Dewpoint, Novo Nordisk to identify drug candidates for diabetic complications

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Dewpoint Therapeutics has formed a research and development partnership with Novo Nordisk for identifying drug candidates to treat insulin resistance and diabetic complications.

Dewpoint’s discovery platform related to biomolecular condensates will be used to identify the drug candidates.

The collaboration will enable combination of Novo Nordisk’s expertise in treating diabetes and metabolic diseases and Dewpoint’s discovery and artificial intelligence (AI) technology platform to detect modulators of biomolecular condensates.

Under the agreement, potential small-molecule drugs against several new condensate targets will be discovered. These are anticipated to be involved in mechanisms of insulin resistance and insulin sensitivity.

Novo Nordisk will also focus on discovering non-small molecule drug candidates against the identified condensates using its internal capabilities. It will also receive rights to further develop as well as commercialise such potential drugs.

Dewpoint will receive up to $55m in the near term. It will cover an upfront payment, research funding and potential research milestone payments across two programmes.

Furthermore, the firm can secure up to $690m of clinical, commercial and sales milestones along with royalties across two commercial products.

Dewpoint can receive total milestones of up to $107.5m per product if Novo Nordisk opts for pursuing other modalities for the condensates.

Dewpoint Therapeutics CEO Ameet Nathwani said: “Our partnership with Novo Nordisk brings together Dewpoint’s cutting-edge condensate science with deep expertise from a global leader in diabetes.

“We believe that by discovering and hopefully reversing the dysregulation of biomolecular condensates that leads to insulin resistance, we have the potential to profoundly impact the development and clinical course of diabetes, one of the most profound global health challenges affecting society today.”

FDA grants fast track status to Prestige’s PBP1510 for pancreatic cancer

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The US Food and Drug Administration has granted fast track designation to Prestige Biopharma’s PBP1510 (Ulenistamab) to treat unresectable or metastatic pancreatic adenocarcinoma (PDAC).

PBP1510 will mainly act on a tumour-specific protein called pancreatic adenocarcinoma upregulated factor (PAUF), which is overexpressed in most pancreatic cancer patients.

PAUF overexpression is said to advance major cellular functions such as proliferation, migration, invasion, and growth of pancreatic cancer cells. It will also lead to the development of acquired resistance to chemotherapeutic agents.

PBP1510 is expected to target these crucial biological mechanisms.

Prestige is currently carrying out a global Phase I/IIa clinical study with PBP1510 in the US, Europe, and Asia.

According to the company, the first-in-human Phase 1/2a study is an open-label, multicentre and two-part study in advanced/metastatic pancreatic cancer patients.

Phase I is a dose-escalation phase, under which PBP1510 will be administered either as monotherapy or along with gemcitabine in two separate dose-escalation cohorts.

Following this part of the study, a recommended Phase IIa dose (RP2D) will be determined based on pharmacokinetics, safety, and efficacy data analysis, noted the company.

In the Phase II dose-expansion phase, PBP1510 at the RP2D along with gemcitabine will be administered for assessing the efficacy and safety of PBP1510.

Furthermore, the Phase I/IIa study intends to gather significant safety data on the application of PBP1510 as a single agent or in combination with gemcitabine besides evaluating the efficacy of a combined PBP1510 and gemcitabine regimen.

The study is also expected to justify the preclinical data of PBP1510’s synergistic antitumour activity in combination therapy with gemcitabine without increased toxicity.

FDA grants fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 to reduce triglycerides

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The US Food and Drug Administration (FDA) has granted fast track designation to Arrowhead Pharmaceuticals’ ARO-APOC3 that helps to lower triglycerides in adult patients with familial chylomicronemia syndrome (FCS).

Earlier, ARO-APOC3 received Orphan Drug designation from the FDA and the European Union.

ARO-APOC3 is the firm’s investigational RNAi therapeutic targeting apolipoprotein C-III (APOC3).

It is being developed as a therapy for patients suffering with severe hypertriglyceridemia (SHTG), mixed dyslipidemia (MD), and FCS.

A rare genetic disorder, FCS causes severely high triglyceride levels, which can lead to acute and potentially fatal pancreatitis.

Currently, there are no therapies approved by the FDA to treat FCS.

The Phase 3 PALISADE clinical study (NCT05089084) is investigating ARO-APOC3 in patients with FCS.

ARO-APOC3 is also being studied in the Phase 2 SHASTA-2 clinical study (NCT04720534) in patients with SHTG, as well as in the Phase 2 MUIR clinical study (NCT04998201) in patients with MD.

Arrowhead Pharmaceuticals develops medicines to treat intractable diseases by gene silencing approach.

Leveraging a wide portfolio of RNA chemistries and effective modes of delivery, Arrowhead’s treatment triggers the RNA interference system to lead to the quick and durable knockdown of target genes.

Orion receives approval from Chinese NMPA for darolutamide

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Orion has received approval from the Chinese National Medical Products Administration (NMPA) for darolutamide along with docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients.

The oral androgen receptor inhibitor (ARi) darolutamide already received approval in China to treat non-metastatic castration-resistant prostate cancer (nmCRPC) patients at high risk of developing metastatic disease.

The NMPA granted the approval based on the positive results obtained from the Phase III ARASENS clinical trial of darolutamide.

In this randomised, multi-centre, double-blind, placebo-controlled trial, darolutamide and androgen deprivation therapy (ADT) along with docetaxel demonstrated significant reduction in death risk by 32.5% against ADT with docetaxel, in patients with mHSPC.

The darolutamide combination also showed consistent benefits across clinically relevant secondary endpoints.

The overall incidence of treatment-emergent adverse events in the trial were found to be similar between treatment arms.

Darolutamide is developed by Orion and Bayer jointly.

In the ARASENS trial, a total of 1,306 newly diagnosed patients were randomised in a 1:1 ratio to receive 600mg of darolutamide two times a day or matching placebo, plus ADT and docetaxel.

Overall survival (OS) was the primary endpoint of the trial and secondary endpoints included time to pain progression, time to castration-resistant prostate cancer (CRPC), time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all measured at intervals of 12 weeks.

Secondary endpoints also included adverse events (AEs).

Darolutamide has a distinct chemical structure that attaches to the receptor with high affinity and demonstrates strong antagonistic activity, thereby inhibiting the receptor function and prostate cancer cells growth.

Everest gets Chinese approval for Xerava to treat cIAI

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Biopharmaceutical company Everest Medicines has received approval from China’s National Medical Products Administration (NMPA) for its new drug application (NDA) related to Xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI) in adults.

With this approval, the firm intends to introduce Xerava in the Chinese market in the third quarter of this year.

Xerava is a new fully synthetic, broad-spectrum, fluorocycline and parenteral antibiotic of the tetracycline class, which has demonstrated a wider in vitro activity against gram-negative and gram-positive pathogens.

These pathogens have acquired multidrug resistance (MDR) and are widely spread in China.

Everest Medicines CEO Rogers Yongqing Luo said: “We are very excited to receive NMPA approval for Xerava and launch the product as the first product Everest will commercialise in China.

“This will lead Everest’s transformation from a biotech to a fully-integrated biopharmaceutical company.

“We expect to have three or more product approvals in 2023-2024, including Nefecon to be approved and commercialized later this year. Together with Xerava, these products will help Everest develop into a full commercial-stage company.”

Currently, Xerava is approved to treat cIAI in the US, EU, UK, Singapore and Hong Kong.

This medicine is also under assessment for cIAI in the Taiwan region.

Everest secured the license for Xerava from Innoviva’s wholly-owned subsidiary Tetraphase Pharmaceuticals.

Under the licence, the company has exclusive rights to develop and commercialise Xerava in Greater China, South Korea, and certain Southeast Asian markets.

Mediar Therapeutics announces $105m financing to advance fibrosis therapies

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Biotechnology firm Mediar Therapeutics has announced a $105m financing, which includes a recent $85m Series A round.

The Series A round was co-led by Novartis Venture Fund and Sofinnova Partners and has seen participation from Pfizer Ventures, Mission BioCapital, Gimv, Pureos, Bristol Myers Squibb, Eli Lilly & Company, Ono Venture Investment and Mass General Brigham Ventures.

Mediar was established on the pioneering research on fibrosis from Mass General and Brigham and Women’s Hospitals in collaboration with Mass General Brigham Ventures with the aim to transform fibrotic disease therapy by targeting myofibroblast, which is an important cell type that drives advances fibrosis.

Mediar is led by industry veterans – CEO Rahul Ballal, and chief scientific officer Paul Yaworsky.

The board of Mediar is being joined by Nandita Shangari from Novartis Venture Fund, Maina Bhaman from Sofinnova Partners, and Andreas Jurgeit from Gimv.

The company’s portfolio consists of three novel targets, which besides being detectible in blood also correlate to disease severity, thereby allowing a de-risked approach to clinical development.

Proceeds from the Series A round will support the advancement of Mediar’s portfolio of first-in-class antibody treatments, which offer potential to tackle fibrosis at varying stages of the disease, with two programmes progressing into human studies next year.

Ballal said: “We are applying a precision approach to our fibrosis programs to improve the odds of success in human proof-of-concept studies and identify the right patients for each therapy. “The support of this broad syndicate of investors enables us to leverage our deep insights into fibrosis pathology and drive meaningful clinical impact in the treatment landscape.”

Yaworsky added: “We are particularly excited about our lead WISP-1 programme, which is near candidate selection and has advanced largely through investigations in primary human preclinical systems.

“We are also progressing promising leads from our two other first-in-class portfolio programs into preclinical in-vivo proof-of-concept studies.”

In the industrialised world, fibrosis is claimed to contribute to 45% of deaths.

China’s NMPA accepts GSK’s drug application review for Nucala to treat SEA

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China National Medical Products Administration has accepted the review of GSK’s drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA).

If given approval, Nucala will become the first targeted anti-Interleukin-5 (IL-5) treatment in the country for adult and adolescent patients with SEA.

A first-in-class monoclonal antibody to target IL-5, Nucala was first approved in 2015 for SEA in the US.

It prevents IL-5 from binding to its receptor on the surface of eosinophils, lowering blood eosinophils and maintains them under normal levels.

The application to China National Medical Products Administration has been submitted based on positive data from Phase III trial undertaken on patients in China and the global SEA development programme, which included three important clinical trials – DREAM 2, MENSA3 and SIRIUS4.

These trials established the efficacy and safety profile of mepolizumab for SEA patients.

The Phase III trial for 52 weeks studied the impact of mepolizumab as adjunctive therapy in Chinese patients with SEA. The primary endpoint was reduction, relative to placebo, in the annual rate of clinically significant exacerbations.

The efficacy and safety of mepolizumab in the Chinese population were found to be consistent with that in non-Chinese population suffering with SEA.

Asthma impacts an estimated 46 million adults in China, with 6% experiencing severe asthma.

Patients suffering with SEA have a higher risk of exacerbations and need hospitalisation or experience a potentially fatal asthma attack.

Currently, Nucala is approved in the country for use in adults with eosinophilic granulomatosis with polyangiitis (EGPA).

It was also included on the National Reimbursement Drug List earlier this year.

Presently, Nucala is not approved in the country for the treatment of SEA.

Evergreen Theragnostics raises $15m from Series B round

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Evergreen Theragnostics, a clinical stage contract development and manufacturing organisation (CDMO), has completed capital raise of $15m from Series B round.

This funding round was primarily subscribed by current shareholders exercising their rights of first refusal.

Leveraging this fund raise, Evergreen is launching a new business unit, called Evergreen Discovery.

Evergreen Discovery will be focused on developing novel radiopharmaceuticals for cancer treatment.

Evergreen has appointed Dr. Thomas Reiner as the chief scientific officer to support the new business unit.

Before this, Dr. Reiner served as head of Radioligand Therapy Drug Discovery on the executive leadership team of Advanced Accelerator Applications (AAA), a Novartis Company.

Reiner said: “I am very excited for the opportunity to join Evergreen Theragnostics and to lead their new R&D business unit, Evergreen Discovery. Over the last few years, Evergreen has established itself as a leader in the radiopharmaceutical space, and joining their growing team was an easy choice to make.

“Radioligand Therapy is a new and exciting therapeutic modality, uniquely positioned to treat some of the most devastating types of cancer. Our team will innovate the way we treat these cancers, focusing on unprecedented and first-in-class radiopharmaceuticals.”

Evergreen Theragnostics president and CEO James Cook said: “Launching Evergreen Discovery represented the next logical step for us, and we are excited to have recruited Thomas as a leader of this new team.

“With Evergreen Discovery, we will develop novel radiopharmaceuticals to address some of the most urgent unmet clinical needs.”

Based in a new research facility near Princeton, New Jersey, Evergreen Discovery will open in Q3 2023.

The company will leverage the proceeds from the capital raise to prepare for the launch of Ga-68 DOTATOC, if approved.

Among the activities to be taken by the company will include building commercial capabilities and staffing, as well as inventory build.

The product is planned to be available through Evergreen’s radiopharmacy partners in the US.

Cook added: “Evergreen is focused on improving the available options for cancer patients through radiopharmaceuticals. We do so by ensuring product availability for clinical trials through our core CDMO business, and in new ways such as the development of Ga-68 DOTATOC and the establishment of Evergreen Discovery.

“We are glad to have secured this important funding to enable our continued pursuit of these goals.”

Sumitovant Biopharma completes acquisition of Myovant Sciences

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Sumitovant Biopharma has closed the acquisition of Myovant Sciences in an all-cash deal with a total transaction value of around $1.7bn.

The deal was announced on 23 October 2022.

Sumitovant has acquired all outstanding shares of Myovant it did not own through the all-cash deal.

Following the completion of the transaction, Myovant will be delisted from the New York Stock Exchange.

Sumitovant CEO Myrtle Potter said: “We are excited to have officially completed our acquisition of Myovant and look forward to working together to address unmet needs in women’s health and prostate cancer.

“By combining our unique expertise, platforms and resources, we will be better positioned to drive the growth of Myovant’s products and accelerate the development of our robust combined pipeline.”

Sumitovant is a completely owned subsidiary of Sumitomo Pharma.

Sumitomo Pharma CEO Hiroshi Nomura said: “I am confident that bringing together the capabilities and strengths of Sumitovant and Myovant will best position us to continue delivering innovative therapies to patients sooner and accelerate the potential opportunities for ORGOVYX and MYFEMBREE.”

Myovant CEO David Marek said: “I look forward to all we will be able to achieve with the support of Sumitovant and Sumitomo Pharma to expand the impact of our differentiated therapies and advance our clinical programmes.

“We remain steadfast in our commitment to advance life-changing medicine and health equity for the patient communities we serve.”

Since its establishment in 2016, Myovant has received five regulatory approvals in the US and Europe for its products ORGOVYX and MYFEMBREE in hormone-sensitive oncology and women’s health, respectively.

J.P. Morgan Securities acted as financial advisor and Sullivan & Cromwell as legal counsel to Sumitovant and Sumitomo Pharma.

Goldman Sachs & Co acted as financial advisor to the special committee of the board of directors of Myovant, while Skadden, Arps, Slate, Meagher & Flom served as legal counsel to the special committee.

QurAlis raises funds to develop neurodegenerative disease medicines

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Clinical-stage biotechnology company QurAlis has closed $88m in oversubscribed Series B financing round to advance precision medicines for neurodegenerative diseases.

The financing round, which brings the total funds raised by the firm to $143.5m, was led by EQT Life Sciences, investing from Droia Ventures, Sanofi Ventures and the LSP Dementia Fund.

It also involved participation from the ALS Investment Fund and existing investors LS Polaris Innovation Fund, INKEF Capital, Dementia Discovery Fund, Mission BioCapital, Amgen Ventures, MP Healthcare Venture Management, Mitsui Global Investment, Dolby Family Ventures, Mission Bay Capital, and Sanford Biosciences.

QurAlis plans to use the financing proceeds to fund clinical development of its lead product candidates, QRL-201 and QRL-101 in amyotrophic lateral sclerosis (ALS), as well as to support ongoing and planned research.

The proceeds will also be used to advance the company’s pipeline with therapeutic candidates.

These candidates target specific ALS components and genetically related frontotemporal dementia (FTD) pathology and defined ALS patient populations based on disease-causing genetic mutation(s) as well as clinical biomarkers.

QurAlis board of directors chair Anne Whitaker said: “This financing reflects significant investor confidence in the science behind QurAlis’ next-generation precision medicines, world-class team, and commitment to bringing new therapies to patients suffering from ALS and other neurodegenerative diseases.”

QRL-201 is a first-in-class therapeutic product candidate. It aims to restore the ALS patients’ STMN2 expression.

It helps address STMN2 function loss in QurAlis ALS patient-derived motor neuron disease models using TDP-43 pathology.

QurAlis recently initiated first-ever clinical trial of QRL-201 to rescue STMN2 in ALS people.

QurAlis CEO and co-founder Kasper Roet said: “This financing round recognises our scientific track record and will help us advance the clinical development of our two lead programmes in ALS and robust pipeline through near-term value-creating milestones.”