On November 8, 2021 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) reported that the board of directors has resolved on a directed new share issue of 1,612,904 shares at a price of SEK 62 per share, corresponding to in total approximately SEK 100 million (Press release, Xspray, NOV 8, 2021, View Source [SID1234649574]).

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The board of directors of Xspray Pharma has, based on the authorisation granted by the annual general meeting on 20 May 2021, resolved on a directed new share issue of 1,612,904 shares. The subscription price in the directed new share issue is set to SEK 62 per share, which has been determined based on the volume-weighted average share price of Xspray Pharma’s share on Nasdaq Stockholm during the five-day period ending on 5 November 2021. The company receives approximately SEK 100 million through the directed new share issue.

The shares have been subscribed by Flerie Invest, a Swedish investment company in biotechnology and pharmaceuticals, founded by Thomas Eldered. As Xspray Pharma has chosen to increase its focus on the improved version of dasatinib, Dasynoc , the proceeds from the share issue will mainly be used to strengthen the development of the company’s presence in the US, primarily with the strategic marketing resources needed for the market launch of Dasynoc. Resources will also be invested in accelerating the development of the fast-growing portfolio.

"Xspray Pharma has a very promising and growing product portfolio where Dasynoc is now facing the application for market approval at the same time as HyNap-Nilo will undergo studies and registration-based studies. Several products in the early phase will also reach the clinical development stage within the next year. It is of course very gratifying that Flerie Invest, in this important phase for Xspray Pharma, chooses to invest in the company. Flerie Invest is a specialized and long-term investor whose management has a deep and broad competence and experience in commercial pharmaceutical production. They also have a very strong network of contacts in the global pharmaceutical industry. Flerie Invest will be a very valuable addition to Xspray Pharma’s shareholder base", says Per Andersson, CEO of Xspray Pharma.

"We have been following Xspray Pharma for a long time and are impressed with the potential in the company’s unique technology. The recently decided focus on improved PKIs, and not pure generics, makes the company even more interesting. The improved drugs have the potential to provide fewer side effects and better effects and thus constitute essential therapies for affected patients. We therefore look forward to being involved in the company’s continued development", comments Thomas Eldered, founder and board member of Flerie Invest.

The board of directors has resolved on the issue by utilizing the authorisation granted by the annual general meeting and the reason for the deviation from the shareholders’ preferential rights is that the board of directors considers that the investment from Flerie Invest is for Xspray Pharma, and thus for its shareholders, the most advantageous way to raise capital in a time and cost-efficient manner and in the meanwhile onboarding a reputable, specialized and a long-term investor.

In its deliberations, the board of directors has further taken into account that there are no time- and cost-effective ways to successfully carry out a rights issue on terms favorable to the company, that the subscription price negotiated with Flerie Invest at arm’s length is not discounted but has been based on the volume-weighted average price of Xspray Pharma’s share during the five-day period ending on 5 November 2021, the last trading day before the issue resolution, and that Flerie Invest is not previously a shareholder in Xspray Pharma. The board of directors’ overall assessment is thus that there are good reasons to deviate from the preferential rights and carry out a directed new share issue.

Flerie Invest has, in connection with the share issue, agreed not to sell any shares in Xspray Pharma during a lock-up period of 360 days, subject to customary exceptions. In connection with the share issue, Xspray Pharma has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 90 days.

Through the directed new share issue, the total number of shares and votes will increase by 1,612,904, from 19,067,504 to 20,680,408, which corresponds to a dilution of approximately 7.8 percent based on the total number of shares and votes in Xspray Pharma after the directed new share issue. The share capital increases with SEK 1,612,904, from SEK 19,067,504 to SEK 20,680,408.

Xspray Pharma has, in connection with the directed new share issue, appointed Advokatfirman Vinge as legal advisor.

On November 8, 2021 Kronos Bio, Inc, a company dedicated to transforming the lives of those affected by cancer, and Tempus, a leader in artificial intelligence and precision medicine, reported a multi-year collaboration that provides Kronos Bio with access to Tempus’ real-world genomic and transcriptomic data and data analytics tools (Press release, Kronos Bio, NOV 8, 2021, View Source [SID1234643240]).

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Under the agreement, Kronos Bio will have access to a number of precision medicine tools, including Tempus’ modeling lab, which houses a growing repository of molecularly profiled organoids. Access to such data and tools will help Kronos Bio accelerate the preclinical and clinical development of its current and future portfolio, by for example, using organoid models to generate biomarker hypotheses that can be tested in the clinic or in virtual molecularly defined patient cohorts drawn from Tempus’ extensive data sets.

The collaboration builds on an earlier agreement announced in February under which Tempus is performing molecular characterization of tumor samples from patients enrolled in Kronos Bio’s Phase 1/2 clinical study of the company’s CDK9 inhibitor KB-0742. Tempus will retrospectively sequence and analyze these patient samples to assess the relationship between MYC copy number, MYC expression levels and clinical response. Tempus will also explore a path to developing a companion diagnostic.

The expanded relationship leverages Kronos Bio’s deep expertise in transcriptional regulation and Tempus’ next-generation-sequencing capabilities, as well as drawing on each company’s computational biology capabilities. Kronos Bio also has the option to join Tempus’ TIME Trial Network, which supports rapid patient identification, site activation and enrollment of select clinical trials.

"With a shared commitment to improving patient outcomes, we are building upon our existing work with Kronos Bio to advance the company’s portfolio of clinical programs, including lanraplenib and KB-0742," said Marc Yoskowitz, executive vice president and chief strategy officer for Life Sciences at Tempus. "We look forward to harnessing the strength of our entire platform to support the discovery and development of novel cancer therapeutics."

The capabilities provided under the expanded agreement offer Kronos Bio the opportunity to access real-world data to further refine current understanding of transcription regulatory networks (TRNs), which could help accelerate clinical development.

"This partnership will bring together Kronos Bio’s knowledge and experience with transcriptional regulatory networks and Tempus’ sequencing expertise and exceptional data analytics tools and organoid models," said Jorge DiMartino, M.D., Ph.D., chief medical officer and executive vice president, Clinical Development at Kronos Bio. "We are looking forward to working together now and in the future, as we continue to progress our current clinical candidates, test rational combinations, and bring forward new ones, with the goal of getting medicines to patients as quickly as possible."

On November 8, 2021 Leadingtac Bio, a company in Zhangjiang Science City announced the completion of a Pre-A round of financing led by Yuan Sheng Venture Capital, with additional investment from long-time shareholder ZJ LEADING VC (Press release, Leadingtac Pharmaceutical, NOV 8, 2021, View Source [SID1234640717]). This funding round will be used primarily to advance the company’s first Protein Degrader pipeline for autoimmune disease treatment to the clinical research stage and to develop follow-on programs and pipelines, including oncology and other autoimmune diseases. With the previous angel round, Leadingtac has raised nearly 100 million RMB in cumulative early-stage financing.

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Leadingtac Bio was founded by Dr. Yan Feng in September 2019 in Zhangjiang Science Park. The company’s R&D direction is dedicated to the development of target protein degradation drugs and focuses on disease areas such as autoimmunity and oncology to address unmet clinical needs.

The target protein degradation drug is a bifunctional small molecule compound, a ligand that binds the target protein at one end and E3 ubiquitin ligase at the other. A Linker connects the ligands to form a complex that draws the target protein closer to the E3 ligase and promotes the ubiquitination of the target protein, which is then degraded through the ubiquitin-proteasome pathway to remove the disease-causing target protein. Targeted protein degradation drugs are characterized by high drug-forming ability, overcoming drug resistance, small dosage, low toxicity, and drug resistance. Therefore, this research direction has received close attention from domestic and international pharmaceutical companies and capital markets.

Since its inception, the company has taken the mission of "leading innovation, Thailand’s people", based on the source of innovation in new drug development, looking for new targets, using protein degradation technology to develop new small molecule drugs that are currently not drug-ready targets, to provide maximum therapeutic value for patients. As a result, we have developed a series of lead compounds with fully independent intellectual property rights based on our Nano-SPUD platform for specific protein ubiquitination and degradation drug discovery. The company’s fastest progressing project is the LT001 project for autoimmune diseases. The project has obtained expected results from a series of in vitro and in vivo experiments, such as degradation activity, pharmacokinetics, and efficacy, and has already carried out IND-enabling studies, which are expected to be submitted to IND at the end of 2022 and enter clinical trials in 2023. In addition, Leadingtac is also actively developing several pipeline projects.

Dr. Yan Feng, the founder of Leadingtac Bio, said, "As a significant direction for future drug development, the development of targeted protein degradation drugs (Protein Degrader) has received much attention from academia, the pharmaceutical industry, and the capital market in the past few years. As a newcomer in this field, Leadingtac has developed its R&D technology platform and pipeline within two years of its efforts. One of the pipelines will enter the clinical filing stage soon. In this financing round, Leadingtac was honored to receive the approval and lead investment from Yuan Sheng Venture Capital, and ZJ LEADING VC also decided to continue to invest. We are very grateful to our new and old investors for their recognition and support. This financing round will help to rapidly advance the clinical filing of Leadingtac’s first pipeline and also provide a strong guarantee for developing several subsequent projects, high-end talent team building, and site expansion. I believe that with the help of our investors and the efforts of the team at Leadingtac, we will be able to maximize our potential for new drug development and make greater contributions to the pharmaceutical field!"

Jay Chen, Founding Partner of Yuan Sheng Ventures, said, "We are pleased to invest in Leadingtac as the lead investor in this round. As a newcomer in the field of Protein Degrader, Leadingtac Bio has established a more mature technology platform, the first product has also started the filing of IND, and the subsequent product pipeline is various and has great potential for development. As a result, we believe Leadingtac Bio will have great international competitiveness in the future."

Yu Xiaoyong, the founding managing partner of ZJ LEADING VC, said, "We congratulate Leadingtac on the completion of this financing round. As the round angel investor of Leadingtac, we had the honor to work with Dr. Yan Feng two years ago to help Leadingtac plow through the new drug development track of protein degradation. Over the past two years, we have witnessed the continuous growth of Leadingtac’s team and the company together and have gained a deep understanding of the company’s continuous innovation powerhouse, which is why we have sufficient confidence in Leadingtac’s future development, and that is why we continue to invest in this round. We believe that after this round of financing, Leadingtac Bio will continue to achieve good results in the advancement of clinical filing projects, the layout of pipeline projects, and the reinforcement of the team."

On November 8, 2021 iOnctura SA, a clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface, reported it has fully enrolled the metastatic uveal melanoma expansion cohort of the DIONE-01 study evaluating iOnctura’s lead compound, the selective PI3Kδ inhibitor IOA-244 (Press release, iOnctura, NOV 8, 2021, View Source [SID1234640243]).

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The DIONE-01 study entitled "A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients with Metastatic Cancers" (NCT04328844) consists of two parts, A and B. In Part A, now complete, the objective was to determine the safety, tolerability, and dosage of IOA-244 in cancer patients to determine the predicted biologically effective dose range. Safety, PK and PD data from Part A will be presented as a poster (#405) at ESMO (Free ESMO Whitepaper) IO in Geneva between December 8-11, 2021.

Part B of the DIONE-01 study consists of expansion cohorts of patients with different tumor types, including patients with metastatic uveal melanoma. It will include the assessment of whether IOA-244 can increase the anti-tumor immune response in patients both as monotherapy and in combination with pemetrexed/cisplatin and an immune checkpoint inhibitor. The study will enroll up to 182 patients with uveal melanoma, cutaneous melanoma, NSCLC, mesothelioma, myelofibrosis, and NHL.

Within Part B, up to 26 patients with metastatic uveal melanoma will be recruited to determine the monotherapy activity of IOA-244. Patients with metastatic uveal melanoma currently have no approved treatment options. Positive outcome from this part of the trial is expected to support transition to subsequent registration studies for metastatic uveal melanoma. Interim data is expected in Q2 2022 with final top-line data scheduled for Q4 2022.

"iOnctura is entering a highly exciting phase as it progresses two tumor-stroma-immune interface targeting programs through clinical development. IOA-244 continues to demonstrate an unprecedented clinical profile among PI3Kδ inhibitors," said Catherine Pickering, CEO of iOnctura. "iOnctura is moving rapidly in the use of IOA-244 to treat a range of solid tumor types including metastatic uveal melanoma, an underserved cancer with no currently approved drug treatments and poor patient outcomes. We look forward to releasing early data from our preclinical and clinical evaluations of this exceptional molecule at ESMO (Free ESMO Whitepaper) IO."

Contacts

iOnctura
Catherine Pickering
Chief Executive Officer
T : +41 79 952 72 52
E: [email protected]

Press Relations
Jeremy Nieckowski
LifeSci Advisors
T: +41 79 699 97 27
E: [email protected]
iOnctura SA is clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface. iOnctura’s best-in-class drug development programs combine immune-mediated and direct anti-tumor activity to deliver molecules with superior clinical efficacy and safety in oncology. Its lead program, IOA-244 is the only semi-allosteric PI3Kδ specific, orally dosed, small molecule inhibitor that is being developed in solid and hematologic malignancies to address tumor and stroma induced immune suppression. IOA-244 is currently in a Phase 1 study which will support transition to subsequent registration studies. iOnctura’s second program, IOA-289, is an oral small molecule that inhibits the cross-talk between the tumor and its stroma and is in a Phase 1 study. iOnctura is backed by blue chip investors including M Ventures, Inkef Capital, VI Partners, Schroders Capital, and 3B Future Health Fund. For more information, please visit www.ionctura.com

IOA-244 is a PI3Kδ specific, orally dosed, small molecule inhibitor that overcomes tumor and stroma induced immune suppression. Its unique chemistry, semi allosteric binding mode and mechanism of action contribute to its unprecedented clinical profile. IOA-244 is currently in the cohort expansion phase of the DIONE-01 trial, a two-part, first-in-human dose study evaluating IOA-244 in solid tumors and hematologic malignancies and as a combination partner for conventional and immune-therapies.

Uveal melanoma (UM) is a rare malignancy arising within the uveal tract of the eye. There are approximately 7,000 newly diagnosed cases of uveal melanoma each year (around 2,000 in the United States). Over 50% of patients will progress to metastatic disease. Median overall survival is approximately 1 year for metastatic uveal melanoma and there are no approved therapies.

On November 8, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into a strategic agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for the sale of RedHill’s American Depositary Shares ("ADSs") in a private placement of up to $10 million at a 20% premium to the prior 30 trading days’ volume weighted average price ("VWAP") (Press release, RedHill Biopharma, NOV 8, 2021, View Source [SID1234595344]).

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Kukbo’s strategic investment in RedHill is to be made in two tranches, with the first tranche of $5 million already paid and the second tranche of $5 million to follow within six months, subject to satisfaction of certain conditions. As part of the first tranche, RedHill is to issue 827,586 ADSs at a purchase price of $6.04, representing a 20% premium based on the VWAP of RedHill’s ADS on NASDAQ over the 30 trading days ending on the effective date. All ADSs are to be issued with a 180-day transfer restriction.

In addition, under the terms of the agreement, RedHill has agreed to grant Kukbo a right of first offer, for a period of six months, for a license with respect to one or more of RedHill’s late-stage clinical assets, opaganib, RHB-107 (upamostat)1 and Talicia, for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and Malaysia. Kukbo has the right to elect not to purchase the ADSs in the second tranche if no such license agreement is executed within six months of the closing of the first tranche.

Dror Ben-Asher, RedHill’s CEO said: "We are rapidly advancing with opaganib’s COVID-19 data package submissions to regulators in several territories including the U.S., EU and others, ahead of planned regulatory advice. We are pleased with the addition of Kukbo as a committed strategic investor and look forward to evaluating opportunities for opaganib, RHB-107 and Talicia in South Korea and other territories in Asia where large unmet medical needs exist."

"As Kukbo proceeds in its planned strategic expansion into healthcare, we believe that RedHill’s opaganib, RHB-107 and Talicia, if approved, hold substantial promise in South Korea and other Asian countries and are eager to leverage our local expertise and network in those territories," said Hyun Ha, Kukbo’s CEO.

Nexpedia Holdings Co., Ltd. and Network 1 Financial Securities, Inc. facilitated the introduction between the parties.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation, or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.