On March 22, 2022 Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, reported that its venture capital arm, Hikma Ventures has led an $15 million USD round of financing for Activ Surgical, a pioneering digital surgery imaging startup that is developing groundbreaking interoperative surgical intelligence hardware and software (Press release, Hikma, MAR 22, 2022, View Source [SID1234610702]). The investment is an extension of the Series B round that was previously announced by Activ Surgical in September 2021. This most recent financing, which also saw participation from existing investors, brings the total Series B round to $60 million USD.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Activ Surgical aims to revolutionize access to surgical care, enabling a future of augmented reality (AR)-based and artificial intelligence (AI)-driven surgery that is safe, smart, and accessible to all. The company’s patent-protected surgical intelligence platform – ActivEdge – is being designed to reduce unintended and preventable surgical errors by enhancing a surgeon’s interoperative decision-making through the use of AI. Activ Surgical’s first product — the ActivSight imaging module — seamlessly upgrades existing operating room equipment, serving as the "eyes" of the ActivEdge platform. It allows surgeons to access critical intraoperative visual data as AR overlays. In 2021, the ActivSight imaging module was cleared by the FDA and successfully used in its first-in-human studies. To date, multiple major hospital networks across the U.S. and Europe have been established as pilot sites. The ActivSight imaging module is available now via a limited market release and will be broadly available in 2022.

"Hikma Ventures’ investment in Activ Surgical comes at a critical inflection point in the company’s history as our team is hard at work preparing for the global launch of our ActivSight imaging module later this year," said Todd Usen, CEO, Activ Surgical. "This investment will allow us to scale our business quickly and add resources needed to ensure a successful rollout of the ActivSight imaging module, helping to fulfil our mission to empower surgeons’ intraoperative decision-making and, ultimately, enhance patient safety. Hikma’s position in the global healthcare landscape helps validate our mission to provide better patient outcomes globally."

"We are thrilled to invest in Activ Surgical and support their mission to democratize surgical care and to eliminate unintended surgical complications to improve patient outcomes and empower surgeons across the globe," said Lana Ghanem, Managing Director of Hikma Ventures. "This is the latest example of Hikma Ventures’ commitment to supporting pioneering companies utilizing cutting-edge technologies to meaningfully improve patients’ lives. We look forward to working with the talented Activ Surgical team to help them expand the global reach of their innovative platform to different geographies, especially the Middle East."

On March 22, 2022 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported that it has commenced a global offering of $500 million (approximately €453 million) of ordinary shares, which may be represented by American Depository Shares ("ADSs") (Press release, argenx, MAR 22, 2022, View Source [SID1234610983]). The global offering will be comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the United Kingdom. Each of the ADSs represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are expected to close simultaneously.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, argenx intends to grant the underwriters of the offering a 30-day option to purchase additional ordinary shares (which may be represented by ADSs) in an aggregate amount of up to 15% of the total number of ordinary shares (including represented by ADSs) proposed to be sold in the offering, on the same terms and conditions.

Baillie Gifford Overseas Limited and entities affiliated with it have indicated an interest in purchasing on behalf of their clients an aggregate of up to $170.0 million of ordinary shares in the offering at the offering price per share and on the same terms as the other purchasers in the offering. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, fewer or no ordinary shares to these potential purchasers, and these potential purchasers could determine to purchase more, fewer or no shares in the offering.

argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX" and argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX".

J.P. Morgan, Morgan Stanley, Cowen and SVB Leerink are acting as joint bookrunning managers for the offering.

The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities being offered in the United States will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities being offered in the United States may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by email at [email protected], or by telephone at (866) 718-1649; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926.; or from SVB Securities LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected].

A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made following pricing of the offering.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

On March 22, 2022 Nucleai, an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data, reported that it had closed a $33 million Series B financing round, jointly led by Section 32 and Sanofi Ventures (Press release, Debiopharm, MAR 22, 2022, View Source [SID1234610576]). Andy Harrison, Managing Partner at Section 32, and Cris De Luca, Global Head, Digital Investments at Sanofi Ventures, will join Nucleai’s Board of Directors. Section 32 Managing Partner Michael Pellini, MD, will join Nucleai’s Board as an observer. Nucleai plans to use the new funding to further develop its platform and expand its commercial footprint across biopharmaceutical companies and contract research organizations (CROs), who are applying its technology throughout translational research, clinical trials, and novel applications for drug discovery.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Existing investors, including Debiopharm, Fosun RZ Capital, Vertex Ventures, and Grove Ventures, participated in this round. This Series B financing brings Nucleai’s overall funding to close to $50 million since the company was founded four years ago.

"Nucleai’s vision is to bring spatial biology to the forefront of precision medicine and to embed the use of our platform in every clinical trial involving tissue over the next few years," said Avi Veidman, CEO of Nucleai. "We are pleased to bring world-class investors who share our passion and vision to transform drug development and clinical treatment decisions by combining artificial intelligence, big data, spatial biology, and a comprehensive software platform."

Andy Harrison commented, "Mapping biological microenvironments with spatial mapping technology is an exciting area of discovery that is paving the way for innovative new therapies and diagnostic tools. Nucleai has built a platform that makes spatial analysis scalable and operational, enabling the next generation of actionable insights from massive pathology data sets that have not been analyzed to their fullest potential and could provide significant value to pharmaceutical companies and diagnostic labs."

"The rapid growth and achievements of the Nucleai team have them well-positioned to be spatial biology platform leaders, transforming current approaches to pathology," said Cris De Luca. "By harnessing artificial intelligence with spatial data and other data modalities, Nucleai is enabling researchers and clinicians to make better treatment decisions for patients based on a comprehensive, holistic view of cellular locations, interactions, and the tumor microenvironment."

Nucleai is working with most of the leading pharmaceutical companies to harness spatial biology for new drug development, clinical trials, and clinical treatment decisions. Nucleai’s platform is leveraged for retrospective and prospective patient stratification analysis in clinical trials, driving improvement of the probability of success and improved patient outcomes. Nucleai delivers a comprehensive solution that brings the computational power and scales needed to discover novel biomarkers, predicts patient response with higher-quality predictive biomarkers, identifies new targets, and develops the next generation of pathology-based companion diagnostics.

On March 22, 2022 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for cancer patients suffering from solid tumors, reported financial results for the fourth quarter ended December 31, 2021 and provided a corporate update (Press release, TCR2 Therapeutics, MAR 22, 2022, View Source [SID1234610601]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Consistent execution throughout the last year has positioned TCR2 for a series of important readouts as we accelerate our clinical progress in 2022," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We were able to successfully conclude the dose escalation portion of our ongoing gavo-cel Phase 1/2 clinical trial with the identification of a RP2D and submit a protocol amendment with the FDA for the upcoming Phase 2 clinical trial. We also submitted an IND with the FDA for our first enhanced TRuC-T cell that incorporates a PD-1:CD28 switch. In the meantime, we have been identifying new clinical trial sites and expanding manufacturing capacity for the reproducible process used by Miltenyi and ElevateBio to support our clinical trials. In addition to the clinical readouts from gavo-cel and TC-510, we will continue to provide updates on the innovations in our rapidly growing pipeline, most immediately with a preclinical data presentation on our allogeneic TRuC targeting mesothelin at the AACR (Free AACR Whitepaper) Annual Meeting in April."

Recent Developments

Gavo-cel:

•TCR2 announced the submission of a protocol amendment to the US Food and Drug Administration (FDA) in the first quarter of 2022 for the gavo-cel Phase 2 expansion cohort, including the amendment to treat patients with gavo-cel in combination with Opdivo and/or Yervoy which forms the basis of the Company’s clinical trial collaboration with Bristol Myers Squibb.

TC-510:

•TCR2 announced the submission of an Investigational New Drug (IND) to the FDA in the first quarter of 2022 for TC-510, the Company’s first enhanced TRuC-T cell targeting mesothelin with a PD-1:CD28 chimeric switch receptor.
Pipeline:

•TCR2 announced it will present a poster at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 featuring new preclinical data on an allogeneic (off-the-shelf) TRuC-T cell, taking place on April 8-13, 2022 in New Orleans, Louisiana. In preclinical studies, this allogeneic product candidate without an enhancement demonstrated improved anti-tumor efficacy associated with enhanced persistence and increased antigen sensitivity in vivo compared to donor-matched autologous TRuC-T cells targeting mesothelin. Furthermore, allogeneic TRuC-T cells generated with an additional knockout of Beta-2-microglobulin (B2M) maintained their potency.
•TCR2 announced a strategic research collaboration agreement with Arbor Biotechnologies focused on the further development of a defined set of allogeneic TRuC-T cell therapies. The collaboration leverages Arbor’s proprietary CRISPR gene-editing technology, which is tailored to address the underlying pathology of genetic diseases and TCR2’s first-in-class TRuC platform, which has demonstrated clinical activity in multiple treatment-refractory mesothelin-expressing solid tumor indications with gavo-cel.

Corporate:

•TCR2 announced the appointment of experienced biotech executive Rosemary Harrison, Ph.D., as Chief Business and Strategy Officer where she will be responsible for supporting a range of activities including commercial strategy, operational planning, corporate partnerships and long-term growth opportunities.

Anticipated Milestones

•Gavo-cel:
oPresent the expanded and complete Phase 1 dataset for gavo-cel in the second quarter of 2022.
oInitiate the Phase 2 expansion cohort of the ongoing gavo-cel Phase 1/2 clinical trial in the first half of 2022.
oProvide an initial update from at least one of the Phase 2 expansion cohorts of the ongoing gavo-cel Phase 1/2 clinical trial in the second half of 2022.
•TC-510:
oReport initial safety, efficacy and translational data from at least one of the Phase 1 dose escalation cohorts of the TC-510 Phase 1/2 clinical trial in the second half of 2022.
•Pipeline:
Initiate IND-enabling studies for TC-520, an enhanced CD70 targeting TRuC-T cell program, in 2022.
oSelect a lead candidate for its allogeneic program in 2022.
•Manufacturing:
oProduction of clinical trial material to commence at ElevateBio BaseCamp as capacity is increased in anticipation of demand from the Phase 2 expansion trial of gavo-cel in 2022.

Financial Highlights

•Cash Position: TCR2 ended the fourth quarter of 2021 with $265.6 million in cash, cash equivalents, and investments compared to $228.0 million as of December 31, 2020. Net cash used in operations was $23.3 million for the fourth quarter of 2021 compared to $13.5 million for the fourth quarter of 2020. TCR2 projects net cash use of $115-125 million for 2022. We expect cash on hand to support operations into 2024.

•R&D Expenses: Research and development expenses were $22.4 million for the fourth quarter of 2021 compared to $14.3 million for the fourth quarter of 2020. The research and development expenses for the fourth quarter of 2021 include restructuring costs of $3.7 million and are partially offset by a $2 million settlement from a vendor due to a commercial dispute. The remaining increase in R&D expenses was primarily due to an increase in headcount and manufacturing facilities.

•G&A Expenses: General and administrative expenses were $5.2 million for the fourth quarter of 2021 compared to $4.3 million for the fourth quarter of 2020. The increase in general and administrative expenses was primarily due to an increase in personnel costs.

•Net Loss: Net loss was $27.7 million for the fourth quarter of 2021 compared to $18.5 million for the fourth quarter of 2020.

On March 22, 2022 Median Technologies (ALMDT:PA) reported outstanding performance of its iBiopsy LCS AI/ML tech-based end-to-end CADe/CADx Software as Medical Device, intended to enable early detection and characterization of lung cancer nodules and improve clinical management of patients (Press release, MEDIAN Technologies, MAR 22, 2022, View Source [SID1234610618]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Median’s iBiopsy LCS SaMD offers a unique end-to-end detection/diagnosis approach (CADe/CADx) based on AI/ML technologies. Median aims at drastically improving the ability to detect and characterize lung cancers at their earliest stages, enabling a better patient care while avoiding unnecessary medical tests and procedures, and reducing healthcare costs. No product is currently approved for both lung cancer detection and diagnosis in the US or Europe. With this breakthrough innovation, Median’s iBiopsy LCS SaMD brings a unique AI-powered solution for clinicians to fight lung cancer, the deadliest cancer worldwide.

Results released today show unrivalled performance for Median’s end-to-end detection/diagnosis approach for lung cancer screening.

The study was based on a cohort of 1,760 patients from the National Lung Screening Trial (NLST) consisting of a total of 16,789 lung nodules. The training set was composed of a subset of 1,289 patients with 12,108 nodules and the test set represented 471 patients with a total of 4,681 nodules.

The performance of iBiopsy LCS CADe/CADx SaMD to detect and characterize lung cancer nodules achieves an AUC of 0.976 and an outstanding sensitivity of 94.7% for a specificity of 93.3%.

"We are thrilled to announce our performance. These results pave the way for a disruptive approach in lung cancer screening management", Fredrik Brag, CEO and founder of Median Technologies said. "We have already initiated our interactions with the FDA with the recent 513(g) submission, which will allow us to determine the best FDA regulatory pathway for our iBiopsy LCS SaMD. Our next step will be to integrate the FDA’s comments in the protocols of the pivotal clinical studies that we will launch in the second half of 2022. In parallel, we are reviewing our regulatory pathway to the CE-Mark in Europe", Brag added.

Median Technologies aims to obtain a device approval and market authorization by the end of 2023.

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of innovative AI/ML-based Software as Medical Device, to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on lung cancer, liver cancer (HCC) and liver fibrosis (NASH).