Securing a new pipeline and accelerating the development of new microbiome drugs

On March 27, 2023 CJ Bioscience reported it has signed a contract to acquire a promising new drug candidate and platform technology owned by 4D Pharma, a microbiome company based in the UK and Ireland (Press release, CJ Bioscience, MAR 27, 2023, View Source [SID1234632171]).

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A total of nine new drug candidates are introduced, targeting solid cancers, digestive diseases, brain diseases, and immune diseases. In addition, it plans to acquire all related intellectual property rights such as patents, including two cases of 4D Pharma’s diagnostic and new drug candidate discovery technology platforms, and the contract amount has not been disclosed in accordance with the agreement between the two companies.

In addition, greater synergy is expected when the new drug candidate secured through this contract is combined with the Ez-Mx Platform, which is based on CJ Bioscience’s bioinformatics technology. In addition, 4D Pharma’s new drug development technology and know-how accumulated over 10 years are added to accelerate the development of new microbiome drugs.

CJ Bioscience plans to reflect it in its R&D strategy after analyzing detailed data of each pipeline. The company plans to prioritize clinical trials focusing on candidates with high potential for success, including CJRB-101, an immune anti-cancer treatment that received clinical approval from the US Food and Drug Administration (FDA) in January. The microbiome drug market is expected to grow explosively to $1 billion by 2030, and CJ Bioscience plans to conduct clinical research with the goal of leading the market.

An official from CJ Bioscience said, "The introduction of the new pipeline has given us the world’s best microbiome-based new drug development competitiveness. I will do it," he said.

Evotec SE preliminary fiscal year 2022 results: "Ahead of the curve" – very strong performance in a challenging year

On March 27, 2023 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported preliminary financial results and corporate updates for the fiscal year ended 31 December 2022 (Press release, Evotec, MAR 27, 2023, View Source;very-strong-performance-in-a-challenging-year-6267 [SID1234629405]).

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FINANCIALS REFLECT GREAT PERFORMANCE
Group revenues significantly exceeded the revenue target, up 22% to € 751.4 m (+15% like for like, excluding portfolio and fx effects (2021: € 618.0 m))
Excellent base business up 30% to € 725.3 m in 2022
Adjusted Group EBITDA at € 101.7 m, adjusted for portfolio effects at € 104.1 m (2021: € 107.3 m) after a very strong fourth quarter
Unpartnered R&D expenses of € 70.2 m up 20% (2021: € 58.1 m)
GREAT PROGRESS AND STRONG DEMAND IN ALL LANES
Significant progress in and 8-year extension of targeted protein degradation alliance with Bristol Myers Squibb ("BMS")
Important milestones achieved in iPSC-based neuroscience collaboration with BMSMultiple new strategic partnerships e.g. in metabolic diseases, ophthalmology, dermatology, oncology, as well as an iPSC-based beta cell replacement therapy alliance with Sernova to advance a functional cure for diabetes
Just – Evotec Biologics: Multiple new collaborations initiated at first J.POD in Redmond (US) laying foundation for strong strategic growth (e.g. Alpine, Department of Defense, …); Construction of second J.POD at Evotec’s Campus Curie in Toulouse started and progressing according to plan
Excellent progress in data-driven precision medicine platforms; Commercial launch of unique multi-omics data analysis platform PanHunter; Launch of translational molecular patient database E.MPD
Collaboration with Janssen to develop first-in-class targeted immune-based therapies for oncology (after period-end)
European Investment Bank ("EIB") has granted an additional unsecured loan facility of € 150 m (after period-end)
CORPORATE HIGHLIGHTS
Expansion of footprint with the acquisition of cell therapy manufacturing facility (Evotec Modena) and clinical & commercial manufacturing facility for small molecules (Evotec DS)
Laetitia Rouxel joins Evotec as Chief Financial Officer effective 01 April 2023 (after period-end)
FINANCIAL GUIDANCE 2023 – CONTINUED STRONG GROWTH
Group revenues expected to be in a range of € 820 – 840 m; € 835 – 855 m at constant exchange rates (2022: € 751.4 m)
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2022: € 70.2 m)
Adjusted Group EBITDA expected to be in the range of € 115 – 130 m;
€ 125 – 140 m at constant exchange rates (2022: € 101.7 m)
FINANCIAL PERFORMANCE
Another year with double-digit top line growth
In 2022, Evotec has once more increased its Group revenues at a double-digit rate of 22%: During the twelve months ended 31 December 2022 Group revenues increased significantly by € 133.4 m to € 751.4 m compared with the same period of the previous year (2021: € 618.0 m) (€ 748.4 m excluding acquisitions and M&A-related revenues). The substantial rise against the prior-year period is based on a strong performance of the base business, compensating a slower start of Just – Evotec Biologics, which is still in its ramp-up phase. In addition, the comparable basis for revenues from milestones, upfronts and licenses was exceptionally strong in 2021. Growth of the base business was 30% from € 556.7 m in 2021 to € 725.5 m in 2022.

Adjusted Group EBITDA for the twelve months ended 31 December 2022 amounted to € 101.7 m and € 104.1 m excluding acquisitions and M&A-related costs (2021: € 107.3 m) which is the result of a well-balanced development between the very favourable growth and profitability of Evotec’s base business, preparations for future growth of Just – Evotec Biologics, and a lower contribution from milestones, upfronts and licenses. Moreover, higher energy costs as well as overall inflation affect the year-over-year comparison.

In the financial year 2022, unpartnered R&D expenses increased by 20% (€ 70.2 m vs. 2021: € 58.1 m) reflecting continued strong investments in Evotec’s capabilities to improve its efficiency and precision medicine platforms.

GREAT PROGRESS AND STRONG DEMAND IN ALL LANES
Selected highlights
Evotec continued its successful development in 2022 with new and extended alliances. In 2022, Evotec was involved in > 800 alliances and recorded a repeat business of 92%. Evotec achieved notable progress within its strategic partnerships, important clinical trial initiations, the generation of the milestone income and signed multiple new partnerships e.g., with Eli Lilly in metabolic diseases, with Almirall in medical dermatology, and with Boehringer Ingelheim in ophthalmology.

Evotec also made significant progress towards building globally leading data-driven precision medicine platforms with the launch of its molecular patient database ("E.MPD"). E.MPD is Evotec’s central data repository of PanOmics data for precision drug understanding. Starting out from metabolic diseases, the database is continuously growing through proprietary screens and data partnerships to build up critical mass into other disease areas. Also in 2022, a first commercial version of PanHunter, Evotec’s A.I./M.L.-enabled multi-omics data analysis platform, was launched.

In May 2022, Evotec significantly expanded its alliance with BMS in targeted protein degradation for an additional 8 years with the goal of generating a promising pipeline of molecular glue degraders. The partnership has a deal potential of $ 5 bn and Evotec received an upfront payment of $ 200 m. In March 2023 (after period-end), Evotec announced that further performance- and programme-based achievements in the strategic partnership triggered payments of in total $ 75 m to Evotec.

Over the course of 2022, further important progress was achieved within the iPSC-based neuroscience collaboration with BMS leading to payments totalling $ 57 m from BMS.

In May 2022, Evotec and Sernova Corp., announced a partnership in the field of diabetes. Both Companies will leverage their respective strengths to develop an implantable iPSC-based beta cell replacement therapy for the treatment of insulin-dependent diabetes, including type 1 and 2. In conjunction with the agreement, Evotec made a strategic € 20 m equity investment in Sernova.

Just – Evotec Biologics laid the foundation for strong growth in 2023 and beyond by continuing the collaboration with the US Department of Defense. In September 2022, Evotec’s Seattle-based subsidiary was awarded a contract valued up to $ 49.9 m for the rapid development of monoclonal antibody-based drug product prototypes targeting plague, one of the designated targets of interest under the Accelerated Antibodies Program. In September 2022, Evotec launched the construction of its second J.POD biologics manufacturing facility at Evotec’s Campus Curie in Toulouse. J.POD Toulouse, France (EU) is expected to be operational in the second half of 2024.

In January 2023 (after period-end), Evotec entered into a strategic collaboration and licence agreement with Janssen to develop first-in-class targeted immune-based therapies for oncology. Besides research funding, Evotec is entitled to an undisclosed upfront payment, success-based research and commercial milestones exceeding $ 350 m as well as tiered royalties on products resulting from the collaboration.

In February 2023 (after period-end), Evotec announced that the European Investment Bank granted Evotec an unsecured loan facility of € 150 m to support the Company’s R&D activities, equity investments and the building of the new J.POD biologics manufacturing facility on Evotec’s Campus Curie in Toulouse, France.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "2022 was a successful year for Evotec because of significantly increased revenues, our excellent base business, and a strong balance sheet as a solid base for future growth. Together with our partners, we focus on a comprehensive disease understanding at the molecular level, cutting-edge technologies and platforms to translate this understanding into effective precision therapeutics. Evotec’s technological leadership in all our focus areas is why we consider ourselves ‘ahead of the curve’ for medicines that matter."

OUTLOOK
In 2023, Evotec expects revenues of € 820 – 840 m based on current exchange rates of major currencies (esp. USD; GBP). Based on constant exchange rates compared to 2022, Group revenues are expected to increase to € 835 – 855 m. This assumption is based on the current orders on hand, foreseeable new contracts and the extension of contracts as well as prospective milestone payments. Furthermore, the forecast takes account – as far as possible – of the potential impact of current global uncertainties.

Adj. EBITDA is expected to be in a range of € 115 – 130 m. This projection takes into account the strong order book, an improving revenue mix, but also increasing expenses for wages, materials, energy, promising R&D projects, the adoption of organisation structures to ensure sustainable growth, and the continued ramp-up of the Just – Evotec Biologics business via the remaining investments in the further expansion of the J.POD capacity in the US and the construction of a second J.POD in Europe (Toulouse, France). At constant currencies, Evotec expects the adjusted Group EBITDA to grow to € 125 – 140 m.

Evotec’s activities are all related to R&D. Aside from the partnered and funded R&D, Evotec will continue to strongly invest in its own unpartnered R&D to further expand its long-term and sustainable pipeline of first-in-class projects and platforms. Evotec expects unpartnered R&D investments in this area between € 70 and 80 m in 2023.

Annual report
The full annual report 2022 as well as the sustainability report 2022 will be available for download on 25 April.

Webcast/Conference Call
The Company is going to hold a conference call to discuss the preliminary results as well as provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Tuesday, 28 March 2023

Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

To join via phone, please pre-register via this link. You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialling in via phone is available under this link.

Webcast details

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

The on-demand version of the webcast will be available on our website: View Source

Acorda Therapeutics CEO Ron Cohen, M.D., to Hold Virtual Company Presentation and Q&A

On March 27, 2023 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported that it will hold a virtual, video Q&A with its CEO, Ron Cohen, M.D., on Tuesday, April 4 at 1:00pm ET, 10:00am PT (Press release, Acorda Therapeutics, MAR 27, 2023, View Source [SID1234629354]).

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Dr. Cohen will present an overview of the Company and review its 2022 financial and business performance. Participants will be able to submit questions to Dr. Cohen, which he will address live.

Video Q&A Participation Instructions

To participate in the video event:

Click the link below from a laptop or mobile device. (Mobile device users will be prompted to download the BlueJeans app.)
View Source
If prompted, enter the following case-sensitive Event ID: yewueufw
To participate over the phone:

Dial 1-800-520-9950 (US: Toll Free)
Enter Meeting ID: 1224536
Smartphone users can click on the following link to automatically be connected:
800-520-9950,,,1224536#
To submit a question:

Prior to the Q&A, questions can be emailed to [email protected].
During the live Q&A, questions can be typed into the BlueJeans chat window.

TME Pharma Announces 83% of Glioblastoma Patients Still Alive After 12 Months on Study (Median) in GLORIA Expansion Arm Evaluating NOX-A12 in Combination With Radiotherapy and Bevacizumab

On March 27, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported a clinical update on survival of newly diagnosed glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, TME Pharma’s CXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab (Press release, TME Pharma, MAR 27, 2023, View Source [SID1234629404]).

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After 12 months on study (median), 83% of patients (5 of 6) are still alive. With treatment or follow-up for these patients continuing, median overall survival (mOS) has not yet been reached. The 12-month timepoint is an important landmark for assessment since it exceeds the expected survival of approximately 10 months for patients with MGMT unmethylated tumors and incomplete resection1.

"We are pleased to see that data emerging from the expansion arm with NOX-A12 and bevacizumab continue to support our approach. With this trend, we expect NOX-A12 in combination with bevacizumab to outperform the treatment with NOX-A12 alone, for which we reported a median overall survival of 12.7 months. We will continue to provide clinical updates as the data mature and look forward to reporting updated survival data around the 15-month timepoint when we target a presentation at an international scientific congress," said Aram Mangasarian, CEO of TME Pharma.

Agenus’ Botensilimab in Combination with Balstilimab Shows 33% Durable Responses in Ovarian Cancer

On March 27, 2023 Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with a pipeline of immunological agents targeting cancer and infectious disease, reported results from a cohort of 24 evaluable patients in an expansion of the Company’s Phase 1b study of botensilimab (multifunctional CTLA-4 antibody) in combination with balstilimab (PD-1 antibody) in patients with recurrent platinum resistant/refractory ovarian cancer (Press release, Agenus, MAR 27, 2023, View Source [SID1234629403]). These findings, presented in an oral plenary session at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer, showed a 33% overall response rate (ORR).

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"These results add to the growing body of data showing deep and durable efficacy signals for botensilimab across nine cold and treatment-resistant cancers," said Steven O’Day, M.D., Chief Medical Officer of Agenus. "Botensilimab is designed with a unique mechanism of action that stimulates both innate and adaptive immune responses against cancer, resulting in an improved benefit compared to what has been reported for other checkpoint therapies."

"The combination of botensilimab and balstilimab in platinum-resistant ovarian cancer shows promise for a substantial improvement in efficacy compared to existing therapies, which typically only yield single-digit response rates," said Bruno Bockorny, M.D., Harvard Medical School, Beth Israel Deaconess Medical Center, and principal investigator for the study. "The remarkable efficacy and manageable tolerability profile of this combination suggest a transformative potential for ovarian cancer patients."

The ovarian cancer cohort is part of a large study evaluating the safety, efficacy, and dose optimization of botensilimab alone and in combination with balstilimab in multiple solid tumors. Agenus is currently enrolling in Global Phase 2 ACTIVATE trial programs in metastatic microsatellite stable colorectal cancer, melanoma and pancreatic cancers. Based on recent positive findings presented at SITC (Free SITC Whitepaper), Agenus is also expanding enrollment of its anti-PD-(L)1 relapsed/refractory non-small cell lung cancer cohort of the Phase 1b study and planning additional NSCLC studies.

Study Design and Highlights

A total of 24 evaluable patients with recurrent platinum resistant/refractory ovarian cancer received either 1 or 2 mg/kg botensilimab every 6 weeks and 3 mg/kg balstilimab every 2 weeks.

Patient Demographics

79% were high grade serous, which has a poor prognosis
Patients were heavily pre-treated, with a median of 4 prior lines of therapy including 21% with prior immunotherapy
Majority of patients had biomarkers associated with poor response to immunotherapy:
90% had a low tumor mutation burden (<10 mutations per megabase)
Over half of patients were PD-L1 negative by IHC
Clinical Findings

33% overall response rate (1 complete response, 7 partial responses)
Other PD-(L)1 + CTLA-4 combinations in other trials reported 3-10% response rates in a comparable patient population.1,2
67% disease control rate
Median duration of response not reached
Manageable tolerability profile
Presentation Details

Abstract Title: Botensilimab, a Novel Innate/Adaptive Immune Activator, plus Balstilimab (Anti-PD-1) in Patients with Recurrent Platinum Refractory/Resistant Ovarian Cancer (NCT03860272)

Presenting Author: Bruno Bockorny, MD, Harvard University, Beth Israel Deaconess Medical Center

Data presented will be available to view in the Publications section of the Agenus website (View Source) following the SGO Conference.

References

1 View Source
2 Hinchcliff et al. Gynecologic Oncology 2021

About Botensilimab

Botensilimab is a novel, multifunctional CTLA-4 investigational antibody that has been designed to extend clinical benefits to "cold" tumors that have not historically responded to standard of care or investigational therapies. In addition to binding to the CTLA-4 receptor, its Fc-enhanced structure induces a memory immune response, downregulates regulatory T cells, and delivers better priming and activation of T cells, thereby amplifying immune responses.

In a Phase 1b clinical study of more than 300 patients, botensilimab has demonstrated clinical responses in nine solid tumor cancers, either alone or in combination with Agenus’ PD-1 antibody, balstilimab. Agenus is conducting global, randomized Phase 2 trials in microsatellite-stable colorectal cancer (MSS CRC), pancreatic cancer, and melanoma as part of its ACTIVATE trial program. Additional information about these botensilimab trials can be found at www.clinicaltrials.gov under the identifiers NCT05608044, NCT05630183, and NCT05529316, respectively. A global Phase 3 trial in MSS CRC is expected to launch in 2023.