On March 25, 2021 Immodulon Therapeutics reported that First patient enrolled in a phase I/II study for IMM-101 in limited metastatic pancreatic cancer patients at Erasmus University Medical Center (Press release, Immodulon Therapeutics, MAR 25, 2021, View Source [SID1234577114])

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Erasmus MC initiates recruitment for new investigator-sponsored phase I/II study to investigate the safety and efficacy of IMM-101 in limited metastatic pancreatic cancer

Uxbridge, UK – 25 March 2021 – Immodulon, the immuno-oncology company, is pleased to announce enrolment of the first patient in MEPANC-1, an investigator-sponsored, multi-centre, phase I/II, open label study in patients with limited metastatic (oligo-metastatic) pancreatic cancer. This study is being conducted in collaboration with Professor van Eijck and his team at the Erasmus University Medical Center Rotterdam ("Erasmus MC").

This study follows the initial collaborative study, LAPC-2, a phase I/II study combining IMM-101 with stereotactic radiotherapy in locally advanced pancreatic cancer which has completed its recruitment and is nearing completion. MEPANC-1 is designed to enrol 100 eligible patients and evaluate the safety and efficacy of IMM-101 administered in combination with stereotactic radiotherapy in patients with oligo-metastatic pancreatic cancer, who have either completed at least eight cycles of FOLFIRINOX or who could not tolerate FOLFIRINOX. The primary efficacy endpoint is one-year progression-free survival calculated from the start of the FOLFIRINOX regimen. The study was approved in December 2020 by the local Erasmus MC Medical Ethics Review Committee and the national Central Committee on Research Involving Human Subjects.

Professor Casper H J van Eijck, hepatobiliary surgeon and Professor in surgery, commented:
"We look forward to this new original study which has not been performed before in patients with limited metastatic pancreatic cancer. Since the recruitment in the LAPC-2 study was highly successful, we expect to include patients from all Dutch Pancreatic Cancer Group hospitals within the allocated time frame. We are pleased that Immodulon is providing us with the IMM-101 study drug again as well as their support. We hope that combining IMM-101’s positive effects on the immune system with those of radiotherapy will potentially lead to a major step forward in the search for new and effective treatments for pancreatic cancer."

Dr. Jaap Kampinga, Chief Executive Officer of Immodulon, commented:
"We are extremely pleased to announce our continued collaboration with Professor van Eijck and his team at this Centre of Excellence for pancreatic cancer at Erasmus MC. The MEPANC-1 study is designed to complement the ongoing LAPC-2 study. Immodulon is dedicated and highly motivated to develop better therapies for pancreatic cancer, a vision that is strongly shared by Professor van Eijck and his team. Pancreatic cancer is a devasting disease and remains exceedingly challenging to treat effectively, despite the advances in other cancer treatments."

Dr. Cellia Habita, Chief Medical Officer of Immodulon, added:
"Professor van Eijck and his team are a fantastic group to collaborate with. The MEPANC-1 study recruited its first patient which is exciting news. We hope that IMM-101 may help to improve the prognosis for these patients."

On March 25, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809)reported financial results and corporate updates for the fiscal year ended 31 December 2020 (Press release, Evotec, MAR 25, 2021, View Source;announcements/press-releases/p/evotec-se-fiscal-year-2020-results-gaining-speed-on-the-data-driven-rd-autobahn-to-cures-6042 [SID1234577113]).

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FINANCIALS REFLECT GREAT PERFORMANCE
Group revenues exceed revenue target – up 12% (+14% at constant fx rates) to € 500.9 m (2019: € 446.4 m)
Strong performance in base business (+16%)
Adjusted Group EBITDA in line with guidance by € 106.6 m (€ 110.8 m at constant fx rates) (2019: € 123.1 m); adjusted EBITDA for EVT Execute shows increase of 6% to € 129.3 m in 2020, despite planned loss of Sanofi subsidy.
Unpartnered R&D expenses of € 46.4 m (2019: € 37.5 m)
Very strong liquidity position with € 481.9 m.
STRONG PERFOMANCE DESPITE ONGOING PANDEMIC
Important clinical trial initiations and significant progress in co-owned pipeline
Milestone achievements within strategic collaborations with Bayer and BMS
New and extended partnerships in e.g. kidney disease, protein degradation, rare diseases, and oncology
Focus on "omics", machine-learning and artificial intelligence platforms in all modalities
Strong year for Just – Evotec Biologics with several new collaborations signed and J.POD 1 US on track to open in H2 2021; Initiation of J.POD 2 EU in Toulouse still in H1 2021
Multiple new and extended drug discovery collaborations
Successful step into gene therapy with new gene therapy R&D centre Evotec GT
Good progress of equity-based co-ownership engagements and BRIDGEs
Expansion of alliance with US Department of Defense ("DOD") for Just – Evotec Biologics (after period-end)
Multi-RNA target alliance with Takeda (after period-end)
CORORATE HIGHLIGHTS
Mubadala Investment Company and Novo Holdings A/S endorse strategy, together investing € 250 m through capital increase
Acquisition of land, buildings and full takeover of staff from "Biopark by Sanofi SAS", now "Campus Curie Toulouse" (France)
Expansion of infrastructure for growth in Abingdon (UK), Goettingen (GER); Munich (GER)
Implementation of Action Plan 2025 "The data-driven R&D Autobahn to Cures"
FINANCIAL GUIDANCE 2021 – CONTINUED STRONG ORGANIC GROWTH
Group revenues expected to be in a range of € 550 – 570 m (€ 565 – 585 m at constant exchange rates) (2020: € 500.9 m)
Adjusted Group EBITDA expected to be in the range of € 105 – 120 m (€ 115 – 130 m at constant exchange rates) (2020: € 106.6 m)
Unpartnered research and development expenses expected to be in a range of € 50 – 60 m (2020: € 46.4 m)
Given current global insecurities surrounding the pandemic, a likely negative impact – though less pronounced than in 2020 – is already estimated within the guidance for revenues and adjusted EBITDA stated above.

 

FINANCIALS REFLECT STRONG GROWTH
In 2020, Evotec’s Group revenues increased by 12% to € 500.9 m (€ 507.7 m at constant exchange rates) (2019: € 446.4 m), despite the difficulties arising from the global COVID-19 pandemic, which led to delays in milestone payments, and despite the absence of payments from Sanofi for the Toulouse site since April 2020 (loss of € 18.0 m). This increase resulted primarily from the growth performance in the base business (+ 16%), and the revenue contribution from Just – Evotec Biologics (including J.POD) of € 39.3 m (2019: € 16.1 m, as the company was acquired in July 2019), which strongly accelerated in H2 2020. Revenues from upfront, milestone and licence payments were lower than in the previous year (2019: € 39.0 m) at € 30.1 m.

In 2020, Evotec focused its unpartnered R&D expenses of € 46.4 m (2019: € 37.5 m) primarily on initiatives in platform projects, in particular on "omics", artificial intelligence ("AI"), machine learning and data analytics platforms as well as on its cell therapy platform. Its partnered R&D expenses declined to € 17.5 m (2019: € 20.9 m). This is related to its infectious disease portfolio as R&D expenses are costs fully reimbursed by its partner Sanofi, but also recognised under other operating income, and thus do not negatively affect the operating result or adjusted EBITDA. The split into unpartnered and partnered R&D expenses has only been applied since July 2018 when the infectious diseases portfolio and Lyon site was acquired from Sanofi.

In 2020, the Group’s selling, general and administrative ("SG&A") expenses increased by 16% to € 77.2 m (2019: € 66.5 m). This increase resulted primarily from higher personnel costs arising from the continued expansion in all areas, as well as from start-up costs for the planned launch of J.POD 1 US in the current year as well as increased IT costs.

Adjusted Group EBITDA declined to € 106.6 m in 2020 (€ 110.8 m at constant exchange rates) (2019: € 123.1 m), but were fully in line with guidance. One of the main reasons for the anticipated lower adjusted EBITDA was the planned loss of the subsidy from Sanofi for the Toulouse site as well as planned start-up costs for the commissioning of J.POD 1 US. In addition, lower milestone payments (due to pandemic-related delays), higher unpartnered R&D expenses, the loss of R&D tax credits in Italy due to changes in legislation, and the increase in SG&A costs due to expansion also had a negative impact on the adjusted EBITDA and the adjusted EBITDA margin. However, the EVT Execute adjusted EBITDA still shows an increase above 6% to € 129.3 m (2019: € 122.5 m).

Evotec recorded an operating result for 2020 of € 48.5 m (2019: € 62.6 m), mainly due to lower gross profit, higher R&D expenses and the loss of R&D tax credits in Italy. Evotec recorded a net result for the financial year 2020 of € 6.3 m (2019: € 37.2 m).

Evotec ended the year 2020 with a net debt position of € 10.0 m versus € 143.1 m at the end of 2019. The massive improvement is mainly due to the capital increase by Mubadala Investment Company and Novo Holdings of € 250 m in October more than compensating for higher investments related to the ramp up of capacity, for Just – Evotec Biologics and Evotec Innovate.

STRONG PERFOMANCE OF BOTH EVT INNOVATE AND EVT EXECUTE, GREAT START OF JUST – EVOTEC BIOLOGICS
EVT Innovate was characterised in 2020 by multiple important clinical trial initiations, continued milestone income in its strategic partnerships (iPSC neurodegeneration and oncology protein degradation alliances with Bristol Myers Squibb ("BMS"); kidney disease and endometriosis/chronic cough alliances with Bayer) as well as the signing of multiple new partnerships (e.g. Novo Nordisk)

Evotec made significant progress towards building the globally leading precision medicine platform, based on the proprietary industrialised data generation PanOmics technology and a unique AI/ML-driven data analytics software PanHunter. Additionally, Evotec expanded its leading position in iPSC (induced pluripotent stem cells).

In the field of anti-infectives, Evotec is involved in a number of activities in the global fight against COVID-19, virology, and antibiotic resistance and closed additional collaborations. Evotec initiated multiple partnerships with the Bill & Melinda Gates Foundation (especially in Tuberculosis). Furthermore, after period-end, Evotec started the clinical development of a therapeutic antibody for the treatment of chikungunya virus infection with NIAID and a leading academic research organisation.

In 2020, Evotec’s academic BRIDGE model was accelerated through the launch of Autobahn Labs and the first spin-off of Lab282, Dark Blue Therapeutics. The Company made further new investments in promising Biotech companies, Curexsys, leon-nanodrugs, panCELLa, Quantro Therapeutics, and participated in follow-on financings of e.g. Eternygen, Exscientia, Facio, and Topas.

Despite the circumstances of COVID-19, the EVT Execute segment continued to demonstrate strong progress in 2020 with new and extended alliances. In 2020, Evotec was involved in 829 alliances and recorded a repeat business of 90%. With the opening of the gene therapy R&D centre Evotec GT and a multi-year gene therapy research alliance with Takeda in April 2020, Evotec added an important component to its fully integrated, modality-agnostic drug discovery & development platform. Just – Evotec Biologics continued its strong growth with important new partnerships, e.g. ABL, Ology, OncoResponse, US DOD. The building of J.POD 1 US in Redmond remains on track to start operations in H2. Furthermore, the decision to initiate J.POD 2 EU in Toulouse has been taken, and will be put in action still in H1 2021.

"THE DATA-DRIVEN R&D AUTOBAHN TO CURES"
The updated strategy roadmap of Evotec is called Action Plan 2025 "The data-driven R&D Autobahn to Cures", and will be implemented in 2021. Action Plan 2025 consists of eight strategic building blocks. These building blocks perfectly fit to the strategy to increase innovation and accelerate growth of Evotec towards 2025 and beyond. Most elements within Evotec’s strategy start with human databases and modern artificial intelligence instruments to accelerate drug discovery & development projects. More detailed information on the Action Plan 2025 can be found in the Annual Report 2020 on our website.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "Excellence in all modalities from discovery to commercial manufacturing, human databases and modern artificial intelligence to accelerate the drug discovery & development are the key drivers for for Action Plan 2025. 2020 was a key year to generate the strategic evidence and data for our long term vision."

FINANCIAL GUIDANCE 2021 – CONTINUED STRONG GROWTH
In 2021, Evotec expects Group revenues to grow in a range of € 550–570 m. At unchanged exchange rates compared to 2020, this range is € 565 m to € 585 m. This assumption is based on current orders on hand, foreseeable new contracts and the extension of contracts as well as prospective milestone payments.

Regardless of the challenges arising from COVID-19, Evotec still expects the adjusted Group EBITDA to grow to € 105 – 120 m. At unchanged exchange rates in 2020, this would represent a growth to around € 115 – 130 m. This projection takes account of increasing expenses for promising R&D projects and the ramp-up of the Just – Evotec Biologics business via investments, the expansion of the J.POD 1 US capacities, and plans to initiate J.POD 2 EU in Toulouse still in H1 2021.

Evotec’s activities are all related to research and development ("R&D"). Aside from the partnered and funded R&D, Evotec will invest in its own unpartnered R&D more than ever before to further expand its pipeline of first-in-class projects and platforms. Evotec expects unpartnered R&D investments in this area between € 50 and 60 m in 2021. Revenues, research and development expenses, and adjusted EBITDA remain the financial key performance indicators of the Evotec Group.

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. Furthermore, the Management Board will present an outlook for fiscal year 2021. The conference call will be held in English.

Conference call details

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 201744221 (Germany) or +44 20 3364 5150 (UK) and in the USA by dialling +1 (844) 307-9362. The access code is 315614520#. The on-demand version of the webcast will be available on our website: www.evotec.com/financial-reports

On March 24, 2021 SunRock Biopharma reported the consortium formed by SunRock Biopharma and the Vall d’Hebron Institute of Oncology (VHIO) has been awarded the 2021 Public-Private Collaboration Projects call from the State Research Agency (Press release, SunRock Biopharma, MAR 24, 2021, View Source [SID1234647346]). Both entities are jointly participating in the TRADBI project, which seeks new BISPECIFIC ANTIBODIES TARGETING HER3 FOR THE TREATMENT OF AGGRESSIVE TUMORS, funded with 1.7 million euros from the Recovery, Transformation, and Resilience Plan.

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Cancer is one of the leading causes of morbidity and mortality worldwide, with over 19 million new cases and 10 million deaths worldwide in 2020. Despite advances in survival due to the introduction of immunotherapy treatments, there are still limitations in patients who do not respond or develop resistance to these therapies, making it necessary to develop new approaches to overcome these deficiencies.

In this regard, the TRADBI project will use a completely novel perspective to accelerate the arrival of a new, more effective and safe biological drug for the treatment of solid tumors such as breast cancer, colorectal cancer, or head and neck cancer. It is a next-generation antibody-drug-conjugate (ADC) that will be developed from SunRock Biopharma’s SRB19 antibody, a molecule targeting HER3 and EGFR, which has already demonstrated its high efficacy in preclinical models. This combination increases the antitumor efficacy of the treatment and reduces both the adverse effects of chemotherapy and the appearance of associated resistances.

This consortium brings together SunRock’s capacity for the development of innovative therapeutic antibodies with the experience of VHIO’s Tumor Biomarkers Group in identifying predictive tumor biomarkers in patients. The consortium also counts on the clinical leadership of Dr. Javier Cortés (IBCC) as a reference in the treatment of breast cancer, who will complete the transition of this new compound (SRB19-ADC) from its earliest stages of development to the arrival at clinical phases. The results of the TRADBI project will be of great significance for the upcoming arrival of this new therapy focused on the treatment of tumors with unmet clinical needs.

On March 24, 2021 The Korea Research Institute of Bioscience and Biotechnology reported on the 24th that it had transferred technology to the biotech Ingenium Therapeutics for the differentiation and mass proliferation of highly active NK cells (natural killer cells) from hematopoietic stem cells and the treatment of leukemia and lung cancer using the same (Press release, Ingenium Therapeutics, MAR 24, 2021, View Source [SID1234643518]).

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Ingenium Therapeutics (CEO: Jin-ok Ko) is a biotech company established in 2020 to develop immune cell therapy technology.

Through this technology transfer (exclusive license) contract, Korea Life Insurance receives a total of KRW 9.5 billion in fixed technology fees from Ingeniom and an additional technology fee of KRW 145 billion based on future sales performance. After technology transfer, we plan to conduct joint research with the goal of obtaining commercial clinical trial approval within this year.

NK cells are immune cells that make up approximately 10% of human blood immune cells. It has cancer cell killing ability (cytotoxicity) that kills cancer cells at the forefront without any other stimulation. The Korea Life Research Institute explained that the NK cell-based anti-cancer immune cell therapy technology transferred this time is expected to cause fewer side effects compared to T cell-based immune cell therapy because it does not proliferate on its own after injection into the human body but attacks cancer cells and gradually disappears. .

Dr. Inpyo Choi’s team at the Life Research Center’s Immunotherapy Research Center developed a technology to separate and differentiate NK cells from hematopoietic stem cells and to mass proliferate highly active NK cells. The explanation is that the efficacy and safety of NK cells were confirmed in non-clinical tests.

Afterwards, in a clinical trial conducted jointly by Dr. Choi’s team and Professor Lee Kyu-hyung’s team at Asan Medical Center, NK cells were administered to 41 patients with incurable leukemia, and the results showed that cancer progression was suppressed and survival rate was increased, and several papers were published. According to the researcher’s clinical results published in Blood Marrow Transplant in 2014 as a representative paper, administering NK cells to patients with incurable leukemia slowed the progression of the disease and increased the survival rate compared to the non-administered group (doi: 10.1016/j.bbmt.2014.01.031).

Director Kim Jang-seong of the Korea Life Research Institute said, "The Korea Life Research Institute is currently actively conducting research on CAR-NK cell therapy and iNK (induced NK) cell therapy using dedifferentiation technology, creating continuous research results in the field of gene cell therapy." "Based on this, we expect to contribute to the development of safe and highly effective anti-cancer immunotherapy agents for the future aging era."

Meanwhile, the technology is being developed through the Immunotherapy (Customized i-Medicine, CiM) convergence research group project of the National Science and Technology Research Council (NST) under the Ministry of Science and ICT, the national research and development project of the Ministry of Science and ICT and the Ministry of Health and Welfare, and the unique project of the Life Research Institute. This is a research achievement achieved through long-term, stable support.

On March 24, 2021 Ascentage Pharma, a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has recommended the novel candidate drug olverembatinib (HQP1351) of Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of Ascentage Pharma, for a Breakthrough Therapy Designation (BTD) for the treatment of patients with chronic-phase chronic myeloid leukemia (CP CML) resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs) (Press release, Ascentage Pharma, MAR 24, 2021, View Source [SID1234633502]). This BTD recommendation marks another major development for olverembatinib following the Priority Review granted by the CDE in October 2020. The indication of BTD recommendation is an expansion from that of the Priority Review designation.

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According to the NMPA’s Provisions for Drug Registration (SAMR Order No. 27) and Working Procedures for Review of Breakthrough Therapeutics (No. 82 of 2020) implemented on July 1, 2020, the breakthrough therapy review policy is designed to promote the research and creation of drugs with apparent clinical advantages, which are intended for the prevention or treatment of serious life-threatening diseases or diseases which severely impact the qualify of life for which there is no existing treatment or where sufficient evidence indicates advantages of the novel drug over currently available treatment options. Drugs that have been granted the BTD are prioritized by the CDE in communications and exchange, and in receiving guidance to promote the drug development progress. Furthermore, BTD designated drugs will be eligible to the Priority Review status that will accelerate the review process at the stage of application for commercialization. In conclusion, this measure will effectively accelerate the development and review of drugs presenting significant clinical value or addressing urgent clinical needs.

CML is a hematologic malignancy of the white blood cells. Following the commercialization of BCR-ABL TKIs, the treatment of CML has been revamped. However, despite clinical benefits offered by the first-generation BCR-ABL inhibitor imatinib (GLEEVEC), and several second-generation TKIs, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, presenting an urgent unmet medical need for an effective new generation treatment.

Olverembatinib is a novel, orally active, potent third-generation BCR-ABL inhibitor designed to effectively target BCR-ABL mutants, including T315I, and the first China-developed third-generation BCR-ABL inhibitor targeting drug-resistant CML. In July 2019, olverembatinib was cleared by the US Food and Drug Administration (FDA) to enter a Phase Ib clinical study. In May 2020, olverembatinib was granted an Orphan Drug Designation and a Fast Track Designation by the FDA. In October 2020, olverembatinib was granted Priority Review by the CDE in China for the treatment of adult patients resistant to TKI and with T315I-mutant chronic phase CML or accelerated phase CML. In December 2020, clinical trial results of olverembatinib were selected for oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting for the third consecutive year. These data further demonstrated the favorable safety and promising efficacy profiles of olverembatinib.

"Acquired drug resistance to TKIs remains an urgent unmet medical need and a major challenge in the treatment of CML," commented Professor Xiaojun Huang, Director of the Institute of Hematology, Peking University, and the principal investigator of olverembatinib in China. "Currently, no third-generation TKI has been approved in China, and no TKIs approved overseas is expected to enter China anytime soon. Multiple studies of olverembatinib, a China-developed BCR-ABL TKI, have consistently demonstrated promising efficacy and favorable safety in patients with drug-resistant CML, signifying significant potential clinical benefit to the patient population. We hope this BDT will further accelerate the clinical development and the review process for olverembatinib, and ultimately allow patients to soon benefit from this novel therapeutic."

"Olverembatinib is our first candidate drug entering the NDA-stage, and it is expected to become the first approved third-generation BCR-ABL inhibitor in China," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "This BTD for olverembatinib for the treatment of patients with CP CML intolerant or resistant to first- and second-generation TKIs represents the strong recognition of olverembatinib’s therapeutic potential in addressing the unmet medical needs in the treatment of CML. Being granted this BTD will strengthen our communication with the CDE, and more importantly, pave the way for a Priority Review designation to the future NDA for this indication, thus accelerate the clinical development and the approval of olverembatinib in China, and help us to make olverembatinib available to patients as early as possible."