On November 18, 2021 Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) reported that the application for US market approval of its first product candidate Dasynoc (dasatinib) has been submitted, in accordance with plans, to the Food and Drug Administration (FDA) under the 505(b)(2) NDA procedure, which is the registration path that applies to improved drugs (Press release, Xspray, NOV 18, 2021, View Source [SID1234649575]).

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The application consists of the results from the registrational studies on healthy volunteers, where bioequivalence was achieved at about 30 percent lower dosage than the original drug, Sprycel. The studies confirms that:

Dasynoc is unaffected by the pH value of the stomach, and can thus be used in combination with proton-pump inhibitors such as omeprazole for treatment of peptic ulcers
Dasynoc has significantly lower variability than Sprycel, and did not demonstrate cases where there was no uptake of dasatinib at all in the subjects the uptake of Dasynoc is not affected by food intake Dasynoc can be administered at a lower dosage than the reference product, which is expected to yield fewer side effects
Under the application procedure, the FDA has up to 60 days to conduct an initial review of the company’s application, and afterward will announce whether the application is ready to continue to a complete review or if additional information is needed. If the application moves on to a full review, approval will take ten months but may also take longer depending on the questions from the FDA during the review process. The application will be supplemented with stability data for lower dosages of Dasynoc. The point in time at which this is to be done will be determined in consultation with the FDA.

The application includes Dasynoc for the treatment of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML), which are blood cancer indications in an area where only one new drug has been registered for a number of years. The leading product, Sprycel, sold globally for USD 2.1 billion in 2020, of which USD 1.3 billion was in the US.

"This is our first application for market approval, and it marks a major milestone for Xspray Pharma. Our unique technology is especially suited to overcoming many of the shortcomings that PKI substances generally possess, and the technology is applicable to a majority of the 72 PKIs being marketed today. In this way, we are now developing a portfolio of improved PKI drugs that create value for the company and make better quality of life possible for patients," says CEO Per Andersson.

On November 18, 2021 Ribonexus (previously Aglaia Therapeutics), a biotechnology startup developing promising new therapies that can overcome resistance to current targeted therapies in cancer patients, and French pharmaceutical group Pierre Fabre reported the signing of an exclusive license agreement on a series of Pierre Fabre patented small molecules targeting the Eukaryotic translation initiation factor 4A (eIF4A) (Press release, Pierre Fabre, NOV 18, 2021, https://ribonexus-project.com/wp-content/uploads/2022/11/2021-11-18-Ribonexus-Pierre-Fabre-EN.pdf [SID1234628868]). This target is highly expressed in a variety of solid and hematologic cancers, including melanoma, and associated with resistance to many current therapies. Inhibiting eIF4A appears therefore to be a promising therapeutic approach.

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In return for the license rights granted to Ribonexus, Pierre Fabre will receive development and sales milestones payments and royalties on future sales. Financial details are not disclosed.

To foster its pre-clinical development program, Ribonexus will benefit from Pierre Fabre’s knowledge and support on the pharmacology and chemistry of the licensed molecules.

Scientific co-founders of Ribonexus, Pr Caroline Robert, Head of the Dermatology Unit at Gustave Roussy Cancer Campus and Dr Stéphan Vagner, Research Director at Institut Curie, said: "While targeted therapies have dramatically improved cancer patient outcomes, global efficacy of these treatments decreases over time, with patients rapidly developing resistance to therapies. We aim to deliver best- and first- in class drugs that can restore sensitivity to current targeted therapies in those cancer patients."

"We are very pleased to enable a license agreement with a young French biotech company, whose strategic direction is based on the solid and recognized oncology expertise of its founders. This cooperation was an obvious choice for Pierre Fabre as we share with Ribonexus the same ambition to bring the best innovative treatments to cancer patients. We look forward to providing Ribonexus with our compounds directed against eIF4A, an emerging target to fight cancer and resistance to targeted therapies", added Francesco Hofmann, Head of R&D at Pierre Fabre Medical Care.

The startup changed its name to Ribonexus, effective since November 2021, to reflect the central role of eIF4A in the translation of specific mRNAs (messenger ribonucleic acids), cancer development and resistance to targeted therapies.

About the eIF4A target
EIF4A, an RNA helicase, is one of the three proteins composing the eIF4F complex, essential for the cap-dependent translation initiation of many oncogenic proteins.
The abnormal activity of this complex, observed in many cancers, leads to the synthesis of proteins involved in tumor
growth and metastasis. In addition, the selective translation of cellular mRNAs, controlled by this eIf4F complex, also
contributes to the resistance to cancer treatments such as targeted therapies and checkpoint inhibitors.

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]).

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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.

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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]).

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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.