OSE:PHO), the Bladder Cancer Company, reported Hexvix/Cysview revenues of NOK 81.6 million in the first quarter of 2021 (Q1 2020: NOK 54.4 million), and EBITDA of NOK 18.1 million (NOK -4.8 million), following the continued successful launch in markets previously operated by Ipsen Pharma SAS (Press release, PhotoCure, MAY 19, 2021, View Source [SID1234580326]). The third Covid-19 wave impacted operations in the quarter, but a strong March performance indicates the environment is improving.

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"For the first quarter of 2021, Photocure delivered a 50% YoY increase in Hexvix/Cysview sales, unit growth in our U.S. segment, and positive EBITDA driven by the added revenue in Europe, cost containment, and the payment from Asieris to license Hexvix in China and Taiwan. I am pleased with this performance, particularly given the negative impact from the third wave of Covid-19 in January and February of this year, foreign currency headwinds during the quarter, and the difficult comparison to the same period last year when pandemic lockdowns and limited access to care did not occur until mid-March. While access is still closed or significantly restricted in many areas, strong performance in the last month of the quarter in both our U.S. and European segments suggests that the environment is improving," says Daniel Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 88.2 million in the first quarter of 2021 (NOK 55.0 million), with an EBITDA* before restructuring of NOK 18.1 million (NOK -4.8 million) including signing fees from Asieris totaling NOK 6.4 million for the commercialization of Hexvix in Mainland China and Taiwan. Hexvix/Cysview revenues were NOK 81.6 million (NOK 54.4 million) following the successful transition of the Ipsen territories, while unit growth in the U.S. increased 4% despite the limited access to hospitals and physicians due to Covid-19. EBIT grew to NOK 12.3 million (-10.5 million) and the cash balance at the end of the first quarter 2021 was NOK 329.5 million (127.6 million).

The installed base of blue light cystoscopes in the U.S. was 280 at the end of the first quarter, an increase of 42 units, or 18%, compared to the same period in 2020. Blue Light Cystoscopy (BLC) in the surveillance setting is a key priority for Photocure in the U.S. market. By the end of the first quarter, a total base of 41 flexible cystoscopes had been installed giving more patients access to the procedure with less constraints.

"Despite the ongoing commercial challenges, we continued to advance several initiatives to grow the installed base of Blue Light Cystoscope towers and to prepare for increasing procedure volumes when full access to care reopens. In the U.S., we installed 12 new towers during the quarter including 3 flexible Blue Light Cystoscope units. Our growing pipeline suggests the potential for acceleration of Blue Light Cystoscope installations during the remainder of the year, and we believe that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care, " Schneider adds.

The ongoing Covid-19 pandemic adds continued uncertainty to Photocure’s near-term business forecast, but the Company believes that in places where procedures have been postponed due to the fear of exposure to Covid-19, the number of procedures is expected to rebound back to pre-Covid-19 growth rates in the U.S. and positive growth in the Company’s newly acquired European markets.

"Our contracting strategies in the U.S. are also gaining traction and expected to lead to new account growth and higher penetration into our existing institutional customers and physician clinics. In Europe, where we are introducing Photocure as the new sponsor of Hexvix, we have had strong buy-in from leading key opinion leaders in target countries. Despite limited access to our new customers, we are seeing early indications of a turn-around in our key growth markets such as the UK, France, and Italy. As access improves, we will continue to staff our European operations and invest in order to generate additional growth in the region. Our performance in dealing with the ongoing business volatility, including the sales rebound that we saw in March, gives me confidence that we are taking the right steps to return to strong growth and to execute on our strategy to become a leader in the diagnosis and treatment of bladder cancer patients around the world" Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the first quarter 2021 financial report on page 23.

Photocure will present its first quarter 2021 report on Wednesday 19 May 2021 at 14:00 CET. The investor presentation will be streamed live and be hosted by Daniel Schneider, CEO and Erik Dahl, CFO.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20210519_6/. The presentation is scheduled to conclude at 14:45 CET.

On May 19, 2021 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that it is presenting updated results of their first-in-human multicenter study of GC012F for the treatment of relapsed and/or refractory multiple myeloma, a FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy currently in development for the treatment of multiple myeloma, at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 ("EHA2021") Congress (Press release, Gracell Biotechnologies, MAY 19, 2021, View Source [SID1234580325]).

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GC012F is a BCMA/CD19 dual-targeting CAR-T cell therapy developed on Gracell’s proprietary FasTCAR next-day manufacturing technology platform and is being evaluated in a Phase 1 investigator-initiated trial study.

As of January 12, 2021, the study had enrolled and treated 19 patients at three dose levels with the highest dose level of 3×105 cells per kg. Additional patients were treated since last update (reported at ASH (Free ASH Whitepaper) 2020) in the highest dose level.
Early Overall Response Rate (ORR) shows a promising 94.7% (18/19) with all responses being VGPR or better (sCR), demonstrating fast, deep and durable responses in all dose levels.
100% of the patients treated at the highest dose level (n=9) obtained MRD negative sCR.
18 of the 19 patients (94.7%) treated were classified as high-risk according to mSMART 3.0 guidelines and patients had received a median of 5 prior lines of therapy.
94.7% (18/19) of the patients were triple exposed to a PI, IMiD, and at least a third treatment modality, including anti-CD38 targeted therapy.
The safety profile of GC012F was consistent with previous findings with mostly low grade of cytokine release syndrome (CRS) (84% Grade 1/2, 11% (n=2) patients Grade 3). No Grade 4 or 5 CRS and no ICANS (immune effector cell-associated neurotoxicity) were observed in any of the 19 patients. Treatment-emergent adverse events (TEAEs) presented predominantly as cytopenias and AST increase. All TEAEs resolved with standard therapy.
Patients are continued to be followed for efficacy and safety.
"The longer-term follow-up and additional patients treated with GC012F confirm the previous findings presented at ASH (Free ASH Whitepaper) 2020 and are an additional confirmation for the impressive safety and efficacy shown with our dual-targeting CAR-T therapy, including in high risk patients," said Dr. Martina Sersch, MD, Chief Medical Officer of Gracell. "High-risk patients are difficult to treat. All patients in the highest dose level showed an initial 100% MRD negative sCR, and these deep responses were maintained at month six post-infusion after treatment with GC012F and beyond. These are very encouraging data and they hold a promise for multiple myeloma patients with high risk features and beyond, including those who have failed or are no longer responding to standard treatment options. We are planning to expand our program globally including earlier lines of therapy and are looking forward to sharing updates as we advance our programs."

Details on the poster presentations are shown below:

2021 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract 8014: Long-term follow-up results of a multicenter first-in-human study of the dual BCMA/CD19 targeted FasTCAR-T GC012F for patients with relapsed/refractory multiple myeloma

Poster Release Date: June 4, 2021

EHA2021 Virtual Congress

Abstract EP962: Long-term follow-up results of a multicenter first-in-human study of the dual BCMA/CD19 targeted FasTCAR-T GC012F for patients with relapsed/refractory multiple myeloma

Poster Release Date: June 11, 2021

About Multiple Myeloma

Multiple myeloma (MM) is the third most common type of blood cancer in the United States, originating from plasma cells, a type of immune cell that is typically responsible for secreting antibodies to fight infection. Globally, approximately 160,000 patients are diagnosed with MM every year with over 32,000 expected to be diagnosed in the United States in 2020. In recent years, many advances have been made to treat MM, however, the disease is still considered incurable. Multiple myeloma patients with certain cytogenetic and other abnormalities are classified by the International Myeloma Working Group, or IMWG, and Mayo Stratification for Myeloma and Risk-Adapted Therapy, or mSMART, criteria as high-risk patients. They represent 20-30% of the overall MM patient population. High-risk patients have a much higher risk of early relapse and shorter progression free and overall survival. These patients are considered the most difficult to treat MM patients, typically with a poor prognosis.

About GC012F

GC012F is a FasTCAR-enabled dual-targeting CAR-T product candidate that is currently being studied in an ongoing investigator-initiated Phase 1 trial across multiple centers in China for the treatment of MM. GC012F tackles MM by simultaneously targeting both malignant plasma cells expressing BCMA and early progenitor cells expressing CD19 in order to drive fast, deep and durable responses in MM patients.

About FasTCAR

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

On May 19, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that an abstract detailing clinical data from its U.S. phase 1 study of uliledlimab in combination with atezolizumab (TECENTRIQ) in patients with advanced cancer will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 4-8, 2021 (Press release, I-Mab Biopharma, MAY 19, 2021, View Source [SID1234580324]). The abstract has been selected as one of the Top 12 abstracts for poster discussion during the Developmental Therapeutics – Immunotherapy session.

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Uliledlimab is a humanized CD73 antibody and is designed to counter the adenosine-mediated immunosuppressive tumor microenvironment, rendering anti-tumor immune cells to act more effectively in response to checkpoint immunotherapies. Preclinical studies have shown that when combined with a PD-(L)1 antibody, uliledlimab exhibited a superior and synergistic inhibitory effect on tumor growth versus PD-(L)1 mono-therapy. Uliledlimab is a highly differentiated CD73 antibody that binds to a unique epitope of CD73 to confer pharmacological advantages by avoiding the "hook effect" commonly seen with other CD73 antibodies.

The U.S. phase 1 dose escalation study of uliledlimab in combination with atezolizumab showed that the treatment is safe and well tolerated with no dose-limiting toxicity. All treatment related adverse events were either grade 1 or grade 2. Uliledlimab demonstrated a linear pharmacokinetic (PK) profile and reached full receptor occupancy on B cells at the middle and high dose levels with no "hook effect." Patients who participated in the study had advanced cancers and exhausted other cancer therapies. Among the 13 efficacy-evaluable patients dosed at ≥ 10 mg/kg, three patients had complete or partial responses (objective response rate = 23%) and three had stable disease (disease control rate = 46%). The clinical activity was observed in both PD-(L)1 treatment naïve and refractory cancer patients, including one partial response patient who previously failed nivolumab. Tumor types of patients who had complete or partial responses or stable disease included ovarian clear cell carcinoma, non-small cell lung cancer and a few other cancers. The three responders were identified as the only patients who exhibited higher co-expression of tumor CD73 and PD-L1 as compared to non-responders, indicating a correlation between higher CD73 expression and clinical activity of uliledlimab and a potential role of CD73 as a predictive biomarker to warrant further investigation.

Details of the poster discussion session are as follows:

Abstract No.

2511

Poster Title

Preliminary safety, pharmacokinetics (PK), pharmacodynamics (PD) and clinical efficacy of uliledlimab (TJ004309), a differentiated CD73 antibody, in combination with atezolizumab in patients with advanced cancer

Poster Discussion Session

Developmental Therapeutics – Immunotherapy

Presentation Date and Time

June 4, 2021, 9:00 AM (ET)

Presenting Author

Dr. Francisco Robert, Professor of Medicine, University of Alabama-Birmingham

"Despite recent breakthroughs with PD-1/PD-L1 therapies, clinical non-response rates to such treatments remain high in cancer patients. Uliledlimab, through its unique mechanism of action, has shown its promise to address this unmet medical need by breaking tumor resistance to immunotherapies through combination therapy," said Dr. Joan Shen, CEO of I-Mab. "The results from this phase 1 study are very encouraging in terms of potential therapeutic role of uliledlimab to treat multiple cancers, especially in patients who do not respond to PD-1/PD-L1 therapies. The differentiated properties of uliledlimab may provide additional pharmacological and treatment advantages, and we look forward to advancing the development of uliledlimab both globally and in China."

In parallel development, I-Mab has made significant progress in clinical trials in China to evaluate uliledlimab in combination with toripalimab (TUOYI) in patients with advanced or metastatic cancers, including non-small cell lung cancer, who are refractory to or intolerant of available therapies.

I-Mab will host an investor call on June 7, 2021 to discuss the clinical data presented at the conference. Details of conference call and webcast information will be provided subsequently.

About Uliledlimab (TJD5)

Uliledlimab (TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine in turn binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in tumor microenvironment. Uliledlimab is expected to offer clinical benefit by suppressing tumor growth in concert with checkpoint therapies such as PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties as evident in preclinical studies.

On May 19, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that three abstracts with data on melflufen (INN melphalan flufenamide) in relapsed refractory multiple myeloma, RRMM, have been accepted by the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), ASCO (Free ASCO Whitepaper), and have now been published online (Press release, Oncopeptides, MAY 19, 2021, View Source [SID1234580323]). The clinical data presentations include updates on Oncopeptides’ ANCHOR and LIGHTHOUSE studies as well as a pooled analysis of the O-12-M1 and HORIZON studies in patients who have been exposed to or become refractory to prior alkylators.

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"The phase 1/2 ANCHOR study of melflufen plus dexamethasone in combination with either daratumumab or bortezomib shows encouraging clinical activity in heavily pre-treated patients with relapsed refractory multiple myeloma, and the optimal dose of melflufen has now been established for both regimens," says Klaas Bakker, MD, PhD, Executive Vice President and Chief Medical Officer, Oncopeptides AB. "We will now complete patient enrolment in the bortezomib arm, while the daratumumab arm is already fully accrued, as presented at the American Hematology Association meeting in December 2020, where updated safety and efficacy data from ANCHOR were presented. The data presented here at ASCO (Free ASCO Whitepaper) data clearly support further development of melflufen in triplet regimens and reinforce the rational for the ongoing phase 3 LIGHTHOUSE study, comparing melflufen plus dexamethasone in combination with subcutaneous daratumumab with daratumumab alone."

Below is a brief description of the abstracts that have been accepted by the ASCO (Free ASCO Whitepaper). They will be available online at View Source, on May 19th at 23:00 (CET).

1. ANCHOR (OP-104): MELFLUFEN PLUS DEXAMETHASONE AND BORTEZOMIB IN RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS
The ANCHOR study determined that the optimal dose of melflufen is 30 mg plus dexamethasone and bortezomib and the results showed clinical activity in heavily pretreated RRMM patients. Recruitment for this study is ongoing and updated data including efficacy and safety will be presented at ASCO (Free ASCO Whitepaper).

2. LIGHTHOUSE (OP-108): A PHASE 3 STUDY OF MELFLUFEN IN COMBINATION WITH DEXAMETHASONE AND DARATUMUMAB IN RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS
The phase 3 LIGHTHOUSE study is a randomized, controlled, open-label study of melflufen plus dexamethasone in combination with daratumumab vs daratumumab alone in patients with RRMM previously treated with an immunomodulatory agent and a proteasome inhibitor, similar to the indication for daratumumab monotherapy. The primary objective is superiority of PFS. Key secondary endpoints include ORR (≥ PR), DOR, and safety. Patient recruitment is ongoing with a planned enrolment of 240 patients.

3. A POOLED ANALYSIS OF THE O-12-M1 AND HORIZON STUDIES: MELFLUFEN PLUS DEXAMETHASONE IN RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS (RRMM) WHO ARE EXPOSED OR REFRACTORY TO PRIOR ALKYLATORS
This pooled analysis of the O-12-M1 and HORIZON studies showed that melflufen in combination with dexamethasone showed meaningful efficacy and demonstrated a clinically manageable safety profile in patients with RRMM who had been exposed or become refractory to prior alkylators.

PEPAXTO (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

For more information, please contact:

Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
E-mail: [email protected]
Cell phone: + 46 70 262 96 28

Linda Holmström, Director of Investor Relations, Oncopeptides AB (publ)
E-mail: [email protected]
Cell phone: +46 70 873 40 95

About melphalan flufenamide

Melphalan flufenamide, also known as melflufen, is a first-in-class peptide-drug conjugate that targets aminopeptidases and rapidly releases alkylating agents inside cancer cells. Aminopeptidases are overexpressed in multiple myeloma cells and are associated with advanced disease and tumor mutational burden. Targeting aminopeptidases causes selective activity in cancer cells, sparing healthy cells.

In the US, PEPAXTO (melphalan flufenamide) is indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

On May 19, 2021 Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that the updated Phase I clinical study (NCT04272944) data on the safety and efficacy of MSB2311, a pH-dependent PD-L1 antibody, in Chinese patients with advanced solid tumors and hematological malignancies have been presented as an abstract online publication at the 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Abstract #e14547, 5:00 PM, U.S. East Time, Wednesday, May 19, 2021) (Press release, Transcenta, MAY 19, 2021, View Source [SID1234580322]).

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The study, presented at the 2021 ASCO (Free ASCO Whitepaper) annual meeting by abstract, was led by Professor Lin Shen from Beijing Cancer Hospital, and was a Phase I study of MSB2311 with a unique pH-dependent antigen binding property in Chinese patients with advanced solid tumors and lymphoma. Its primary objectives were to evaluate the safety and tolerability and to identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The secondary objectives included the assessment of pharmacokinetic parameter, immunogenicity, and preliminary anti-cancer activity per RECIST version 1.1.

The study included a dose escalation Phase and a dose expansion Phase. In the dose escalation Phase, MSB2311 was given at dose levels of 3, 10, and 20mg/kg intravenously every 3 weeks. At the dose expansion Phase, patients with biomarker expression, including EBV+, PD-L1+ (TPS≥50%), MSI-High or TMB-High (≥10muts/Mb), were dosed at 20mg/kg Q3W or 10mg/kg Q2W.

As of data cutoff by Aug 31, 2020, 33 Chinese patients had been treated, including 27 heavily pre-treated solid tumor patients and 6 lymphoma patients. No dose limiting toxicity was reported and MTD has not been reached. The most common AEs (>20%) included: anemia, hypothyroidism, aspartate aminotransferase elevated, proteinuria and weight loss. 13 patients (39.4%) experienced grade 3 AEs, and 6 patients (18.2%) experienced serious adverse events (SAEs). No treatment related grade 4 or 5 AEs was reported.

Of the 17 efficacy evaluable solid tumor patients with biomarker expression, 6 achieved confirmed partial response with an ORR of 35%: 2/8 (25%) at 10mg/kg Q2W and 4/9 (44%) at 20mg/kg Q3W. Additionally, one patient achieved sustained iPR per iRECIST. 4 out of 7 responding patients (including one iPR) achieved tumor shrinkage of more than 50%, 3 of them got durable response (≥24 weeks). 1 out of 6 lymphoma patients achieved PR.

"In recent years, tumor immunotherapy has gradually become a research hotspot in the field of tumor treatment. It has played a great role in the treatment of tumors, and we have been making efforts in this area," said Professor Lin Shen, the leading investigator from Beijing Cancer Hospital. "Patients with metastatic solid tumors or selected lymphoma progressed on or after standard treatments were enrolled in this Phase I study. This Phase I study showed promising preliminary efficacy and tolerability of MSB2311 in patients with advanced solid tumors and hematological malignancies."

"MSB2311 demonstrated a manageable safety profile and promising antitumor activity in patients with advanced solid tumors and lymphomas." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta. "We are excited to see how our in-house developed medicines can help to benefit the patients. We will continue to forge ahead with our commitment to differentiated and affordable biologics for patients around the world."

About MSB2311

MSB2311 is an investigational humanized PD-L1 with pH dependent binding property. PD-L1 is involved in inhibiting the immune system’s response to fight cancer. MSB2311 blocks the interaction between PD-L1 and PD-1, which reactivates the suppressed or exhausted anti-tumor effector T cell function in the tumor microenvironment. MSB2311 employs engineered IgG1 which lacks FcR binding. In addition, the binding of MSB2311 to PD-L1 results in internalization of MSB2311 and MSB2311 can dissociate from bound PD-L1 in endosome with pH level lower than 5.5. This allows MSB2311 to be recycled to plasma membrane and be reused to bind with PD-L1 on another tumor cell or immune cell. Results from preclinical studies demonstrate that MSB2311 can inhibit tumor growth of PD-L1 expressing tumor cells in syngeneic mouse-model. Two Phase 1 studies of MSB2311 have been completed in the US and China. MSB2311 is currently to be tested in Phase 2 trial in patients with solid tumors expressing selected biomarker in China.