On May 17, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Sernova Corp. (TSX-V: SVA; OTCQB: SEOVF; FSE: PSH), a clinical-stage company and leader in regenerative medicine cell therapeutics reported a partnership in the field of diabetes (Press release, Evotec, MAY 17, 2022, View Source [SID1234614703]). 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 .

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 partnership leverages iPSC-based beta cells from Evotec’s QRbeta initiative. Evotec reliably produces human iPSC-based beta cells in islet-like clusters in a quality controlled ("QC") scalable bioreactor process. Those islet-like clusters are functionally equivalent to primary human islets in their ability to normalise blood glucose levels in in vivo models over several months.

Evotec’s iPSC-based beta cells will be combined with Sernova’s proprietary Cell Pouch, which is the leading implantable and scalable medical device in its class. In particular, it enables vascularisation of the cell implant and thus ensures long-term survival and optimal function in patients. The combination of primary donor islets and Cell Pouch has achieved long-lasting therapeutic results in patients enrolled in Sernova’s US-based Phase I/II clinical trial, including sustained insulin-independence in high-risk Type 1 Diabetes patients who previously required insulin injections for survival. Moreover, Sernova will evaluate local immune protection technology to protect non-modified beta cells and avoid the requirement for immunosuppressive treatment. The goal of the partnership is the development of an off-the-shelf iPSC-based beta cell replacement therapy device for the treatment of patients living with insulin-dependent diabetes.

Sernova has acquired an option for an exclusive global license to Evotec’s Induced Pluripotent Stem Cell (iPSC)-based Beta cells for use with its Cell Pouch system to treat diabetes. From an operational perspective, the pre-clinical development programme(s) will be jointly funded until IND acceptance. Sernova has the right to exercise its option for an exclusive global license upon IND filing. Evotec will contribute cell manufacturing through commercialisation and decide in the future on joint funding of clinical development. Upon commercialisation, there will be a profit-sharing arrangement between the two companies, with the split dependent upon Evotec’s participation in the clinical development programme.

In conjunction with the agreement, Evotec has committed to a strategic € 20 m equity investment in Sernova (approx. CAD$ 27 m at an €/CAD$ fx rate of 1.355).

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We searched long and hard for the right partner. Sernova clearly ticks all boxes with their clinically validated Cell Pouch technology, which fits perfectly to Evotec’s iPSC-based beta cells. Together we will progress a highly differentiated first-in-class beta cell therapy into clinical development with the common goal to bring a truly transformative therapy to insulin-dependent diabetic patients. The operational synergies of Evotec’s and Sernova’s technologies puts Sernova in position to become the world’s leader in beta cell replacement therapy. Our equity investment underlines our strategic interest in this collaboration with Sernova. We are very much looking forward to collaborate with them on the project as well as to be part of their Supervisory Board."

Dr Philip Toleikis, President, and Chief Executive Officer of Sernova, commented: "In tandem with our current clinical islet cell programme, Sernova entered into multiple pharmaceutical research collaborations to identify the highest quality and most compatible iPSC cell technology, and validate the cells pre-clinically within our Cell Pouch System. Evotec is an iPSC powerhouse having dedicated many years and substantial resources to developing high quality and stable stem cell technologies for multiple therapeutic applications. In every sense, both as a global strategic partner and as an iPSC expert, Evotec has exceeded all our expectations and we welcome them to join our advisory board. Today’s announcement of this joint iPSC beta-cell partnership completes the three pillars of our diabetes cell therapy platform. Alongside our clinically validated Cell Pouch System and recently acquired conformal coating immune protection technology, this now establishes a total regenerative medicine cell therapy solution for insulin-dependent diabetes."

Sernova and Evotec are going to hold a joint conference call on the transaction. The conference call will be held in English.

On May 17, 2022 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that the first patient has been randomized in the company’s proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor, setanaxib (Press release, Calliditas Therapeutics, MAY 17, 2022, View Source [SID1234614701]).

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 trial is a randomized, placebo-controlled, double-blind, proof-of-concept Phase 2 study. It will investigate the effect of setanaxib 800 mg twice daily in conjunction with pembrolizumab 200mg IV, administered every 3 weeks (the standard treatment regimen for this immunotherapy), in approximately 50 patients with moderate or high CAF-density tumours. A tumour biopsy will be taken prior to randomization and then again after at least 9 weeks of treatment. Treatment will continue until unacceptable toxicity or progression, as is typical for oncology trials.

"Today marks an important milestone for Calliditas, with the enrolment of the first patient into our proof-of-concept study in SCCHN. We believe that a successful translation into the clinic of the promising pre-clinical observations of co-administration of setanaxib and check point inhibitors, could result in important new treatment approaches for patients with CAF rich solid tumors, and we look forward to working with our clinical trial sites, investigators and site staff to successfully execute the study," said CMO Richard Philipson.

Interim biomarker analysis is targeted for Q4 2022, and the study is expected to read out final data (including impact on tumour size) in 2023. Further details of this study can be found at www.clinicaltrials.gov, with the reference NCT05323656.

On May 17, 2022 AstraZeneca reported that it has entered into a licence agreement with RQ Biotechnology Ltd (RQ Bio) for a portfolio of early-stage monoclonal antibodies (mAbs) targeted against SARS-CoV-2, the virus that causes COVID-19 (Press release, AstraZeneca, MAY 17, 2022, https://www.astrazeneca.com/media-centre/press-releases/2022/astrazeneca-signs-licence-agreement-with-rq-biotechnology-for-monoclonal-antibodies-against-covid-19.html [SID1234614700]).

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!

Under the agreement, AstraZeneca has acquired an exclusive worldwide licence to develop, manufacture and commercialise mAbs against SARS-CoV-2.

Iskra Reic, Executive Vice President, Vaccines & Immune Therapies, AstraZeneca, said: "The COVID-19 pandemic has changed the landscape for immune therapies, including the use of monoclonal antibodies to protect vulnerable patients who can’t respond adequately to vaccination alone. Scientific innovation is rapidly accelerating, and this agreement reflects our continued commitment to the discovery and development of new medicines to help prevent and treat infectious disease, including COVID-19."

RQ Bio is a UK-based biotechnology company focused on developing treatments and preventative therapies based on potent broad-spectrum mAbs to address areas of unmet need in vulnerable patient populations.

On May 17, 2022 iOnctura SA, a clinical-stage oncology company targeting key resistance mechanisms in solid tumors, reported that it will present Phase Ib data on its lead pipeline asset, IOA-244, the highly differentiated novel phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, at the 2022 ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) Annual Meeting, taking place June 3-7 in Chicago (Press release, iOnctura, MAY 17, 2022, View Source [SID1234614681]).

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!

"We believe IOA-244 has a wider therapeutic window than other molecules in the PI3Kδ inhibitor class because of its unique semi-allosteric binding properties," said Catherine Pickering, PhD, CEO of iOnctura. "The data presented at ASCO (Free ASCO Whitepaper) will show that IOA-244 has potentially best-in-class tolerability and impressive overall survival in refractory uveal melanoma patients. We are looking forward to presenting the data and accelerating development of IOA-244 to treat uveal melanoma and other solid tumors."

High expression of PI3Kδ in both cancer cells and in the tumor immune landscape is a contributing factor to many solid tumor types escaping the host’s immune response. This is achieved by tumors, in part, through PI3kδ-mediated upregulation of T regulatory (Treg) cells, making the tumors "cold", or difficult to detect by the body’s immune system. IOA-244 inhibition of PI3kδ blocks proliferation of Treg cells, thus making "cold" tumors "hot", unveiling them to immune system detection and facilitating an anti-tumor immune response.

Exquisite selectivity for PI3Kδ over other subtypes, including the closely related PI3Kγ, taken together with IOA-244’s unique semi-allosteric mechanism, which is achieved through differentiated binding to the PI3kδ protein’s kinase domain, represents a unique first-in-class mechanism in solid tumors. This mechanism may allow IOA-244 to lock the kinase in its resting state, completely preventing initiation of downstream cell signalling pathways normally triggered when it is activated at the cell membrane.

"We believe IOA-244’s semi-allosteric non-ATP competitive mechanism may block Treg upregulation and simultaneously avoid initiating other signalling cascades that may lead to toxicities," explained Lars Van Der Veen, PhD, CTO of iOnctura. "Other PI3kδ inhibitors are thought to act on PI3kδ by blocking the ATP pocket without preventing the kinase from being activated at the cell membrane."

IOA-244 is being investigated in the DIONE-01 Phase I trial in metastatic cancers. The objective of Part A, now complete, was to determine the safety, tolerability, and dosage of IOA-244 in cancer patients to determine the biologically effective dose range. The continuing Part B of the study consists of expansion cohorts of patients with different tumor types, including patients with metastatic uveal melanoma. The poster at ASCO (Free ASCO Whitepaper) will include Phase Ib data from DIONE-01 in refractory uveal melanoma patients.

Details of the presentation:

Title: First-in-human (FIH) phase I study of the highly selective phosphoinositide 3-kinase inhibitor delta (PI3Kδ) inhibitor IOA-244 in patients with advanced cancer: Safety, activity, pharmacokinetic (PK), pharmacodynamic (PD) results.
Type: Poster
Session: Developmental Therapeutics-Molecularly Targeted Agents and Tumor Biology
Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
IOA-244 is a PI3Kδ specific, orally dosed, small molecule inhibitor that overcomes tumor and stroma induced immune suppression. Its unique chemistry, semi allosteric binding mode and mechanism of action contribute to its unprecedented clinical profile. IOA-244 is currently in the cohort expansion phase of the DIONE-01 trial, a two-part, first-in-human dose study evaluating IOA-244 in advanced cancers and as a combination partner for conventional and immune-therapies (ClinicalTrials.gov Identifier: NCT04328844).

Uveal melanoma (UM) is a rare malignancy arising within the uveal tract of the eye. There are approximately 7,000 newly diagnosed cases of uveal melanoma each year (around 2,000 in the United States). Over 50% of patients will progress to metastatic disease. Median overall survival is approximately 1 year for metastatic uveal melanoma and there are no approved therapies.

On May 16, 2022 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, reported the appointment of Johan Baeck, MD, as Executive Vice President and Chief Medical Officer (Press release, Promontory Therapeutics, MAY 16, 2022, View Source [SID1234615802]). Dr. Baeck joins Promontory Therapeutics from Jounce Therapeutics where he served as Senior Vice President, Clinical Development and Medical Affairs.

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!

Joseph F. O’Donnell, MD, who previously served as Chief Medical Officer, will remain with Promontory Therapeutics and assume the role of Senior Medical Director focusing on patient eligibility, enrollment and clinical case management.

"We are especially pleased to welcome Dr. Baeck to the Promontory team. His extensive clinical development and medical affairs experience with both large pharmaceutical and smaller biotech companies complements our growth strategy," said Promontory President and Chief Executive Officer Robert Fallon. "In addition, Dr. Baeck’s strong background in immuno-oncology fits well with our focus on small molecule immunotherapy as we advance our lead agent, PT-112, in clinical trials for treating multiple cancer types, including prostate and lung cancers, and the rare disease of thymoma."

"I am excited to be part of a great group of dedicated, smart and driven people at Promontory," said Dr. Baeck. "The company is operating within the heart of the immuno-oncology field and new approaches will favor modalities with novel I-O mechanisms and single agent anti-cancer activity such as Promontory’s immunogenic cell death inducer, PT-112. The company is poised to make a major impact in the field."

Dr. Baeck completed his Medical Degree in Leuven, Belgium and was a practicing physician in Belgium before transitioning to the pharmaceutical industry. After many years with Abbott Laboratories and Novartis in key commercial, clinical development and medical affairs roles, as well as with smaller biotechs, he joined Immunocore as VP and Global Head of Medical Affairs and later Jounce Therapeutics. He has published in the immuno-oncology field and frequently speaks on recent I-O developments at key medical meetings.