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Lupin Partners with TTP plc UK for Soft-mist Inhalation Technology Platform

On December 2, 2021 Lupin Inc., a wholly-owned subsidiary of global pharma major, Lupin Limited (Lupin) reported that it has entered into an agreement with TTP plc (The Technology Partnership plc) to acquire the exclusive worldwide rights to develop, manufacture and commercialize inhalation products using TTP’s soft-mist inhalation technology platform (Press release, Lupin, DEC 2, 2021, View Source [SID1234596429]). By leveraging this technology, Lupin expects to provide healthcare professionals with alternative solutions for delivering affordable inhaled medicines to patients across the globe.

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Soft-mist inhalation (SMI) technology allows for delivery of inhalation drugs from a small, portable hand-held inhaler device without the use of propellants. The individual doses are delivered using a precisely engineered nozzle system to produce a slow-moving and long-sustaining aerosol cloud. Lupin anticipates applications across respiratory care.

Lupin and TTP will jointly develop the device. Lupin will commercially manufacture the device through its network of in-house and external manufacturing locations. Lupin will also develop and manufacture formulations to be delivered through the device, obtain the necessary regulatory approvals, and commercialize the products globally.

Commenting on the development Vinita Gupta, Global CEO, Lupin said, "Inhalation is a strategic pillar of Lupin’s growth story, as we strive to bring affordable medicines to patients across the globe. The partnership with TTP for SMI technology platform is a strategic addition to our broad Inhalation capabilities."

Alok Sonig, CEO – US Generics & Global R&D Head, Lupin added, "Lupin is excited to be partnering with TTP. The organizations will work together to develop products using TTP’s SMI technology that complement Lupin’s portfolio of complex inhalation products."

Commenting on the development, Sam Hyde, Managing Director, TTP said, "We are excited to be partnering with Lupin to commercialize our SMI technology so that it can benefit patients suffering with chronic respiratory conditions. TTP has deep expertise in aerosol science, and we have been working with our clients for over 30 years in complex drug delivery device development – this partnership represents an exciting next step for us in this innovative area of respiratory drug delivery."

IMMUTEP REPORTS GOOD SAFETY FROM FIRST FIVE PATIENTS IN TRIPLE COMBINATION THERAPY EFTI STUDY, INSIGHT-003

On December 2, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported the first five patients have been treated in the INSIGHT-003 study (Press release, Immutep, DEC 2, 2021, View Source [SID1234596428]).

No additional safety signals have been observed in the study which is the first time a triple combination therapy consisting of eftilagimod alpha ("efti") and an existing approved standard of care combination of chemotherapy (carboplatin) and an anti-PD-1 therapy has been administered.

Lead investigator, Prof. Dr. Salah-Eddin Al-Batran of the Institute of Clinical Cancer Research IKF said: "The INSIGHT-003 study has commenced well. We are very pleased with the safety of the triple combination so far and all patients are still participating in the study. This is important as it is the first time patients have received a triple combination therapy with efti. Patient recruitment is advancing in line with our projections."

INSIGHT-003 is evaluating a triple combination therapy consisting of efti in conjunction with an existing approved standard of care combination of chemotherapy and anti-PD-1 therapy. The study will continue to recruit up to 20 patients with various solid tumours and additional results are expected in calendar year 2022.

About INSIGHT-003

INSIGHT-003 is an investigator-initiated study conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy consisting of efti in conjunction with an existing approved standard of care combination of chemotherapy (carboplatin) and anti-PD-1 therapy.

Up to 20 patients with solid tumours will be recruited to participate in the trial. Patients will receive 30 mg subcutaneous doses of efti every two weeks in conjunction with standard of care chemotherapy plus anti-PD-1 therapy. The trial will assess the safety, tolerability and initial efficacy of the combination.

MingMed Biotechnology Announces U.S. FDA Approval for IND Application of HPK1 Small Molecule Inhibitor PRJ1-3024, and Completion of Phase I Clinical Trials for Dry AMD Treatment Drug QA102

On December 2, 2021 MingMed Biotechnology, a clinical stage company dedicated to developing first-in-class pharmaceutical products, reported the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for PRJ1-3024, a HPK1 small-molecule inhibitor for cancer immunotherapy (Press release, MingMed Biotechnology Co, DEC 2, 2021, View Source [SID1234596425]).

Dr. Xuebin Liao, a professor of Pharmaceutical Science at Tsinghua University and a member of the board of directors at MingMed Biotechnology, said, "HPK1 plays a key role in controlling immune responses against various cancers. Targeting HPK1 effectively regulates several important immune cells, activating their synergistic anti-tumor effects."

"MingMed’s scientists have built a solid foundation around the molecular mechanism underlying how HPK1 functions in promoting the exhaustion of local anti-tumor immunity," Liao introduces. "Additionally, our HPK1 inhibitor PRJ1-3024 has showed very good selectivity as a drug candidate and FDA approval is a crucial milestone announcing MingMed as a potential key player in the competition to find novel cancer immunotherapeutics. We will continue to push our clinical studies for the benefits of cancer patients around the world."

Meanwhile, MingMed also announced completion of Phase I clinical trials for their dry age-related macular degeneration (dry AMD) drug QA102 in the US.

Mr. Yan Zhang, CEO of MingMed Biotechnology, commented, "QA102 is a new drug to treat dry AMD, a blinding eye disease with currently no cure that attracts enormous clinical demand with broad market prospects. Successful completion of Phase 1 clinical trials for QA102 in the US represents the first endeavor from a Chinese R&D team to develop a first-in-class ophthalmic drug," Zhang continues. "The progress achieved by our scientists in the development of PRJ1-3024 and QA102 demonstrates that MingMed Biotechnology has built a solid foundation to make breakthrough scientific innovations, and is also capable of designing and managing the development of multiple product pipelines in an effective and efficient manner. It is our hope to develop more innovative medicines for human health."

Leucid Bio and Lonza Enter Strategic Collaboration to Leverage the Cocoon® Platform for Automated Manufacturing of Personalised CAR T-Cells

On December 2, 2021 Leucid Bio ("Leucid" or the "Company"), a biotech company pioneering next-generation cell therapies for hard-to-treat cancers, reported that it has entered a strategic collaboration with Lonza to utilize Lonza’s Cocoon Platform for the Company’s forthcoming Phase I clinical trial, through to commercial manufacturing (Press release, Lonza, DEC 2, 2021, View Source [SID1234596422]).

Under the terms of the collaboration, Leucid will utilise Lonza as its preferred manufacturer, aiming to deliver high quality cell therapies quickly and cost-effectively to patients in a decentralized manufacturing model. Leucid is, in turn, one of Lonza’s preferred collaborators on the Cocoon Platform, and both companies will work together to optimise and streamline the manufacturing process for Leucid’s CAR-T therapies. As a preferred collaborator, Leucid will have early access to new Cocoon Platform technologies.

Founded to translate 20 years of pioneering CAR-T research led by Dr John Maher at King’s College London, Leucid has developed a proprietary engine that builds upon Dr Maher’s novel parallel CAR-T model which positions these molecules in a more natural biological configuration. The Company’s technology confers properties on the CART-cells that enable them to consistently outperform previous generations of CAR-T therapies in pre-clinical studies. As a result, this leads to enhanced T-cell potency and persistent long-term response with reduced toxicity.

Artin Moussavi, Chief Executive Officer of Leucid Bio, said: "Following on from our successful Series A financing, we are delighted to be working with Lonza and its Cocoon Platform. This agreement will allow us to accelerate our path to the clinic, treating more patients sooner, potentially at point-of-care, and help to solve the key issues facing CAR-T therapeutics."

John Maher, Chief Scientific Officer of Leucid Bio, added: "This is a fantastic opportunity to collaborate with Lonza, enabling us to develop a state-of-the-art scalable manufacturing process. This will significantly help Leucid to efficiently transition our CAR-T pipeline for maximum patient benefit."

Nicholas Ostrout, Head of Commercial Development within Personalized Medicine at Lonza, commented: "We look forward to working with Leucid to bring its revolutionary, novel cancer immunotherapies to the clinic and patients. Use of the Cocoon Platform, coupled with the array of process development, manufacturing expertise and tools that Lonza brings, will provide a smooth route to commercial approval. By leveraging the Cocoon Platform’s unique capabilities, this collaboration aims to illustrate the promise and feasibility of manufacturing autologous immunotherapies in a decentralized model, into approved routine use."

CAR T-cell therapy is a revolutionary technology in which the patient’s own immune cells are reprogrammed so they can recognise and destroy cancer cells. This has proven to be a powerful therapy for refractory blood cancers, but has not yet been very effective for the treatment of solid tumours.

Leucid’s LEU-011 programme is a NKG2D-targeted CAR T-cell therapy in pre-clinical development for the treatment of solid tumours and haematological malignancies. The NKG2D receptor is an activating immune receptor that triggers cell death upon recognition of human NKG2D ligands expressed on transformed, infected or damaged cells. LEU-011 has potential for the treatment of multiple cancer types as NKG2D ligands are expressed on more than 80% of human tumour cells.

OpenBench and Tavros Therapeutics Announce Collaboration to Pursue First-in-class Cancer Target

On December 2, 2021 Tavros Therapeutics, a privately held biotechnology company discovering first-in-class cancer therapies, and OpenBench, an emerging leader in AI-enabled small molecule discovery, reported a collaboration in which OpenBench will identify novel, potent antagonists against an undisclosed cancer target that was identified by Tavros’s proprietary functional genomics platform (Press release, Tavros Therapeutics, DEC 2, 2021, View Source [SID1234596421]).

Under the terms of the agreement, OpenBench will receive payment for the identification and experimental confirmation of novel chemotypes that meet Tavros’s potency and developability criteria. In exchange, Tavros gains exclusive access to OpenBench’s proprietary screening technology with respect to the promising cancer target. Financial terms were not disclosed.

"Tavros is eager to identify quality hit molecules against this high-impact, first-in-class target, and we think OpenBench’s virtual screening platform is perfectly suited to accelerate our drug development timelines. We hope to continue this partnership and take on other promising drug targets identified by Tavros’s proprietary functional genomics discovery platform," said Tavros CEO Eoin McDonnell.

"We are excited to enrich Tavros’s efforts to make a breakthrough therapeutic discovery addressing a serious clinical need," said OpenBench CTO James Yoder. "We feel confident that the partnership will bear fruit and the OpenBench virtual screening platform will identify promising novel chemical material that maximizes the likelihood of Tavros’s success in lead optimization, translation, and clinical development campaigns."

OpenBench adds Tavros to a growing list of partners that includes HemoShear Therapeutics and two other undisclosed U.S.-based biotechnology companies.