Monoclonal antibodies Boehringer Ingelheim and Invetx

On September 27, 2021 Boehringer Ingelheim, a global leader in animal health, and Invetx, a Boston-based pioneer in protein-based therapeutics for animal health, reported that they have entered into a collaboration agreement to develop novel, species-specific monoclonal antibody biotherapeutics targeting a wide range of diseases in the veterinary species, initially focused on dogs and cats (Press release, Boehringer Ingelheim, SEP 27, 2021, View Source [SID1234590353]).

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For each selected disease target, Invetx will apply its unique platform to the discovery and optimization of best-in-class candidates and Boehringer Ingelheim will advance these therapies through clinical and regulatory development to bring them to market. Terms of the agreement were not disclosed.

"This partnership is a prime example of Boehringer Ingelheim’s commitment to address unmet needs in the rapidly growing animal health market," shared Eric Haaksma, Head of Global Innovation, Animal Health at Boehringer Ingelheim. "We were drawn to working with Invetx because of the company’s cutting-edge discovery platform, optimization technologies and antibody expertise. Together, we will leverage innovation to discover breakthrough scientific advancements to improve animal health."

Today, monoclonal antibodies are currently used in the treatment of many human diseases. The therapy is a form of immunotherapy that uses monoclonal antibodies (mAbs) to bind monospecifically to certain cells or proteins, mimicking the body’s own natural response to attack those cells. Leveraging the technology in animal health creates great potential to address unmet needs.

Invetx’s fully integrated platform encompassing discovery, product development and commercial manufacturing sets a new standard for veterinary biotherapeutics. By leveraging validated technologies in human biotech and optimizing them for veterinary application, Invetx can generate differentiated antibodies against a wide range of targets to treat a variety of chronic and serious diseases in animals.

"We are thrilled to partner with global animal health leader Boehringer Ingelheim, using our unique discovery platform to deliver fully species-specific, optimized and half-life extended biotherapeutics," said Juergen Horn, PhD, Chief Executive Officer, Invetx. "These programs will complement our own proprietary portfolio and strengthen our position as a leader in creating novel, transformative and best-in-class therapies for veterinary patients."

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Ribon Therapeutics Named a “Fierce 15” Biotech Company by Fierce Biotech

On September 27, 2021 Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, reported it has been named by Fierce Biotech as one of 2021’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Ribon Therapeutics, SEP 27, 2021, View Source [SID1234590293]).

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"Ribon is pioneering the discovery and development of first-in-class precision therapies targeting stress support pathways in cancer and inflammation for patients with limited options," said Victoria Richon, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "We are thrilled to be recognized by Fierce Biotech among the industry’s leading innovators, reflecting the potential of our novel pipeline and approach. We look forward to building upon the momentum of our clinical programs."

"In 2020, we got to celebrate the best and brightest biotechs trying to dig the world out of the pandemic," said Annalee Armstrong, Senior Editor of Fierce Biotech. "Speaking with this year’s class of Fierce 15 winners showed us that not even a global pandemic can stop incredible innovations in medicine. We’re proud to showcase this esteemed group of emerging biotechs to the world."

Ribon’s lead program is RBN-2397, a PARP7 inhibitor in clinical development for the treatment of cancer. The expansion portion of the RBN-2397 Phase 1 trial is currently enrolling patients in a number of defined cohorts, including squamous cell carcinoma of the lung (SCCL). The dose-escalation portion of the Phase 1 trial, which evaluated RBN-2397 as a monotherapy in patients with advanced solid tumors, was completed earlier this year. In June 2021, data from this portion of the study was presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and showed RBN-2397 was well tolerated with evidence of PARP7 inhibition and preliminary signs of antitumor activity. In the fourth quarter of 2021, Ribon plans to initiate a Phase 1b/2 study of RBN-2397 in combination with checkpoint inhibitors in patients with SCCL. Ribon is also advancing a second clinical candidate, RBN-3143, a potent and selective PARP14 inhibitor for the treatment of patients with inflammatory diseases.

Actinium Announces Expansion of R&D Team and Facilities to Accelerate Research Programs Focused on Solid Tumors and Novel Combinations with Checkpoint Inhibitors and Radioconjugates

On September 27, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported multiple updates on its R&D capabilities. Actinium recently completed expansion of its New York City based research facilities to focus on the development of targeted radiotherapies for solid tumors and blood cancers and to investigate novel radiotherapy combinations with checkpoint inhibitors (Press release, Actinium Pharmaceuticals, SEP 27, 2021, View Source [SID1234590317]). Actinium has more than doubled its laboratory footprint and expanded its R&D capabilities. In addition to infrastructure, Actinium has increased its R&D team to include scientists with expertise across cancer biology, immunology, radiation sciences and chemistry including the appointment of Helen Kotanides, Ph.D., as Vice President, Translational Research and Preclinical Development and Monideepa Roy, Ph.D., as Vice President, Corporate Development – R&D to its R&D leadership team.

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Sandesh Seth, Actinium’s Chairman and CEO, said, "I am delighted to announce the addition of Dr. Kotanides and Dr. Roy to the Actinium R&D leadership team. Targeted radiotherapy is rapidly being established as a differentiated therapeutic modality capable of producing results where other approaches have failed. We intend to continue to be at the forefront of innovation in the field, leveraging our deep understanding of radioconjugate behavior, AWE technology platform, clinical and supply chain experience, and most importantly our team of leading scientists and clinicians to achieve our objectives focused on solid tumor indications and novel targeted radiotherapy combinations. The addition of Dr. Kotanides and Dr. Roy in senior R&D leadership positions and the expansion of our R&D capabilities allows us to significantly accelerate these efforts. We look forward to showcasing our expanded R&D capabilities in the near future and highlight new initiatives and programs to complement our late-stage targeted radiotherapy clinical program led by Iomab-B, which we recently completed enrollment for the pivotal Phase 3 SIERRA trial."

Dr. Kotanides joins Actinium from Eli Lilly after a distinguished career with continued succession through multiple positions culminating as Senior Research Advisor, Cancer Immunobiology. Dr. Kotanides brings nearly 25 years of R&D experience from ImClone Systems and then Eli Lilly with a focus on the preclinical discovery and development of oncology biologic drugs. She has extensive first-hand knowledge and experience in cancer biology and immunotherapy, including target discovery and the testing, development, and advancement of biologics, immune checkpoint therapies, and targeted therapies. As a result, Dr. Kotanides has led several preclinical programs to successful IND filings. Dr. Kotanides received her Ph.D. in Molecular Biology and Biochemistry from the State University of New York at Stony Brook, her master’s degree in Biology from New York University and her bachelor’s degree in Biology from Clark University.

Dr. Roy is a scientist-entrepreneur whose experience includes tenure as CEO of an early-stage oncology drug development company and nearly a decade in academic experience that includes training and work experience at Harvard Medical School/Brigham and Women’s Hospital. Dr. Roy joins Actinium from Akamara Therapeutics, where she most recently served as Vice President, Corporate Development and Operations. As a founding member and interim CEO at Akamara, she played a critical role in recruiting an executive team, establishing the Company’s corporate and R&D strategy, operational execution and growing the global team from 4 to 40. During her tenure at Akamara, she contributed to partnership/collaboration efforts, developed portfolio strategies, evaluated technology platforms, oversaw research activities to support IND filings, led regulatory preparation and submissions, and worked to generate and secure intellectual property. Prior to Akamara, she was Director, Research and Development at Invictus Oncology Pvt. Ltd., a drug discovery company developing novel I/O and conjugated antibody therapies. Here she co-led the licensing of technology from Brigham and Women’s Hospital, raised Series A financing, established the Company’s strategy around a B-cell immunotherapy platform and established an international research capability to advance the Company’s technologies. Additionally, she established a network of KOLs and identified and evaluated supramolecular platform technologies. Prior to industry, Dr. Roy was a Lecturer at Harvard University, was a Leukemia and Lymphoma Society Special Fellow and Research Fellow, Dept. Of Pathology at Brigham and Women’s Hospital/Harvard Medical School. Dr. Roy received her Ph.D. in Molecular Biology from Jawaharlal Nehru University, her master’s degree in Biophysics and Molecular Biology from the University College of Science, Calcutta and her bachelor’s degree in Human Physiology from Presidency College, Calcutta.

Innovent and UNION Therapeutics Enter into Strategic Collaboration and License Agreement for Orismilast, a Next-generation PDE4 Inhibitor for Inflammatory Dermatology Conditions

On September 27, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, reported that they have entered into a strategic collaboration and license agreement for the development and commercialization of orismilast in China (Press release, Innovent Biologics, SEP 27, 2021, View Source [SID1234590356]).

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Under the terms of the agreement, UNION grants Innovent an exclusive license to research, develop and commercialize orismilast in China, including participating in and recruiting Chinese patients for potential future global studies of orismilast. UNION will receive an upfront payment of USD 20 million and is further entitled to receive up to USD 247 million in milestone payments as well as tiered royalties on sales of orismilast in China. UNION will retain global rights for orismilast outside of China.

In China there are approximately fifty million patients suffering from atopic dermatitis and six million patients suffering from psoriasis, and their prevalence is rising with changing lifestyles. Current standard of care treatments are topical steroids, oral immunosuppressants and injectable biologics, all of which have certain limitations in efficacy, safety or route of administration, presenting significant unmet clinical needs. In Phase 2a clinical studies, orismilast has demonstrated potential best-in-class profiles in these conditions, with a combination of improved efficacy and tolerability, and could be well positioned to address the unmet needs of these patient populations.

Dr. Yongjun Liu, President of Innovent, said: "We are very pleased to enter a collaboration with UNION. We have been impressed with our partner’s capability to advance the global development of orismilast and we are excited to help bring orismilast to patients in China. This collaboration further strengthens our position in autoimmune by adding a mid-stage potential best-in-class therapy into our portfolio. Innovent is proud to be an ideal partner for worldwide biotech and pharmaceutical companies in terms of accelerating the development and commercialization progress of novel assets to benefit a broader patient population."

Kim Kjøller, Chief Executive Officer of UNION therapeutics, said, "We are excited to enter into this strategic collaboration with Innovent, whose deep insights and presence in China make them an ideal partner to bring orismilast to Chinese patients. We are impressed by Innovent’s track record of international partnering, advancing assets through clinical development and commercial execution. This agreement provides independent validation of our belief in the best-in-class potential of orismilast, and expands our global footprint in an underserved market with significant potential. Partnering with pharmaceutical companies is core to our strategy of maximizing the value of our product candidates, and we are therefore excited to enter this collaboration with an internationally recognized partner."

About orismilast

Orismilast is a potent and selective, next-generation PDE4 inhibitor with broad anti-inflammatory properties, which was originally developed by LEO Pharma and acquired by UNION in 2020. Orismilast has generated positive proof of concept data orally in psoriasis and topically in atopic dermatitis and is being developed as a potential best- or first-in-class treatment option in both diseases. The selectivity of orismilast for PDE4 subtypes B and D and the novel modified release delivery is expected to result in an attractive therapeutic window, i.e., the combination of improved efficacy and tolerability, compared to other PDE4 inhibitors. UNION has two product candidates with orismilast in Phase 2 clinical development: UNI50001, an oral PDE4 inhibitor investigated for the treatment of psoriasis, atopic dermatitis and hidradenitis suppurativa; and UNI50002, the topical formulation of orismilast investigated for the treatment of atopic dermatitis. The safety and tolerability of PDE4 inhibitors is well understood, with two oral treatments and one topical currently approved and marketed.

Chemomab Therapeutics Announces Collaboration with Leeds University to Further Elucidate the Role of CCL24 in Vascular Damage Associated with Systemic Sclerosis

On September 27, 2021 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab"), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported a research collaboration with Leeds University to further study the role of CCL24 in the vascular damage associated with systemic sclerosis (SSc), a rare rheumatic disease with high morbidity and mortality (Press release, Chemomab, SEP 27, 2021, View Source [SID1234594670]). The collaboration will be led by Francesco Del Galdo, MD, PhD, Professor of Experimental Medicine at the University of Leeds and Head of the Scleroderma Program at the Leeds Musculoskeletal Biomedical Research Centre. Prof. Del Galdo is a recognized expert in the study of SSc and other rheumatic conditions.

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CCL24 is a soluble protein that has been shown to play a key role in mediating fibrotic and inflammatory processes that are the hallmark pathologies related to SSc. It is the novel target for Chemomab’s CM-101, a first-in-class, CCL24 neutralizing monoclonal antibody that Chemomab plans to assess in a Phase 2 trial in SSc patients beginning early next year. Chemomab has generated substantial mechanistic data related to CCL24-associated fibrosis and inflammation in SSc, as well as early data showing that CCL24 is potentially involved in the vascular damage associated with SSc. The partnership with Prof. Del Galdo will seek to provide additional insights into the mechanisms underlying CCL24-associated vascular damage and could also uncover additional application opportunities for CM-101.

"We are delighted to partner with Prof. Del Galdo and his team to further study how CCL24 contributes to the vascular damage in SSc," said Dr. Adi Mor, CEO of Chemomab. "They have developed state-of-the art models of vascular damage based on their large collection of SSc patient samples. At Chemomab, we have extensively studied how CCL24 causes fibrosis and inflammation in preclinical SSc models. This collaboration is expected to increase our understanding of the association between CCL24 and vascular damage using human samples, with the aim of helping guide future SSc registration trials and ultimately providing benefit to these patients who have no effective treatment options."

Prof. Del Galdo said, "Systemic sclerosis is a connective tissue disease caused by an unfortunate combination of fibrosis, inflammation and vascular damage. Because of the nature of the tissue damage caused by SSc, it remains one of the most severe autoimmune diseases, with a poor prognosis and very limited treatment options. Extensive preclinical studies indicate that CCL24 is an important mediator of fibrosis and inflammation. We welcome the opportunity to partner with Chemomab to better understand the role of CCL24 in causing the vascular damage that contributes significantly to the overall morbidity and mortality of SSc patients."

About Systemic Sclerosis

SSc, also known as scleroderma, is a rare autoimmune rheumatic disease characterized by fibrosis and inflammation of the skin, joints and internal organs, as well as vascular abnormalities. It predominantly affects women and is typically diagnosed when patients are between 30 and 50 years old. It is the most lethal of the systemic rheumatic diseases with a median survival of only 10 years. There is no approved disease modifying drug for SSc. There currently are an estimated 100,000 SSc patients in the US.