Anji Pharma Secures $70 Million to Deploy Dynamic Equity and Further Build a Global Medicines Company

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.

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"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.

Immuno-Oncology Summit

On September 28, 2021 ImmunoPrecise (IPA) reported that it will be exhibiting at the Immuno-Oncology Summit in Boston on October 4-6, 2021 (Press release, ImmunoPrecise Antibodies, SEP 28, 2021, View Source [SID1234590389]). The event is being held at the Westin Copley Place and virtually. Visit booth 22 and learn how IPA can accelerate your immuno-oncology programs.

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The Immuno-Oncology Summit focuses on the latest in applied research and provides comprehensive and in-depth coverage across all modalities and stages in the pipelines. The event brings together an international group of thought leaders and decision-makers from both industry and academia to discuss the latest developments in immuno-oncology

Mustang Bio Announces MB-101 (IL13Rα2‐targeted CAR T cells) Scientific Presentations at Upcoming Virtual Conferences

On September 28, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Christine Brown, Ph.D., Deputy Director, T Cell Therapeutics Research Laboratory and The Heritage Provider Network Professor in Immunotherapy, will present updated Phase 1 clinical data regarding MB-101 (IL13Rα2‐targeted CAR T cells) at two upcoming scientific conferences in October 2021 (Press release, Mustang Bio, SEP 28, 2021, View Source [SID1234590406]).

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Details of the virtual presentations are as follows:

First Annual Conference on CNS Clinical Trials, Co-sponsored by the Society for Neuro-Oncology and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)

Title: CAR T Cells in Primary Brain Tumors
Session: Session 3: Immunotherapy – Hype and Hope
Date and Time: Friday, October 1, 2021 at 2:30 PM ET
For more information, please click here.

American Association for Cancer Research Virtual Special Conference: Brain Cancer

Title: Advancing CAR T Cell Therapy for Glioblastoma
Session: Plenary Session 2: Novel Therapeutics
Date and Time: Monday, October 25, 2021 at 1:15 PM ET
For more information, please click here.

Mustang is collaborating with City of Hope on several chimeric antigen receptor T cell clinical trials, including MB‐101 (IL13Rα2‐targeted CAR T cells) clinical trials for brain cancer. Additional information about the brain cancer clinical trials can be found on clinicaltrials.gov using identifiers NCT04661384, NCT02208362 and NCT04003649.

About MB‐101 (IL13Rα2‐targeted CAR T cells)
IL13Rα2 is an attractive target for CAR T therapy as it has limited expression in normal tissue but is overexpressed on the surface of the majority of malignant glioma cells, including glioblastoma multiforme, ependymoma and medulloblastoma. CAR T cells are designed to express a membrane‐tethered IL‐13 receptor ligand (IL‐13) incorporating a single‐point mutation that provides high affinity for IL13Rα2 and reduces binding to IL13Rα1 in order to reduce healthy tissue targeting. Mustang is developing MB‐101 as an optimized CAR T product incorporating enhancements in CAR design and T cell engineering to improve antitumor potency and T cell persistence. MB‐101 includes a second‐generation hinge optimized CAR containing mutations in the IgG4 linker to reduce off‐target Fc interactions, the 4-1BB (CD137) co‐stimulatory signaling domain for improved persistence of CAR T cells and the extracellular domain of CD19 as a selection/safety marker. To further improve persistence, central memory T cells are enriched and genetically engineered using a manufacturing process that limits ex vivo expansion to reduce T cell exhaustion and maintain a memory T cell phenotype.

Innovent Releases Preliminary Results of the Phase Ia Dose-Escalation study of IBI315 (Anti-Her2/PD-1 Bispecific Antibody) in Patients with Advanced Solid Tumors at CSCO Annual Meeting 2021

On September 28, 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, reported the preliminary results of the Phase Ia study of IBI315 (first-in-class anti-Her2/PD-1 bispecific antibody) in an oral presentation at the 2021 Annual Meeting of Chinese Society of Clinical Oncology (CSCO) (Press release, Innovent Biologics, SEP 28, 2021, View Source [SID1234590427]).

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By data cutoff date of May 25, 2021, 27 patients have been enrolled and received IBI315 at one of seven pre-specified dose levels of 0.03mg/kg QW to 15mg/kg Q3W. No dose limited toxicity (DLT) was observed, and maximum tolerated dose (MTD) has not been reached. Among 15 patients who have completed at least one post-treatment tumor assessment at active dose levels (≥1mg/kg), objective response rate (ORR) was 20%. Biomarker analyses also supported the clinical results that clinical responders showed higher proliferation and activation of peripheral immune cells.

Professor Xichun Hu from Fudan University Shanghai Cancer Center, stated, "The satisfying safety profile and preliminary efficacy data of IBI315 seen in current study support the concept of bispecific antibody designed with targeted- and immune- therapies. We are confident to expect more positive results from the upcoming trials of IBI315 in more types of tumors expressing Her2. "

"IBI315 is a first-in-class anti-Her2/PD-1 bispecific antibody. We are excited to see that IBI315 was well tolerated with a manageable safety profile. The efficacy signal was also encouraging," said Dr. Hui Zhou, Senior Vice President of Innovent. "These results have proved the druggability and developability of IBI315. We will start a phase Ib study of IBI315 promptly to further explore the efficacy of IBI315 monotherapy and in combination with chemotherapy in Her2 positive and low-expressed tumors. We are expecting to enlarge the anti-Her2 therapeutic area with our first-in-class agent IBI315 and benefit more patients in the near future."

About CIBI315A101 Study

CIBI315A101 is a phase Ia/Ib open label, dose escalation and expansion study to evaluate the safety, tolerability and efficacy of IBI315 monotherapy and in combination with chemotherapy in advanced Her2 expressing solid tumors. This is the first-in-human study of IBI315. The phase Ia part of the study has 7 prespecified dose levels from 0.03mg/kg to 15mg/kg with dosing frequencies of QW, Q2W, or Q3W. The dose escalation follows a classic 3+3 design. The phase Ia part is ongoing. The phase Ib part is cohort expansions of IBI315 monotherapy or in combination with chemotherapy in specific tumor types.

About IBI315

IBI315 is developed through the collaboration between Innovent and Hanmi, and Innovent is leading its clinical development in China. IBI315 is a first-in-class recombinant fully human IgG1 bispecific antibody that targets PD-1 on the surface of T cells and HER2 expressed by tumor cells simultaneously. In preclinical studies, IBI315 has demonstrated potent anti-tumor activities with blockade of PD-1/PD-L1 and Her2 pathways, as well as a bridging effect between T cells and tumor cells.

Genocea to Present at Upcoming Conferences

On September 28, 2021 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, repoted that senior leadership plans to present at the following conferences in October (Press release, Genocea Biosciences, SEP 28, 2021, View Source [SID1234590458]).

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Scientific conferences:

Event: AACR: Tumor Immunology and Immunotherapy – Details
Topic: GEN-011: A neoantigen-targeted peripheral blood-derived T cell therapy that has broad neoantigen specificity and high T cell purity while avoiding pro-tumor cells
Format: Poster presentation
Date: Tuesday-Wednesday, October 5-6th
Time: Available throughout the conference

Event: Meeting on the Mesa – Details
Topic: Next-generation neoantigen-targeted solid tumor T cell therapy
Format: Presentation
Date: Tuesday-Thursday, October 12-14th
Time: Available throughout the conference

Event: CMO Summit – Details
Topic: Communicating and Pivoting After a Failed Clinical Trial
Format: Panel
Date: Friday, October 15th
Time:
1:00 p.m. ET

Event: TIL Therapies Digital Summit – Details
Topic: Identification of InhibigensTM May be the Key to Successful T cell Therapies for Solid Tumors
Format: Presentation
Date: Tuesday, October 19th
Time:
11:00 a.m. ET

Event: Neoantigen-Based Therapies Summit – Details
Topic 1: Prioritizing Diversity, Equity, and Inclusion in the Neoantigen Field
Roundtable discussion
Tuesday, October 26th
12:40 p.m. ET
Topic 2:
Responses to Inhibitory Tumor Antigens, InhibigensTM, Suppresses Anti-Tumor Immunity & promote Tumor Growth
Presentation
Wednesday, October 27th
12:30 p.m. ET
Topic 3: Unleashing the Titans: The GEN-011 Neoantigen-Targeted Peripheral T cell Therapy for Solid Tumors
Presentation
Wednesday, October 27th
5:30 p.m. ET