On November 15, 2022 Medicines Discovery Catapult (MDC) and Xerion Healthcare reported that have been awarded Innovate UK SMART Grant funding to develop a unique solution that will enhance the effect of post-surgical radiotherapy on aggressive brain tumours and reduce the chance of cancer regrowth (Press release, Medicines Discovery Catapult, NOV 15, 2022, View Source [SID1234624140]).

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!

In recent years good progress has been made to treat certain common cancers; however, there remains a significant unmet need for many areas of oncology, including aggressive brain tumours like glioblastoma. The median survival time for patients with these tumours is 14.6 months1.

The current treatment approach includes surgery to remove as much of the tumour as possible, followed by radiotherapy and chemotherapy. However, it is common for the tumour to return to the site of removal, and regrowth is often rapid. Recurrent tumours require extensive medical interventions, which, unfortunately, often do not translate into significantly increased rates of survival and instead negatively impact the patient’s quality of life.

Radiotherapy can treat solid tumours and increasing the X-ray dose has been shown to improve treatment outcomes, but with a detrimental effect on healthy tissue.

Xerion, an Oxfordshire-based SME spin-out from the University of Oxford, has developed a unique nanoparticle solution that increases the effectiveness of radiotherapy, crucially, without damaging healthy tissue. The radiotherapy-enhancing nanoparticles will be released into areas of remaining tumour in an advanced clinically relevant in-vivo model developed by specialists at MDC. The group will then study tumour regrowth with and without the nanoparticles to demonstrate efficacy, using MDC’s pre-clinical radiotherapy platform and advanced imaging capability at its state-of-the-art laboratory in Cheshire.

The data extracted from the collaborative project between MDC and Xerion is important, as it will form the basis of a submission to the Medicines and Healthcare Products Regulatory Agency (MHRA), enabling Xerion to take the novel therapeutic approach to clinical trials and one step closer to patients.

Dr Gareth Wakefield, Chief Technology Officer at Xerion Healthcare, said:

"High-grade brain tumours are an extremely challenging disease type with little improvement in outcomes over the last forty years. New treatment options are urgently needed to reduce the almost inevitable regrowth of these tumours following resection. To develop these treatments, advanced models and imaging are required. By partnering with the experts at MDC, Xerion will be able to apply its nanoparticle radiotherapy enhancing technology to a realistic model of this disease, bringing novel treatments closer to the clinic."

Dr Martin Main, Chief Scientist at Medicines Discovery Catapult, said:

"At MDC, we are driven by reshaping drug discovery for the benefit of patients, and this project is the epitome of that. Tragically, brain tumours kill more people under 402 than any other type of cancer, so there is an urgent need for new therapeutic approaches to treat this disease. Combining Xerion’s radiotherapy expertise with MDC’s advanced imaging capability will allow us to address a critical unmet need for treating aggressive brain tumours and move one step closer to improving the quality of life for many patients."

Dr David Jenkinson, Chief Scientific Officer at The Brain Tumour Charity, which funds world-class research and provides trusted support for anyone affected by brain tumours, said:

"Brain tumours remain the biggest cancer killer of the under 40s, and, unlike many other cancers, survival rates have not yet significantly improved over the last 40 years. We urgently need to find kinder, more effective treatments to reduce the harm this devastating disease causes for so many.

"This is a promising research avenue, and we look forward to the results of this study to better understand whether the use of nanoparticles could help enhance the effectiveness of targeted radiotherapy in high-grade brain tumours."

MDC is reshaping drug discovery for patient benefit, transforming great UK science into better treatments through partnership. It works to tackle industry-led challenges, overcoming the barriers that limit today’s drug discovery with effective interventions. By industrialising new technologies to better predict the probability of successful medicines discovery, connecting the Life Sciences ecosystem and supporting drug discovery innovators, MDC accelerates business growth, leading to improved outcomes for patients.

MDC and Xerion are part of a cohort of UK organisations to receive a share of the £25 million funding from Innovate UK for potentially ground-breaking and commercially viable R&D innovations that can significantly impact patient outcomes and support the UK economy.

On November 15, 2022 Ferring Pharmaceuticals and Gubra reported that entered into a collaboration agreement to further develop and characterize preclinical animal models of inflammatory bowel disease (IBD) (Press release, Ferring, NOV 15, 2022, View Source [SID1234624138]). The collaboration aims to advance our early pipeline of targets in intestinal inflammation and fibrosis. Over the next year, we will conduct studies to help us understand the onset and progression of disease in preclinical models of IBD and validate tool compounds. In addition, Ferring and Gubra will collaborate to develop and standardise methods to assess fibrosis in the intestine, focusing on histological features that are translatable to human disease.

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!

"This collaboration highlights Ferring’s commitment to IBD and our ambition to develop better and more translatable models to support target validation", says Bryan Fuchs, VP Gastroenterology, Global Drug Discovery & External Innovation. He adds: "Gubra is a recognized preclinical research organization with expertise in digital imaging and AI quantification of fibrosis, so they are uniquely suited to partner with us in this endeavor."

CEO at Gubra, Henrik Blou, expresses "IBD is a growing part of Gubra’s disease focus, and we see this as an opportunity to make a difference, especially with a knowledgeable player like Ferring. We are thrilled with the collaboration and the possibility to unfold Gubra’s wide palette of advanced digital methods and technologies to assess and quantify histological features of inflammation and fibrosis. Together with our competent partners at Ferring, we look forward to creating strong preclinical models that translate well into the clinic."

On November 15, 2022 Jnana Therapeutics, a biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, reported the company has entered into a second collaboration and license agreement with Roche (SIX:RO, ROG; OTCQX: RHHBY) for the discovery of small molecule drugs for the treatment of cancer, immune-mediated and neurological diseases (Press release, Jnana Therapeutics, NOV 15, 2022, View Source [SID1234624134]). The collaboration covers multiple targets from a diverse range of target classes to address diseases with high unmet need.

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 are excited to partner with Roche, one of the largest healthcare companies and a strong collaborator, for a second time," said Joanne Kotz, Ph.D., co-founder and CEO of Jnana Therapeutics. "Roche has been a valuable strategic partner and we are proud that our success to date has led to the opportunity to broaden our work together in immune-mediated and neurological diseases, as well as to extend our collaboration into cancer."

Under the terms of the agreement, Jnana will receive an upfront payment of $50 million, significant near-term milestone payments, and additional potential future payments that could exceed $2 billion, as well as tiered royalties. Jnana will conduct discovery and preclinical activities against multiple cancer, immune-mediated and neurological disease targets, and Roche will be responsible for development and commercialization of any resulting products.

"We have made great progress in our existing partnership with Roche, which is focused on targeting SLC metabolite transporters, and have also made exciting progress in our internal pipeline against an array of target classes including transcription factors," said Joel C. Barrish, Ph.D., co-founder, President and CSO of Jnana Therapeutics. "We are delighted to now bring the full power of our RAPID platform to our second partnership with Roche as we advance a diverse set of compelling therapeutic targets that have proven challenging to drug."

"We have been impressed by Jnana’s team and their RAPID drug discovery platform, as part of our first collaboration that focused on SLC metabolite transporters," said James Sabry, Global Head of Roche Pharma Partnering. "As fostering truly symbiotic partnerships with our partners where we learn and grow together is a key focus of our overall partnering strategy, we are excited to now build on our successful existing collaboration with Jnana to address new target classes as we expand our efforts to discover new medicines for patients with cancer, immune and neurological diseases."

On November 15, 2022 Apollomics Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination-oncology therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to vebreltinib (APL-101) for the treatment of non-small cell lung cancer (NSCLC) with MET genomic tumor aberrations. The FDA granted the Orphan Drug Designation in August (Press release, Apollomics, NOV 15, 2022, View Source [SID1234624133]).

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!

"While NSCLC is the most common type of lung cancer, a subset of patients will have MET genomic dysregulations in their tumors which make them more resistant to treatment, presenting an unmet medical need," said Guo-Liang Yu, PhD, co-founder, Chairman and Chief Executive Officer of Apollomics. "We are pleased to have received the Orphan Drug Designation for vebreltinib, as patients need new and better treatment options. Through genomic testing, we can identify patients who will benefit most from a targeted treatment like vebreltinib. Orphan Drug Designation brings significant developmental benefits to the vebreltinib program, most notably seven-ear market exclusivity upon its approval."

Apollomics’ ongoing global Phase 2 SPARTA study is evaluating vebreltinib in patients with NSCLC and other solid tumors with MET genomic dysregulation.

Dysregulation of the c-MET tyrosine kinase receptor is implicated in the development of tumor malignancy and can arise through several mechanisms, including gene fusion and amplification, overexpression of the receptor and/or its ligand hepatocyte growth factor (HGF), and the acquisition of activating mutations. One type of the activating mutations cause exon 14 to be skipped due to aberrant splicing of MET mRNA. MET exon 14 skipping occurs in approximately 3-4% of NSCLC and has been demonstrated to be an oncogenic driver. MET amplification, another potential oncogenic driver, occurs in ~3% of newly diagnosed NSCLC, as well as in some NSCLC patients treated with targeted TKI therapy, such as EGFR inhibitors, who become treatment resistant.

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation provides certain benefits including assistance in the drug development process, tax credits for clinical costs, exemption from FDA Prescription Drug User Fee Act (PDUFA) fees, and seven years of post-approval exclusivity.

As previously announced on Sept. 14, 2022, Apollomics and Maxpro Capital Acquisition Corp. ("Maxpro") (Nasdaq: JMAC, JMACU, JMACW), announced a definitive agreement for a business combination (the "Transaction" or the "Business Combination") that would result in Apollomics becoming a publicly traded company on the Nasdaq Global Market ("Nasdaq"). The Business Combination is expected to close in the first quarter of 2023 and Apollomics is expected to be listed on Nasdaq under the ticker symbol "APLM."

About vebreltinib (APL-101)

Vebreltinib is a novel small molecule kinase inhibitor that targets c-MET. It is a Type 1b class highly selective c-MET inhibitor. Vebreltinib has demonstrated strong tumor inhibitory effect in a variety of preclinical c-MET dysregulated human gastric, hepatic, pancreatic and lung cancer xenograft animal models and patient-derived xenograft models (PDX). In Phase 1 clinical trials, vebreltinib (PLB1001) demonstrated a generally well-tolerated safety profile with preliminary evidence of clinical activity in NSCLC subjects harboring a mutation that leads to MET exon 14 skipping and in secondary glioblastoma multiforme (sGBM) patients harboring MET fusion and/or exon 14 skipping with evidence of brain penetration. In China, vebreltinib is referred to as PLB1001 where it is being developed by Apollomics’ partner Beijing Pearl Biotechnology Co. Ltd. Details on the Phase 1/2 SPARTA clinical trial can be found on clinicaltrials.gov: NCT03175224. Apollomics is actively assessing the potential of investigating vebreltinib in combination with novel therapies and in a variety of tumor types in addition to developing vebreltinib as single-agent cancer therapy. Vebreltinib is currently under clinical investigation and not approved for any use anywhere in the world.

About the Phase 2 SPARTA Study

SPARTA is the Phase 2 portion of an ongoing Phase 1/2 international multicenter, open-label study evaluating the safety, pharmacokinetics, and preliminary efficacy of vebreltinib. SPARTA is assessing activity in NSCLC with a mutation that leads to MET exon 14 skipping, and across tumor types (pan-cancer) with MET amplification or fusions. SPARTA is enrolling patients into multiple cohorts. In NSCLC, the trial will evaluate both c-MET inhibitor naïve and experienced patients with mutations that lead to MET exon 14 skipping. Two cohorts will enroll patients with solid tumors with MET amplifications and fusions, including glioblastoma multiforme, the most aggressive form of brain cancer. The primary objective of SPARTA is to assess efficacy by overall response rate (ORR) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) or relevant evaluation criteria per tumor type. Secondary objectives include the incidence and severity of adverse events and additional efficacy measurements including time to progression, progression free survival, and overall survival.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is a disease in which malignant cancer cells form in the tissues of the lung. In 2017, there were an estimated 558,000 people living with lung and bronchus cancer in the United States, with new cases estimated to be over 228,000 in 2020. Lung cancer is also one of the more deadly cancers with a relative 5-year survival rate of around 20%. NSCLC is the most common type of lung cancer with about 80% to 85% of lung cancers falling into this category.

On November 15, 2022 Bonum Therapeutics, a biopharmaceutical company using allosteric regulation to create conditionally active and less toxic medicines, reported a $93 million Series A financing (Press release, Bonum Therapeutics, NOV 15, 2022, View Source [SID1234624121]). Bonum is a spinout of Good Therapeutics, which Roche acquired in August 2022 for $250 million upfront plus potential milestone payments. The investor syndicate that financed Good Therapeutics, including Rivervest Venture Partners, Roche Venture Fund, Digitalis Ventures, 3×5 Partners, and Codon Capital participated in the Series A financing, along with a new investor, Vivo Capital. In conjunction with the financing, Mitchell Mutz, Ph.D., of Vivo Capital will be joining the Bonum board of directors.

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!

Bonum is developing new therapies based on the proprietary platform of allosterically regulated, conditionally active therapeutics developed by Good Therapeutics. The value of the platform was validated by the Roche acquisition of Good Therapeutics and its PD-1 regulated IL-2 program.

The core platform makes possible the engineering and development of a broad array of important medicines. The Series A financing will allow Bonum to apply the technology to regulated cytokines, including IL-12, IFN-alpha, and TGF-beta for immuno-oncology applications. In parallel, Bonum will seek collaborators for application of its technology in other disease areas.

The technology consists of two components: an antibody-binding domain that acts as a sensor, and a therapeutic domain, such as a cytokine. Unlike other conditional approaches, these therapeutics are active only when the antibody sensor binds its target. Bonum believes its approach will result in treatments for cancer and other diseases that have improved efficacy and decreased toxicity.

The entire Good Therapeutics team joined Bonum, bringing a track record of success and strong passion for making a difference in the lives of patients. "We believe that this technology has broad potential and we are excited to apply it in new areas, developing drugs that act only when and where they are needed," said John Mulligan, Ph.D., CEO and founder of Bonum Therapeutics, and of its predecessor, Good Therapeutics. "In addition to having a great team, Bonum is fortunate to start with a proven technology, a supportive and knowledgeable investor syndicate, an experienced board of directors, and a wealth of exciting projects. We are excited to add Vivo Capital to the syndicate. Their expertise in guiding later stage companies will be invaluable as Bonum grows."

"We have enormous confidence in the Bonum team’s ability to advance a broad portfolio of first-in-class therapeutics through the development process," said Samuel Bjork, partner at Digitalis Ventures. "With support from this strong syndicate of new and existing investors, Bonum is well positioned to deliver on the potential of its validated platform."