On April 22, 2021 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that it will report financial results and provide a business update for the first quarter ended March 31, 2021, before the US markets open on Thursday, May 6, 2021 (Press release, Adaptimmune, APR 22, 2021, View Source [SID1234578367]). Following the announcement, the Company will host a live teleconference and webcast at 9:00 a.m. EDT (2:00 p.m. BST) that same day (details below).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The press release will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. A live webcast of the conference call and replay can be accessed at https://bit.ly/2Ry9DdR.

To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or
+1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (9271335).

On April 22, 2021 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the New Drug Application (NDA) of serplulimab injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb), for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy, has been accepted by the National Medical Products Administration (NMPA) and proposed to be granted priority review (Press release, Shanghai Henlius Biotech, APR 22, 2021, View Source [SID1234578383]). Serplulimab is potentially to be the first anti-PD-1 mAb in MSI-H solid tumors in China. For this indication, patients are screened for specific MSI-H tumor markers, rather than classifying the tumor types, covering a wide range of cancer types. Henlius adopts the "Combo+Global" development strategy for serplulimab, focusing on indication differentiation and combination therapy, with a total of 10 clinical trials conducted worldwide.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The co-leading principal investigator of serplulimab Phase 2 clinical trial in unresectable or metastatic microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumors, Professor Shukui Qin of Cancer Center of Nanjing Jinling Hospital, said, "Serplulimab showed excellent anti-tumor activity in preclinical and early-stage clinical studies, and the results of the Phase 2 clinical study in MSI-H solid tumors also states the favorable safety and efficacy. We hope that this China-developed novel PD-1 inhibitor will be launched as soon as possible, so that more patients with solid tumors could be accessible to high quality immunotherapy new options."

Executive Director, Chief Executive Officer and President of Henlius, Mr. Wenjie Zhang, said, "Serplulimab is the core innovative mAb of Henlius. Focusing on combination immunotherapy and international clinical trials, we have built up a differentiation development strategy for the product. Steady progress has been made in all clinical studies. We are very grateful to all the subjects, physicians and colleagues that have contributed to the NDA acceptance of serplulimab. We will push forward the clinical process in more indications as soon as possible and look forward to benefiting more patients around the world."

Several pivotal Phase 3 clinical trials covering comprehensive cancer types with high incidence

With the "Combo+Global" strategy, steady progress has been made in the clinical studies of 2 monotherapies and 8 combination therapies of serplulimab with chemotherapy, in-house VEGF and EGFR targets mAbs. Henlius actively carries out combination therapies that cover a wide range of tumor types with high incidence such as lung cancer, esophageal cancer, hepatocellular cancer, gastric cancer, head and neck cancer, and implements differentiation clinical development based on the Chinese cancer characteristics. Among them, while there are few explorations in the gastric cancer neoadjuvant/adjuvant area of PD-1 inhibitors, Henlius has conducted Phase 3 clinical studies in this field, leading the clinical trial progress around the globe, with the aim of enabling gastric cancer patients to benefit from the early line of immunotherapy. What’s more, the company has achieved all-around layout in the first-line of lung cancer, and has entered pivotal Phase 3 clinical trials in first-line squamous non-small cell lung cancer (sqNSCLC), first-line non-squamous non-small cell lung cancer (nsqNSCLC) and first-line small cell lung cancer (SCLC). The NDA filing of HLX10 in combination with chemotherapy for the first-line treatment of sqNSCLC in China will also be expected in the second half of 2021.

The all-around international layout to benefit emerging markets

The manufacturing and development of serplulimab is strictly in accordance with international standards and its manufacturing facility based in Shanghai has passed the European Union (EU) and China GMP certification. Henlius developed the international layout for serplulimab, which has been approved for clinical trials in China, the United States, the EU and other countries and regions. About 2000 patients have been enrolled in China, Turkey, Poland, Ukraine, Russia, etc., which shows confidence and recognition on the quality of the product in the international market. Apart from conducting international trials of HLX10, Henlius also actively seeks for international cooperation opportunities with the aim of benefiting more patients in the world, especially patients in emerging markets. Henlius has reached a collaboration agreement with PT Kalbe Genexine Biologics (KG Bio), upon which KG Bio is granted exclusive rights to develop and commercialize serplulimab in relation to its first monotherapy and two combination therapies in 10 Southeast Asian countries.

With the continuous development of the "Combo+Global" strategy, Henlius continues to build a diversified pipeline of innovative drug candidates with serplulimab as the lead, actively accelerating innovation and improving innovation efficiency, and committing to bringing affordable and high-quality innovative biologics to patients around the world.

About MSI-H solid tumors

The defect of mismatch repair (MMR) that can lead to base mismatch or insert in microsatellites during DNA replication, and the accumulation of incorrect bases usually causes microsatellite instability (MSI)[1]. MSI-H often occurs in several cancer types, such as endometrial cancer, colorectal cancer, gastric cancer, renal cell carcinoma, ovarian cancer, etc[2]. Studies have revealed that the prevalence of MSI-H across all tumor types is 14%[3]. Patients who suffer from this disease usually have higher response rates for immune checkpoint inhibitors[4-5]. Thus, MSI-H is becoming a more and more important biomarker for the immunotherapy predictions of patients with solid tumors. If the patient is MSI-H positive and meets the treatment criteria, the corresponding immunotherapy can be carried out without screening tumor sites and pathological classification, which aligns with the advanced concept of precision medicine and is applicable to a wide range of cancer types. Currently, the U.S. Food and Drug Administration (US FDA) has approved PD-1 target mAb for the treatment of second-line MSI-H/dMMR advanced solid tumors and first/second-line MSI-H/dMMR colorectal cancers. While there are still no anti-PD-1 mAb approved for MSI-H/dMMR advanced solid tumors in China, the treatment needs are far from being met.

On April 22, 2021 Bristol Myers Squibb reported that upcoming cell therapy plant in the Netherlands should help slash turnaround times for patients receiving its CAR-T therapies there (Press release, Bristol-Myers Squibb, APR 22, 2021, View Source [SID1234578425]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Right on the heels of not one, but two CAR-T approvals in the U.S., Bristol Myers Squibb is bolstering its commercial cell therapy ambitions on the other side of the Atlantic.

The company on Thursday pegged Leiden, Netherlands, as the home of its first cell therapy factory in Europe and its fifth worldwide. With planning for site design and development underway, BMS expects construction to kick off later this year.

BMS’ swift cell therapy scale-up, which also includes a commercial plant-to-be in Massachusetts, follows FDA green lights for the company’s closely-watched CAR-T therapies Breyanzi and Abecma in February and March, respectively. Neither med has won an approval yet in Europe.

The new Leiden plant will be kitted out for commercial manufacturing of multiple cell therapy products using cutting-edge tech. For one, the company will tap virtual reality to train incoming cell processing workers, a BMS spokeswoman said via email. The company will make use of electronic batch records, as well as automated bioreactors and automated cartridge-based flow cytometers at the plant, she added.

The site, which will stand at around 19,000 square meters (204,514 square feet), will also be equipped to handle future capacity upgrades.

BMS offered a glimpse at some of the other tech it’s working on during a virtual cell therapy manufacturing tour with reporters last month. At the time, the company said it was working on a platform that could cut CAR-T manufacturing timelines from weeks to less than 10 days, plus new tech to speed up testing, which takes eight days now.

As part of BMS’ cell therapy push in Europe, the company will hire "several hundred" new staffers over the coming years, Ann Lee, Ph.D., senior vice president of cell therapy development and operations at BMS, said in a release.

CAR-T meds are created using a patient’s own T cells, which are extracted, genetically modified and then infused back into patients to help the body kill disease.

The company’s lymphoma CAR-T Breyanzi scored approval in early February with a 24-day target turnaround time from T-cell collection to delivery back to the patient. In the U.S., BMS handles the bulk of the manufacturing work itself.

The Leiden plant will help BMS collect and manufacture cell therapies in Europe without the barrier of intercontinental shipping. Reducing manufacturing lag time is critical for all CAR-T players.

CAR-T manufacturing is a complicated beast—a lesson BMS knows only too well. In December, the FDA hit a Lonza facility producing viral vectors for Breyanzi with a Form 483, a development that might have played a role in the company’s inability to score an FDA approval for the drug in 2020. Breyanzi’s approval by year-end 2020 was a key requirement for a multibillion-dollar payout for investors.

The FDA had also flagged concerns at BMS’ Bothell, Washington, plant in October. Now, however, the Bothell facility is equipped for commercial production, and the company’s Summit, New Jersey, plant is making the switch to turn out therapies for the market.

In late February, BMS unveiled designs on a 244,000-square-foot cell therapy factory in Devens, Massachusetts. The company hopes to start engineering runs at the plant in late 2021 or early 2022, Snehal Patel, global head of cell therapy manufacturing at BMS, said during last month’s tour. Once the plant is up and running, BMS says it will use the site for a good chunk of its commercial cell therapy manufacturing.

On April 22, 2021 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales performance for the first quarter of 2021 (Press release, Ipsen, APR 22, 2021, View Source [SID1234578316]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Total Sales growth of 5.5% at CER, or 0.6% as reported, to €658.5m, despite impact of the pandemic
An increase in Specialty Care sales of 6.4%1 to €611.5m, driven by the growth of Cabometyx (cabozantinib), Decapeptyl (triptorelin), Somatuline (lanreotide) and Dysport (botulinum toxin type A)
A Consumer Healthcare sales decline of 5.4%1 to €47.0m, reflecting the ongoing effects of COVID-19, partly offset by recovery in China
European Commission approval of Cabometyx, in combination with nivolumab, as a first-line treatment for patients living with advanced renal cell carcinoma
Guidance for FY 2021 confirmed
David Loew, Chief Executive Officer, commented:
"We delivered a strong performance in the first quarter, despite the persistently difficult COVID-19 environment, driven by our unrelenting focus on patients. Our execution was in line with our plans and our financial guidance for the year. Ipsen’s Oncology medicines stood out in the period, while the regulatory approval in Europe of the Cabometyx combination with nivolumab in first-line renal cell carcinoma marked the start of an important launch. The anticipated registration of a lanreotide-generic medicine in Europe is fully aligned with our expectations.

In the near term, we look forward to trial results in first-line liver cancer for the Cabometyx combination with atezolizumab, as well as regulatory progress with palovarotene in FOP. We continue to support our ambitions of strengthening the pipeline and driving sustainable growth, based on our patient-focused strategy. I am very proud of the great execution by colleagues around the world, especially as many teams continue to experience challenging conditions during the pandemic."

FY 2021 guidance
The Company today confirms its financial guidance for FY 2021, which incorporates an assumed progressive global recovery from COVID-19 by H2 2021. A phased launch of generic lanreotide in Europe by mid-2021 is also assumed, as is a limited impact of the potential launch of octreotide or lanreotide generics in the U.S.

Total Sales

Growth of more than 4.0% at CER

Core Operating Margin

Greater than 30.0%, excluding any potential impact of incremental investments from external innovation

Currency impact
Ipsen anticipates an adverse impact of 2% from currencies on Total Sales in FY 2021, based on the level of exchange rates at the end of March 2021.

Somatuline-generic update
During the quarter, a positive outcome was received for a generic formulation of lanreotide in 60mg, 90mg and 120mg dose presentations by the Reference Member State, Denmark; the closure of the Decentralized Procedure was also achieved. National marketing authorizations have recently been granted for a lanreotide generic medicine in France, Denmark, Hungary and Latvia. These developments were consistent with Ipsen’s expectations.

Business development
In the quarter, Ipsen and Fusion Pharmaceuticals Inc. completed an asset purchase agreement to acquire Ipsen’s intellectual property and assets related to IPN-1087, a small molecule in Phase I development targeting neurotensin receptor 1, a protein expressed on multiple solid-tumor types.

Conference call
A conference call and webcast for investors and analysts will begin at 2:30pm Paris time today. Participants should dial in to the call early and can register here; a recording will be available on ipsen.com, while the webcast can be accessed here. The event ID is 2495337.

Calendar
The Company intends to publish its H1 2021 results on 29 July 2021 and its nine-months’ sales update on 21 October 2021. The Annual Shareholders’ Meeting will be held behind closed doors on 27 May 2021.

Notes
All financial figures are in € millions (€m). The performance shown in this announcement covers the three-month period to 31 March 2021 (the quarter, the first quarter or Q1 2021), compared to three-month period to 31 March 2020 (Q1 2020) respectively, unless stated otherwise. Growth rates are at CER, unless stated otherwise. Commentary on performance is based on CER, unless stated otherwise.

On April 22, 2021 ArcticZymes Technologies (OSE: AZT) reported sales of NOK 40.4 million (18.5) and an EBITDA of NOK 25.8 million (9.0) for the first quarter of 2021 (Press release, Biotec Pharmacon, APR 22, 2021, View Source [SID1234578334]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights from Q1 2021

ArcticZymes Technologies (AZT) had Q1 sales of NOK 40.4 million growing by 119% (Q1 2020: NOK 18.5 million)
Coronavirus-related sales are estimated at NOK 16.5 million in Q1 2021 (NOK 3.8 million in Q1 2020)
Gross profit improved to NOK 39.9 million with 99% margin (Q1 2020: NOK 18.5 Million)
AZT delivered a positive EBITDA of NOK 25.8 million (Q1 2020: NOK 9.0 million)
Cash-flow for Q1 was positive NOK 23.2 million (Q1 2020: NOK 4.4 million) giving a cash balance of NOK 163.3 million (Q1 2020: NOK 35.7 million)
Successfully upscaled the SAN HQ production process
CEO Jethro Holter comments:

"We are delighted with the performance of our first quarter as a pure enzymes company. The ArcticZymes team has delivered the best ever quarterly performance achieving sales revenues of 40 million NOK and an EBITDA of 26 million NOK. All market segments have experienced quarterly growth including re-establishment of molecular research sales to pre-pandemic levels.

Furthermore, the SAN HQ enzyme production process was successfully upscaled 100-fold. The innovation pipeline and the infrastructure expansion project of R&D and operations are progressing. Such activities are key to leveraging the greater potential ArcticZymes Technologies can accomplish through organic growth."