On January 19, 2022 Engitix reported that With the close of its Series A round at €48M ($54M), the tissue models company has shifted its business from providing drug discovery services to developing its own treatment pipeline for liver diseases (Press release, Engitix, JAN 19, 2022, View Source [SID1234610299]).

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!

When Engitix was spun out of University College London in 2016, the startup primarily aimed to provide tissue models to pharmaceutical companies for speeding up drug discovery in liver disease. As the company closes a €48M Series A round and drug discovery partnership with the Milan-based Dompé Farmaceutici this week, Engitix is reinforcing its plans to become a drug developer in its own right.

Drug candidates are typically tested in the lab using cell cultures, which are easy to grow and screened in large numbers. However, they don’t well resemble the structures of human organs, which are made up of cells and the extracellular matrix between them.

Engitix is developing drug testing models that are a closer imitation of real organs than cell cultures. The company sources extracellular matrix scaffolds from diseased and healthy organs from biobanks and grows cells on the scaffold to simulate a real organ.

Many companies are working on ways to screen drug candidates using more informative methods than cell cultures. Earlier this week, the Swiss startup EraCal deployed a high-throughput drug screening model based on zebrafish in a drug discovery collaboration with Novo Nordisk. There are also many firms that bioprint organs using polymer gels and cells.

By using human tissue scaffolds, Engitix’s models can shed light on local conditions influencing the behavior of tumor cells, such as blood vessels and immune cells, known as the microenvironment.

On January 19, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported that Thomas K. Equels, M.S. J.D., Chief Executive Officer of AIM, will present at the Virtual Investor 2022 Top Picks Conference on Wednesday, January 26, 2022 at 10:00 AM ET (Press release, AIM ImmunoTech, JAN 19, 2022, View Source [SID1234605569]).

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!

As part of the virtual event, the Company will provide a corporate presentation, followed by a moderated interactive Q&A session. In addition to the moderated portion of the event, all investors and interested parties will have the opportunity to submit questions live during the event. Interested parties may also pre-submit questions in advance of the live event, which can be sent via the conference website at virtualinvestorco.com. The Company will answer as many questions as possible during the event.

A live video webcast of the presentation will be available on the Events page of the Investors section of the Company’s website (aimimmuno.com). A webcast replay will be available two hours following the live presentation and will be accessible for one year.

On January 19, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that following receipt of positive Type B meeting correspondence from the U.S. Food and Drug Administration (FDA) yesterday, the company plans to initiate a rolling Biologics License Application (BLA) submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant (Press release, Gamida Cell, 19 19, 2022, View Source [SID1234605659]). As previously disclosed, in late 2021 the FDA requested a revised analysis of the manufacturing data generated at Gamida Cell’s wholly owned commercial manufacturing facility to demonstrate the analytical comparability to the Lonza clinical manufacturing site that produced omidubicel for the Phase 3 study. Gamida Cell and the FDA have now reached alignment that analytical comparability has been established between the commercial manufacturing facility and the product that was manufactured for the Phase 3 study. Based on this demonstration of comparability, along with the positive clinical results of the Phase 3 study, the FDA has agreed that the initiation of a rolling BLA submission is appropriate. Additional clinical data will not be required to initiate the BLA submission.

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!

"We are very pleased that our productive interactions with the FDA have resulted in alignment on the omidubicel manufacturing comparability analysis and agreement to initiate a rolling submission of our BLA application," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the FDA and has the potential to be the first FDA-approved advanced cell therapy for allogeneic bone marrow transplant. Initiating the BLA submission will move us one step closer toward bringing potentially curative therapies to patients. We plan to complete the full BLA submission in the first half of this year, which will be an important achievement for Gamida Cell and the bone marrow transplant community."

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with blood cancers. Omidubicel is the first bone marrow transplant graft to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On 19 January 2022, Oasmia Pharmaceutical AB ("Oasmia" or the "Company") reported that the Board of Directors had resolved to carry out a fully secured rights issue (the "Rights Issue") (Press release, Vivesto, JAN 19, 2022, View Source [SID1234611842]). The Board of Directors’ resolution of the Rights Issue was approved by the Extraordinary General Meeting held on 21 February 2022. Oasmia announces that the final result of the Rights Issue shows that 48,367,120 shares, corresponding to approximately 53.9 percent of the shares offered, were subscribed for by the exercise of subscription rights. 1,519,430 shares, corresponding to approximately 1.7 percent of the shares offered, have been allotted to persons who have subscribed for shares without the use of subscription rights. The remaining 39,787,359 shares offered, corresponding to approximately 44.4 percent, have been allotted to guarantors. Oasmia will receive approximately SEK 151 million through the Rights Issue before issue costs.

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!

Through the Rights Issue, Oasmia’s share capital will increase by SEK 8,967,390.9, from SEK 44,836,954.6 to SEK 53,804,345.5 by issue of 89,673,909 new shares. After the Rights Issue, the number of shares in Oasmia will amount to 538,043,455 shares.

Those who have subscribed for shares without subscription rights will be allotted shares according to the principles in the prospectus published by Oasmia on 3 March 2022. As confirmation of allotment of shares subscribed for without subscription rights, a contract note will be sent on or about 25 March 2022. Subscribed and allotted shares must be paid in cash in accordance with the instructions in the contract note. Nominee-registered shareholders will receive notice of allotment in accordance with the procedures of the nominee. Only those who have been allotted shares will be notified.

The last day of trading in the interim shares ("BTA") will be on 4 April 2022. Trading of the new shares is expected to begin on Nasdaq Stockholm on 8 April 2022.

Advisers

In connection with the Rights Issue, Oasmia has appointed Danske Bank A/S, Danmark, Sverige Filial as financial adviser and Sole Bookrunner. Törngren Magnell & Partners Advokatfirma KB acts as legal adviser to the Company and Schjødt acts as legal adviser to Danske Bank.

On January 19, 2022 Natera reported the company, along with its collaborators, will present new data on Natera’s personalized, tumor-informed molecular residual disease (MRD) test, Signatera, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s 2022 Gastrointestinal Cancers Symposium (ASCO GI), taking place January 20 – 22, 2022 (Press release, Natera, JAN 19, 2022, View Source [SID1234605588]).

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!

Natera has two oral presentations and four collaborative poster presentations highlighting clinical findings on the performance of Signatera across colorectal (CRC), pancreatic and anal cancers. The oral presentations include an interim analysis from the GALAXY cohort of the CIRCULATE-Japan trial, based on 12-month outcomes from more than 1,000 patients, demonstrating how MRD testing can help predict treatment benefit for CRC patients post-surgery, regardless of stage. A second oral presentation addresses results from the first major study on the utility of MRD testing for patients with pancreatic cancer, compared to the standard of care biomarker CA19-9.

"The predictive data coming out of CIRCULATE-Japan is exceptional, and we think it has the potential to transform clinical practice in CRC," said Solomon Moshkevich, general manager of oncology at Natera. "We also look forward to presenting high-impact data from our pancreatic and other GI studies, further expanding the pan-cancer utility of Signatera’s personalized and tumor-informed method."

Natera and its collaborators will present the following studies:

Oral Abstract Session C: Cancers of the Colon, Rectum and Anus |
Presenter: Masahito Kotaka, M.D., Ph.D. | Jan. 22, 11:00 AM – 12:30 PM PST
Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorectal cancer from an observational GALAXY study in CIRCULATE-Japan

Oral Abstract Presentation: Emerging Roles of ctDNA on the Horizon of GI Cancers |
Presenter: Gregory Botta, M.D., Ph.D. | Jan. 20, 3:30 PM – 5:00 PM PST
Association of personalized and tumor-informed ctDNA with patient survival outcomes in pancreatic adenocarcinoma

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: Georges Azzi, M.D. | Jan. 22, 6:30 AM – 7:55 AM PST
Circulating tumor DNA-based molecular residual disease detection and recurrence monitoring in patients with advanced or metastatic anal squamous cell carcinoma

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: RuoBing Xue, M.D. | Jan. 22, 6:30 AM – 7:55 AM PST
Prospective study of the correlation of ctDNA with pathologic complete remission (pCR) and other efficacy outcomes in rectal cancer patients undergoing neoadjuvant chemotherapy and radiation

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: Sherise Rogers, M.D., M.P.H. | Jan. 22, 6:30 AM – 7:55 AM PST
A phase II randomized therapeutic optimization trial for subjects with refractory metastatic colorectal cancer using circulating tumor DNA (ctDNA): Rapid 1 trial

Poster Session C: Cancers of the Colon, Rectum, and Anus |
Presenter: Marwan Fakih, M.D. | Jan. 22, 6:30 AM – 7:55 AM PST
Exploratory biomarker analyses of the single-arm, phase 2 study of regorafenib plus nivolumab in patients (pts) with mismatch repair-proficient (pMMR)/microsatellite stable (MSS) colorectal cancer (CRC)

Additionally, Natera will host an investor call to discuss ASCO (Free ASCO Whitepaper) GI results:

Event:

ASCO GI Conference Data Review

Date:

Monday, Jan. 24, 2022

Time:

1:30 p.m. PT (4:30 p.m. ET)

Live Dial-In:

(877) 823-0171, Domestic

(617) 500-6932, International

Password:

7697903

Webcast:

View Source

A webcast replay will be available at investor.natera.com.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.