On March 9, 2022 IN3BIO Research Limited, a leader in developing cancer treatments that, based upon clinical data, show significant promise and appear to be more tolerable for patients, reported that it has received Clinical Trial Application approval from the British Medicines & Healthcare Products Regulatory Agency (MHRA) to initiate a Phase I/II clinical trial of its colorectal cancer vaccine (Press release, In3Bio, MAR 9, 2022, View Source [SID1234609850]). This is the company’s second global regulatory approval for the trial, having obtained approval to conduct the study in Bulgaria earlier this year.

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With these approvals, IN3BIO is one step closer to bringing its innovative cancer treatments to market. The company is in the process of a Series A financing round for the Phase I/II trial as well as for developing a second molecule to advance its global mission.

On March 9, 2022 ArcticZymes Technologies ASA (OSE: AZT) reported the establishment of a new application development laboratory at ShareLab in Oslo (Press release, Biotec Pharmacon, MAR 9, 2022, View Source [SID1234609848]).

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ArcticZymes Technologies has signed an agreement with ShareLab AS to lease laboratory facilities at its premises in the Oslo Science Park. These facilities will support application development activities to demonstrate the utility of the Company´s enzymes in customer relevant workflows and technologies. This is an essential part of the innovation process and strengthens the commercial value proposition of the Company´s product offerings.

ShareLab is a service platform provider of laboratory and office facilities to biotechnology companies. It conveniently provides the necessary amenities and shared core equipment suited to ArcticZymes´ requirements which means minimal capital investments to get started. Furthermore, ShareLab´s location in the Oslo Science Park is central to the Norwegian biotechnology industry and life science research.

The Oslo location will allow access to a broad talent pool of commercially-experienced application scientists. Also, as the Company continues to grow it has strategic relevance to have part of ArcticZymes located at the heart of the Norwegian biotech industry.

Dr. Darren Ellis has been hired to lead the activities at ShareLab and is currently recruiting two application scientists. Dr. Ellis brings over 20 years of industrial R&D experience (from Solexa (now Illumina) and Thermo Fisher Scientific) in leading and developing molecular research and In Vitro Diagnostic (IVD) applications, technologies, and products. Furthermore, he has global expertise in Business-to-Business (B2B) application development, successfully helping commercial partners/customers to bring their technologies and product developments to market.

On March 9, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported its fourth quarter and full year financial results for the full year 2021 (Press release, NexImmune, MAR 9, 2022, View Source [SID1234609841]).

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"2021 was a landmark year for NexImmune and the continued development of our AIM platform technology," said Kristi Jones, Chief Executive Officer. "The funding received from our successful IPO in February of 2021 has allowed us to advance Phase 1/2 clinical trials for NEXI-001 and NEXI-002 and other programs towards the clinic. We plan to provide a clinical update for the NEXI-001 trial in AML during the second half of 2022, as well as provide an update on our expansion cohort in the NEXI-002 trial in relapsed / refractory multiple myeloma. Additionally, we have identified our antigen peptide targets to be included in our first solid tumor IND application for HPV-associated malignancies and expect to file our IND in the first half of this year. We will also be providing an update on AIM INJ direct injectable modality as we continue our IND enabling work. These updates will include preclinical data supporting an IND in oncology and data from our research collaboration with the lab of Professor Kevan Herold at Yale University, which explores the effects of our AIM injectable nanoparticle as a therapeutic for type 1 diabetes. Despite the challenges the biotech market has experienced over the last months, our team continues to execute on all fronts and we remain on track to achieve our key catalysts for 2022."

Select Fourth Quarter and Full Year 2021 Clinical and Business Highlights

Clinical and Preclinical Updates

NEXI-001

Robust immune responses with signs of clinical activity across all dose levels to date
NEXI-001 continues to be well tolerated across all dose levels administered to date, with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Due to the favorable emerging clinical profile, plans are underway to expand the addressable population with an additional study arm to include patients with haplo-identical donors
Updated clinical results are expected to be announced in the second half of 2022
NEXI-002

Safety cohort completed and expansion phase continues to enroll and dose
NEXI-002 continues to be well tolerated with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Further clinical data from the Phase 1/2 trial are expected to be announced in the second half of 2022
NEXI-003

Preclinical data supporting the selection of multiple immunogenic antigen peptides commonly expressed on HPV-associated tumors was presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting (SITC 2021) in November 2021
Finalized antigen selection for NEXI-003 and manufactured nanoparticles for clinical trials
Investigational New Drug (IND) submission planned for the first half of 2022
Injectable AIM-np and other Preclinical

First collaboration in autoimmune diseases announced with Yale University Professor Kevan Herold to evaluate AIM INJ nanoparticles as a therapeutic for Type 1 diabetes to suppress or eliminate antigen specific autoreactive T cells
Advancing in vivo work for other areas of development in autoimmune, oncology and infectious disease
Announced research collaboration with Rutgers, The State University of New Jersey, for neuroendocrine tumor checkpoint targets, which may also have utility in other cancers
Business Updates

Completed successful $126.5M IPO in February 2021
Announced the appointment of Kristi Jones as Chief Executive Officer and Member of the Board of Directors
Announced the formation of the Scientific Advisory Board and the Autoimmune and Infectious Diseases Advisory Board
Continued to strengthen the management team with key appointments across the organization
Select 4Q and Full 2021 Financial Highlights

Cash, cash equivalents and marketable securities for the company as of December 31, 2021 were $81.8 million compared to $5.0 million at December 31, 2020. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its operating and capital expenditure requirements into the second quarter of 2023.

Research and development expenses were $12.0 million in the fourth quarter ended December 31, 2021, compared to $4.4 million for the same period in the prior year. Research and development expenses were $37.5 million for the full year period ended December 31, 2021, an increase of $19.7 million compared to $17.8 million for the full year ended December 31, 2020. The increase in R&D expenses was mainly attributable to costs for research related to preclinical manufacturing and the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $3.5 million for the fourth quarter ended December 31, 2021, an increase of $0.9 million compared to $2.6 million for the same period in the prior year. General and administrative expenses were $15.8 million for the full year period ended December 31, 2021, an increase of $5.8 million compared to $10.0 million for the full year ended December 31, 2020. The increase was due primarily to increases in headcount and fees related to professional and consulting services.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $15.4 million for the quarter and $50.9 million for the full year 2021, or a basic and diluted GAAP loss per share of $0.68 and $2.54 respectively. This compared to a net loss of $33.1 million, or a basic and diluted GAAP loss per share of $26.42, for the same period the prior year.

On March 9, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported that it is entering into a strategic laboratory relationship with Prisma Health, a nonprofit and the largest health system in South Carolina (Press release, LabCorp, MAR 9, 2022, View Source [SID1234609840]).

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Through this new relationship, Labcorp will acquire select assets of Prisma Health’s outreach laboratory business. In addition, Labcorp and Prisma Health have entered into a technical support agreement to apply Labcorp’s knowledge and expertise in Prisma Health’s hospital laboratories. Collectively, the strategic collaboration enhances Labcorp’s diagnostic footprint and capabilities in the Carolinas and allows Prisma Health’s patients and providers the benefit of enhanced care across multiple clinical areas.

"Prisma Health is an established leader in providing health care and diagnostic services to South Carolina residents, and its dedication to its patients closely aligns with Labcorp’s mission to improve health and improve lives," said Traci Butler, senior vice president of Labcorp Diagnostics’ Atlantic Division. "This relationship builds on Labcorp’s strong track record of providing the critical information that patients and providers need to make the best possible health decisions. It also underscores our commitment and dedication to the people who call the Carolinas home."

The strategic relationship will expand Prisma Health patients’ access to laboratory testing throughout South Carolina and offer individualized, dedicated support to physician practices. It follows other strategic collaborations with local and regional health systems that have enabled Labcorp to enhance service for patients and providers.

"Labcorp brings the scale and expertise of its internationally recognized laboratory services to help us achieve the next level of service and quality in this highly specialized area," said Clarence Sevillian, executive vice president and chief operating officer of Prisma Health. "We pride ourselves on providing the best possible experiences for our patients and providers. This relationship is another way we are building on our strong reputation of quality care and compassionate service, helping people in communities across South Carolina live their healthiest lives."

Once the transactions are complete, Prisma Health patients and clinicians will have access to a broad spectrum of services through Labcorp’s extensive lab test menu, along with its national network of patient service centers for improved patient access and convenience. Labcorp will also offer expanded health plan coverage, additional access to rural markets and the potential for reduced out-of-pocket lab costs for patients. Additionally, Labcorp will collaborate with Prisma Health to provide same-day STAT testing in local communities.

The transactions are expected to close in the second half of 2022. Specific terms of the transactions were not disclosed.

On March 9, 2022 Nordic Nanovector ASA (OSE: NANOV), a clinical-stage biotech company focused on CD37-targeted therapies for haematological cancers and immune diseases, reported that an E-poster regarding Alpha37, entitled "Targeted alpha therapy with 212Pb-NNV003 in treatment of NHL", will be presented at the 2022 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held 8-13 April in New Orleans, USA (Press release, Nordic Nanovector, MAR 9, 2022, View Source [SID1234609836]).

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The data in the E-poster show that a single injection of 212Pb-NNV003, or Alpha37, is safe and effective for the treatment of CD37-positive chronic lymphocytic leukaemia (CLL) and non-Hodgkin’s lymphoma (NHL) in mouse models. Promising efficacy in both ibrutinib-resistant and ibrutinib-sensitive CLL models was observed and treatment with Alpha37 was superior to both ibrutinib and oblinutuzumab, confirming that further clinical development is warranted. These data were previously presented at the company’s R&D Day in November 2021.

Alpha37 has been developed as a targeted alpha radioimmunotherapy where the CD37-specific antibody NNV003 is coupled to the alpha particle generating isotope 212Pb for the treatment of NHL and CLL. Despite the availability of current treatments, most patients with these diseases inevitably relapse meaning that there is a significant unmet need for new, alternative therapies.

Jostein Dahle, Co-founder and CSO of Nordic Nanovector, commented: "The pre-clinical data that we have amassed on Alpha37 is taking us closer towards our goal of filing for an IND to begin human clinical testing. We are focussed on high risk and/or ibrutinib resistant/refractory CLL as the entry indication but believe there is a broader unmet need beyond this that Alpha37 may be able to fulfil. We look forward to the further development of this next generation targeted anti-CD37 alpha radio-immunoconjugate."