On March 30, 2020 LifeMax Laboratories, Inc. ("LifeMax"), a private company focused on treating orphan diseases that have few or no therapeutic options, reported the formation of AmMax Bio, Inc. ("AmMax") and an exclusive worldwide license from Amgen for the right to develop, manufacture and commercialize AMG 820, a monoclonal antibody against the colony-stimulating factor 1 receptor ("CSF-1R") that has completed Phase I/II clinical studies in solid tumors.

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"We are very excited to continue the development of AMG 820. Given the CSF-1/CSF-1R biology and its critical role in a number of orphan disorders with significant unmet needs, we plan to take AMG 820 forward in several orphan indications. Leveraging our patented novel delivery technology, we aim to develop AMG 820 into a best-in-class, well-differentiated and broadly applicable therapy for the treatment of Tenosynovial Giant Cell Tumors (TGCT). Additional orphan indications will be explored as well. The licensing of AMG 820 fits very well with our focus on developing first-in-class or best-in-class therapies for orphan diseases with significant unmet needs. We look forward to bringing this much needed therapy to people with TGCT and other orphan diseases that involve CSF-1/CSF-1R biology," said Larry Hsu, LifeMax’s Co-founder and CEO and AmMax’s CEO, an industry veteran who previously founded and built Impax Laboratories into a publicly traded multi-billion-dollar company.

CSF-1/CSF-1R signaling plays a critical role in the survival, differentiation and proliferation of tissue macrophages and tumor-associated macrophages (TAMs). Its activity is implicated in, among others, cancers, fibrosis and inflammatory diseases. In TGCT, a serious and debilitating, though not life-threatening, synovial tumor, over-expression of CSF-1 caused by a chromosomal translocation leads to the recruitment of TAMs that constitute the bulk of the tumor mass. CSF-1R is a clinically validated target for the treatment of TGCT. TGCT has a reported prevalence as high as 50 per 100,000 people.

On March 30, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported validation data for its multi-cancer early detection blood test were published in Annals of Oncology (Press release, Grail Bio, MAR 30, 2020, View Source [SID1234556008]). These data demonstrate GRAIL’s technology can detect more than 50 cancer types across all stages, with a very low false positive rate of less than one percent, through a single blood draw. When a cancer signal is detected, the test can also identify where the cancer is located in the body (the tissue of origin) with 93% accuracy.

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Today, the majority of deadly cancers do not have guideline-recommended screening tests available, and as a result, most cancers are detected too late, after they have progressed to late stages when chances of survival are much lower. When cancer is diagnosed after it has spread, the five-year cancer-specific survival rate is 21%, compared to 89% when the cancer is diagnosed early and still localized.1

"At GRAIL, we believe that multi-cancer early detection has the potential to significantly reduce cancer mortality," said Alex Aravanis, MD, PhD, Chief Scientific Officer and Head of R&D, and a co-founder of GRAIL. "This is a seminal moment in the field of cancer detection. We’ve built what we believe to be one of the largest clinical study programs ever conducted in genomic medicine, and the data published in Annals of Oncology further support GRAIL’s approach and commitment to clinical and scientific rigor."

The publication includes data from GRAIL’s foundational Circulating Cell-free Genome Atlas (CCGA) study, which included more than 15,000 participants with or without a diagnosis of cancer. In the sub-study reported in today’s publication (N=6,689), results from the validation set (N=1,969) showed that GRAIL’s proprietary targeted methylation technology achieved high specificity (99.3%), or a single low false positive rate of less than 1%, across more than 50 cancer types. The detection rate for a pre-specified set of 12 deadly cancer types, that together account for approximately 63% of U.S. cancer deaths annually, was 67.3% across stages I-III (95% confidence interval [CI]: 60.7-73.3%). The overall detection rate for all cancer types was 43.9% across stages I-III (95% CI: 39.4-48.5%). When a cancer signal was detected, a tissue of origin result was provided for 96% of the samples, and of these, the test correctly identified the tissue of origin in 93% of cases. Importantly, performance of the test was consistent across training and validation sets.

"The promising results from this independent validation data set demonstrate the robustness of the test performance, including its ability to detect multiple cancer types, and its generalizability to broader populations due to a low false positive rate," said Minetta Liu, MD, Research Chair and Professor, Department of Oncology, Mayo Clinic, co-lead author and investigator in the CCGA study. "In addition, the high accuracy in identifying the anatomic origin of the primary cancer, in conjunction with detection of a positive cancer signal in the blood, will allow providers to efficiently direct next steps for each individual’s diagnostic work-up and subsequent clinical care."

The impact of early detection on cancer mortality can be modeled using data from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program. Today, GRAIL also published new data modeling the most recent SEER statistics in Cancer Epidemiology, Biomarkers & Prevention, showing that if all cancers currently diagnosed at stage IV could be diagnosed earlier, evenly distributed across stages I-III, cancer deaths could fall by 24%. These findings support the potential significant public health benefit of an accurate and highly specific multi-cancer early detection test.

"The Human Genome Project ushered in the era of precision medicine, but the benefits have largely impacted patients with specific mutations or genetic diseases. GRAIL has combined the advances in human genomics with machine-learning data science to develop a multi-cancer early detection test that can maximize overall population detection while minimizing potential harms," said Joshua Ofman, MD, MSHS, Chief Medical Officer and External Affairs at GRAIL. "These validation data suggest that GRAIL’s test could be one of the first examples of a technology derived from insights from the Human Genome Project to have an impact at the broader population level, and could facilitate an important transition from screening for individual cancers, to screening individuals for all cancer types."

The CCGA data from the second sub-study were previously presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Breakthrough and are available on GRAIL’s website. The CCGA study is ongoing, and additional findings will be made publicly available at future medical meetings and/or in peer-reviewed publications.

About CCGA

The Circulating Cell-free Genome Atlas (CCGA) study is a prospectively designed, observational, longitudinal, case-control study that has completed enrollment of approximately 15,000 participants with and without cancer across 142 sites in the United States and Canada. CCGA is designed to characterize the landscape of genomic cancer signals in the blood, and to discover, train, and validate GRAIL’s multi-cancer early detection blood test through three pre-planned sub-studies. To learn more about CCGA, please visit www.grail.com.

About GRAIL’s Multi-Cancer Early Detection Test

GRAIL’s multi-cancer early detection test is designed to detect cancers in early stages, when the chance of survival is higher than if cancer is detected after symptoms appear. Clinical data have shown the ability of this technology to detect more than 50 cancer types with a very low false positive rate of less than one percent. GRAIL’s test was designed to minimize false positives in order to limit associated harms, including patient anxiety and unnecessary diagnostic workups. When a cancer signal is detected, the test has been able to identify where in the body the cancer is located with high accuracy, an important step to guiding diagnostic next steps and care.

GRAIL’s methylation-based technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin. GRAIL believes its sequencing database of cancer and non-cancer methylation signatures is the largest of its kind.

On March 30, 2020 IMV Inc. (the "Company" or "IMV") (TSX:IMV; NASDAQ:IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported its financial and operational results for the fourth quarter and full year ended December 31, 2019 (Press release, IMV, MAR 30, 2020, View Source [SID1234556007]).

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"We have made significant progress this past year at IMV, with multiple encouraging readouts from clinical and translational studies of our lead candidate, DPX-Survivac. Taken together, these data not only provide important validation of our platform’s novel mechanism and survivin as a target antigen, but also demonstrate its ability to elicit sustained clinical activity in both solid and hematologic tumors," said Frederic Ors, Chief Executive Officer of IMV. "In particular, the recent results from DeCidE1, our ongoing Phase 2 study in advanced ovarian cancer, show DPX-Survivac’s potential to deliver improved outcomes over standard-of-care chemotherapy across key measures in a heavily pre-treated solid tumor population while also providing for excellent benefits and being well tolerated by patients during treatment."

Mr. Ors continued, "More recently, the 2019 novel coronavirus (COVID-19) pandemic has significantly impacted businesses across all sectors and the healthcare industry is not spared. In this context, we implemented a continuity plan for our current business and clinical operations following the FDA guidance. Vaccines against infectious disease have been a core part of IMV’s heritage across the DPX platform technology, and we have decided to launch the development of a DPX-based vaccine against COVID-19."

"Even in these challenging times, we expect to keep a forward momentum with planned updates from ongoing Phase 2 studies. Looking ahead, as we hope to accumulate proof-of-concept in multiple hard-to-treat indications, we plan to engage with the U.S. Food and Drug Administration (FDA) on the design of potential pivotal trials in support of an accelerated pathway for DPX-Survivac in advanced ovarian cancer and r/r DLBCL."

Development of the DPX-COVID-19 vaccine candidate

On Wednesday, March 18, 2020, IMV announced in a press release plans to develop of a DPX-based vaccine candidate for COVID-19 in collaboration with experts in the field. Earlier today, we announced an update on our progress:

The Company has used sequences of the virus and immunoinformatics to predict and identify several hundred epitopes, of which 23 were selected for their biological relevance to the virus and potential to generate neutralizing antibodies against SARS-CoV-2;
Based on this analysis, IMV has begun manufacturing peptide candidates targeting these epitopes as well as planning with IMV’s suppliers and contract manufacturers to prepare for the cGMP batch required to support a clinical study in humans;
In collaboration with Gary Kobinger, Ph.D., Director of the Research Centre on Infectious Diseases at the University Laval in Quebec City, preclinical assays in animal models are also planned in April through May of this year to validate the safety and potency of the vaccine candidate before initiating the human clinical study;
In collaboration with Joanne Langley, M.D. at the Canadian Center for Vaccinology (CCfV) and the Canadian Immunization Research Network (CIRN) the design of a Phase 1 clinical study in 48 healthy subjects has been completed and clinical sites identified in both Nova Scotia and Quebec;
IMV has initiated discussions with Health Canada in preparation for a Clinical Trial Application (CTA). A meeting is being scheduled in the week of April 20, 2020 with the goal to initiate the clinical study in the summer of 2020; and
The company has submitted several grant applications in Canada in an effort to help support its clinical program.
IMV will continue to provide updates on the development of DPX-COVID-19, and is working on a dedicated DPX-COVID-19 page on its website.

DPX-Survivac Clinical Program Updates

Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer

DeCidE1 is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and efficacy of DPX-Survivac with intermittent low dose cyclophosphamide (CPA). This phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and/or resistant ovarian cancer.

In February 2020, IMV reported interim data from this study, demonstrating amongst others:

15/19 (79%) evaluable subjects demonstrated disease control, including 10 tumor regressions (53%);
7/19 subjects (37%) achieved clinical benefit with partial/stable responses lasting > 6 months; and
Treatment was well-tolerated with majority of adverse events being grade 1-2 reactions at the injection site.
At the time of the data cutoff, six (31%) patients remained on therapy. Five (26%) of these patients were still on treatment at > 6 months. Additional data available here.

Phase 2 SPiReL Study in r/r DLBCL

SPiReL is an investigator-initiated Phase 2 study evaluating DPX-Survivac and CPA in combination with Keytruda (pembrolizumab) in r/r DLBCL.

In December 2019, updated clinical results were reported in a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, FL. Highlights of the data included:

7/9 (77.8%) evaluable subjects exhibited clinical benefit, including three (33.3%) complete responses and two (22.2%) partial responses;
Reproducible survivin-specific T cell responses observed in all subjects that achieved clinical responses on treatment;
One subject, who received three prior lines of systemic therapies and failed autologous stem cell transplant, reached a complete response at the first on-study scan following treatment with the DPX-Survivac combination regimen and remained free of disease recurrence after completing the study; and
Clinical benefits and favorable toxicity profile observed in a heterogenous population of r/r DLBCL patients, including patients of advanced age and/or with comorbidities, who are more susceptible to adverse effects and more difficult to treat.
The study remains ongoing, with preliminary topline results expected in 2020.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

The Basket Trial is an open label, multi-center Phase 2 study, evaluating the safety and efficacy of DPX-Survivac and CPA in combination with Keytruda across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer (with and without CPA), NSCLC and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

As of March 24, 2020, a total of 82 patients were enrolled across all five indications out of a maximum target number of 184 patients.

In the context of the COVID-19 pandemic, IMV expects to report preliminary topline clinical results on several of the solid tumor indications later in 2020.

Clinical Translational Studies

In November 2019, IMV presented translational data from the DeCidE1 clinical study at the 34th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in National Harbor, MD. The data validate DPX-Survivac’s underlying mechanism of action and are available here.

In February 2020, Dr. Oliver Dorigo, MD, Ph.D. presented, on behalf of IMV, translational data supporting DPX-Survivac’s mechanism of action at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium in Orlando, FL. The data included samples collected from three Phase 1 and/or Phase 2 studies evaluating DPX-Survivac alone or in a combination regimen in patients with advanced, platinum-sensitive or resistant ovarian cancer and are available here.

Operational Highlights:

Update on IMV’s clinical operation following the COVID-19 pandemic: It is anticipated that the COVID-19 pandemic crisis will impact ongoing trial activities across the industry due to the pressure placed on the healthcare system as well as governmental and institutional restrictions. IMV’s clinical team is working closely with each clinical site and our CRO on a contingency plan to ensure that patient safety and the integrity of data is maintained. IMV is following the FDA guidance issued for the COVID-19 pandemic: "FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards".

Additionally, the team continues to monitor updated institutional, regional and national guidance to fully comply with applicable guidelines as they are issued. It is noted that some clinical sites have paused or slowed enrollment in clinical trials, while other sites, less impacted, are continuing activities as planned. The overall enrollment rate may decrease, but clinical activities are continuing, and patients are encouraged to comply with directives from public health officials and, subject to such compliance, to attend visits as planned or to discuss alternatives with their physician.

The current activities performed at central labs to assess the eligibility of patients and the management of clinical samples is not impacted, and IMV is working with the vendors to ensure continuity of activities. Finally, drug supply is not expected to be impacted at this time. As added precaution, IMV is working on a contingency plan to ensure proper provisioning of drugs to all clinical sites in the event of future transportation or other constraints.
Appointment of Joanne Schindler, M.D., D.V.M. as Chief Medical Officer: Dr. Schindler joined IMV in November 2019 and has over 15 years of experience in the biopharmaceutical industry, primarily in early-stage oncology drug development. Most recently, she served as Vice President, Clinical Development at H3 Biomedicine, and will oversee IMV’s clinical development efforts.
Research collaboration with Navidea Biopharmaceuticals: In November 2019, IMV entered into a preclinical research collaboration with Navidea to explore the potential combinatory effect of DPX-based immunotherapies with Navidea’s activated macrophage-targeting therapeutics. IMV and Navidea will jointly conduct research throughout the duration of the study.
Upcoming Milestones:

Over the course of upcoming quarters, the Company expects to deliver the following milestones:

Top line Phase 2 clinical results update in the DLBCL combination trial in 2020
Updated Phase 2 clinical results for Basket trial in 2Q20
Potential initiation of Phase 1 clinical trial for DPX-COVID-19 during the summer of 2020
Overview of Year-End 2019 Financial Results

Research and development expenses increased by $6,044,000 for the year ended December 31, 2019, compared to 2018. These increases are mainly due to expenses related to the ongoing basket trial, pre-clinical development of DPX-SurMAGE for bladder cancer and personnel costs due to an increase in headcount. The increase is also attributable to manufacturing activities to support the increased clinical activity, which included purchasing raw materials and contract manufacturing organization costs.

General and administrative expenses increased by $897,000 for the year ended December 31, 2019 compared to 2018. This increase is mainly due to personnel costs as a result of increased head count, investor relations activities, a full year of increased insurance premiums and regulatory fees following the Nasdaq listing in mid-2018, and a full year of increased rent, lease interest accretion, and utilities following the move to its new Dartmouth facility in mid-2018.

The net loss and comprehensive loss of $27,365,000 ($0.55 per share) the year ended December 31, 2019 was $5,430,000 higher than the net loss and comprehensive loss for the year ended December 31, 2018.

At December 31, 2019, the Corporation had cash and cash equivalents of $14,066,000 and working capital of $13,199,000, compared with $14,895,000 and $12,247,000, respectively at December 31, 2018. For the year ended December 31, 2019, IMV’s cash burn rate, defined as net loss for the period adjusted for operations not involving cash (interest on lease obligation, depreciation, accretion of long-term debt, stock-based compensation and DSU compensation), was $25.5 million. IMV expects research and development expenditures to increase over time due to the continuing development of product candidates and other clinical, preclinical, and regulatory activities.

As of March 30, 2020, the number of issued and outstanding common shares was 51,028,180 and a total of 1,959,452 stock options and deferred share units were outstanding.

The Corporation’s audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2019 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

Conference Call and Webcast Information

Management will host conference call and webcast tomorrow, March 31, 2020 at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 7482187 Other interested parties will be able to access the live audio webcast at this link: View Source

On March 30, 2020 Compass Therapeutics, a clinical-stage biotechnology company focused on drugging the human immune synapse, reported the publication of extensive data demonstrating the preclinical efficacy and safety of the company’s lead investigational therapy, CTX-471, which is currently being evaluated in a Phase 1 clinical trial (Press release, Compass Therapeutics, MAR 30, 2020, View Source [SID1234556006]). The paper, "Differentiated Agonist Antibody Targeting CD137 Eradicates Large Tumors without Hepatotoxicity," was published in the peer-reviewed journal JCI Insight. It describes the discovery and preclinical characterization of CTX-471, a fully human antibody that binds and activates a unique epitope of the CD137 receptor and has demonstrated a favorable and differentiated efficacy and safety profile, including monotherapy activity against multiple syngeneic tumor models and excellent tolerability in animals.

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The CTX-471 Phase 1 clinical trial is ongoing in patients with selected metastatic or locally advanced solid cancers who have received at least one prior line of therapy. The dose escalation portion of the study is projected to complete in mid-2020, and a dose expansion phase will follow.

"CTX-471 binds a unique epitope on the CD137 receptor, not targeted by other CD137 agonists, and as a monotherapy, it has demonstrated eradication of large, fast-growing tumors in mice where other immuno-oncology therapies have had minimal effect in these models. Interestingly, our antibody appears to generate long-term, functional immunological memory leading to complete rejection of newly inoculated tumors in those treated animals," said Thomas Schuetz, M.D., Ph.D., co-founder and chief executive officer at Compass Therapeutics. "We know that many patients do not respond to PD-1 or PD-L1 blockers as monotherapies, leaving them with limited alternative therapeutic options. We hope CTX-471 can address those needs and improve the lives of those patients."

Highlights from the publication include:

CTX-471 as monotherapy achieved high rates of complete tumor regression in multiple syngeneic mouse models.
CTX-471 selectively and profoundly reprogrammed the tumor microenvironment, increasing CD8+ T cell infiltration and penetration while reducing T cell exhaustion and regulatory T cell infiltration.
The anti-tumor activity of CTX-471 was driven by immunoglobulin FC receptor (FcyR)-engagement and required the coordinated involvement of both T cells and NK cells.
CTX-471 is believed to work by stabilizing the receptor trimer while allowing the natural ligand to bind to the receptor.
About CTX-471

CTX-471 is a fully human monoclonal antibody that binds and activates a novel epitope of the co-stimulatory receptor CD137, also known as 4-1BB, a member of the tumor necrosis factor receptor superfamily. The antibody is currently being evaluated in a Phase 1 clinical trial in patients with solid tumors that have progressed despite at least three months on an approved PD-1 or PD-L1 inhibitor. In preclinical studies, CTX-471 has demonstrated potent monotherapy activity against multiple syngeneic tumor models, including the generation of long-term functional immunological memory. Most notably, CTX-471 shows a unique ability to completely eradicate large, established tumors where other preclinical CD137 antibodies and antibodies against PD-1, PD-L1, CTLA-4 and OX40 have minimal effects in these models. In contrast to other CD137 antibodies, CTX-471 shows no evidence of hepatic toxicity in either mice or non-human primates, supporting the potential for a wide therapeutic window in patients.

On March 30, 2020 ElevateBio, LLC, a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies, reported it has closed a $170-million Series B financing that will support and accelerate the company’s next phase of growth. New investors, The Invus Group, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures, join existing investors, F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, and Samsara BioCapital, all of whom also participated in this financing (Press release, ElevateBio, MAR 30, 2020, View Source [SID1234556005]). Additionally, the company announced Germano Giuliani will join its Board of Directors.

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"In less than a year since launching ElevateBio, we have firmly established our first-of-its-kind business model in cell and gene therapy, by announcing our initial two therapeutic companies, commencing operations for additional companies, and entering into a 10-year manufacturing partnership with one of the world’s top hospital systems," said David Hallal, Co-Founder and Chief Executive Officer of ElevateBio. "With the support of our new and existing investors, our highly disruptive, capitally efficient model uniquely positions ElevateBio to accelerate the rate of innovation in cell and gene therapy manufacturing, enabling technology platforms, and therapeutic development for many years to come."

The Series B proceeds will enable:

ElevateBio BaseCamp to be fully operational with cGMP manufacturing;
The advancement of clinical development with at least six cell and gene therapies from across its portfolio companies to enter clinical studies this year and into 2021;
Key milestones and continued development of ElevateBio’s enabling technology platforms.
"Cell and gene therapies are recognized as the future of precision medicine globally, and we believe ElevateBio’s platform enables product innovation to be accelerated with their unique business model and manufacturing expertise," said Chu Swee Yeok, Chief Executive Officer and President of EDBI, a Singapore-based global investor in fast growing technology industries. "As ElevateBio continues to expand their global footprint, they are ideally suited to partner with biotech companies and academic centers in Asia to discover and develop novel therapies to treat cancers and rare diseases."

Germano Giuliani, Board Member

Along with the Series B financing, ElevateBio also announced that Germano Giuliani will join ElevateBio’s Board of Directors. Mr. Giuliani is an industry expert who is a member of the Board of Directors at HBM Healthcare Investments AG, a role he has had since 2012. Mr. Giuliani is also a member of the Investment Committee at Royalty Pharma. Additionally, Mr. Giuliani previously served as the Chief Financial Officer, Chairman and Chief Executive Officer of Giuliani SpA – a 131-year-old Italian pharmaceutical company that continues to develop, manufacture, and distribute health and beauty products. He currently serves, or has served, on several boards where he provided his extensive expertise and oversight across all aspects of the businesses. Mr. Giuliani has a degree in economics and commerce from the Catholic University of the Sacred Heart in Milan, Italy.

"We are thrilled to welcome Germano to the ElevateBio Board," said Mr. Hallal. "Germano’s deep pharmaceutical executive experience building long-term value for all stakeholders as an operator, Board member, and investor will play a significant role at ElevateBio as we advance development of life-transforming therapies to serve patients around the world."

Update Regarding ElevateBio’s Recent Milestones

ElevateBio is completing the buildout of its R&D, process development, and manufacturing operation, ElevateBio BaseCamp, a centralized 140,000 square foot cell and gene therapy innovation hub located in Waltham, Mass.
ElevateBio launched AlloVir, a late-clinical stage T-cell immunotherapy company, with technology stemming from the Baylor College of Medicine’s Center for Cell and Gene Therapy in May 2019 with a $120-million Series B financing led by Fidelity Research and Management Company. In 2019, AlloVir received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. This year, the European Medicines Agency granted AlloVir two designations for Viralym-M (ALVR105), the company’s lead allogeneic, off-the-shelf, multi-virus specific T-cell therapy, targeting six commonly occurring, devastating viruses in allogeneic hematopoietic stem cell transplantation (HSCT) recipients: PRIority MEdicines (PRIME) designation for the treatment of serious infections with BK virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus, and/or adenovirus in allogeneic hematopoietic stem cell transplantation (HSCT) recipients; and Orphan Drug Designation as a potential treatment of viral diseases and infections in patients undergoing HSCT. AlloVir plans to initiate pivotal studies of Viralym-M in stem cell transplant and proof-of-concept studies in solid organ transplant patients and the company will also advance its second product candidate, ALVR106, into a proof-of-concept study for four devastating community acquired respiratory viruses in 2020. AlloVir also announced an expanded research agreement with Baylor College of Medicine to discover and develop a coronavirus-specific T-cell therapy for immunocompromised patients at risk for COVID-19.
In October 2019, HighPassBio was launched with technology from the Fred Hutchinson Cancer Research Institute. HighPassBio is dedicated to advancing novel, T-cell receptor therapies targeting HA1-expressing tumors which are designed to treat, and potentially prevent, relapse of leukemia following hematopoietic stem cell transplant (HSCT). A Phase 1 clinical trial is open and recruiting for adult and pediatric patients who have relapsed with leukemia or related conditions following stem cell transplantation.
In July 2019, ElevateBio announced a 10-year agreement with Massachusetts General Hospital (MGH) to manufacture innovative cell and gene therapies at ElevateBio BaseCamp as well as to create cell and gene therapy-focused companies together over time.
Throughout 2019, ElevateBio commenced operations of additional cell and gene therapy companies, including highly innovative AAV-based gene therapies, TCR, and CAR T cells, which will be publicly disclosed later in 2020.