On September 28, 2021 Anji Pharma ("Anji"), an emerging global medicines company, reported the close of a $70 million Series B financing round to seed its oncology pipeline and continue global trials of its two late-stage clinical programs in metabolic disorders (Press release, Anji Pharmaceuticals, SEP 28, 2021, View Source [SID1234590426]). The Series B round was solely invested by CR Capital, a leading cross-border venture capital firm with a growing life science investment footprint in North America.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Anji is pioneering a unique ‘dynamic equity’ approach to build a broad, global pipeline of high-value drug candidates backed by compelling biological mechanisms," said Lin Sun, CR Capital’s founding partner. "With an experienced team of domain experts and a dual U.S./China clinical trial strategy, we expect Anji to achieve higher clinical success rates with lower development costs, creating long-term value for its investors and partners."

Anji’s dynamic equity approach establishes a joint venture with a program’s originator where additional equity vests as Anji meets clinical milestones. Anji identifies programs with high probability of clinical success and then leverages its hub-and-spoke infrastructure to perform definitive studies for each program.

"Anji is bucking the trend of paying large upfront payments to acquire clinic-ready programs, choosing instead to share a potential upside that could far exceed traditional deal structures," said Brian Hubbard, Ph.D., CEO of Anji Pharma. "It’s a win-win-win approach for Anji, its partners, and its investors, as dollar resources are laser focused on advancing assets through clinical trials. We look forward to using these proceeds to expand our Phase 3 program for ANJ900, deliver clinical data next year for ANJ908, and continue building a broad pipeline that addresses global health needs."

Anji’s lead clinical asset, ANJ900, is designed for gut-targeted delivery of metformin and is in Phase 3 clinical trials for Type 2 diabetes (T2D) patients with moderate renal impairment (the "DREAM-T2D" trial, NCT04854512). Recent published research highlights the major role of the gut in metformin-induced glucose disposal, akin to how other T2D medications, such as SGLT2 inhibitors, promote glucose excretion via the kidney. With full systemic exposure of metformin no longer required for HbA1c lowering, ANJ900 has the potential to be used in patient populations where metformin is currently contraindicated. Anji plans to expand its clinical study of ANJ900 into T2D patients with severe chronic kidney disease in 2022.

Anji’s second clinical asset, ANJ908, is in Phase 2 clinical trials to treat chronic idiopathic constipation (NCT04620161). ANJ908 is designed to address disease pathophysiology by increasing fecal water content and bowel movement frequency, serving a patient population where current treatments are poorly effective. The synchronous development of ANJ908 in the U.S. and China reflects a key Anji strategy: to reduce the approval "white space" between important regions across the globe. Data from the combined U.S. and China trials are expected in mid-2022.

A portion of the Series B proceeds will be used to advance additional assets into first-in-human clinical trials. Using its dynamic equity approach, Anji plans to add programs in oncology, neuroscience, and infectious disease to go alongside its metabolic disease portfolio. In June, Anji acquired global rights to an MCL1 inhibitor program through its subsidiary Anji Onco, Inc. and will continue to expand the pipeline through additional acquisitions.

On September 28, 2021 Precision Molecular (PMI), a clinical-stage company with the mission to develop imaging biomarkers and targeted alpha therapy (TAT) for patients with cancer, reported publication of preclinical data in Proceedings of the National Academy of Sciences (PNAS) detailing development of PMI06 and its use to quantify accessible levels of programmed death-ligand 1 (PD-L1) in solid tumors (Press release, Precision Molecular, SEP 28, 2021, View Source [SID1234590423]). The study also demonstrated how accessible target levels can be used to derive insights into pharmacologic activity of antibodies in tumors and elucidate therapeutic response. The study was led by researchers at the Johns Hopkins University School of Medicine.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PMI06 is a radiolabeled peptide that binds to PD-L1, marking the ligand for visualization using positron emission tomography (PET) imaging.

In the paper entitled "Pharmacodynamic measures within tumors expose differential activity of PD(L)-1 antibody therapeutics", the authors report on development of PMI06 and its evaluation in tumor models with variable PD-L1 expression. The authors note that rapid quantification of PD-L1 pharmacodynamics to interrogate the pharmacologic activity of antibodies offers the potential to select drugs with desired tumor penetration and targeting properties and optimize dosing to reduce therapeutic resistance. In addition, quantification of pharmacokinetics and pharmacodynamics of PD-1/PD-L1 therapeutics at the tumor site could advance the development of personalized therapies tailored to the unique properties and needs of each patient.

"There are several approved immune checkpoint inhibitors currently available to patients and more in development," said Seulki Lee, Ph.D., CEO of PMI. "Unfortunately, it has been difficult to predict which patients may benefit from which drug – which is determined, in part, by the presence of PD-L1 on the surface of their tumors. With PMI06, we can measure baseline PD-L1 levels in the whole body and follow the interaction between PD-L1 and a PD-L1 inhibitor, measuring how quickly and effectively the drug engages with the target. We can also measure how PD-1 inhibitors change PD-L1 levels in the tumors. In doing so, PMI06 offers the potential to guide selection of more targeted therapy, optimize the therapeutic dose, and avoid treatments that are not likely to work. Given the potential of this noninvasive biomarker, we look forward to studying it in patients and evaluating its potential to help direct personalized doses of immunotherapy."

Currently, the only registered biomarker to guide checkpoint inhibitor selection is immune histochemical analysis of PD-L1 expression. Unfortunately, this approach has limited predictive value and correlates only moderately with patient survival and response to PD-L1 based treatment.

Changes in PD-L1 levels could be measured using PMI06 without a biopsy during immune checkpoint therapy. Importantly, preclinical studies showed that PMI06 did not alter or interfere with the binding of the PD-L1 inhibitor to its target; PMI06 does not replace the checkpoint inhibitor once the inhibitor has bound to its target on the cell surface. Structural studies have shown that PMI06 binding to PD-L1 is similar to other approved checkpoint inhibitors which target PD-L1, suggesting its use as a biomarker could be translated to other immune checkpoint drugs.

On September 28, 2021 Massive Bio reported it has entered a partnership with TheSocialMedwork to increase clinical trial and real-world evidence research participation for cancer patients (Press release, Massive Bio, SEP 28, 2021, View Source [SID1234590422]). This collaboration will bolster Massive Bio’s abilities to reach out to more cancer patients globally in need of clinical trials, and will provide TheSocialMedwork with new ways to help their members fight cancer, at no cost and at scale using Massive Bio’s SYNERGY-AI clinical trial matching solution. "This partnership between Massive Bio and TheSocialMedwork provides the patients with a best-in-class search and navigation tool to effectively guide thousands of patients to new treatments and clinical trials, at the click of a button from their computer or mobile phone," stated Selin Kurnaz, Co-Founder and CEO of Massive Bio.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On September 28, 2021 Envigo RMS Holding Corp. (or Envigo) reported a collaboration with Biocytogen, a global biotech company that drives the research and development of new drugs with innovative technologies (Press release, Biocytogen, SEP 28, 2021, View Source [SID1234590421]). The two companies are committed to supporting research applications of the triple immunodeficient B-NDG mouse. Envigo is the exclusive provider of B-NDG mice in the United States, Europe, and certain Asia-Pacific regions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The triple immunodeficient B-NDG mouse model was independently designed and produced by Biocytogen. B-NDG mice were created by deleting the IL2rg gene from NOD-scid mice with severe immunodeficiency phenotype. Lacking mature T cells, B cells or functional NK cells, and displaying cytokine signalling deficiencies, this mouse model is highly immunodeficient and capable of supporting human immune cell transplantation. The model is widely used in research and drug discovery in many fields including oncology, immuno-oncology, infectious disease, and stem cell biology.

Dr. Adrian Hardy, President and CEO of Envigo, commented: "Our collaboration with Biocytogen further expands the range of models available to Envigo’s customers. The B-NDG model and future models to follow, offer a robust alternative to existing immunodeficient models for critical research and the development of life-saving therapies."

Dr. Yuelei Shen, President and CEO of Biocytogen, said: "Both companies are dedicated to supply good non-clinical models for basic research and drug development. We believe that such collaboration leveraging the high quality of mouse models generated by Biocytogen and the state-of-the-art breeding facilities & health monitoring programs at Envigo can satisfy the needs in those related fields."

On September 28, 2021 Care Access, the world’s leading decentralized research organization (DRO), reported its expanded partnership with global biopharma leader Eli Lilly and Company (Lilly) to broaden patient access to clinical trials and increase representation of minority group members, including African American, Hispanic, and LatinX populations (Press release, Eli Lilly, SEP 28, 2021, View Source [SID1234590419]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Lilly has tapped Care Access in its phase III breast cancer clinical trial, eMonarcHER, designed to evaluate the safety and efficacy of Abemaciclib (LY2835219) in participants with hormone receptor positive and human epidermal receptor 2 positive, high risk, early breast cancer who are taking hormone therapy after surgery. Oncology clinical trials have historically under-enrolled minority group members due to geographical barriers, cultural differences, and a persistent distrust in health care. This study aims to engage diverse groups of physicians and patients to conduct research that is more fully representative of the U.S. population. There is a more intentional focus on the recruitment of Black women with breast cancer, whom we know when diagnosed with early breast cancer have a 40% higher mortality rate than white women. To increase enrollment, Care Access will utilize its dedicated Patient Access team to establish and foster local community partners including health care systems, physician groups, diversity-focused groups, advocacy groups, and community centers that serve underrepresented minority populations.

"Over the past decade, we have been committed to increasing enrollment of racially and ethnically diverse clinical trials, including educating physicians and patients about the importance of diversity and partnering with organizations dedicated to expanding representation," said Amy Davis, Senior Director of Oncology Clinical Development at Eli Lilly and Company. "This is critical for an illness like breast cancer in which women of color have been historically underrepresented in clinical trials. Our work with Care Access–an organization equally committed to increasing representation of minority group members in clinical trials–brings us one step closer to achieving these diversity goals."

Building on its work with Lilly through highly successful COVID-19 trials, Care Access will take a three-pronged approach: first, Care Access will create partnerships with surgical and medical oncologists in underrepresented minority groups to serve as PIs for the trial, helping set up and run a research program within their oncology practice. This lessens the administrative or regulatory burdens on physicians that come with running a research program. Second, Care Access will establish community-based partnerships through its Patient Access team to better reach trial gatekeepers and patients. Third, Care Access will educate patients through its Patient Education team so they can make informed decisions on whether to participate in the trial based on their medical needs.

"We have the unique ability to deliver quality care to patients in their own communities through our Sites on Demand program, creating more access and encouraging participation of all populations," said Ahmad Namvargolian, CEO of Care Access. "While there’s been a 40% decline in breast cancer deaths over the last 30 years, a stark mortality gap remains between Black women and Caucasian women. It’s absolutely critical for our industry to address these hollowing disparities. We are confident in our ability to expand patient access to deliver lifesaving treatments to patients faster and are excited to partner with Lilly on eMonarcHER to increase representation in clinical trials for minority group members immediately and for decades to come."

These enhanced measures to increase diversity for eMonarcHER is a step toward a more equitable future for all populations. Increasing representation of diverse groups in clinical trials helps to develop and deliver innovative treatments that make a meaningful difference in the lives of all people living with cancer.