On May 5, 2021 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), reported its first quarter 2021 financial results and provides a corporate update (Press release, Arbutus Biopharma, MAY 5, 2021, View Source [SID1234579213]).

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William Collier, President and Chief Executive Officer of Arbutus, stated, "We had a productive first quarter of 2021. With the initiation of the Phase 1a/1b clinical trial of AB-836, our oral capsid inhibitor, together with the ongoing clinical development of AB-729, we now have two proprietary HBV agents in development. This progress reflects our objective to develop a combination regimen that provides a functional cure for people living with HBV. We were also gratified to establish an innovative collaboration with X-Chem, Inc. and Proteros biostructures GmbH. The objective of this alliance is to expedite our efforts to discover an effective oral antiviral therapy against coronaviruses including SARS-CoV-2 targeting the main protease."

Mr. Collier added, "Looking ahead, we expect an eventful 2021 including: continued longer term Phase 1a/1b dosing results for AB-729; initiation of two Phase 2 proof-of-concept clinical trials for AB-729 with one or more approved or investigational agents; and initial Phase 1a/1b data from our proprietary oral capsid inhibitor, AB-836."

Pipeline Update

AB-729

Arbutus is currently conducting a single- and multi-dose Phase 1a/1b clinical trial to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-729 in healthy subjects and in subjects with chronic HBV infection.

Results to date demonstrate that treatment of AB-729 using the 60 mg and 90 mg doses has been well tolerated after a single dose. Efficacy results to date suggest that repeat dosing using the 60 mg dose every 4 weeks resulted in a continuous and robust mean HBsAg decline at week 24 (-1.84 log10 IU/mL, N=7). Repeat dosing using the 60 mg dose every 8 weeks results in comparable mean HBsAg declines relative to the 60 mg dose every 4 weeks at week 16 (-1.39 log10 IU/mL vs -1.44 log10 IU/mL, p<0.7). In HBV DNA positive CHB subjects, a single 90 mg AB-729 dose resulted in robust mean HBsAg (-1.02 log10 IU/mL) and HBV DNA (-1.53 log10 IU/mL) declines at week 12, as well as decreases in HBV RNA and core-related antigen.

Arbutus expects to provide additional data from ongoing cohorts of the Phase 1a/1b clinical trial in the second quarter of 2021, including 60 mg multi-dose data (dosing interval every 4 and 8 weeks) and 90 mg multi-dose data (dosing interval every 8 weeks). Data from the 90 mg every 12 weeks in HBV DNA negative subjects and the 90 mg every 8 weeks in the HBV DNA positive subjects is expected in the second half of 2021. Arbutus also intends to advance AB-729 into two additional proof-of-concept Phase 2 combination trials with one or more approved or investigational agents in the second half of 2021 with dosing of AB-729 as infrequently as every 8 or 12 weeks.
Arbutus and Assembly initiated a Phase 2 proof-of-concept combination clinical trial to evaluate AB-729 in combination with Assembly’s lead core (capsid) inhibitor candidate VBR and an NrtI for the treatment of subjects with chronic HBV infection. The randomized, multi-center, open-label Phase 2 clinical trial will evaluate the safety, pharmacokinetics, and antiviral activity of the triple combination of VBR, AB-729 and an NrtI compared to the double combinations of VBR with an NrtI and AB-729 with an NrtI. Approximately 60 virologically-suppressed subjects with HBeAg negative chronic HBV are expected to be enrolled in the first cohort of the trial. Subjects will be dosed for 48 weeks with VBR 300 mg orally once daily and AB-729 60 mg subcutaneously every 8 weeks, with a 48-week follow-up period.
AB-836: Oral Capsid Inhibitor

In January 2020, Arbutus selected AB-836 as its next-generation oral capsid inhibitor. AB-836 is from a novel chemical series differentiated from competitor compounds, with the potential for increased efficacy and an enhanced resistance profile. Arbutus completed CTA/IND-enabling studies in the fourth quarter of 2020 and initiated a Phase 1a/1b clinical trial for AB-836 in the first quarter of 2021, with initial data expected in second half of 2021.
HBV Discovery Programs

Arbutus’ drug discovery efforts are focused on follow-on compounds for its current HBV pipeline. Arbutus expects to continue to advance its research in its oral PD-L1 inhibitor and RNA-destabilizer programs.
Research Efforts to Combat COVID-19 and Future Coronavirus Outbreaks

Based on its extensive antiviral drug discovery experience, Arbutus has established an internal research program to identify new small molecule antiviral medicines to treat COVID-19 and future coronavirus outbreaks. This effort, led by Dr. Michael Sofia, Arbutus’ Chief Scientific Officer, is focused on the discovery and development of new molecular entities that address specific viral targets including the nsp12 viral polymerase and the nsp5 viral protease. These targets are essential viral proteins which Arbutus has experience in targeting. Arbutus recently entered into a discovery research and license agreement with X-Chem, Inc. and Proteros biostructures GmbH focused on the discovery of novel inhibitors targeting the SARS-CoV-2 nsp5 main protease (Mpro). The agreement is designed to accelerate the development of pan-coronavirus agents to treat COVID-19 and potential future coronavirus outbreaks.
Financial Results

Cash, Cash Equivalents and Investments

Arbutus had cash, cash equivalents and investments totaling $132.0 million as of March 31, 2021, as compared to $123.3 million as of December 31, 2020. During the three months ended March 31, 2021, Arbutus used $17.9 million in operating activities, which was offset by $26.4 million of net proceeds from the issuance of common shares under Arbutus’s ATM program. The Company believes its cash, cash equivalents and investments of $132.0 million as of March 31, 2021 are sufficient to fund the Company’s operations through the third quarter of 2022.

Net Loss

Net loss attributable to common shares for the three months ended March 31, 2021 was $19.6 million ($0.21 basic and diluted loss per common share) as compared to $16.8 million ($0.25 basic and diluted loss per common share) for the three months ended March 31, 2020. Net loss attributable to common shares for the three months ended March 31, 2021 and 2020 included non-cash expense for the accrual of coupon on the Company’s convertible preferred shares of $3.2 million and $3.0 million, respectively.

Operating Expenses

Research and development expenses were $13.4 million for the three months ended March 31, 2021 compared to $10.4 million in the same period in 2020. The increase in research and development expenses for the three months ended March 31, 2021 versus the same period in 2020 was due primarily to higher expenses for the Company’s clinical development and discovery programs, including activities under our collaboration with Assembly and internal research efforts to treat COVID-19 and future coronavirus outbreaks, both of which initiated in mid-2020. General and administrative expenses were $3.8 million for the three months ended March 31, 2021 compared to $3.6 million for the same period in 2020. This increase was due primarily to an increase in non-cash stock-based compensation expense.

Outstanding Shares

The Company had approximately 96.2 million common shares issued and outstanding as of March 31, 2021. In addition, the Company had approximately 13.4 million stock options outstanding and 1.164 million convertible preferred shares outstanding, which (including the annual 8.75% coupon) will be mandatorily convertible into approximately 23 million common shares on October 18, 2021.

COVID-19 Impact

In December 2019 an outbreak of a novel strain of coronavirus (COVID-19) was identified in Wuhan, China. This virus continues to spread globally, has been declared a pandemic by the World Health Organization and has spread to nearly every country in the world. The impact of this pandemic has been, and will likely continue to be, extensive in many aspects of society. The pandemic has resulted in and will likely continue to result in significant disruptions to businesses. A number of countries and other jurisdictions around the world have implemented extreme measures to try and slow the spread of the virus. These measures include the closing of businesses and requiring people to stay in their homes, the latter of which raises uncertainty regarding the ability to travel to hospitals in order to participate in clinical trials. Additional measures that have had, and will likely continue to have, a major impact on clinical development, at least in the near-term, include shortages and delays in the supply chain, and prohibitions in certain countries on enrolling subjects in new clinical trials. While we have been able to progress with our clinical and pre-clinical activities to date, it is not possible to predict if the COVID-19 pandemic will negatively impact our plans and timelines in the future.

Conference Call and Webcast Today

Arbutus will hold a conference call and webcast today, Wednesday, May 5, 2021 at 8:45 AM Eastern Time to provide a corporate update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus’ website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 4445858.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 4445858.

About AB-729

AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

About AB-836

AB-836 is an oral HBV capsid inhibitor. HBV core protein assembles into a capsid structure, which is required for viral replication. The current standard-of-care therapy for HBV, primarily nucleos(t)ide analogues that work by inhibiting the viral polymerase, significantly reduce virus replication, but not completely. Capsid inhibitors inhibit replication by preventing the assembly of functional viral capsids. They also have been shown to inhibit the uncoating step of the viral life cycle thus reducing the formation of new covalently closed circular DNA (cccDNA), the genetic reservoir which the virus uses to replicate itself.

About HBV

Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

On May 5, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the Chinese Society of Clinical Oncology (CSCO), the most prominent organization in oncology in China, added multiple selinexor regimens to its 2021 Diagnosis and Treatment Guidelines (CSCO Guidelines) for treatment of multiple myeloma and lymphoma (Press release, Antengene, MAY 5, 2021, View Source [SID1234579230]). Three selinexor regimens recommended by the Guideline for the Diagnosis and Treatment of myeloma include: (i) selinexor plus dexamethasone; and (ii) selinexor plus dexamethasone plus bortezomib; and (iii) selinexor plus dexamethasone plus pomalidomide for the treatment of relapsed myeloma. Meanwhile, the guideline has also recommended selinexor for the treatment of relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). As the gold standard guiding Chinese oncologists in their clinical practice, the CSCO Guidelines is the one of the most recognized guidelines in China.

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Multiple myeloma (MM) is a malignancy caused by the dysregulated proliferation of plasma cells. It is the second most common hematologic malignancy in many countries. MM is hard to treat and prone to relapse. Despite availability of a number of treatments for relapsed patients, most still succumb to their disease and new treatment options are needed. As a growing number of novel therapies enter into clinical treatment, it has become a challenge to choose the most effective treatment option. Diffuse large B-cell lymphoma (DLBCL) is an aggressive hematologic malignancy that about half of patients with DLBCL will not reach complete remission after receiving first-line treatments, and approximately 60% of patients with rrDLBCL lack effective treatment options.

Selinexor is the world’s first approved oral selective inhibitor of nuclear export (SINE), representing a novel mechanism of action (MoA) in cancer therapy. Selinexor induces the apoptosis of cancer cells through the targeted inhibition of the nuclear export protein XPO1 that leads to the nuclear storage and activation of tumor-suppressor proteins and other growth-regulating (GR) proteins, and by down-regulating the levels of various oncogenic proteins.

Myeloma

For the treatment of relapsed myeloma

Level 1 recommendation for selinexor plus dexamethasone (based on Class 1 evidence)
Level 2 recommendation for selinexor plus dexamethasone plus bortezomib (based on Class 2 evidence)
Level 2 recommendation for selinexor plus dexamethasone plus pomalidomide (based on Class 2 evidence)

The STORM trial is a multicenter, single-arm, open-label trial designed to evaluate the efficacy of selinexor plus dexamethasone (Xd) in patients with relapsed or refractory multiple myeloma (rrMM) that had previous exposure to multiple lines of therapy. Results from this trial showed an objective response rate (ORR) of 26% in rrMM with the Xd combination regimen in patients with rrMM who have received a median of seven previous regimens.

The STOMP trial is a multicenter, open-label, randomized Phase I/II trial designed to evaluate the safety and efficacy of various Xd combination regimens in patients with rrMM. Results from this trial showed a median progression-free survival (mPFS) of 12.2 months in patients that received the combination of selinexor, pomalidomide, and dexamethasone, and an ORR of 60% in patients that received selinexor at recommended Phase II dose (RP2D). In proteasome inhibitor (PI) nonrefractory patients, the combination of selinexor, bortezomib, and dexamethasone has demonstrated an ORR of 84%.

Lymphoma

The guideline has also recommended selinexor for the treatment of lymphoma. In the comments on the treatment of patients with rrDLBCL, the guideline recommended second-line therapies or personalized treatments that have no cross-resistance with the combination of cyclophosphamide, hydroxydaunorubicin, vincristine, and prednisolone (CHOP). In addition, the guideline also noted that multiple novel therapies including chidamide, ibrutinib, zanubrutinib, orelabrutinib, brentuximab vedotin, anti-PD-1 monoclonal antibodies, XPO inhibitor (selinexor), BCL-2 inhibitors have all demonstrated preliminary efficacy either as monotherapy or in combinations.

The SADAL trial is a registrational trial of selinexor in patients with rrDLBCL. Results of this trial demonstrated an ORR of 28.3% and a complete response (CR) of 12% in all patients, and an ORR of 34% in patients with the germinal center B-cell (GCB) subtype.

Depei Wu, MD, chairman of the Chinese Society of Hematology of the Chinese Medical Association, and director of the hematology department at the First Affiliated Hospital of Soochow University, said: "DLBCL is a highly heterogeneous hematologic malignancy, and a type of heterogeneous and invasive lymphoma with a large transformed B-cell phenotype that leads to the diffuse damage to normal lymph nodes. Patients with DLBCL commonly have high XPO1 expression that indicates a poor prognosis. The world’s first approved oral XPO1 inhibitor, selinexor, has been recommend by the National Comprehensive Cancer Network (NCCN) Guidelines for the treatment of patients with DLBCL that have received least two prior lines of therapy (including those with disease progression after transplant or CAR-T therapy). The recommendation of selinexor by the 2021 CSCO Guidelines for Diagnosis and Treatment of Lymphoma offers a new treatment option to patients. We are confident that selinexor will soon benefit more patients in need."

Wenming Chen, MD, Chairman of the Chinese Medical Education Association Committee on Hematology, and director of the hematology department at Beijing Chao-Yang Hospital of the Capital Medical University, commented: "MM is a common type of hematologic malignancy. The survival of patients with MM has been steadily prolonged, thanks to the development and introduction of some new therapies in the recent years. But these patients still lack curative treatment and would eventually relapse after developing acquired drug-resistance. Enabled by its unique mechanism of action, selinexor can effectively address drug-resistance in MM and deliver deep response in lymphoma patients in various states of the disease. This recommendation by the CSCO Guidelines brings a new treatment option into the clinical setting. We look forward to seeing more patients benefit from selinexor."

About Selinexor (XPOVIO)

Selinexor, a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed or refractory multiple myeloma (rrMM) and in June 2020 approved selinexor as a single-agent for the treatment of relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, selinexor also received FDA approval as a combination treatment for multiple myeloma (MM) after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with rrMM or rrDLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of MM.

Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

Antengene is currently conducting five mid- or late-stage clinical trials of selinexor for the treatment of MM, DLBCL, non-small cell lung cancer, and peripheral T and NK/T-cell lymphoma. Furthermore, Antengene has submitted New Drug Applications (NDAs) for selinexor in five Asia Pacific markets including mainland China, Australia, South Korea, Singapore and Hong Kong, and was granted the Priority Review status by China’s NMPA and an Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS).

On May 5, 2021 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the first quarter ended March 31, 2021 (Press release, Vericel, MAY 5, 2021, View Source [SID1234579257]).

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First Quarter 2021 Financial Highlights

Total net revenue increased 30% to $34.6 million, compared to $26.7 million in the first quarter of 2020
MACI net revenue of $23.8 million, Epicel net revenue of $9.8 million and NexoBrid revenue of $0.9 million related to the U.S. Biomedical Advanced Research and Development Authority (BARDA) procurement for emergency response preparedness
Gross margin of 66%, compared to 63% in the first quarter of 2020
Net loss of $3.3 million, or $0.07 per share, compared to $4.7 million, or $0.10 per share, in the first quarter of 2020
Non-GAAP adjusted EBITDA of $4.6 million, or 13% of net revenue, compared to adjusted EBITDA loss of $0.7 million in the first quarter of 2020
Operating cash flow of $10.1 million
As of March 31, 2021, the Company had $110 million in cash and investments, compared to $100 million as of December 31, 2020, and no debt
Business Highlights and Updates

MACI implant and biopsy growth of more than 20% compared to the first quarter of 2020
Epicel net revenue growth of 54% compared to the first quarter of 2020, with record monthly volume in February and the second highest quarterly Epicel revenue in history
Expansion of UnitedHealthcare’s MACI medical policy to include patella and multiple cartilage defects in the knee
Joined the S&P SmallCap 600
"We entered 2021 with a great deal of momentum and delivered another quarter of strong results across both our sports medicine and burn care franchises," said Nick Colangelo, President and CEO of Vericel. "Our first quarter results demonstrate the strength of the Company’s financial profile as we continue to generate strong revenue growth and increase profitability and cash flow. Based on these results and our strong underlying business fundamentals, we remain on track for significant growth across both of our franchises and have raised our full-year 2021 revenue and adjusted EBITDA guidance."

Full-Year 2021 Financial Guidance

Total net revenue now expected to be in the range of $165-$168 million, compared to previous guidance of approximately $161-$164 million
Adjusted EBITDA margin now expected to be in the range of 21.5% to 23.5%, compared to previous guidance of 21 to 23%
Gross margin guidance of 70% to 71% and estimated operating expenses of approximately $115 million maintained
First Quarter 2021 Results
Total net revenue for the quarter ended March 31, 2021 increased 30% to $34.6 million, compared to $26.7 million in the first quarter of 2020. Total net product revenue for the quarter included $23.8 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $9.8 million of Epicel (cultured epidermal autografts) net revenue, compared to $20.3 million of MACI net revenue and $6.4 million of Epicel net revenue, respectively, in the first quarter of 2020. Total net revenue for the quarter also included $0.9 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by BARDA for emergency response preparedness.

Gross profit for the quarter ended March 31, 2021 was $23.0 million, or 66% of net revenue, compared to $16.8 million, or 63% of net revenue, for the first quarter of 2020.

Total operating expenses for the quarter ended March 31, 2021 were $26.3 million, compared to $21.8 million for the same period in 2020. The increase in operating expenses was primarily due to an increase in stock-based compensation expense driven by share price appreciation over the past year.

Net loss for the quarter ended March 31, 2021 was $3.3 million, or $0.07 per share, compared to $4.7 million, or $0.10 per share, for the first quarter of 2020.

Non-GAAP adjusted EBITDA for the quarter ended March 31, 2021 was $4.6 million, or 13% of net revenue, compared to an adjusted EBITDA loss of $0.7 million in the first quarter of 2020. A table reconciling non-GAAP measures is included in this press release for reference.

As of March 31, 2021, the Company had $110 million in cash and investments, compared to $100 million as of December 31, 2020, and no debt.

Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software, if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s first quarter 2021 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.

If you are unable to participate in the live call, the webcast will be available at View Source until May 5, 2022. A replay of the call will also be available until 11:30am (EDT) on May 12, 2021 by calling (855) 859-2056, or from outside the U.S. by calling (404) 537-3406. The conference ID is 9036676.

On May 5, 2021 Inivata, a leader in liquid biopsy, reported that NeoGenomics, Inc (NASDAQ: NEO.), a leading provider of cancer-focused genetic testing services and global oncology contract research services, has agreed to acquire Inivata (Press release, Inivata, MAY 5, 2021, View Source [SID1234579315]). The acquisition follows a $25 million minority equity investment by NeoGenomics in Inivata in May 2020, at which time NeoGenomics was granted a fixed price option to purchase the remainder of Inivata for $390 million.

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Inivata, with its leading liquid biopsy technology platform, will remain a separate business division alongside NeoGenomics’ growing clinical, pharma and informatics divisions. Current Inivata CEO Clive Morris will become the President of Inivata and will report to Mark Mallon, CEO of NeoGenomics.

Inivata will be focused on the continued development of leading liquid biopsy tests including RaDaR, the highly sensitive personalized assay for the detection of residual disease and recurrence (MRD). Proof-of-principle data presented at this year’s AACR (Free AACR Whitepaper) Annual Meeting showed RaDaR demonstrated excellent specificity (100%) and sensitivity (100%) in detecting MRD in patient cohorts with head and neck cancer and early-stage breast cancer. These results provided growing evidence in support of RaDaR’s capabilities in different cancer types, building on data previously reported in non-small cell lung cancer (NSCLC), where RaDaR detected ctDNA 6-12 months ahead of clinical progression in the majority of cases and predicted lower progression free survival.

Clive Morris, CEO of Inivata, commented: "Joining the NeoGenomics Group provides Inivata with an excellent foundation to support our growth ambitions. Our two organizations have highly complementary capabilities and we are excited to combine with NeoGenomics following a successful year of working together. By leveraging our combined resources, we expect to accelerate the development of our promising RaDaR minimal residual disease assay and bolster commercialization efforts with biopharma before driving a successful launch into the clinical setting."

Mark Mallon, CEO of NeoGenomics, commented: "NeoGenomics has spent the better part of the last year working in partnership with the exceptional team of professionals at Inivata while conducting confirmatory due diligence on Inivata and its world-leading liquid biopsy platform technology. We are exercising our option to purchase Inivata eight months ahead of plan and are delighted to welcome Inivata’s world class team of liquid biopsy experts and talented employees to NeoGenomics."

Douglas M. VanOort, Executive Chairman of NeoGenomics commented: "Testing for minimal residual disease has the potential to revolutionize oncology care to benefit millions of patients as they manage through their cancer journey and we are excited to innovate our offerings with Inivata’s best-in-class platform. Combining Inivata’s compelling technology with our unrivaled reach into the clinical community channel and existing relationships with biopharma is a winning strategy."

Perella Weinberg Partners LP acted as financial advisor to Inivata. Inivata was represented by K&L Gates LLP through a cross-border, multi-disciplinary transactional legal team spread across offices in Raleigh, Chicago, New York, San Francisco, Washington D.C. and London.

On May 5, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that preclinical data on its agonist anti-CD40 antibody mitazalimab has been published in the scientific journal Cancer Immunology, Immunotherapy (Press release, Alligator Bioscience, MAY 5, 2021, View Source [SID1234579145]).

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The published data show that mitazalimab activates dendritic cells and tumor-reactive T cells resulting in enhanced anti-tumor efficacy in combination with a model cancer vaccine.

Title: The human anti-CD40 agonist antibody mitazalimab (ADC-1013; JNJ-64457107) activates antigen-presenting cells, improves expansion of antigen-specific T cells and enhances anti-tumor efficacy of a model cancer vaccine in vivo

Journal: Cancer Immunology, Immunotherapy

View Source

Authors: Adnan Deronic et al.

"A publication in a prominent peer-reviewed journal such as Cancer Immunology, Immunotherapy is very encouraging and validates our findings. These data further highlight the strong potential for mitazalimab to be combined with other therapies, including chemotherapies, immune checkpoint inhibitors and cancer vaccines," said Malin Carlsson, interim CEO at Alligator.

A summary of the findings was presented at the World Immunotherapy Congress 2021 on March 31, 2021, by Alligator’s CSO, Peter Ellmark.

Mitazalimab is Alligator’s most advanced drug candidate for immunotherapy and is designed for the treatment of metastatic cancers, including pancreatic cancer. A phase II study, OPTIMIZE-1, in patients with pancreatic cancer is under preparation. The Phase II study is an open-label, multicenter study to assess the clinical efficacy of mitazalimab as a first-line therapy combined with chemotherapy (mFOLFIRINOX). It will be conducted at several European medical centers and inclusion of the first patient is planned for the first half of 2021.