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Monte Rosa Therapeutics Expands Leadership Team with Appointment of Filip Janku, M.D., Ph.D., as Chief Medical Officer

On June 10, 2021 Monte Rosa Therapeutics, a biotechnology company focused on discovering and developing precision medicines that degrade disease-causing proteins, reported the appointment of Filip Janku, M.D., Ph.D., as the company’s first chief medical officer (Press release, Monte Rosa Therapeutics, JUN 10, 2021, View Source [SID1234583838]).

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"Our team is excited to welcome Filip on board as we continue to identify disease-causing protein targets that may be amenable to molecular glue-based degradation," said Markus Warmuth, M.D., CEO of Monte Rosa Therapeutics. "We are looking forward to continuing to advance our programs toward the clinic with Filip’s leadership and expertise."

Prior to joining Monte Rosa, Dr. Janku served in various roles at The University of Texas MD Anderson Cancer Center, or MD Anderson, including center medical director for the Clinical and Translational Research Center, associate professor and medical oncologist in its Department of Investigational Cancer Therapeutics. There, he specialized in the development of new cancer drugs with a special focus on proof-of-concept studies of novel personalized therapies. Dr. Janku received his M.D. and Ph.D. from Charles University Prague in the Czech Republic.

Bright Peak Therapeutics Announces $107 Million Series B Financing and Expanded Board of Directors

On June 10, 2021 Bright Peak Therapeutics, a biotechnology company developing next-generation cytokine immunotherapies to treat cancer and autoimmune disease, reported that it raised $107 million in a Series B financing (Press release, Bright Peak Therapeutics, JUN 10, 2021, View Source [SID1234583837]). The round was led by RA Capital, with participation by founding investor Versant Ventures and new investors Fidelity Management & Research Company, Invus, Qatar Investment Authority, funds and accounts managed by BlackRock, Alexandria Venture Investments and an undisclosed leading healthcare investment fund.

Bright Peak uses a novel technology to chemically synthesize therapeutic cytokines by ligating together customized peptide segments. This proprietary technology provides unique flexibility to both tune and enhance cytokine biology through affinity modification and orthogonal, site-specific conjugation. The company’s platform also allows for the conjugation of its enhanced cytokines as payloads to certain antibodies, creating novel and proprietary "Bright Peak Immunocytokines." These Immunocytokines will allow tissue- and cell-specific targeting of the cytokine payload with the added potential for synergistic efficacy through potency-enhancing avidity effects.

"The investment from this accomplished crossover syndicate underscores the enthusiasm for our platform and re-affirms our commitment to transform the therapeutic utility of cytokines to treat people with cancer and autoimmune diseases," said Fredrik Wiklund, president and CEO of Bright Peak. "This capital will allow us to expand our Immunocytokine platform and advance our deep pipeline of programs across IL-2, IL-18 and IL-7."

Also today, Bright Peak announced key additions to its board of directors with the appointments of independent directors Laura Shawver, Ph.D., and Christine Siu. Dr. Shawver, currently CEO of Silverback Therapeutics, is an industry veteran with an extensive scientific, translational and clinical background as well as a broad range of strategic expertise. Most recently, she was president and CEO of Synthorx, a developer of engineered cytokines for cancer and autoimmune disorders that was acquired by Sanofi in 2020 for $2.5 billion. She received her Ph.D. in pharmacology from the University of Iowa.

Ms. Siu is the chief operating officer in-residence at BridgeBio Pharma Inc., and former CFO at Eidos Therapeutics Inc., a BridgeBio subsidiary, where she transformed Eidos from a preclinical biotech start-up company to a late-stage clinical public company. Prior to that, she was the CBO at The Bluefield Project to Cure Frontotemporal Dementia, where she built a therapeutic pipeline and executed seven collaborations with the pharmaceutical industry. Earlier, she was senior director, corporate development at Global Blood Therapeutics, Inc. (GBT), and before that, a venture principal at Third Rock Ventures. Previously, Ms. Siu invested in life science companies in venture capital and private equity and held roles of increasing responsibility at Warburg Pincus LLC and Thomas, McNerney & Partners, LLC and began her career in healthcare banking at Bear, Stearns & Co. Inc. Ms. Siu holds an MBA from Harvard Business School and a B.S. with distinction in cellular molecular biology and economics from the University of Michigan.

On the Bright Peak board, Dr. Shawver and Ms. Siu join RA Capital’s Josh Resnick, M.D., and Michael Rosenzweig DVM, Ph.D., who joined in connection with the Series B financing, as well as existing board members Alex Mayweg, Ph.D., and Tom Woiwode, Ph.D., of Versant Ventures.

"We are pleased to lead a financing that will enable Bright Peak to broadly invest in its platform technologies, development programs, people, and, ultimately, towards delivering a pioneering new category of cytokine immunotherapies to patients in need," said Dr. Resnick.

"We warmly welcome Laura, Christine, Josh, and Michael to our Board of Directors. Their deep domain expertise and business acumen will serve as a tremendous resource to the Company," said Dr. Mayweg.

ITM Announces EUR 25 Million (USD 30 M) Private Equity Financing to Support Advancement of Proprietary Precision Oncology Pipeline

On June 10, 2021 ITM AG, a leading radiopharmaceutical company, reported the close of a private equity financing round from existing and new investors, related and connected parties to Portland Holdings, along with FRIBA Investment, raising a total of EUR 25 million (USD 30 million) (Press release, ITM Isotopen Technologien Munchen, JUN 10, 2021, View Source [SID1234583836]). The funding will support the company’s ongoing global expansion and the addition of novel programs into its leading precision oncology pipeline, as well as the further advancement of ITM’s existing clinical candidates in a broad range of oncology indications. The EUR 25 million private financing is additional to the EUR 90 million convertible loan agreement announced in April, 2021. Further details on the financing were not disclosed.

"We greatly value the continued support we receive from our current and new investors to fund our progress in providing the most precise cancer radiotherapeutics and diagnostics to patients in need of novel treatment options. This raise reinforces the commitment of both existing and new investors and highlights their confidence that we will successfully deliver on the potential of Targeted Radionuclide Therapy for cancer patients," commented Steffen Schuster, Chief Executive Officer of ITM.

"ITM’s data has proven compelling to date and the ongoing Phase III trial, COMPETE looks very promising, thereby further validating the company’s approach to addressing important therapeutic needs in the oncology field and contributing to the future wellbeing of patients. We are excited to contribute to the company’s financial strength and look forward to seeing ITM maintain this positive momentum in 2021," said Robert Collan, Managing Director at FRIBA Investment.

"The current private equity financing round represents a significant capital raise by a Canadian investment firm in the area of life sciences, where we are rapidly expanding our domain experience and investment portfolio. This investment is a product of our reputation, our global footprint, and access to capital, and represents our commitment to democratizing wealth by offering everyone – from the sophisticated institutional investors and family offices to eligible retail clients – an opportunity to co-invest with us in what we believe are high-quality firms. We welcome to ITM’s shareholder roster our friends and like-minded investors at FRIBA Investment. In keeping with our philosophy of doing well and doing good, we look forward to contributing toward the collective mission of improving medical outcomes for cancer patients worldwide," commented Michael Lee-Chin, Supervisory Board Member of ITM and founder and chairman of Portland Holdings.

ITM is a leader in the production and supply of high-quality medical radioisotopes for cancer treatment and diagnosis and has established its own global supply network. The company has forward-integrated to develop Targeted Radionuclide Diagnostics and Therapies designed to provide medical benefit for hard-to-treat cancer indications. ITM’s goal is to advance a broad pipeline by combining its first-class radioisotopes with targeting molecules capable of addressing a range of tumors, including gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM will validate this approach with its lead candidate, n.c.a. 177Lu-Edotreotide currently in a Phase III clinical trial for GEP-NETs.

Kyowa Kirin: New Data Analysis Shows Link between Blood Involvement and Response to Treatment in Cutaneous T-cell Lymphoma (CTCL) Patients

On June 10, 2021 Kyowa Kirin International PLC (Kyowa Kirin), a wholly owned subsidiary of Kyowa Kirin Co., Ltd., reported a new analysis of data showing statistically significant improvements in quality of life in cutaneous T-cell lymphoma (CTCL) patients treated with mogamulizumab with blood involvement, compared to vorinostat (Press release, Kyowa Hakko Kirin, JUN 10, 2021, View Source [SID1234583835]).1 The new findings from the MAVORIC trial compared the impact of treatment with POTELIGEO (mogamulizumab) and vorinostat by patient blood tumour burden in adult patients with mycosis fungoides (MF) and Sézary syndrome (SS), two types of CTCL.

Professor Doctor Pier Luigi Zinzani of the Institute of Hematology "L. e A. Seràgnoli" at the University of Bologna said: "This new analysis helps us to understand more about the importance of blood involvement in CTCL, which is relatively common in the more advanced stages of the disease and may be present in some less advanced cases. We know that increasing levels of malignant T-cells in the blood correlate with increased risk of CTCL disease progression and an overall reduction in patient survival. Treatment with mogamulizumab has also been shown to be more effective in CTCL patients who have blood involvement as part of their disease and treatment with mogamulizumab also generates quality of life benefits for CTCL patients with blood involvement. This new information underlines the importance of blood monitoring in the clinical management of CTCL patients."

In the study, patients classified as B0 were considered to have no blood involvement and patients classified as B1 and B2 were considered to have blood involvement.1 B1 is a measurable low level of blood involvement of between 250 to 1000 abnormal T-cells per µL. B2 is higher level of blood involvement, greater than 1000 abnormal T-cells per µL, detected using flow cytometry.

Statistically significant differences in quality of life were seen for patients with blood involvement, with patients treated with mogamulizumab seeing improvements in the Skindex-29 and ItchyQoL questionnaires, compared to vorinostat. Quality of life improvements were also seen in patients treated with mogamulizumab with blood involvement assessed by the Pruritus Likert Scale and the FACT-G Total Score questionnaires, compared to vorinostat. For patients with no blood involvement there was no statistically significant differences in quality of life between mogamulizumab and vorinostat.1

MF and SS are subtypes of CTCL, a rare type of non-Hodgkin’s lymphoma that can affect the skin, blood, lymph nodes and internal organs.2 As a chronic and generally incurable disease associated with disfiguring skin lesions, intractable itching, sleep disturbance, and psychosocial problems, CTCL has a serious negative effect on quality of life.1 MAVORIC is the largest multinational, randomised, Phase 3 trial of systemic CTCL therapy. MAVORIC evaluated the safety and efficacy of mogamulizumab versus vorinostat in patients who had received at least one previous systemic therapy.3 This new post hoc analysis of the MAVORIC trial looked at data from patients’ quality of life using a range of recognised and validated assessment tools.1

The MAVORIC trial met its primary endpoint of overall investigator-assessed progression-free survival (PFS), which was shown to be significantly greater for patients treated with mogamulizumab compared to vorinostat, at 7.7 months and 3.1 months, respectively (P<0.0001).3

About Mycosis Fungoides (MF) and Sézary syndrome (SS)

Cutaneous T-cell lymphomas (CTCL) are rare, serious and potentially life-threatening, forms of non-Hodgkin’s lymphoma,2 affecting around 240 persons per 1,000,000 population across Europe.4 Mycosis fungoides (MF) and Sézary syndrome (SS) are the two best studied types of CTCL,5 together accounting for around two thirds of all CTCLs.6,7

MF and SS can affect the skin, blood, lymph nodes (part of the body’s immune system which is spread throughout the body) and internal organs.2 MF and SS can be very distressing for patients and have a significant negative impact upon many aspects of patients’ lives.3,8 Disease stage in MF and SS is the most important prognostic factor,9 and draws upon the type and extent of skin involvement, as well as the presence or absence of extracutaneous disease in lymph nodes, viscera, and blood.10 Hence, assessment of all four anatomical ‘compartments’ is recommended, first at diagnosis and then to assess patient response to treatment.10,11

Neoplastic T lymphocytes in MF and SS, consistently express CC chemokine receptor 4 (CCR4),3 making this a relevant target for treatment at all stages of disease. All disease stages can include blood involvement10,12 and blood tumour burden may be relevant for prognosis13 and treatment6,10,14,15 in MF and SS.

Due to its likeness to more common skin conditions such as eczema and psoriasis,16 CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.17 It is critical for doctors to accurately diagnose CTCL as early as possible as the patient’s prognosis can be affected if the disease progresses to later stages.13 Whilst most individuals that present with early stage do not progress to a more advanced stage,18 patients with advanced disease have significantly poorer outcomes with only around half of patients (52%) surviving for just 5 years.19

About POTELIGEO (mogamulizumab) and the MAVORIC Trial

POTELIGEO (mogamulizumab), a humanised monoclonal antibody that selectively binds to CCR4,20 elicits anti-tumour activity by antibody-dependent cellular cytotoxicity (ADCC).3

Following a positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission (EC) granted marketing authorisation for mogamulizumab in November 2018 for the treatment of adult patients with MF or SS who have received at least one prior systemic therapy.20 The CHMP’s opinion was based on results of the MAVORIC trial, the largest randomised study of systemic therapy in MF and SS,3 and the first trial to compare systemic therapies using progression-free survival as a primary endpoint.3

MAVORIC evaluated the safety and efficacy of mogamulizumab versus vorinostat in patients who had received at least one previous systemic therapy:3

Mogamulizumabmore than doubled median progression-free survival (PFS) in patients with relapsed or refractory MF/SS, compared with vorinostat (7.7 months vs 3.1 months), which is a relative reduction in the risk of disease progression of 47% (HR=0.53, 95% CI: 0.41–0.69; P<0.0001). 3
Overall, significantly more patients responded to mogamulizumab than vorinostat (overall response rate [ORR] 28.0% versus 4.8% (P<0.0001). 3
Median time-to-next-treatment (TTNT), an additional measure of clinical benefit and disease control, was significantly superior in patients treated with mogamulizumab compared to those that received vorinostat (11.0 months vs 3.5 months; P<0.0001). 3
In post hoc analyses, patients with B1 and B2 levels of blood tumour burden that received mogamulizumab have been shown to draw significantly more benefit in terms of PFS,21 TTNT, 21 and improvement in mSWAT22 compared to patients that received vorinostat.
Mogamulizumab shows good tolerability with a manageable safety profile. 3,23,24,25
Important Prescribing information and Safety Information

Refer to the full Summary of Product Characteristics (SmPC) for prescribing information and the full safety information: View Source

PROTHENA TO PARTICIPATE IN JMP SECURITIES LIFE SCIENCES CONFERENCE ON JUNE 16

On June 10, 2021 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that members of its senior management team will participate in a fireside chat at the JMP Securities Life Sciences Conference on Wednesday, June 16 at 3:00 PM ET (Press release, Prothena, JUN 10, 2021, View Source [SID1234583834])

A live webcast of the fireside chat can be accessed through the investor relations section of the Company’s website at www.prothena.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for at least 90 days following the presentation date.