On July 25, 2022 Chimeric Therapeutics Ltd (ASX:CHM) reported that has strengthened its leadership team with the appointment of cell therapy industry leader Dr Jason B. Litten as chief medical officer (CMO) (Press release, Chimeric Therapeutics, JUL 25, 2022, View Source [SID1234616893]).

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Dr Litten brings almost 15 years of leadership in drug development with the past five years dedicated to advancing NK and CAR T cell therapy clinical-stage programs in oncology.

He will join Chimeric’s s world-class team of cell therapy pioneers and experts focused on the discovery, development and commercialisation of innovative cell therapies.

"Major inflection point"
Chimeric CEO and managing director Jennifer Chow said: "I am truly delighted to welcome Jason to Chimeric as his deep experience and expertise in the development of autologous CAR T and allogeneic NK cell therapies in oncology will be invaluable to us as we continue to advance the development of our CAR T and NK cell therapies.

"Chimeric is moving towards a major inflection point with the expansion of our CHM 0201 and 1101 clinical programs and the initiation of our CHM 2101 clinical program.

"Jason’s unique breadth and depth of cell therapy development experience will provide us with the clinical leadership necessary to advance our development rapidly and effectively.

"Exciting opportunities"
"I am very excited to join Chimeric at this important time in its growth," said Dr Litten.

"The potential for these innovative autologous CAR T cell and allogeneic NK cell therapy programs creates exciting opportunities to bring novel and potentially transformative therapies to cancer patients who need them."

Pioneer in cellular immunotherapy
Entering the cellular immunotherapy field in the early days, Dr Litten has been part of the foundational clinical understanding of cell therapies, working on numerous CAR T and NK cell drug candidates.

Most recently, He served as the CMO at Artiva Biotherapeutics where he led the development of a portfolio of allogeneic Natural Killer (NK) cell therapies.

Prior to Artiva, Dr Litten was vice president of clinical development at Juno Therapeutics where he built and oversaw the autologous solid tumour CAR T and TCRs cell therapy programs.

On July 25, 2022 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment of cancer and fibrosis, reported that an abstract describing the Company’s ACCENT clinical trial of AMP945 in first-line patients with advanced pancreatic cancer has been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer, being held from September 13-16 in Boston, MA (Press release, Amplia Therapeutics, JUL 25, 2022, View Source;[email protected] [SID1234616890]).

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The presentation will be entitled "Rationale for the use of pulsed rather than continual dosing of the novel Focal Adhesion Kinase inhibitor AMP945 in pancreatic cancer" and will describe the scientific rationale and clinical trial design for ACCENT. The trial is currently open for recruitment and has been registered on ClinialTrials.gov with an identifier number of NCT05355298.

"The AACR (Free AACR Whitepaper) special topic meetings attract the world’s leading cancer researchers who are working at the cutting edge of cancer research and new drug development. We’re delighted to have Amplia’s work accepted for presentation in this forum and expect it will raise awareness in the global clinical community of AMP945 and its potential in this devastating cancer."

This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.

On July 24, 2022 Italfarmaco, an Italian multinational company in the chemical-pharmaceutical sector, reported that it has acquired 100% of Lacer Pharmaceuticals, one of the leading companies in Spain in the area of health and personal hygiene (Press release, Italfarmaco, JUL 24, 2022, View Source [SID1234616943]).

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With an experience of over 70 years, a turnover in 2021 of over 150 million euros and almost 500 employees, Lacer is the market leader in practically all the areas in which it operates, in particular in the oral and dental sector with the Lacer brand, and brands such as Thrombocid, Pilexil, Anso and Talquistina. Lacer also has a broad portfolio of drugs in the cardiovascular and urogynecological sectors.

With this acquisition, Italfarmaco is strengthening its presence in the Spanish healthcare market, where it is already present with established brands, and is consolidating its current business areas in which it has been successfully operating for over 30 years in Italy and around the world. These include the thrombosis and critical ischemia sector, with brands such as Ghemaxan; gynecology with Natalben, Nuperal / Cariban and Ainara; and neurology and psychiatry sectors with brands such as Sonirem and Gliatilin. The Company recently achieved a major breakthrough with Givinostat, the first product that has been shown to be clinically significant in a Phase 3 study of patients with Duchenne muscular dystrophy (DMD), for which registration in the United States and Europe will be requested in the following months.

Furthermore, Italfarmaco, by incorporating the Lacer production plant in Cerdanyola del Valles, will add an important asset to the industrial activities of the Group which already has 5 production plants.

The integration into Italfarmaco will allow Lacer to consolidate its leading position in Spain, actively investing in existing brands and expanding its product portfolio, both in the healthcare sector and in the Prescription Medicines division. Furthermore, Lacer, benefiting from Italfarmaco’s global sales network of branches and distributors, will be able to increase its growth internationally.

Francesco De Santis, President of Italfarmaco, comments: "This acquisition represents a strong consolidation of our company in the Spanish market and represents a further impetus for our growth at international level. Lacer’s business, brands and our pool of talented people represent a strong element of continuity to Italfarmaco’s spirit of growth both in the areas where we are already present and in new therapeutic alternatives that can improve people’s health".

Lacer comments: "Lacer will benefit from the support of a new experienced partner that will allow both companies to grow towards the creation of a European pharmaceutical leader. This integration will allow Lacer to continue its success story and ensure that the legacy that started over 70 years ago will continue".

On July 24, 2022 Qiming Venture Partners’ portfolio company InventisBio (SHSE: 688382), a leading company in innovative drug development, reported that listed on the Science and Technology Innovation Board (the "STAR Market") of the Shanghai Stock Exchange (Press release, InventisBio, JUL 24, 2022, View Source [SID1234616892]). The issue price is CNY 18.12 per share, representing a market cap of CNY 10.419 billion.

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Qiming Venture Partners invested in InventisBio in September 2020. The successful listing of the company marks the fourth IPO in Qiming’s portfolio in 2022. InventisBio has become the ninth portfolio company listed on the STAR Market.

InventisBio is a China-based global biotech company dedicated to the research and development (R&D) of innovative drugs, with a focus on cancer, metabolic diseases and other major diseases. The company is co-founded by several professional experts with international backgrounds. InventisBio’s core R&D team members have an average of more than 20 years of experience in innovative drug R&D and team management in multinational pharmaceutical companies.

With strength and rich experience in drug R&D, InventisBio has independently developed a series of innovative targeted drugs with patent protection, covering non-small cell lung cancer (NSCLC), breast cancer, colorectal cancer and other solid tumors, as well as metabolic diseases such as hyperuricemia and gout.

InventisBio has business cooperation with well-known pharmaceutical enterprises including Betta Pharma, Pfizer, and Merck (MSD) among many others. Currently, with three core products at the clinical trial stage, five projects at the pre-clinical stage, and three core products entering phase II or phase III clinical registration trials, the company has been foremost among those who have made progress in drug R&D in China and even the world.

According to InventisBio, the company is committed to addressing unmet medical needs, developing innovative drugs with proprietary rights to be marketed worldwide, and consistently providing patients with safer, more effective and more affordable treatments. The successful listing on the STAR Market brings a new opportunity to InventisBio. The company will accelerate its product industrialization and commercialization, while continuing to enrich the product pipeline by advancing more candidate compounds into global clinical trial phases.

Dr. Kan Chen, Partner of Qiming Venture Partners, said, "Equipped with rich experience in innovative drug development, InventisBio’s team has profound insights into the industry trends. The company’s product pipeline has made progress to date. Many projects have entered the clinical stage or late-clinical stage and demonstrated best-in-class potential. The company’s IPO is a new starting point, and we look forward to InventisBio strengthening its industrialization and commercialization capability to better benefit patients with more of its products entering the late-clinical stage and obtaining approval to be marketed."

On July 24, 2022 QBiotics Group Limited (QBiotics), a life sciences company developing novel small molecule oncology and wound healing pharmaceuticals, reported that it has been granted approval of its Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for lead oncology molecule, tigilanol tiglate (Press release, QBiotics, JUL 24, 2022, View Source [SID1234616891]). The approval enables initiation of a Phase II clinical trial (QB46C-H07) in patients with STS.

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The QB46C-H07 trial will be undertaken in the USA. This is an open label study that will enrol at least 10 patients with advanced or metastatic STS. Patients will receive up to five intratumoural treatments of tigilanol tiglate, administered four weeks apart, to evaluate the drug candidate’s efficacy and safety in the treatment of STS.

Tigilanol tiglate is a plant-derived small molecule, administered by injection directly into a solid tumour. Injected tumours are rapidly destroyed by tumour cell necrosis, tumour vascular disruption, and immune-mediated mechanisms2.

Dr Victoria Gordon, Managing Director and CEO of QBiotics, said "IND approval for our Soft Tissue Sarcoma trial is an important milestone for QBiotics. It is QBiotics’ first FDA IND and the culmination of a very significant body of work by our team. IND approval is underpinned by a robust data package, including data from our first-in-human QBC46-H01 Phase I study, where tigilanol tiglate demonstrated clinically relevant monotherapy activity in 22 patients with a broad range of refractory solid tumours3."

"This STS trial builds on our overall development approach for tigilanol tiglate, which is exploring this drug candidate’s potential as a pan-tumour treatment for a broad range of solid tumours. QBiotics is also undertaking clinical trials in melanoma and head and neck cancer as part of this broad programme. Implementing a clinical trial in a third cancer indication is a strong move for the company."

"STS are a group of rare and heterogeneous solid tumours that occur in the soft tissues of the body, such as muscles and nerves," continued Dr Gordon. "Due to the complexity of this disease, treatment is challenging 4. We hope that through our research, we may be able to bring forward a new therapeutic option."

Global Data estimates that there were 124,573 new cases of STS globally in 2021, with the incidence growing at 0.54% per year1.

FURTHER

DR VICTORIA GORDON, CEO & MANAGING DIRECTOR, QBIOTICS GROUP

ABOUT TRIAL QB46C-H07
QB46C-H07 is a Phase II, open label clinical trial to evaluate the efficacy and safety of intratumoural tigilanol tiglate in 10 patients with advanced and/or metastatic Soft Tissue Sarcomas of the extremities and body wall.

Primary objective:
Evaluate the degree of tumour ablation in tumours and or tumour segments treated with one or more injections of tigilanol tiglate.

Secondary and exploratory objectives:
Safety and tolerability assessments of tigilanol tiglate, and translational research to evaluate changes in the tumour micro environment, immune responses, and tumour recurrence rate after 6 months following treatment.