Weekly Quick Hits (BioHealth Capital Region) – Week of June 5, 2023

By Sarah Ellinwood
June 9, 2023

Funding, Awards and Collaborations

American Gene Technologies Announces New Spin-off as a Separate Company With a Focus on Curing HIV

The new company, called Addimmune, will build on the success of the Phase I trial assessing AGT’s Gag-specific AGT103-T, a genetically modified cell product that demonstrated a highly impressive safety signal, as well as significant therapeutic promise in its clinical trials. The Phase I data from this first-in-human study was published in November 2022 in Frontiers in Medicine, a peer-reviewed scientific journal focused on medical advancement. Trial data revealed that 100% of participants showed active immune responses to HIV after participants ceased taking their antiretroviral therapy. The data showed that several of the participants achieved significant viral suppression, which signals that AGT103-T has the potential to deliver a functional cure to HIV patients.

TEDCO Announces Investment in NanoBioFAB

TEDCO announced a recent investment of $350,000 into Tao Treasures LLC, DBA NanoBioFAB, a woman- and minority-led healthcare technology company. The most recent funding for NanoBioFAB comes from TEDCO’s Builder Fund. This recent investment, combined with previous TEDCO funding, resulted in another opportunity for NanoBioFAB—$550,000 in Phase II enhancement funding from the Defense Health Agency (DHA) SBIR office. The Department of Defence used the two TEDCO investments to deploy a funding match, providing NanoBioFAB with more support to continue their research and innovation. 

TEDCO Announces an SSBCI Investment into Nanocrine

TEDCO also announced a recent State Small Business Credit Initiative (SSBCI) investment of $300,000 into Nanocrine, a biotechnology company. Nanocrine, based in Frederick, Md., is a business that seeks to create a more efficient process for studying living cells. The company has created surfaces that utilize techniques from the semiconductor industry and physical chemistry disciplines. By using these surfaces, scientists are able to take more precise measurements for quality control, ensuring reproducibility and standardization of starting points.

TEDCO Invests SSBCI Funding into Hememics Biotechnologies, Inc.

But wait, we’re not done yet! TEDCO also announced a $500,000 State Small Business Credit Initiative (SSBCI) investment into Hememics Biotechnologies, Inc., a biotechnology company. The investment came through TEDCO’s Venture Funds. Hememics Biotechnologies, Inc., based in Gaithersburg, Md., is using graphene monolayer biosensors to revolutionize point-of-care testing for viruses and environmental toxins. The HemBox™, a cellphone-sized reader and chip platform, allows users to test for multiple viruses and toxins from samples as diverse as soil, water, saliva and blood.

TEDCO Signs Partnership Intermediary Agreement With the National Cancer Institute Technology Transfer Center

This agreement will codify the relationship between NCI and TEDCO, allowing the two organizations to help promote and foster more opportunities for Maryland’s life sciences community to work together with NCI on cooperative research. In addition, this agreement creates various support mechanisms for the Maryland ecosystem, which you can read more on in the release.

Announcing the BLUE KNIGHT™ Resident QuickFire Challenge: Accelerating Project NextGen

In alignment with the Project NextGen focus on advancing promising potential solutions aimed at addressing potential health security threats and improving preparedness, this challenge offers current and alumni Blue Knight residents and their collaborators the opportunity to apply for the chance to receive award funding from a total pool of $10M to help them reach their next critical developmental milestones. Through this opportunity, Project NextGen hopes to accelerate potential vaccines, therapeutics, and other enabling technologies be part of the future solutions of tomorrow. The deadline is 6/30/23.

Hememics Biotechnologies, Inc. and General Graphene Corporation Cement Strategic Partnership for Large-Scale Production of Graphene-Based Biosensors

Hememics Biotechnologies, Inc. has entered into a strategic partnership with General Graphene Corporation of Knoxville Tennessee, the culmination of a four-year collaborative effort to develop a scalable, non-clean-room process for the manufacturing of the company’s 32-plex, graphene biosensor chips. Combined with Hememics’ expertise in long-shelf-life detection biology, this partnership promises to revolutionize point-of-care diagnostics tools for pathogens and environmental toxins. In the past nine months alone, Hememics in conjunction with General Graphene has manufactured more than 100,000 graphene biosensors. Using its patented desiccation technology for detection biology, Hememics has functionalized and tested these biosensors through numerous molecular and antigen tests to detect SEB and ricin at consistent sensitivities in the low picomolar range and get results within 5 minutes.

Novavax Announces Agreement with Bill & Melinda Gates Medical Research Institute to Include Matrix-M™ Adjuvant as Potential Component in Vaccine Research

Novavax (Nasdaq: NVAX), who is advancing protein-based vaccines with its novel Matrix-M™ adjuvant, has signed a three-year agreement with the Bill & Melinda Gates Medical Research Institute to provide its adjuvant for use in preclinical vaccine research. The Matrix-M adjuvant is a key component of Novavax’s COVID vaccine and its development-stage vaccines including influenza and COVID and influenza combined. In addition, the adjuvant is being used through partnerships in clinical and preclinical programs across the world for the development of both human and animal vaccines.

In the Clinic

Sirnaomics Reports Interim Results of STP705 Phase I Clinical Study for Medical Aesthetics Treatment in Adults Undergoing Abdominoplasty

Sirnaomics (Stock Code: 2257.HK) announced the interim results of an ongoing Phase I clinical trial of STP705, an siRNA (small interfering RNA) drug candidate, for fat reduction in adults undergoing abdominoplasty. The initial results of the Phase I trial appear to indicate that the use of STP705 in the treatment of unwanted fat is safe and show clear signs of efficacy. The interim analysis results include data from six participants with 42 tissue samples in total. There were no significant adverse events and all tissue samples examined in this review using variables doses of STP705 showed histological evidence suggestive of fat remodeling. The 240 μg at the volume of 1.0 ml treatment group has demonstrated the most potent activity.

NexImmune Presents Initial Positive Data from the NEXI-001 Phase 1 Trial for Relapsed/Refractory Post Allo-HSCT AML at ASCO

NexImmune (Nasdaq: NEXI), announced results from its Phase 1/2 clinical trial of NEXI-001 in patients with relapsed/refractory acute myeloid leukemia (AML) post-allogeneic hemopoietic stem cell transplant (allo-HSCT). In this clinical trial to date, NEXI-001 is well tolerated with a favorable safety profile while eliciting an immune response to target antigens and a clinical effect in some patients. The data describing two patients from the dose escalation study of NEXI-001 were presented in a poster session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting in Chicago.

Ascentage Pharma Shares Updated Data Showing APG-2449’s Potential as a New Treatment for Drug-Resistant NSCLC

Ascentage Pharma (6855.HK) has released updated data of APG-2449, a novel FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI), in patients with non-small cell lung cancer (NSCLC), in a Poster Discussion at the recent ASCO Annual Meeting. The updated clinical data of APG-2449 showed the potential as a new treatment option that can effectively overcome drug resistance through the targeted inhibition of FAK. These data indicated efficacy and safety of APG-2449 in patients with NSCLC, with 8 partial responses (PRs) in the 28 patients who had failed treatment with the second-generation ALK TKIs.

Ascentage Pharma Shares First Dataset of Lisaftoclax in WM, Revealing Encouraging Therapeutic Potential

Ascentage Pharma (6855.HK) also released preliminary results from a Phase Ib/II study of the Bcl-2 inhibitor, lisaftoclax (APG-2575), as a monotherapy or combined with ibrutinib or rituximab in patients with Waldenström macroglobulinemia (WM) at ASCO – the first data readout from a multicenter global study of lisaftoclax in WM. Lisaftoclax showed safety and efficacy of the drug candidate as a monotherapy and in combinations, including an overall response rate (ORR) of 100% in treatment-naïve patients,and low risk of tumor lysis syndrome (TLS) with the daily-dose ramp-up (3 days at fixed doses) with lisaftoclax plus ibrutinib. In addition, only negligible drug-drug interaction (DDI) was observed in the study.

Ascentage Pharma Also Shares Results of Alrizomadlin Plus Pembrolizumab in Patients with Cutaneous Melanoma that Failed Immuno-Oncologic (IO) Therapies

In addition to the above, Ascentage Pharma (6855.HK) released updated results from a Phase II study of MDM2-P53 inhibitor, alrizomadlin (APG-115), in combination with pembrolizumab in patients with unresectable or metastatic cutaneous melanoma that had failed immuno-oncologic (IO) drugs. The data of alrizomadlin in combination with pembrolizumab have demonstrated efficacy in patients with relapsed or IO drug-resistant cutaneous melanoma, with 2 complete responses (CRs) and 4 partial responses (PRs) that resulted in an overall response rate (ORR) of 23.1% in 26 efficacy evaluable patients.

Innovent Presents Phase 1 Clinical Data of IBI351 (KRASG12C Inhibitor) as Monotherapy for Metastatic Colorectal Cancer

Innovent Biologics (HKEX: 01801) shared the preliminary data of IBI351 (GFH925, KRASG12C inhibitor) at ASCO as well. Of 42 evaluable subjects at 600mg BID, ORR was 42.9% (18/42), confirmed ORR was 31.0% (13/42), DCR was 88.1% (37/42). A total of 23 subjects at 600mg BID received ≥2 lines of systematic anticancer therapy prior to enrollment. ORR was 65.2% (15/23), confirmed ORR was 43.5% (10/23), DCR was 87.0% (20/23). As data cutoff, IBI351 was well tolerated. Treatment-related adverse events (TRAEs) occurred in 87.0% (47/54) subjects and the majority of the TRAEs were grade 1-2.

Innovent and IASO Bio Updated Efficacy and Safety Clinical Data of Equecabtagene Autoleucel (BCMA CAR-T Cell Therapy) for Multiple Myeloma

Innovent Biologics and IASO Biotechnology jointly announced that the updated data from Phase 1b/2 study of Equecabtagene Autoleucel (Innovent R&D code: IBI326, IASO Bio R&D code: CT103A), a fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (RRMM), was presented at the recent ASCO conference. Among the 103 patients, 68.9% (71/103) had high-risk cytogenetic abnormalities per mSMART 3.0, 12.6%（13/103had extramedullary multiple myeloma (EMM), and 11.7%（12/103）had received prior CAR-T therapy.

Innovent Also Presents Phase 1 Clinical Data of IBI351 (KRASG12C Inhibitor) as Monotherapy for Metastatic Colorectal Cancer

Innovent Biologics also shared the preliminary data of IBI351 (GFH925, KRASG12C inhibitor), which was presented at ASCO. Of 42 evaluable subjects at 600mg BID, ORR was 42.9% (18/42), confirmed ORR was 31.0% (13/42), DCR was 88.1% (37/42). A total of 23 subjects at 600mg BID received ≥2 lines of systematic anticancer therapy prior to enrollment. ORR was 65.2% (15/23), confirmed ORR was 43.5% (10/23), DCR was 87.0% (20/23).

Precigen Announces Positive Phase 1 Data for PRGN-3005 Autologous UltraCAR-T® Cells Manufactured Overnight for Infusion Next Day to Advanced Stage Platinum Resistant Ovarian Cancer Patients

Precigen (Nasdaq: PGEN) presented positive data at ASCO from the Phase 1 portion of the Phase 1/1b clinical study evaluating safety and efficacy of PRGN-3005 UltraCAR-T® in advanced stage platinum resistant ovarian cancer patients (Abstract# 5590). The presentation was delivered by John B. Liao, MD, PhD, Cancer Vaccine Institute, University of Washington Medicine, and a lead investigator for the PRGN-3005 clinical trial. PRGN-3005 UltraCAR-T is an autologous chimeric antigen receptor T (CAR-T) cell therapy manufactured using non-viral gene delivery and is under investigation for the treatment of patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer.

New Products

CELLF BIO Achieves Milestone With First In Human Implantation of BioSphincter™

CELLF BIO achieved a major milestone with the world’s first human implantation of BioSphincter™, an autologous bioengineered sphincter made of smooth muscle and differentiated neural stem cells. The Phase 1 clinical trial is being conducted to treat patients with fecal incontinence (FI), a condition that affects millions of people worldwide. The implantation surgery was performed by Dr. Jaime Bohl, chief of colon and rectal surgery at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

Research Roundup

Medical School Discovery Advances Efforts To Prevent and Treat MS

Multiple sclerosis is a potentially disabling autoimmune disorder in which the immune system begins to attack the sheath-like coverings that protect nerves. This leads to symptoms such as muscle weakness and stiffness, spasms, fatigue, numbness and difficulty moving. New work from Garcia-Blanco and his collaborators sheds important light on how our immune systems are calibrated to prevent MS. It also identifies several key places where things might go wrong. For example, the researchers conclude that the master gene they identified, DDX39B, is an “important guardian of immune tolerance.” This means that it helps keeps the body’s immune response working at appropriate levels so that the immune system doesn’t begin to attack the body’s own cells.

This master gene, the researchers found, directs the activity of another gene critical in the production of important immune cells called T regulatory cells (Tregs), previously linked to MS. This second gene, FOXP3, is already known to play a critical role in autoimmune disorders.

People on the Move

RS BioTherapeutics Appoints Michelle L. Shuffett, MD as SVP of Medical and Scientific Affairs

Dr. Shuffett attended medical school at the University of Kentucky, completed her residency at UCLA Mattel Children’s Hospital, and practiced at Children’s Hospital Los Angeles. She began her career in the pharmaceutical industry at Boehringer Ingelheim, focusing on COPD opinion leader development and advocacy, medical marketing communications, research, and medical-legal review. During that time, she also attended the London School of Economics and earned certifications in Healthcare Economics and Quantitative Analysis.

Altoida Appoints Marc Jones as Chief Executive Officer

Jones brings invaluable experience from both public and private diagnostic companies, and he has served in various leadership positions in the life science industry over the past 25 years. Most recently, Jones was the COO & CFO of binx health, a first-of-kind, commercial, digital healthcare technology and molecular diagnostics company. While at binx, he raised approximately $120M in equity and debt capital. Prior to binx health, he was COO & CFO at Good Start Genetics, where he played a pivotal role in the successful turnaround of the company to record business growth culminating in its sale to publicly-traded Invitae (NYSE:NVTA).

Eric Lindquist Joins Zephyr AI as Chief Business Officer

Lindquist, the Co-Founder of Companion Bio, a therapeutics company focused on age-related diseases, is an astute and highly skilled pharmaceutical and diagnostic executive who brings decades of experience to Zephyr AI. Before joining the company, Lindquist was the Chief Business and Commercial Officer at Celcuity, a biotechnology company responsible for the organization’s commercial and business development. In addition, Lindquist served as the Global Vice President of Oncology and Transplant Business and Commercial Development at genetic testing company Natera (NASDAQ: NTRA), where he helped launch Signatera, the first diagnostic individualized to a patient’s unique cancer signature. Lindquist holds a B.S. in genetics and cell biology from the University of Minnesota and an MBA from Capella University.

Ribosome Expert Rachel Green, PhD, Selected to Direct Molecular Biology and Genetics Department at Johns Hopkins Medicine

Dr. Green, a 25-year faculty member at Johns Hopkins Medicine, has been tapped to lead its Molecular Biology and Genetics department. Green is a Bloomberg Distinguished Professor of Molecular Biology and Genetics and holds a joint academic appointment in the Department of Biology in the Krieger School of Arts and Sciences at The Johns Hopkins University. She has been an investigator at the Howard Hughes Medical Institute since 2000.