On June 2, 2020 TAE Life Sciences (TLS), a biological-targeting radiation therapy company developing next-generation boron neutron capture therapy solutions (BNCT), reported the launch of an innovative in-house boron delivery drug development program supported by an influx of $30M in funding (Press release, TAE Life Sciences, JUN 2, 2020, View Source [SID1234560776]). The initial phase of the B-round funds comes from a consortium of investors including ARTIS Ventures, who led the company’s initial funding in 2018.

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The investment will enable TLS to move beyond the current boron-10 drug, BPA, and speed development of novel proprietary boron-10 target drugs at the same time that it hones its neutron beam accelerator technology for BNCT. BNCT is a particle therapy designed to selectively destroy cancer cells without damaging neighboring healthy cells. TLS is the only company to focus on the parallel development of new boron-10 drugs and a neutron accelerator system, a combination aimed at difficult-to-treat cancers.

The TLS diversified drug program objectives include improved targeting of cancer cells, increased boron accumulation in target cells, longer boron retention time, and more boron homogeneity. TLS is developing approaches that include small molecule and antibody boron conjugates that meet these objectives. The company has established a state-of-the-art drug development facility in Santa Monica, Calif., that includes dedicated labs for cell biology and antibody production, medicinal chemistry, and molecular biology.

The company has on staff a highly skilled team of scientists with proven track records in developing antibody target drugs, and TLS has filed more than a dozen patents. Additionally, TLS is collaborating with Dr. Fuhuhiko Tamanoi from the University of Kyoto in Japan on using patented biodegradable nanoparticles for delivery of boron-10.

"Our research tells us that antibodies and antibody fragments are a natural fit for targeted delivery of boron to a multitude of tumor types," said Kendall Morrison, Chief Scientific Officer, TAE Life Sciences. "Adapting our knowledge of antibody-drug conjugates (ADCs) should enable us to develop antibody boron conjugates (ABCTM) with significant amounts of boron attached. The boron-10 attached to ABCs will be non-toxic and safe to handle in contrast to the hazardous and costly cytotoxic molecules used in ADCs. We expect that these antibody boron conjugates, in addition to new boron-containing small molecules we are developing, will help improve tumor uptake and simplify manufacturing. This should result in even better BNCT outcomes and lead to a shorter and simpler path to the clinic."

Unlike conventional radiotherapy and even more advanced particle therapy such as the proton and carbon ion, BNCT is a combination treatment that uses the biological targeting precision of boron-10, which acts as a homing beacon and the activation by a neutron source. When the boron-containing cells are irradiated by epithermal neutrons, the combination releases a highly localized therapeutic dose that destroys cancer on a cell-by-cell basis with minimal damage to healthy tissues. BNCT minimizes the need for physical targeting accuracy and complex tumor motion management procedures. Instead, the therapy targets cancer cells biologically by the boron-carrying drugs that preferentially target tumor tissue as well as undetected microscopic cancer cells.

Importantly, during a time when the clinic and hospital space is at a premium, the increased accuracy offered by biological targeting means that BNCT requires only one or two treatments. Conventional radiotherapy requires fractionated treatments to offset side effects.

"For patients suffering from complex cancers, BNCT may offer a quicker, effective path to cancer cell destruction, with fewer side effects," said Bruce Bauer, Chief Executive Officer of TAE Life Sciences. "TLS’s goal is to continue to increase the efficacy of the combination while bringing costs down so that more clinicians, hospitals, and patients can access this treatment."

On June 2, 2020 Sanofi reported that the European Commission (EC) has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (Press release, Sanofi, JUN 2, 2020, View Source [SID1234560778]).

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Sarclisa is a monoclonal antibody (mAb) that binds to a specific epitope on the CD38 receptor of MM cells.

"The EC approval of Sarclisa represents an important additional therapeutic option and may set a new standard of care for myeloma patients in Europe who are in need of new effective treatments because their disease has returned or they have become refractory to their previous treatment," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "Sarclisa in combination with pom-dex demonstrated median progression-free survival of nearly one year, a five-month improvement over pom-dex alone, in patients who had already failed at least two prior therapies."

Sarclisa Efficacy and Safety Profile in Difficult-to-Treat Patients

In the Phase 3 ICARIA-MM study, Sarclisa added to pom-dex (Sarclisa combination therapy, n=154) demonstrated a statistically significant improvement of progression-free survival (PFS), with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone (n=153) (HR 0.596, 95% CI: 0.44-0.81, p=0.001). Sarclisa combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone (60.4% vs. 35.3%, p<0.0001). In additional analyses, Sarclisa combination therapy compared to pom-dex alone showed a treatment benefit consistent across select subgroups reflective of real-world practice, including patients with high risk cytogenetics, those aged 75 years and older, patients with renal insufficiency and patients who were refractory to lenalidomide.

"As patients experience relapse of their multiple myeloma or become refractory to their current therapy, they become more difficult to treat with increasingly poor prognoses. In the ICARIA-MM trial, Sarclisa combination therapy showed a treatment benefit consistent across relapsed and refractory multiple myeloma subgroups," said Philippe Moreau, M.D., Department of Hematology, University Hospital of Nantes, France. "Sarclisa offers an important new treatment option and a potentially new standard of care for these patients with relapsed, refractory disease."

As outlined in the Summary of Product Characteristics (SmPC), the most frequent adverse reactions observed with Sarclisa (occurring in 20% or more of patients) are neutropenia (46.7%), infusion reactions (38.2%), pneumonia (30.9%), upper respiratory tract infection (28.3%), diarrhea (25.7%) and bronchitis (23.7%). The most frequent serious adverse reactions are pneumonia (9.9%) and febrile neutropenia (6.6%).

For more information on the safety of Sarclisa, please refer to the SmPC.

An Important New Option for Treating Multiple Myeloma

Sarclisa is administered by intravenous (IV) administration and is dosed at 10 mg/kg, in combination with pom-dex, every week for four weeks and then every two weeks, until disease progression or unacceptable toxicity. Assuming no rate adjustments based on infusion-related reactions, the first infusion takes three to four hours, the second infusion takes less than two hours, and the remaining infusions can decrease to 75 minutes from the third infusion onwards. A treatment cycle is 28 days. The EC marketing authorization for Sarclisa is applicable to the 27 member states of the European Union (EU), plus the UK, Iceland, Liechtenstein and Norway.

Multiple Myeloma: A Significant Burden to Patients

MM is the second most common hematologic malignancy,1 with more than 138,000 new cases worldwide each year.2 In Europe, approximately 40,000 patients are diagnosed with MM yearly.3 MM remains incurable in the vast majority of patients, resulting in significant disease burden.

About Sarclisa

Sarclisa is a mAb that binds to a specific epitope on the CD38 receptor. CD38 is highly and uniformly expressed on MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa. It is designed to induce programmed tumor cell death (apoptosis) and immunomodulatory activity.

In addition to the EU, Sarclisa has also been approved in the U.S., Switzerland, Canada and Australia in combination with pom-dex for the treatment of certain adults with relapsed refractory MM. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide.

On June 2, 2020 Sanofi reported that Sarclisa (isatuximab) added to carfilzomib and dexamethasone (Sarclisa combination therapy) reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007, n=179) compared to standard of care carfilzomib and dexamethasone (Kd) in patients (n=123) with relapsed multiple myeloma (MM) (Press release, Sanofi, JUN 2, 2020, View Source [SID1234560779]). Sarclisa combination therapy compared to Kd alone showed a treatment benefit consistent across multiple subgroups.

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These results from the Phase 3 IKEMA trial follow the topline announcement on May 12, 2020 that Sarclisa combination therapy met the trial primary endpoint at the pre-planned interim analysis. Interim results will be presented during the late-breaking session of the European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress (EHA25) on June 14, 2020 and will form the basis for global regulatory submissions later this year.

"In the Phase 3 IKEMA trial, the addition of Sarclisa to carfilzomib and dexamethasone reduced the risk of disease progression or death by 47 percent compared to treatment with carfilzomib and dexamethasone alone," said Philippe Moreau, M.D., Department of Hematology, University Hospital of Nantes, France. "These results suggest the potential of Sarclisa to become a new standard of care in the relapsed multiple myeloma setting."

While median progression free survival (PFS), defined as time to disease progression or death, for Kd was 19.15 months, the median PFS for patients receiving Sarclisa combination therapy had not been reached at the time of the pre-planned interim analysis. The safety and tolerability of Sarclisa observed in this trial was consistent with the observed safety profile of Sarclisa in other clinical trials, with no new safety signals observed.

"This is the second Phase 3 trial to demonstrate superior results with Sarclisa combination therapy over a standard of care regimen, adding to the growing body of evidence that our anti-CD38 monoclonal antibody has the potential to make a meaningful difference for patients," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "We believe Sarclisa has the potential to become the anti-CD38 of choice for the treatment of multiple myeloma. We look forward to seeing the results from future clinical trials to understand the impact of Sarclisa in earlier stages of disease."

Depth of Disease Response with Sarclisa Combination Therapy

Secondary endpoints of the IKEMA trial examined the consistency and depth of response for Sarclisa combination therapy compared to Kd, including overall response rate (ORR), complete response (CR), very good partial response (VGPR) and minimal residual disease (MRD)-negative response. There was no statistically significant difference in ORR, which remained similar for each arm at 86.6% for the Sarclisa combination versus 82.9% for Kd (p=0.1930). The rate of CR was 39.7% in the Sarclisa combination arm and 27.6% in the Kd arm. The rate of VGPR was 72.6% for patients receiving Sarclisa combination therapy and 56.1% for patients receiving Kd. MRD-negative complete response was observed in 29.6% of patients in the Sarclisa combination arm versus 13% of patients in the Kd arm, indicating that nearly 30% of patients treated with Sarclisa combination therapy achieved undetectable levels of MM at 10-5 sensitivity as measured by next generation sequencing (NGS). At the time of the interim analysis, overall survival (OS) data were still immature.

In this trial, treatment emergent adverse events (TEAEs) of Grade ≥3 were observed in 76.8% of patients treated with Sarclisa combination therapy versus 67.2% of patients treated with Kd. Treatment-emergent serious adverse events (SAEs) and fatal TEAEs were similar in the Sarclisa combination therapy arm versus the Kd arm, reporting 59.3% versus 57.4% and 3.4% versus 3.3%, respectively. Infusion reactions were reported in 45.8% (0.6% Grade 3-4) of patients treated with Sarclisa combination therapy versus 3.3% (0% Grade 3-4) of patients treated with Kd. Respiratory infections of Grade ≥3 were seen in 32.2% of patients in the Sarclisa combination therapy arm versus 23.8% of patients in the Kd arm, and cardiac failure Grade ≥3 was reported in 4.0% for Sarclisa combination therapy versus 4.1% for Kd. Grade 3-4 thrombocytopenia and neutropenia were 29.9% for Sarclisa combination therapy versus 23.8% for Kd, and 19.2% for Sarclisa combination therapy versus 7.4% for Kd. Main reasons for treatment discontinuation were disease progression (29.1% for Sarclisa combination therapy versus 39.8% for Kd) and AEs (8.4% for Sarclisa combination therapy versus 13.8% for Kd).

About the trial

The randomized, multi-center, open label Phase 3 IKEMA clinical trial enrolled 302 patients with relapsed MM across 69 centers spanning 16 countries. All study participants had received one to three prior anti-myeloma therapies. During the trial, Sarclisa was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with carfilzomib twice weekly at the 20/56mg/m2 dose and dexamethasone at the standard dose for the duration of treatment. The primary endpoint of IKEMA was PFS. Secondary endpoints included ORR, the rate of CR or better, the rate of VGPR or better, rate of MRD-negativity, OS and safety.1

The results from IKEMA are anticipated to form the basis of regulatory submissions planned for later this year. The use of Sarclisa in combination with carfilzomib and dexamethasone in relapsed MM is investigational and has not been evaluated by any regulatory authority.

About Sarclisa

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Sarclisa is approved in the EU, U.S., Switzerland, Canada and Australia in combination with pom-dex for the treatment of certain adults with relapsed refractory MM. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide.

For more information on Sarclisa clinical trials please visit www.clinicaltrials.gov.

About Multiple Myeloma (MM)

MM is the second most common hematologic malignancy, with more than 138,000 new diagnoses of MM worldwide yearly.2,3 Despite available treatments, MM remains an incurable malignancy and is associated with significant patient burden. Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.

On June 2, 2020 Orion Corporation, reported that 520,144 A shares have been converted into 520,144 B shares (Press release, Orion , JUN 2, 2020, View Source [SID1234560763]). The conversion has been entered into the Trade Register on 2 June 2020.

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The total number of shares in Orion Corporation is 141,257,828 which, after the conversion, consists of 35,507,125 A shares and 105,750,703 B shares. The number of votes of the company’s shares is after the conversion 815,893,203.

On June 2, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy (Press release, Hoffmann-La Roche, JUN 2, 2020, View Source [SID1234560747]).

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"We’re excited that today’s approval of Tecentriq in combination with Avastin for unresectable or metastatic hepatocellular carcinoma brings a cancer immunotherapy option to people with this aggressive form of liver cancer," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "The application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this new treatment option rapidly to patients in the United States and around the world."

"The results of the IMbrave150 study are really transformative for patients with advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting," said Dr Richard Finn, Professor of Medicine at the David Geffen School of Medicine at UCLA and Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center. "For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favourable tolerability profile."

The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions.1 Simultaneous applications were submitted to regulators in the United States, Australia, Canada and Singapore under Project Orbis. Additionally, the FDA rapidly reviewed and approved the application under its Real-Time Oncology Review (RTOR) pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

The approval was based on results from the Phase III IMbrave150 study, which demonstrated that Tecentriq in combination with Avastin reduced the risk of death (overall survival; OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) and reduced the risk of disease worsening or death (progression-free survival; PFS) by 41% (HR=0.59; 95% CI: 0.47-0.76; p<0.0001), compared with sorafenib. IMbrave150 is the first Phase III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Serious adverse reactions (Grade 3-4) occurred in 38% of people in the Tecentriq and Avastin arm. The most frequent serious adverse reactions (≥2%) were bleeding in the gastrointestinal tract, infections and fever. These results were published in the New England Journal of Medicine on 14 May 2020.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMbrave150 study
IMbrave150 is a global Phase III, multicentre, open-label study of 501 people with unresectable or metastatic HCC who had not received prior systemic therapy. People were randomised 2:1 to receive the combination of Tecentriq and Avastin or sorafenib. Tecentriq was administered intravenously (IV), 1200 mg on day 1 of each 21-day cycle, and Avastin was administered IV, 15 mg/kg on day 1 of each 21-day cycle. Sorafenib was administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle. People received the combination or the control arm treatment until disease progression or unacceptable toxicity. The two primary endpoints were OS and independent review facility (IRF)-assessed PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Additional study endpoints were IRF-assessed overall response rate (ORR) per RECIST and mRECIST.

About hepatocellular carcinoma
HCC is an aggressive cancer with limited treatment options and is a major cause of cancer deaths worldwide.2 Every year, more than 750,000 people worldwide are diagnosed with HCC,2,3 with the majority of cases in Asia and almost half of all cases in China.3,4 In the US, the number of liver cancer cases have more than tripled since 1980 and HCC represents the fastest-rising cause of cancer-related death, while in Europe, liver cancer is also on the rise.5-7 HCC develops predominantly in people with cirrhosis due to chronic hepatitis (B or C) or alcohol consumption, and typically presents at an advanced stage.2 The prognosis for unresectable HCC remains poor, with few systemic therapeutic options and a 1-year survival rate of less than 50% following diagnosis.8

About the Tecentriq and Avastin combination
There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF)-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer and in PD-L1-positive metastatic triple-negative breast cancer. In the US, Tecentriq in combination with Avastin is approved for people with unresectable or metastatic HCC.

About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:
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