On April 15, 2022 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that the Company has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (Press release, TG Therapeutics, APR 15, 2022, View Source [SID1234612319]). The decision to withdraw was based on recently updated overall survival (OS) data from the UNITY-CLL Phase 3 trial that showed an increasing imbalance in OS. Additional details are included below in the section entitled "ABOUT UNITY-CLL PHASE 3 TRIAL AND THE WITHDRAWAL OF THE BLA/sNDA SUBMISSION."

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In addition, the Company announced that it has voluntarily withdrawn UKONIQ from sale for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with follicular lymphoma (FL) who have received at least three prior systemic therapies. UKONIQ was granted accelerated approval in these indications in February 2021. The Company’s decision to withdraw UKONIQ from sale was primarily based on the withdrawal of the BLA and sNDA for U2 in CLL.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, "We were very disappointed to see that the recently updated overall survival data showed an increasing survival imbalance in favor of the control arm. Accordingly, we and our advisors determined that we should withdraw the BLA/sNDA for U2 in CLL. Additionally, we made the difficult decision to withdraw UKONIQ from sale for the approved indications in MZL/FL. We want to thank the patients, families and practitioners who worked with us in our search for novel treatment options for patients with B-cell malignancies."

Mr. Weiss continued, "While we had hoped to bring U2 to patients with CLL, this will now permit us to focus our attention, passion and energy to building out our multiple sclerosis and autoimmune platform. With our ublituximab BLA pending for patients with relapsing forms of multiple sclerosis and a PDUFA goal date of September 28, 2022, we are excited about the possibility of bringing ublituximab to patients with RMS. If approved, we believe the differentiated profile of ublituximab with its one-hour infusion will be welcomed by the MS community."

ABOUT UNITY-CLL PHASE 3 TRIAL AND THE WITHDRAWAL OF THE BLA/sNDA SUBMISSION
UNITY-CLL, a global, Phase 3, randomized, controlled clinical trial, compared the U2 combination, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial met its primary endpoint, with U2 significantly prolonging independent review committee (IRC) assessed progression-free survival (PFS) vs. the control arm. The UNITY-CLL Phase 3 trial was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Based on the results of the UNITY-CLL trial, a BLA and sNDA were submitted to the FDA for U2 to treat patients with CLL/SLL.

In November 2021, the FDA notified the Company that it planned to host an Oncologic Drug Advisory Committee (ODAC) meeting in connection with its review of the pending BLA/sNDA and to discuss the benefit risk of UKONIQ in its approved indications. While the FDA identified a number of concerns, the FDA’s desire to host an ODAC appeared to stem from an early ad hoc analysis of overall survival (OS) from the UNITY-CLL trial.

OS was designated as a secondary efficacy endpoint in the UNITY-CLL protocol but was not part of the primary analysis in accordance with the study’s statistical analysis plan agreed upon via a SPA, and therefore, was not analyzed or included in the BLA/sNDA. Additionally, the study was not powered for overall survival. As part of the ongoing review of the BLA/sNDA, the FDA requested an early analysis of OS from the UNITY-CLL trial. In a first analysis of OS using a cut-off date of September 2021, there was an imbalance in favor of the control arm (HR: 1.23). However, based on the ad hoc nature of the analysis, approximately 15% of patients had missing or outdated survival data. Further, when excluding deaths related to COVID-19, the two arms were approximately balanced (HR: 1.04). In February 2022, the Company submitted updated OS data with the same September 2021 cut-off date, but with reduced missing data and additional OS events, which showed an improvement from the previously reported OS data. Neither the original preliminary OS results nor the updated preliminary OS results were statistically significant.

Pursuant to a recent information request made by the FDA, updated OS data were collected that showed an increasing imbalance in favor of the control arm, differing from the improved results provided to the FDA in February 2022. Based on these new data, the Company decided to withdraw the pending BLA/sNDA for U2 to treat CLL/SLL and accordingly the April 22, 2022, ODAC meeting will be canceled.

In addition, based on the Company’s decision to withdraw UKONIQ from sale, we anticipate that the FDA will withdraw the accelerated approval for the product.

The FDA also has scheduled an ODAC meeting for April 21, 2022, in which it plans to discuss the appropriate approach for phosphatidylinositol-3-kinase inhibitors under development for treatment of hematologic malignancies. UKONIQ is within this class of drugs and may be discussed during this
meeting.

CONFERENCE CALL INFORMATION
The Company will host a conference call Monday, April 18, 2022, at 8:30 AM ET, to discuss the regulatory updates.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Update Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.

On April 15, 2022 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that the China National Medical Products Administration (NMPA) has granted approval to BeiGene’s anti-PD-1 antibody, tislelizumab, as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy (Press release, BeiGene, APR 15, 2022, View Source [SID1234612314]).

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"As a second-line treatment for patients with ESCC, this differentiated checkpoint inhibitor demonstrated significant improvements in overall survival and was generally well-tolerated in our Phase 3 trial of tislelizumab," commented Mark Lanasa, M.D., Ph.D., Senior Vice President, Chief Medical Officer, Solid Tumors, at BeiGene. "Tislelizumab regulatory submissions in this indication submitted by Novartis are under review by the U.S. FDA and the European Medicines Agency, highlighting our commitment to advancing its progress on behalf of the many patients around the world with ESCC and other forms of cancer."

"With eight approved indications in China, our science-based commercial team of more than 3,100+ professionals is working to make tislelizumab more broadly available to those in China who may benefit from this important immunotherapy," commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China, at BeiGene. "Today’s approval is a great step for patients in China with ESCC."

"The NMPA’s approval of tislelizumab is welcome news to patients with previously treated ESCC, for whom we are pleased to now be able to provide this new treatment option," said Lin Shen, Vice President of Clinical Oncology, Beijing Cancer Hospital, and the principal investigator of the trial. "The global Phase 3 clinical trial of tislelizumab demonstrated positive safety and efficacy outcomes as a second-line treatment for patients with ESCC, one of the most common malignant tumors in the digestive tract."

This approval was supported by clinical results from a randomized, open-label, multi-center, global Phase 3 clinical trial, RATIONALE 302 (NCT03430843), to evaluate the efficacy and safety of tislelizumab as a second-line treatment for patients with locally advanced or metastatic ESCC compared to chemotherapy. The primary endpoint of this trial is overall survival (OS) in the intent-to-treat (ITT) population; a key secondary endpoint is OS in patients with high PD-L1 expression (defined as visually-estimated combined positive score [vCPS] ≥10%); and other secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety. A total of 512 patients were enrolled in the trial in 11 countries and regions in Asia, Europe, and North America, randomized 1:1 to either the tislelizumab arm or chemotherapy arm (investigator’s choice of paclitaxel, docetaxel, or irinotecan). Results of this trial were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Tislelizumab is also under regulatory review in the U.S. and the European Union, submitted by Novartis in their licensed territories, as a second-line treatment for patients with locally advanced or metastatic ESCC.

About Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer is one of the most common malignant tumors in the digestive tract. As a country with a high incidence of esophageal cancer, China accounts for 53.7% of the world’s new cases of esophageal cancer and 55.7% of the world’s deaths every year.i Esophageal cancer is mainly divided into squamous cell cancer and adenocarcinoma. Esophageal squamous cell cancer is the dominant cancer worldwide (approximately 90%), and it accounts for more than 90% of esophageal cancer patients in China.ii

About Tislelizumab

Tislelizumab is an anti-programmed death receptor-1 (PD-1) inhibitor designed to help aid the body’s immune cells to detect and fight tumors. Tislelizumab, a humanized monoclonal antibody, is specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for eight indications, including multiple approvals in non-small cell lung cancer (NSCLC). Tislelizumab has been submitted for regulatory review in one additional indication in China and as a potential treatment for unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy in the U.S., and in NSCLC and ESCC in Europe. In January 2021, BeiGene announced a collaboration with Novartis to accelerate the clinical development and marketing of tislelizumab in North America, Europe and Japan.

Tislelizumab is not approved for use outside of China.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor, ociperlimab, that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On April 15, 2022, Foghorn Therapeutics Inc. (the "Company") reported that entered into a sales agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen") pursuant to which the Company may offer and sell shares of its common stock, $0.0001 par value per share ("Common Stock"), having an aggregate offering price of up to $200.0 million from time to time through Cowen as its sales agent (Filing, 8-K, Foghorn Therapeutics, APR 15, 2022, View Source [SID1234612313]). Sales of Common Stock through Cowen, if any, will be made by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including, without limitation, sales made directly on The Nasdaq Global Market or any other existing trading market for the Common Stock. Cowen will use commercially reasonable efforts to sell Common Stock from time to time, based upon instructions from the Company (including any price, time or size limits or other parameters or conditions the Company may impose). The Company will pay Cowen a commission of up to 3.0% of the gross sales price of any Common Stock sold through Cowen under the Sales Agreement. The Company has also provided Cowen with customary indemnification rights.

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The Company is not obligated to make any sales of Common Stock under the Sales Agreement. The offering of Common Stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Common Stock subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The Common Stock is being offered and sold pursuant to the Company’s previously filed and currently effective shelf registration statement on Form S-3, dated February 14, 2022, containing a base prospectus (Registration Statement No. 333-262711), as amended by Post-Effective Amendment No. 1 dated April 15, 2022, and a prospectus supplement, dated April 15, 2022.

On April 14, 2022 Ubix Therapeutics reported that it has entered into a research collaboration agreement with SK Biopharmaceuticals to develop new therapeutic compounds and medicines for a potential treatment of cancer (Press release, Ubix Therapeutics, APR 14, 2022, View Source [SID1234635866]).

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The two companies will develop anti-cancer treatments by using Ubix’s Degraducer platform technology, through the application of targeted protein degradation(TPD) and SK Biopharmaceutical’s drug development skills. TPD has been gaining attention as an emerging therapeutic modality that is able to "tackle and eliminate" proteins that cause cancer – an alternative to using conventional small molecules.

Under the terms of the agreement, Ubix Therapeutics and SK Biopharmaceuticals will jointly research and develop anti-cancer drugs, including immunotherapy.

SK Biopharmaceuticals will have exclusive option rights to the compounds after both sides successfully complete their early phase clinical trials. Ubix Therapeutics will be eligible to receive undisclosed upfront and milestone payments based on the progress in the development, as well as share profit with its new partner following commercialization.

"We are excited to forge ties with Ubix Therapeutics that is domestically leading the application of targeted protein degradation. SK Biopharmaceuticals will continue to join forces with new partners to further expand its CNS and oncology portfolio," said Cheol-Young Maeng, Chief Technology Officer and Vice President of SK Biopharmaceuticals.

"We are pleased to collaborate with SK Biopharmaceuticals, which has experience ranging from discovering drug candidates, conducting clinical trials to developing and commercializing global products in the central nervous system area. Through this partnership, we will successfully develop innovative anti-cancer drugs utilizing Ubix’s core platform technology." said BK Seo, CEO of Ubix Therapeutics.

On April 14, 2022 Market leading innovator in laboratory digital transformation, Scitara, reported a collaboration with scientific analytical technology leader, PerkinElmer (Press release, PerkinElmer, APR 14, 2022, View Source [SID1234613232]). The move will support the integration of the PerkinElmer Signals Research Suite informatics platform, which provides seamless, end-to-end scientific data and workflow management, with laboratory instruments, applications and resources via the Scitara Scientific Integration Platform SIP. The Scitara SIP provides a universal connectivity solution in a cloud native infrastructure that allows scientific laboratories using the PerkinElmer Signals platform to realize the full benefits of digital transformation. The combination of technologies facilitates a fully connected laboratory with standard data integrity, data mobility, system flexibility and user reconfigurability.

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This new connectivity aligns with PerkinElmer’s strategy of using its informatics offerings to drive digital transformation in the lab. Around the world today, more than 2 million scientists across pharmaceutical, agrochemical, advanced materials and food labs are using PerkinElmer’s cloud-based informatics solutions to capture, store, and analyze research data, collaborate, and support data-driven R&D and clinical decisions.

Ajit Nagral, founder and CEO of Scitara, said: "Our collaboration with PerkinElmer will create a new model of the modern lab, in which self-enabled scientists have timely access to the cross-functional data needed to advance science. The agile integration framework facilitated by the Scitara SIP adapts to changing work demands, facilitating on-the-fly workflow reconfiguration, rapid instrumentation deployment and best-of-breed informatics systems."

He added, "This comprehensive approach offers system flexibility as standard. It provides the ability to extract maximum value from legacy equipment, while dramatically lowering the barrier to introduce new, innovative technology into the connected lab. We drive data aggregation to any selected customer repository in an agile, compliant and future-proof solution. A breakthrough level of automation – from the simplest to the most complex tasks – is achieved while complying with the most stringent requirements of regulated markets."

Kevin Willoe, VP and General Manager, Informatics at PerkinElmer, Inc., commented on the collaboration further, stating: "The synergy between our two offerings, expertise areas and how we can help our respective customers, is exciting. Our market-leading informatics solutions empower scientists and researchers to improve productivity by leveraging the true value of their data. Use of the Scitara Scientific Integration Platform with our informatics solutions provides customers the ability and flexibility to work in a truly integrated laboratory environment. This will help tie together instruments, software and systems and support our customers in curating data in a standardized platform. This is the power of the lab of the future in action."

As the pharmaceutical and biopharmaceutical industries come under growing pressure to bring new drugs to market faster and more cost-effectively, they increasingly depend on new technology to support their goals. The ability to integrate the SIP infrastructure with the PerkinElmer Signals Research platform presents a new approach to data management that will enhance collaboration and drive lab automation. Integrated scientific data can also be used in tandem with AI and analytics tools, providing scientists with new insights to drive faster decision making and turn data into knowledge, helping accelerate products to market.

To learn more, join our webinar on April 27th at 11am EST.