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.

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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 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it will report its financial results for the fourth quarter and year ended December 31, 2021, after the market close on Tuesday, March 29, 2022, and will host a corporate update conference call at 4:30pm Eastern Time (Press release, CorMedix, MAR 22, 2022, View Source [SID1234610575]).

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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

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On March 22, 2022 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that Coherus plans to host an Analyst Day on March 29, 2022 at 9:30 a.m. ET in New York City (Press release, Coherus Biosciences, MAR 22, 2022, View Source [SID1234610574]). Coherus executives and scientists will provide updates on the preparation for multiple potential new product launches anticipated over the next 15 months as well as the Company’s transformational entry into immuno-oncology with PD-1 inhibitor toripalimab and innovative PD-1 combination candidates.

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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

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Investors and analysts who would like to attend the Coherus Analyst Day event in-person or virtually may pre-register here.

A live webcast of the Analyst Day will be available on the Events & Presentations page of the Coherus website at View Source Please access the website prior to the start of the event to ensure a timely connection to the webcast. A replay of the event will be archived on the Coherus website for 30 days.

On March 22, 2022, Cleveland BioLabs reported obtained a limited waiver ("Waiver") from a certain investor ("Investor") with respect to certain provisions of a Securities Purchase Agreement, dated as of February 6, 2022, by and among the Company and the Investor which limits the ability of the Company to issue common stock and/or warrants except through the confidentially marketed public offering announced on March 22, 2022 (Filing, 8-K, Cleveland BioLabs, MAR 22, 2022, View Source [SID1234610573]). As consideration for the limited waiver, upon consummation of such public offering, the exercise price of the Common Stock Purchase Warrant issued on February 9, 2022, by the Company to the Investor in connection with the Securities Purchase Agreement, will be repriced from $1.00 per share to the public offering price per Unit in the confidentially marketed public offering of the Company, subject to adjustment under the Common Stock Purchase Warrant.

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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

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On March 22, 2022 BioCanRx reported that it has funded important research into immunotherapy, helping to make a promising new avenue for cancer treatment a reality for Canadians whose cancer has not responded to other treatments (Press release, BioCanRx, MAR 22, 2022, View Source;utm_medium=rss&utm_campaign=another-made-canada-car-t-trial-based-canadian-manufacturing-capability [SID1234610572]). An equally important part of its work, however, has been developing the infrastructure needed to provide manufacturing and testing capacity here in Canada, through its support of core facilities across the country.

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Today, thanks to BioCanRx’s investment, we have the capacity to manufacture CAR-T (chimeric antigen receptor) cells, one of the most promising avenues for immunotherapy, here in Canada. CAR-T therapy involves enriching a cancer patient’s own T cells with a CAR gene that contains receptors that bind to specific proteins, or antigens, found on the surface of cancer cells. This helps the patient’s own immune system better fight the cancer.

Now BioCanRx is funding the clinical trials and enabling studies for clinical trials that have been made possible by this manufacturing capability.

First, there was CLIC-01, led by the Ottawa Hospital Research Institute’s Dr. Natasha Kekre and focussing on the CD19 antigen. Now, Dr. Kevin Hay of the BC Cancer Research Institute (with additional support from the BC Cancer Foundation) is leading the development of a second clinical trial (CLIC-02) focussing on the CD22 antigen, which will be the first deliverable in the antigen-to-clinic pipeline BioCanRx has been developing.

Both these trials are targeting B-cell blood cancers and, says Dr. Hay, "are inter-related in terms of developing CAR-T therapies for patients." They also share personnel, ensuring that each project learns from the others, and also help each other out in practical ways. This new trial also ties into another BioCanRx enabling study led by the National Research Council’s Dr. Scott McComb, who is developing CARs targeting multiple B-cell cancer antigens at the same time, one of which is the CD22 CAR that Dr. Hay is using in his research as the basis for the CLIC-02 trial.

The CLIC-01 trial is based on CD19-targeting receptors, for which there are other, commercial products available. The novelty of that first project, says Dr. Hay, was the use of a Canadian biomanufacturing facility to manufacture the CD19 CAR-T cells. His project, focussing on the CD22 target, is, he says, "coming in closer to the ground level," as there are currently no approved CD22-based therapies commercially available, in Canada or elsewhere in the world.

"We are getting CAR-T clinical trials to Canadian patients earlier and earlier," he says.

The work will fill an important gap in options for treating B-cell blood cancers, as not all patients respond to CD19 CAR-T therapy.

Currently, Dr. Hay is assembling the research and knowledge needed to support a clinical trial application (CTA) to Health Canada, which he expects to happen by the end of this year. With Health Canada approval, he then plans to have two phase 1 trials running simultaneously, one for leukemia and one for lymphoma. The trials will focus on determining the optimal dose for the CAR-T therapy by starting at a low level and gradually increasing it if there prove to be no toxic side effects at the lower level. He has already secured funding from the Canadian Institutes of Health Research (CIHR) for the lymphoma trial and is waiting to hear results from other funding applications for the leukemia trial, so that, with Health Canada approval in hand, he and his team will be able to get both CLIC-02 trials underway as quickly as possible.

The project, and its potential results, underscore the importance of BioCanRx’s integrated approach to advancing cancer treatment, one that brings together researchers, their research and the infrastructure they need to improve outcomes for and, ultimately, save the lives of people with cancer.