RemedyBio to lead consortium in a €10.5M DTIF-supported programme to develop groundbreaking new therapies for currently incurable cancers

On April 30, 2021 RemedyBio reported the success of the HEALED Consortium in securing DTIF support of €6.8M as part of a 3-year, €10.5M programme to develop new cell therapies for cancer (Press release, Remedy Biologics, APR 30, 2021, View Source [SID1234644112]). The consortium is comprised of RemedyBio as programme lead, aCGT Vector DAC, Trinity College Dublin & St James’s Hospital, and the NUIG’s Genomics Data Science Centre, bringing together deep capabilities in mass-scale functional biology, GMP clinical deployment, clinical and tumour microenvironment expertise in cancer, and molecular data analytics to create a world first in near-patient, personalised, functional cancer therapeutics. Our goal is to enable a new kind of revolutionary immunotherapy to cure incurable cancers. The Disruptive Technologies Innovation Fund (DTIF) is managed and funded through the Department of Enterprise and Innovation (DBEI) in Ireland.

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!


MEI Pharma Announces the Retirement of Chief Medical Officer Robert Mass and Promotion of Richard Ghalie to Chief Medical Officer

On April 30, 2021 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported the retirement of Robert Mass, M.D., MEI’s chief medical officer (Press release, MEI Pharma, APR 30, 2021, View Source [SID1234578870]). Dr. Mass joined the company in 2010 and will retire on May 3, 2021, after which he will continue to serve as a strategic advisor to the company. The Company also announced that Richard Ghalie, M.D., MEI’s senior vice president, clinical development, has been promoted to chief medical officer.

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!

"Bob’s contributions to MEI over his more than ten years at the company have been invaluable across our drug candidate pipeline, particularly in guiding the strategy and broad clinical development program for zandelisib, which will best be measured by the benefit these programs may ultimately provide to patients. I want to thank Bob for his dedication to MEI and his friendship over these past 10 years. We wish him the very best in his retirement and look forward to continued interaction through his advisory role," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "I also welcome Richard stepping into his role as our new chief medical officer, a role for which he is very well suited, as evidenced by the significant progress in our zandelisib program under Richard’s guidance and its progress with our partners at Kyowa Kirin towards zandelisib’s planned new drug application for consideration by FDA for approval under the accelerated approval pathway."

Dr. Mass commented, "Working with Dan and the entire MEI team over the past decade has been deeply rewarding and this is an ideal time for my transition. We have generated important clinical data with zandelisib indicating its potential as a best-in-class PI3K-delta specific inhibitor and launched a comprehensive clinical development plan, including monotherapy and combinations with other therapies, in low grade lymphomas and additional indications. Our initial registration study, TIDAL, has recently reached its planned recruitment target for its primary efficacy population and we have a plan in place for a future NDA submission for consideration by FDA under the accelerated approval pathway. I am confident that Richard and the extended MEI team will continue to execute our strategy to bring zandelisib to patients across a broad spectrum of B-cell malignancies and look to continued involvement in an advisory role."

Dr. Ghalie was appointed as senior vice president, clinical development in March 2016. He is a hematologist and oncologist with more than 25 years of drug development experience at public and private companies. Dr. Ghalie has held several executive positions in the pharmaceutical industry and has led medical teams that successfully filed NDAs and MAAs resulting in the approval of four new indications. Dr. Ghalie holds a medical degree from the French School of Medicine in Lebanon, a master’s degree from the University Paris XI and an MBA from the University of Washington in Seattle. He has authored or co-authored more than 125 manuscripts, book chapters and scientific publications.

KIYATEC Announces Investment from Seae Ventures and Names Co-founder and Managing Partner Jason Robart to its Board of Directors

On April 30, 2021 KIYATEC, Inc reported that it secured a $2.5 million investment from Boston-based healthcare service and technology venture capital fund Seae Ventures (Press release, KIYATEC, APR 30, 2021, View Source [SID1234578904]). The fund’s focus in disruptive healthcare technologies aligns with KIYATEC’s goal to fundamentally change the way cancer drugs are selected by providing oncologists with patient-specific evidence of response, prior to treatment initiation.

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!

Although significant strides toward personalized medicine have been achieved in the past two decades, oncologists remain largely unable to predict treatment response for individual patients. As a result, many patients receive ineffective drug therapies, while unnecessarily experiencing toxic side effects and shouldering high cost of treatment. KIYATEC’s 3D-Predict platform and associated tests increase the patient-centric value of cancer drugs by informing oncologists’ pre-treatment cancer drug selection. Importantly, the platform also aids pharmaceutical companies by improving decision-making across drug lifecycles.

"We are grateful for Seae Venture’s ’yes’ to KIYATEC and welcome the addition of their managing partner, Jason Robart, to our board of directors. The fund’s healthcare industry relationships coupled with Jason’s personal experience with health insurance innovation will be beneficial as we implement our strategy to impact those who need it most – cancer patients and their providers," said Matthew Gevaert, CEO and co-founder of KIYATEC.

The investment comes on the heels of other recent announcements of success for KIYATEC. The first release of the 3D-PREDICT clinical study data in late 2020, combined with the more recent March 2021 publication demonstrating platform expansion into immuno-oncology, highlight the rapid and disruptive nature of KIYATEC’s progress. The company’s platform has been shown to be clinically predictive for patient-specific response to chemotherapy and targeted agents, and it has been analytically validated in both ovarian cancer and high-grade gliomas.

Robart said, "KIYATEC has the potential to significantly improve outcomes for patients and their providers, not just for one cancer type, but across many solid tumors. We’re excited about the science, the team and the potential. We welcome KIYATEC into our portfolio of companies and I’m thrilled to join its board of directors."

PCI Biotech: First US patient enrolled in the fimaCHEM pivotal RELEASE study

On April 30, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that the first US patient has been enrolled into the fimaChem pivotal RELEASE study with registration intent in inoperable bile duct cancer patients (Press release, PCI Biotech, APR 30, 2021, View Source [SID1234585158]). The RELEASE study spans across Europe, USA and Asia, with patient enrolment initiated in all continents.

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!

Per Walday, CEO, said: "It is reassuring to see screening activity and enrolment picking up across the geographies of the RELEASE study, despite Covid-19 still having an impact on the healthcare systems. We are focused on optimal execution of the RELEASE study, to bring a new treatment option to a patient group with a high unmet medical need."

NOXXON Announces €1.2M Equity Raise Through Conversion of Warrants by Kreos Capital and Other Historical Investors

On April 30, 2021 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that it has received exercise notices from Kreos Capital along with other historical investors who have converted warrants to shares (Press release, Noxxon, APR 30, 2021, View Source [SID1234578905]).

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!

A total of 3,768,449 new shares in NOXXON shall be issued consequently to the transaction, and NOXXON shall receive €1.2 million. This brings the total number of outstanding shares in NOXXON to 65,223,981. Following this warrant exercise, Kreos Capital holds 7.38% of outstanding shares in NOXXON.

The warrants were issued in connection with NOXXON’s €1 million private placement, Kreos Capital’s partial conversion of debt into equity and €10 million convertible notes with warrants on May 2, 2017. Details of the transaction can be found in the associated press release.

"We are pleased to exercise these warrants and increase our investment in NOXXON. We have been involved in NOXXON since 2014 and are confident the company has exciting long-term prospects, based on its differentiated technology, strong oncology-focused pipeline and the development strategy being implemented by management," said Aris Constantinides, General Partner at Kreos Capital.

"I would like to thank Kreos Capital for their ongoing long-term support of NOXXON. We look forward to working closely together as we continue to focus on improving cancer treatments by targeting the tumor microenvironment, including our lead candidate NOX-A12, which is progressing well in a Phase 1/2 brain cancer trial, with data read-outs expected in May and November 2021," said Aram Mangasarian, CEO of NOXXON.