Atavistik Bio Announces $60 Million Series A Financing to Advance Genetically-Validated Targets in Metabolic Diseases and Cancer

On August 24, 2021 Atavistik Bio ("Atavistik", "Company"), a pre-clinical biotechnology company pioneering the identification of metabolite-protein interactions that have the potential to lead to the discovery and development of first-in-class drug candidates powered by distinct allosteric control mechanisms, reported that the Company had completed a $60 million Series A financing round (Press release, Atavistik Bio, AUG 24, 2021, View Source [SID1234586854]). The financing was led by The Column Group and joined by Lux Capital, and Nextech Invest, Ltd.

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The new financing will support development of Atavastik’s drug discovery platform, and future identification of select drug candidates based on deep knowledge of disease relevant pathways that have evolved over millions of years by nature to be allosterically regulated by metabolites.

The Company will be helmed by John A. Josey, PhD, Acting CEO of Atavistik Bio, who was formerly CEO at Peloton Therapeutics, which was acquired by Merck in 2019. Dr. Josey is an experienced CEO with a long track record of novel drug discovery. Marion Dorsch, PhD, has been appointed President and CSO. Dr. Dorsch is a highly accomplished scientist and senior executive with more than twenty years of biotech and pharma experience in oncology, inflammation and rare genetic diseases. She is known for her innovative drug discovery that has contributed to several accelerated drug approvals in oncology. Prior to this role, Dr. Dorsch was CSO at Blueprint Medicines.

"Our unique approach marries a validated platform with structure-aided drug design capabilities and cutting-edge insights into the regulation of metabolic systems, which will be applied to genetically validated targets in metabolic disease and cancer," said John A. Josey, PhD, CEO of Atavistik Bio and Venture Partner at The Column Group. "We are delighted to gain the support of such an esteemed collection of venture investors in our quest to find first-in-class drug compounds in metabolic diseases and cancer."

Atavistik was co-founded by prominent scientific investigators and members of the Howard Hughes Medical Institute. Atavistik’s platform is built on technology developed by co-founder Jared Rutter, PhD, Professor of Biochemistry at the University of Utah. Professor Rutter is well-known for his work regarding novel protein metabolite interactions that has resulted in identification of novel allosteric regulatory sites for proteins of interest in disease. Additionally, co-founder Dr. Ralph DeBerardinis, MD, PhD is a professor at the University of Texas Southwestern Medical Center. He is a leading medical geneticist with a deep understanding of human metabolism with a focus on pediatrics. Dr. DeBerardinis still attends to patients and has a unique understanding of the high unmet need in this critical area of human health. The co-founders will stay closely involved with the scientific direction at Atavistik as advisors.

"Atavistik has a differentiated platform that has tremendous potential to identify novel regulatory sites to tackle the underlying cause of many diseases," said Marion Dorsch, PhD, President and Chief Scientific Officer, Atavistik Bio. "Our technology was founded by a leading metabolism expert and validated by the discovery of numerous known and novel metabolite-protein interactions. We look forward to building on this technology and utilizing our drug discovery platform to identify first-in-class drug candidates."

"Atavistik has positioned itself at the forefront of allosteric regulated metabolic drug discovery, a novel and exciting new area of drug discovery and medicine, that has immense potential," said Tim Kutzkey, Managing Partner at The Column Group and Atavistik Bio board member. "The company is built around Marion’s drug-discovery expertise and successful track record of bringing experimental medicines to market quickly. She will be joined by a team of experts in metabolism and a robust investment syndicate that will support Atavistik’s scientific focus."

Atavistik has opened a new office in Cambridge at 38 Sidney St. To learn more, please visit AtavistikBio.com.

Platinum Resistance in Gynecologic Malignancies: Response and Overall Survival Predicted by Biochemical Signature

On August 24, 2021 Investigators at Nagourney Cancer Institute in collaboration with colleagues at the Federal University of Sao Paulo, Brazil, University of California, Irvine and Todd Cancer Institute reported in a paper published by Gynecologic Oncology that metabolic signatures found in the blood of gynecologic cancer patients can identify those at the highest risk of relapse (Press release, Nagourney Cancer Institute, AUG 24, 2021, View Source [SID1234586855]). The results could herald a future in which oncologists could use a blood test done at the time of diagnosis to better manage patients with advanced gynecologic malignancies.

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Platinum resistance, defined as the lack of response or evidence of clinical relapse within six months of platinum-based chemotherapy, is an important determinant of survival in gynecologic cancer.

"We used quantitative Mass Spectrometry to identify metabolic signatures that predict platinum resistance in patients receiving chemotherapy for ovarian and uterine cancers," said Dr. Robert Nagourney, Founder and Medical Director of the Nagourney Cancer Institute. "The study provides a window into human biology that offers the opportunity for better patient outcomes and more rapid and efficient drug targeting."

With the growing interest in human metabolism as an important component of cancer biology, this study in gynecologic cancer is the most recent of several of the team’s analyses in breast cancer, multiple myeloma and other cancers that confirms metabolomics’ role as one of the most promising platforms in cancer research.

In the study, 47 patients with adenocarcinoma of the ovary or uterus who were candidates for carboplatin plus paclitaxel submitted blood for quantitation of metabolites and surgical specimens for the isolation 3-dimensional organoids used to measure individual patient platinum resistance, ex vivo. Results were correlated with response, time to progression and survival.

The study identified patients with the highest risk of relapse and death with a sensitivity of 92 percent and a specificity of 86 percent.

"With such insight, we are on the cusp of more accurately determining the best course of treatment for those with gynecologic tumors," said Dr. Nagourney.

Alphamab Oncology and CSPC Achieved an Licensing Cooperation on Anti-HER2 Bispecific Antibody KN026 in Mainland China

On August 24, 2021 Alphamab Oncology (stock code: 9966 HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab" or "the Company"), a wholly-owned subsidiary of Alphamab Oncology, signed a contract with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of the company’s proprietary anti-HER2 bispecific antibody KN026 in Mainland China (Press release, Alphamab, AUG 24, 2021, View Source [SID1234586905]). The totaldeal size reaches 1 billion RMB, and the Company will receive a double-digit royalty based on sales revenue.

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According to the terms of the agreement, JMT-Bio will obtain the exclusive license rights of KN026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (GC/GEJ) in mainland China (excluding Hong Kong, Macau and Taiwan), and bear the cost of all planed clinical trials in territory; In addition, JMT-Bio will devote joint efforts with Alphamab to develop more potential indications of KN026 single agent or combo treatment in other solid tumors . Alphamab Oncology will receive 150 million RMB upfront payment, with up to 850 million RMB development and sales milestone payments, and will receive a double-digit royalty based on sales revenue.

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). It can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated equivalent efficacy compared with the combination of Trastuzumab and Pertuzumab and was superior to either single agent in HER2-positive tumor cell lines. Data from several clinical studies have shown that in patients with HER2-positive GC/GEJ or breast cancer, even after first-line or multi-line treatment, KN026 still demonstrated positive data, especially for patients with GC/GEJ.

About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially equivalent efficacy compared with Trastuzumab and Pertuzumab in combination, and was superior to either single agent, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.

KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has good safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.

Vertex and Arbor Biotechnologies Establish New Partnership to Develop Novel ex vivo Engineered Cell Therapies

On August 24, 2021 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Arbor Biotechnologies (Arbor) reported a new collaboration to enhance efforts in developing ex vivo engineered cell therapies, using Arbor’s proprietary CRISPR gene-editing technology for select diseases (Press release, Vertex Pharmaceuticals, AUG 24, 2021, View Source [SID1234586840]).

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The new agreement between Arbor and Vertex builds upon the companies’ first partnership established in 2018. Under this new partnership, Vertex will receive rights to use Arbor’s technology to research and develop ex vivo engineered cell therapies towards Vertex’s goal of generating fully differentiated, insulin-producing hypoimmune islet cells for the treatment of type 1 diabetes, for next-generation approaches in sickle cell disease and beta thalassemia, and for the treatment of other diseases.

"This new collaboration further expands our toolkit in cell and genetic therapies and, specifically, our work to discover and develop cell therapies for the treatment of multiple serious diseases," said Bastiano Sanna, Ph.D., Executive Vice President and Chief of Cell and Genetic Therapies at Vertex. "We are excited to bring Arbor’s technology together with Vertex’s ongoing programs and capabilities in diabetes, hemoglobinopathies and other diseases to create improved cell replacement therapies for broad populations of patients."

"Arbor and Vertex share a common goal to improve the lives of people with life-threatening diseases through the discovery and development of innovative therapies, and Vertex has proven to be an ideal partner in that effort," said Devyn Smith, Ph.D., CEO of Arbor. "This agreement demonstrates the versatility and strength of Arbor’s platform and reinforces our strategic vision of expanding our engineered cell therapy capabilities through partnerships with leading organizations in our industry, while we focus our internal portfolio efforts on genetic medicines."

About the Collaboration
Under the terms of the agreement, Arbor will receive an upfront cash payment and is eligible to receive up to $1.2 billion in potential payments based upon the successful achievement of specified research, development, regulatory and commercial milestones across up to seven potential programs. In addition, Vertex will pay tiered royalties on future net sales on any products that may result from this collaboration. Vertex will also make an investment in Arbor in the form of a convertible note.

Fusion Antibodies partners with Eurofins Discovery to support innovative preclinical drug discovery research

On August 24, 2021 Fusion Antibodies and Eurofins Discovery reported that sign co-marketing agreement to support timely and cost-effective development of innovative products for the benefit of global healthcare (Press release, Fusion Antibodies, AUG 24, 2021, View Source [SID1234586841])

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Fusion Antibodies are delighted to announce that is has entered into a commercial collaboration with Eurofins, a Eurofins Scientific SE group company; a leading provider of products and services to the drug discovery industry.

As leading global innovation-driven and customer-focused providers of antibody development services, Fusion Antibodies and Eurofins share common values in the culture of collaboration and the pursuit of scientific excellence and together, they aim to provide laboratories worldwide with high-quality, cost-effective and efficient services that work seamlessly with one another to support biotherapeutic discovery.

Under the agreement, Fusion Antibodies will provide comprehensive pre-clinical antibody development services from discovery, engineering, and critical reagent supply to Eurofins so that together they can provide a complete workflow solution for busy researchers. This includes Fusion Antibodies services for antibody generation, characterization, sequencing, engineering and expression, and Eurofins Discovery’s in vivo and in vitro services, such as efficacy models, bioanalytical services, biomarker development, phenotypic assays and safety assessment.

Commenting on the partnership, Dr Richard Jones, CEO of Fusion Antibodies, said:

"We are delighted to enter into this commercial collaboration with Eurofins which leverages the respective expertise of both partners, delivering on both our strategic objectives as well as providing a full client service package.

Eurofins are an established global provider of testing and laboratory services, and this partnership is a natural fit with Fusion’s mission to enable pharmaceutical and diagnostic companies to develop innovative products in the most efficient and cost-effective way."

Dr Julie Gormley, Commercial Senior Director of Fusion Antibodies, said: "This partnership brings together two world leaders in their respective fields and will enable scientists to focus on their research while our services ensure efficient and robust results. I look forward to working closely with colleagues at Eurofins Discovery throughout 2021 and beyond."

The collaboration between Fusion Antibodies and Eurofins Discovery will last for an initial two-year period and is a commitment to provide world-class scientific expertise, next-generation technology, and guidance to accelerate the delivery of the best possible antibody against a broad range of targets and therapeutic areas into the clinic.