On November 18, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that $30 million in commitments have been secured in a private placement of common shares for its private affiliate, Beyond Cancer (Press release, Beyond Air, NOV 18, 2021, View Source [SID1234595852]).

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!

Transaction Details
Beyond Cancer has secured commitments of $30.0 million in a private placement of common shares, providing these investors with a 20% equity ownership. The funding is expected to be used to accelerate ongoing preclinical work including the completion of IND-enabling studies, completion of a Phase 1 human study, expansion of preclinical programs for combination studies, hiring of additional Beyond Cancer team members, and optimization of the delivery system, as well as for general corporate purposes. The transaction is expected to close later this quarter.

The common shares to be sold in the private placement have been offered only to certain institutional and/or accredited investors in reliance upon an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"). The common shares have not been registered under the Securities Act or any state or other securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements of the Securities Act and applicable state securities laws. The Securities and Exchange Commission has not passed upon the merits of or given its approval to the common shares, the terms of the private placement or the accuracy or completeness of any private placement materials. The common shares sold in the private placement are subject to legal and contractual restrictions on transfer.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification or otherwise under the securities laws of any such state or jurisdiction.

On November 18, 2021 Pharma Two B Ltd., a privately held company developing innovative therapeutics based on reformulation of previously approved drugs for neurological indications, reported that it has entered into an exclusive licensing agreement with Myung In Pharm Co. Ltd ("Myung In Pharm") to commercialize P2B001 for Parkinson’s disease (PD) in South Korea (Press release, Pharma Two B, NOV 18, 2021, View Source [SID1234595837]). In addition, Myung In Pharm invested $5 million of equity in Pharma Two B.

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!

P2B001 is a novel fixed-dose combination of low dose extended release (ER) formulations of pramipexole (dopamine agonist) and proprietary ER rasagiline (monoamine oxidase-B inhibitor), both widely-prescribed drugs for PD. Based on the potential synergism of these two ER drugs working through different mechanisms, P2B001 was designed to address an unmet medical need, being highly effective with minimal side effects, especially for early-stage patients. It has been formulated in a convenient, once-daily pill, with no titration required.

"We are extremely pleased to enter this licensing agreement for P2B001 and look forward to building a long-term relationship with Myung In Pharm in South Korea," said Dr. Sheila Oren, M.D., M.B.A., Chief Executive Officer of Pharma Two B. "Myung In Pharm has an excellent track record of successfully launching and marketing pharmaceutical products in South Korea, and has particular expertise in CNS products, including treatments for PD."

Under the terms of the agreement, Myung In Pharm will seek regulatory approval for P2B001 in South Korea and will manufacture, commercialize and distribute P2B001 in the region. Myung In Pharm will be responsible for all expenses related to the registration, sales, marketing and distribution of P2B001 in South Korea. In addition to the $5 million equity investment by Myung In Pharm, Pharma Two B is entitled to royalties on sales of P2B001 in the region.

Hang-Myung Lee, President of Myung In Pharm commented, "P2B001 has the potential to be a valuable new treatment for PD and the product is a strategic fit for Myung In Pharm. CNS is one of our core areas and we believe that P2B001 will strengthen our presence in the field, if approved. We look forward to working with Pharma Two B to bring this much needed treatment for PD patients in South Korea."

Pharma Two B recently completed its multinational Phase III study of P2B001 in early PD. The pivotal study was conducted at 70 sites in North America and the EU. Top line results are expected by the end of the fourth quarter of 2021. For more information, refer to ClinicalTrials.gov Identifier: NCT03329508.

On November 18, 2021 NuCana plc (NASDAQ: NCNA) reported that financial results for the third quarter ended September 30, 2021 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, NOV 18, 2021, View Source [SID1234595833]).

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 of September 30, 2021, NuCana had cash and cash equivalents of £71.0 million compared to £73.4 million at June 30, 2021 and £87.4 million as of December 31, 2020. NuCana continues to advance its various clinical programs and reported a net loss of £8.0 million for the quarter ended September 30, 2021, as compared to a loss of £8.4 million for the quarter ended September 30, 2020. Basic and diluted loss per share was £0.15 for the quarter ended September 30, 2021, as compared to £0.24 per share for quarter ended September 30, 2020.

"NuCana had a very productive third quarter," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "We completed enrollment of 418 evaluable patients required to conduct the first interim analysis in the Phase III study (NuTide:121) evaluating Acelarin combined with cisplatin compared to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer. We believe that a statistically significant improvement in the Objective Response Rate (ORR) at the first interim analysis, accompanied by positive trends in other endpoints, has the potential to allow for accelerated approval of a new drug application (NDA) for Acelarin in the United States. We look forward to announcing the outcome of the first interim analysis in the first half of 2022."

Mr. Griffith continued: "Additionally, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Acelarin (NUC-1031) for the treatment of patients with biliary tract cancer. With both Fast Track and Orphan Drug designations in place, we look forward to working closely with the FDA in our efforts to gain approval for Acelarin as the first approved front-line treatment option for patients with biliary tract cancer."

"We also announced positive data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 for three of our programs: NUC-3373 in patients with advanced colorectal cancer (NuTide:302); NUC-3373 in patients with advanced solid tumors (NuTide:301); and NUC-7738 in patients with advanced solid tumors (NuTide:701)," said Mr. Griffith. "Building on the exciting data presentations we made earlier in the year at AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper) GI, the data presented at ESMO (Free ESMO Whitepaper) continue to support the broad potential of our ProTide technology by demonstrating encouraging efficacy signals, durable anti-cancer activity and favorable safety and pharmacokinetic profiles."

Mr. Griffith added: "We would like to express our sincere appreciation to Rafaèle Tordjman who retired as a director in September after ten years on the NuCana Board. We are also pleased to have welcomed Elliott Levy, who was most recently SVP of Global Development and R&D Strategy at Amgen, to the NuCana Board in November."

Mr. Griffith concluded: "Throughout the remainder of 2021 and in the first half of 2022, we look forward to achieving multiple milestones, including: initiating a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer, subject to anticipated regulatory feedback; reporting additional data from the Phase Ib / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer; and initiating and reporting data from the Phase II study of NUC-7738 in patients with solid tumors."

Anticipated Milestones: Q4 2021 & H1 2022

•Acelarin (a ProTide transformation of gemcitabine)

In the first half of 2022, NuCana expects to:

•Announce whether the overall response rate objective for the first interim data from the Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer has been met, which may allow for accelerated approval of an NDA submission in the United States.

•NUC-3373 (a ProTide transformation of 5-FU)

In Q4 2021, NuCana expects to:

•Initiate a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer, subject to anticipated regulatory feedback.

In the first half of 2022, NuCana expects to:

•Initiate a Phase Ib / Phase II basket study of NUC-3373 in combination with other agents in a variety of solid tumors; and
•Expand the Phase Ib / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer to include second-line colorectal cancer patients, as well as evaluate NUC-3373 in combination with monoclonal antibodies such as bevacizumab (Avastin).

•NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In Q4 2021, NuCana expects to:

•Initiate the Phase II study of NUC-7738 in patients with solid tumors.
In the first half of 2022, NuCana expects to:

Report data from the Phase II study of NUC-7738 in patients with solid tumors.

On November 18, 2021 Nordic Nanovector ASA (OSE: NANOV) reported its results for the third quarter 2021 (Press release, Nordic Nanovector, NOV 18, 2021, View Source [SID1234595831]). A presentation by Nordic Nanovector’s senior management team will be held in-person today in Oslo and webcast live beginning at 8:30am CET – details below.

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!

Erik Skullerud, CEO of Nordic Nanovector, said: "We are entering an exciting period for Nordic Nanovector, as the Company draws closer to completing patient recruitment for the PARADIGME trial, for which we expect readout of preliminary data in H1′ 2022. The Company is convinced that Betalutin is uniquely positioned to meet the need for a chemo-free, effective yet tolerable treatment for non-Hodgkin’s lymphoma patients, coupled with a convenient administration schedule. In the meantime, we look forward to sharing our vision for Nordic Nanovector and Betalutin as well as an update on our pipeline at our R&D day on 30 November."

Operational Highlights

102 of a targeted 120 patients have been enrolled into the pivotal PARADIGME Phase 2b trial for Betalutin as of 17 November 2021 (94 patients enrolled as of 26 August 2021)
Three patients were enrolled in the same quarter in 2020
Preliminary three-month data readout expected during H1’2022, following timeline revisions announced on 3 August 2021
Erik Skullerud appointed as new Chief Executive Officer (CEO)
Mr Skullerud brings more than 25 years’ experience in the biopharma industry including more than 15 years at Amgen, including as Marketing Director Europe Oncology/Hematology, and seven years at Bayer
He has launched numerous highly innovative products in therapeutic areas including oncology and haematology, and as a consultant, he has worked with some of the world’s top pharma and biotech companies as well as small, highly specialised start-ups on a wide range of projects
Pierre Dodion MD appointed as Chief Medical Officer
Dr Dodion has over 30 years’ experience in the biopharmaceutical industry, spent mostly in the oncology and haematology areas. He brings deep clinical development and medical affairs expertise and has provided strategic insight and overseen multiple clinical trials
Nordic Nanovector announced its support for The Health Policy Partnership’s initiative to improve readiness for the use of radioimmunotherapy and to facilitate appropriate integration of this innovative cancer treatment modality in lymphoma
The Company entered a research collaboration with the University of Pennsylvania to generate a novel CD37-targeting CAR-T cell therapy approach as a potential treatment for patients with B-cell malignancies
Nordic Nanovector will have an option to license exclusive worldwide rights to any CD37-targeting CAR-T cells that result from the collaboration
Financial Highlights

(Figures in brackets = same period 2020 unless otherwise stated)

Revenues for the third quarter 2021 and the first nine months of 2021 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the third quarter 2021 were NOK 104.3 million (NOK 88.1 million). Total operating expenses for the first nine months of 2021 were NOK 309.3 million (NOK 327.3 million)
Comprehensive loss for the third quarter 2021 amounted to NOK 103.6 million (loss of NOK 88.2 million). Comprehensive loss for the first nine months of 2021 was NOK 307.6 (NOK 305.4 million)
Cash and cash equivalents amounted to NOK 369.5 million at the end of September 2021, compared to NOK 450.1 million at the end of June 2021, and NOK 294.0 million at the end of December 2020
Outlook

Nordic Nanovector is close to completing patient enrolment into PARADIGME and is targeting the readout of preliminary three-month top line data during H1’2022.

The company’s current cash position will support its operations into H2’2022 and will enable further preparatory work on the potential Betalutin BLA filing and planning for commercialisation to be undertaken.

The company believes that, if positive, the PARADIGME trial data could represent a significant value inflection point for the company and its shareholders, confirming Betalutin as a highly promising new targeted radioimmunotherapy that can address the unmet needs of R/R FL patients.

The company intends to discuss the development plan and opportunities for expanding the market for Betalutin into other NHL indications, together with other potential areas for pipeline expansion and collaboration based on CD37-targeting immunotherapies, at its R&D Day, which is planned to take place on 30 November 2021.

Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place in Oslo today at 8:30am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: Bjørvika

The presentation will webcast live and will be available at www.nordicnanovector.com in the section: Investors & Media.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2021.

On November 18, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that results from the investigator-initiated phase II clinical study in patients with squamous cell carcinoma (SCC) has been published in JAMA Dermatology by Kilgour, JM et al (doi:10.1001/jamadermatol.2021.4549) (Press release, Medivir, NOV 18, 2021, View Source [SID1234595830]). The primary objective of the study was to assess the effects of topical remetinostat on biopsy-proven SCC and SCC in situ tumors. This clinical study was conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin. Medivir is providing remetinostat drug supply for this study, and has full access to, and the rights to use, all clinical data after the study is complete.

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!

Four patients with five biopsy-proven cutaneous SCCs were included in this case series and treated with remetinostat gel 1%. All five tumours, including a range of histological subtypes, demonstrated complete clinical and pathological resolution at week 10. All patients experienced a localized cutaneous reaction in response to the treatment, which required one patient to discontinue therapy. No systemic adverse events were reported. Further details of the study can be found at www.clinicaltrials.gov, reference number NCT03875859.

– "This study further supports the potential of remetinostat to be used in multiple skin-associated cancers beyond cutaneous T-cell lymphoma (CTCL)" said Magnus Christensen, interim CEO of Medivir.

About squamous cell carcinoma

Squamous cell carcinoma (SCC) is the second most common form of cancer in humans occurring in the skin. Surgical excision is standard of care and there are currently no marketed products approved for the treatment of SCC. Other therapies for SCC exist, such as imiquimod, 5-fluorouracil and photodynamic therapy, however their use is limited to SCC in situ (SCCIS). There is a clear need for efficacious and safe treatments when surgery is impractical, e.g. multiple lesions and/or difficult treatment sites.

About remetinostat

Remetinostat is a topical histone deacetylase (HDAC) inhibitor. A clinical phase II study in mycosis-fungoides cutaneous T-cell lymphoma (MF-CTCL) has been completed demonstrating that remetinostat reduced severity of CTCL skin lesions with an objective response rate (ORR) of 40%. The study also showed a clinically significant reduction in the severity of pruritus (itching) in 80% of the patients. In addition, two investigator-initiated phase II studies have been conducted at Stanford University in the USA, demonstrating efficacy in both Basal Cell Carcinoma (BCC) and cutaneous Squamous Cell Carcinoma (SCC).