On September 12, 2023 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage oncology company, reported that it has dosed the first patient with MT-302 in a Phase 1 study for advanced or metastatic epithelial tumors (Press release, Myeloid Therapeutics, SEP 12, 2023, View Source [SID1234635122]). MT-302 is the Company’s lead development candidate for in vivo immune cell programming and delivers TROP2-targeting RNA chimeric antigen receptors that express selectively within myeloid cells.

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Dosing with MT-302 represents a significant advance in the development of new therapies for solid tumors, particularly those arising from epithelial tissues. Unlike traditional CAR-T cell therapies, Myeloid’s approach focuses on in vivo programming of immune cells with an off-the-shelf mRNA encoded CAR technology.

TROP2 is a clinically relevant target, as evidenced by clinical findings with several TROP2-targeting antibody-drug conjugates (ADCs). MT-302 advances upon the progress of these existing approaches, by not only targeting TROP2, but also eliciting a comprehensive immune response against the tumor. This immune response is pivotal for sustained immune surveillance and defense against tumor recurrence, aligning with Myeloid’s overarching clinical vision to improve clinical outcomes.

"Initiation of patient dosing with MT-302 is a major milestone for Myeloid in our effort to deliver better treatment options for patients living with solid tumors. We are leading the way with our proprietary approach to in vivo programming, including with many novel CAR constructs designed for selective expression in a wide range of immune cells," said Daniel Getts, Ph.D., CEO of Myeloid. "By advancing MT-302 into the clinic, we are harnessing the power of the innate immune system to overcome many observed limitations of CAR-Ts for solid tumors. We look forward to advancing MT-302 in our Phase 1 study and demonstrating the potential of our innate immunity platform to program cells directly in vivo and drive better outcomes."

Myeloid’s in vivo programming candidates are designed to deliver the highest standard in personalized therapy, providing benefit to patients while reducing time and costs through the elimination of ex-vivo handling of patient cells and complex neoantigen sequencing. The Myeloid platform integrates validated antibody-antigen binding, with novel combinations of myeloid-signaling domains, coded within a simple mRNA that can be delivered repeatedly using LNPs. The platform versatility provides a range of signaling domains and immune cell types useful for combination approaches.

Over 500,000 patients per year in the United States present with TROP2 expressing tumors. Despite the clinical progress observed within the class of TROP2-targeting ADCs, MT-302 goes further, by combining direct tumor targeting and adding immune-stimulation and an adaptive immune response to the tumor neoantigens. The adaptive response is central to long-term immune surveillance and defense against disease recurrence.

About the Phase 1 Study of MT-302

The MT-302 Phase 1 study (NCT05969041) is an open-label dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-302 in adults with advanced or metastatic epithelial tumors that overexpress TROP2. This study will also define the recommended Phase 2 dose (RP2D) of MT-302. The study is currently enrolling patients at multiple clinical sites in Australia.

About MT-302

MT-302 represents the first candidate in an entirely new, therapeutic modality. It is a first-in-class, TROP2-FcA-LNP, with a strong preclinical profile that supports its advance into this first-in-human trial. TROP2 is overexpressed in most human solid epithelial cancers, with lower expression in corresponding normal tissue. Increased TROP2 expression has been linked to tumor growth.

Treatment with MT-302 demonstrates activity as a monotherapy in a TROP2/TNBC preclinical model, confirming the tumor-fighting potency of programmed myeloid cells even in the absence of T cells. Unlike ADCs, MT-302 brings the potential advantages of eliciting a full immune response by also presenting tumor neoantigen to stimulate T cells. MT-302 has demonstrated strong expression and a favorable safety profile in myeloid cells in rodents and in non-human primates.

On September 12, 2023 CyGenica Limited, a dynamic biotech startup reported a significant achievement in the battle against Glioblastoma Multiforme (GBM), a highly aggressive form of brain cancer (Press release, CyGenica, SEP 12, 2023, View Source [SID1234635121]). Dr. Nusrat J M Sanghamitra, Co-founder and CEO of CyGenica, revealed that the U.S. Food and Drug Administration (USFDA) has granted Orphan Drug Designation for their revolutionary drug conjugate for the treatment of GBM. This momentous approval represents a significant advancement for CyGenica’s innovative intracellular delivery platform, GEENIE, and offers new avenues of hope for patients fighting cancer and rare diseases.

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GBM continues to pose a formidable challenge in the field of oncology, calling for novel and effective treatment approaches. CyGenica’s Orphan Drug Designation approval for their novel drug conjugate demonstrates a resolute commitment to address the unmet medical needs of GBM patients.

This momentous achievement marks a pivotal milestone in CyGenica’s journey as the first application of their targeted intracellular delivery platform, GEENIE, for any disease indication. Beyond GBM, the company envisions a world where GEENIE empowers the development of innovative therapies for various cancers and rare diseases, including nucleotide-based therapeutics like antisense oligonucleotides, SiRNAs, and genome editing therapeutics.

Dr. Nusrat J M Sanghamitra stated, "We are incredibly thrilled to receive the USFDA’s approval for our Orphan Drug Designation for our novel drug conjugate in GBM treatment. This validation paves the way for CyGenica to push the boundaries of innovation and expand our intracellular delivery platform, GEENIE to bring hope to countless patients."

As CyGenica continues to advance their novel drug conjugate and GEENIE platform, the company is eager to collaborate with biotech investors and pharmaceutical companies.

"This is a remarkable opportunity for potential partners to join us in the global fight against GBM, other types of cancers, and rare diseases," Dr. Sanghamitra emphasized. "Together, we can unlock the full potential of GEENIE and create a lasting impact on the lives of patients worldwide."

On September 12, 2023 Shanghai Henlius Biotech, Inc. (2696.HK) reported that it has entered into an exclusive license agreement with PT Kalbe Genexine Biologics ("KGbio"), an Indonesian pharmaceutical company and a holding subsidiary to PT Kalbe Farma, Tbk ("Kalbe"), for the development and commercialisation of HANSIZHUANG (serplulimab injection) as a treatment for two indications including ES-SCLC, Henlius’ novel anti-PD-1 mAb, in 12 Middle East and North African (MENA) countries including Saudi Arabia, the United Arab Emirates, Egypt, Qatar, Jordan, Morocco, etc (Press release, Shanghai Henlius Biotech, SEP 12, 2023, View Source [SID1234635120]). In 2019, Henlius reached a collaboration agreement with KGbio, upon which KGbio is granted exclusive rights to develop and commercialize HANSIZHUANG in certain therapies in 10 ASEAN member countries.

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Under the terms of the agreement, Henlius will be responsible for manufacturing and supply and will receive a US$7 million upfront payment, up to US$8 million in regulatory milestones, and royalties from KGbio ranging from 15% to 20% of net sales of HANSIZHUANG in the licensed MENA territory. Henlius will also be eligible to receive up to US$650 million upon the achievement of sales milestones in the licensed 22 countries in Southeast Asia and MENA.

"HANSIZHUANG is the first and only anti-PD-1 therapy approved for first-line treatment of small cell lung cancer. More than 30,000 Chinese patients have benefited from its excellent efficacy. We are excited to join forces with KGbio in MENA after the license granted in Southeast Asia," said Jason Zhu, Chief Executive Officer, President, and Chief Financial Officer of Henlius. "Our aim is to continue supporting and improving the treatment outcomes and quality of life for local patients. Through KGbio’s commercial network and operational capabilities in MENA, we firmly believe that HANSIZHUANG will bring new hope and health to patients in Southeast Asia and MENA."

Ms. Ping Cao, Chief Business Officer, and VP of Business Development of Henlius, said, "The collaboration between Henlius and KGbio since 2019 was driven by a shared vision and mission and has opened a vast potential market for HANSIZHUANG in Southeast Asia. In the past 4 years, both parties have demonstrated a high level of synergistic effect driven by shared objectives. It has laid a strong foundation for our continued collaboration and I’m confident that together, we will continue to achieve more success in MENA."

"We welcome the collaboration between KGbio and Henlius. With KGbio’s network and operational capabilities in the Middle East and North Africa, this collaboration is an effort for the two companies to develop the products, especially for innovative biological products," said Sie Djohan, President Director of KGbio, who is also the Director of Kalbe, KGbio’s holding company.

The company’s first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022. At present, HANSIZHUANG has been approved for 3 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC). With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and its pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association (JAMA). Its synergy with in-house products of the company and innovative therapies are being actively promoted and over 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, gastric cancer, etc., covering full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,600 subjects globally, and the proportion of White is over 30% in two multi-regional clinical trials (MRCTs). Its global clinical trial data will further support marketing applications in global markets and lay a foundation for clinical application all over the world in the future.

In the future, the two companies will fully leverage their respective resources and advantages to promote the commercialisation of HANSIZHUANG in Southeast Asia and MENA. It is anticipated that this will enhance HANSIZHUANG’s accessibility in emerging markets and bring high-quality, affordable, and innovative medicines to more patients.

About HANSIZHUANG

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 3 indications are approved for marketing in China, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was launched in March 2022 and has been approved by the National Medicinal Products Administration (NMPA) for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC). The marketing applications of the first-line treatment for esophageal squamous cell carcinoma (ESCC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (EMA), respectively. Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine, and the British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

On September 12, 2023 Dewpoint Therapeutics and Chemify reported a partnership to develop a suite of digitally discovered and automatically synthesized novel molecules on Chemify’s programmable chemistry platform against condensate targets of interest in Dewpoint’s oncology and neurodegeneration pipeline (Press release, Dewpoint Therapeutics, SEP 12, 2023, View Source [SID1234635119]).

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The partnership brings together Chemify’s pioneering chemistry AI and automation technology platform, capable of designing, discovering and making complex molecules on demand using a chemical programming language, with Dewpoint’s groundbreaking condensate biology and AI technology platform. Chemify, who recently announced raising $43M of funding (read more), has developed an automated design, discovery and synthesis platform, which will be employed to amplify and accelerate Dewpoint’s ongoing chemistry efforts.

Under the partnership, Chemify will design and deliver novel compounds to augment Dewpoint’s advanced oncology and neurodegeneration pipeline. Dewpoint may choose to exercise an option to acquire the compounds designed by Chemify. In exchange, Chemify will receive pre-negotiated, success-driven clinical and regulatory milestones and tiered royalties.

"Dewpoint’s partnership with Chemify offers an innovative pathway to take our novel chemical matter already in optimization and bootstrap Chemify’s novel chemical space exploration tool suite using state-of-the-art digital chemistry AI-powered concepts. This is a new frontier for drug discovery and we’re delighted to partner with Chemify who is at the cutting-edge of this approach," commented Ameet Nathwani, M.D., CEO at Dewpoint.

"We are extremely excited by this partnership which combines Chemify’s technology for molecular design, discovery and synthesis with Dewpoint’s condensate biology approach to produce a seamless drug discovery and design platform. It is truly inspiring to be using the Chemify technology I have been building for 15 years to change and improve the lives of patients," commented Professor Lee Cronin, Chemify’s CEO and Regius Professor of Chemistry at the University of Glasgow.

About Condensates
Condensates are membraneless organelles that form dynamically throughout the cell via a process called phase separation. These subcellular compartments organize and concentrate molecules within cells to enable certain key biochemical processes. The dysregulation of biomolecular condensates has been observed in many diseases, including cancer, diabetes and neurological disorders. Dewpoint’s platform has discovered disease-driving condensates and developed condensate-modifying drugs that potentially provide novel therapeutic options for complex diseases and historically undruggable targets.

On September 12, 2023 Traverse Biotech, a US-based biotechnology company focused on the development of immunotherapies from international biopharma companies, reported that it has signed a license agreement with Genmab under which Traverse will develop and commercialize a bispecific antibody for cancer immunotherapy (Press release, Traverse Biotech, SEP 12, 2023, View Source [SID1234635118]). This next-generation antibody was created using Genmab’s proprietary DuoBody bispecific antibody technology platform as a targeted treatment candidate for cancers expressing an undisclosed tumor-associated antigen. Targeting this tumor-associated antigen with the bispecific antibody will direct T cell-mediated cytotoxicity against both solid and liquid tumors.

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Under the terms of the license agreement, Traverse will use its operational and development expertise to advance and commercialize the bispecific antibody program. This license agreement is expected to bring a much-needed novel oncology product to patients. The aim of the license agreement is to leverage DuoBody, a proven technology and the basis of four FDA-approved bispecific medicines and develop and commercialize a novel immuno-oncology product.

"We are highly motivated to work with a product candidate derived from Genmab’s state-of-the-art bispecific technology," said Brandy Houser, Ph.D., CEO of Traverse Biotech. "By focusing our energy on developing assets from clinically validated technologies, we can accelerate development and ultimately improve the treatment landscape for patients battling cancer," said Bill Polvino, M.D., Executive Chairman.