On March 5, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported that the company will be available for 1×1 meetings at the following upcoming conferences (Press release, Cellectar Biosciences, MAR 5, 2021, View Source [SID1234576146]):

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H.C. Wainwright Global Life Sciences Conference
Date: March 9-10, 2021
Time: Available for 1×1 meetings
To schedule, click on the link HERE

Roth Capital Partners 33rd Annual Conference
Date: March 15-17, 2021
Time: Available for 1×1 meetings
To schedule, click on the link HERE
The company’s presentation is available for on-demand viewing in the link HERE.

On March 5, 2021 Seagen Inc. (Nasdaq:SGEN) reported that it has been notified of an unsolicited "mini-tender" offer dated February 22, 2021, made by TRC Capital Investment Corporation, an Ontario, Canada corporation, to purchase up to 1,000,000 shares of Seagen’s common stock (Press release, Seagen, MAR 5, 2021, View Source [SID1234576145]). According to TRC, its "mini-tender" offer price of $151.00 per share was approximately 4.28% below the closing price of Seagen’s common stock on February 19, 2021, the last trading day prior to the date of its offer.

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Seagen does not endorse TRC Capital’s unsolicited "mini-tender" offer and is not associated in any way with TRC Capital, its "mini-tender" offer, or its "mini-tender" offer documents. Seagen recommends that Seagen shareholders reject the offer and not tender their shares in response to this unsolicited offer, for the reasons described below.

TRC has made many similar "mini-tender" offers for the shares of other companies. "Mini-tender" offers are designed to seek less than five percent of a company’s outstanding shares, thereby avoiding many disclosure and procedural requirements of the U.S. Securities and Exchange Commission (SEC) because they are below the SEC’s threshold to provide such disclosure and procedural protections for investors.

The SEC has cautioned investors about "mini-tender" offers in an investor alert. The SEC noted that these offers "have been increasingly used to catch investors off guard" and that many investors who hear about "mini-tender" offers "surrender their securities without investigating the offer, assuming that the price offered includes the premium usually present in larger, traditional tender offers."

To read more about the risks of "mini-tender" offers, please review the alert on the SEC’s website at View Source

TRC’s "mini-tender" offer is subject to numerous conditions, including TRC obtaining sufficient financing available to consummate the offer on terms satisfactory to TRC in its reasonable discretion. Seagen urges shareholders to obtain current stock quotes for their shares of Seagen common stock, review the terms and conditions to the offer, consult with their broker or financial adviser and exercise caution with respect to TRC Capital’s "mini-tender" offer. Shareholders who have already tendered shares should consider the advisability of withdrawing their shares as permitted under TRC’s Offer to Purchase documents.

According to the offer documents, the offer is currently scheduled to expire at 12:01 a.m., Eastern time, on March 23, 2021.

Seagen requests that a copy of this news release be included with all distributions of materials relating to TRC’s "mini-tender" offer related to shares of Seagen’s common stock.

On March 5, 2021 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that Vaccibody has decided to change its financial reporting from NGAAP (Norwegian Generally Accepted Accounting Principles) and instead adopt IFRS (International Financial Reporting Standards) as its new accounting standard (Press release, Vaccibody, MAR 5, 2021, View Source [SID1234576141]).

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Vaccibody has experienced a continued growing international interest in its stock, including a significant increase in its international investor base which has led to the Company’s decision to change its accounting standard to IFRS. The above change will be adopted with effect from the Company’s annual report as of the financial year 2020.

In addition, Vaccibody has initiated a process to explore a possible listing of Vaccibody on the Nasdaq Global Market in the United States. This process reflects the continued clinical and strategic advancement of Vaccibody’s portfolio of innovative vaccines and novel immunotherapies as well as the growing interest of international investors in Vaccibody. The timing of any potential listing will be considered as part of this review process and any potential listing would be subject to prevailing equity capital markets conditions at such possible relevant time.

On March 5, 2021 Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), reported that The Lancet has published data from the pirtobrutinib (previously referred to as LOXO-305) global Phase 1/2 BRUIN clinical trial in relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin’s lymphomas (Press release, Eli Lilly, MAR 5, 2021, View Source [SID1234576138]). Pirtobrutinib is an investigational, highly selective, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor.

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The data in the publication include key findings previously presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The publication includes safety and efficacy data for 323 relapsed or refractory patients (including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström’s macroglobulinemia and 66 with other B-cell lymphomas) that were enrolled to the BRUIN Phase 1/2 trial as of September 27, 2020.

"Patients with B-cell malignancies who have been previously treated with the most commonly used regimens represent an area of growing and urgent unmet need", said Anthony Mato, M.D., director of the CLL Program at Memorial Sloan Kettering Cancer Center and lead author of The Lancet paper. "These data establish that the third generation BTK inhibitor pirtobrutinib possesses a compelling efficacy and safety profile with the potential to address this exact unmet need."

"While covalent BTK inhibitors and venetoclax have transformed the treatment of CLL, we now see many patients needing new therapeutic alternatives," said Brian Koffman, MDCM (retired), chief medical officer of the CLL Society. "In the coming years, we envision that this need will grow, and we are pleased to see data that pirtobrutinib may be a new option for these patients."

"We are extremely pleased to see the pirtobrutinib data from the ongoing Phase 1/2 BRUIN study published in The Lancet and shared with the broader clinical community", said David Hyman, M.D., chief medical officer of Loxo Oncology at Lilly. "The data to date from this study have continued to strengthen our conviction that pirtobrutinib has the potential to meaningfully improve the inadequate treatment options available to CLL and MCL patients who have been previously treated with the main treatment classes of today’s standard of care. We are focused on quickly advancing the pirtobrutinib development program, including through a series of Phase 3 studies that will be initiated over the course of 2021."

In addition to the Phase 1/2 BRUIN clinical trial, Loxo Oncology at Lilly plans to initiate four global, randomized Phase 3 studies for pirtobrutinib in 2021, three in CLL and one in MCL.

About Pirtobrutinib (LOXO-305)
Pirtobrutinib is an investigational, oral, highly selective, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including chronic lymphocytic leukemia, mantle cell lymphoma, Waldenström macroglobulinemia, and marginal zone lymphoma. Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations. In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition. Pirtobrutinib was designed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate, preserve activity in the presence of the C481 acquired resistance mutations, and avoid off-target kinases that have complicated the development of both covalent and investigational non-covalent BTK inhibitors. Interested patients and physicians can contact the Loxo Oncology at Lilly Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305 or email [email protected].

About the BRUIN Phase 1/2 Trial
This first-in-human, global, multi-center Phase 1/2 trial evaluates pirtobrutinib as a single agent in patients with previously treated chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin’s lymphomas (NHL). The trial includes a Phase 1 dose escalation phase and a Phase 2 dose expansion phase. The Phase 1 dose escalation enrolls patients with CLL/SLL or NHL who have received at least two prior lines of therapy and have progressed or are intolerant to standard of care. The dose escalation phase followed a "3+3" design with pirtobrutinib dosed orally in 28-day cycles. As dose cohorts were cleared, additional patients could enroll in cleared cohorts and intra-patient dose escalation was permitted. The primary objective of the Phase 1 portion of the trial is to determine the maximum tolerated dose and recommended Phase 2 dose. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Overall Response Rate (ORR) and Duration of Response, as determined by appropriate histology-specific response criteria). In the Phase 2, patients are enrolled across various cohorts, depending on disease type and prior therapy. The primary endpoint for Phase 2 is ORR. Secondary endpoints include duration of response (DOR), overall survival (OS), safety, and pharmacokinetics (PK).

About Loxo Oncology at Lilly
Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo Oncology at Lilly brings together the focus and spirit of a biotech with the scale and resources of large pharma, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.

On March 5, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that a supplemental Biologics License Application (sBLA) for anti-PD1 antibody tislelizumab was accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for treatment in the second- or third-line setting of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on prior platinum-based chemotherapy (Press release, BeiGene, MAR 5, 2021, View Source [SID1234576137]).

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"We are excited to submit the third marketing application for tislelizumab from its broad program in lung cancer which consists of five completed or ongoing Phase 3 trials. Results from our Phase 3 RATIONALE 303 trial demonstrated improved overall survival over chemotherapy in advanced NSCLC patients who have progressed after treatment with chemotherapy at its interim analysis, which we have been able to file quickly with the CDE for its review," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "With three approvals for tislelizumab in China, as well as three sBLAs under review, we are excited to continue to build upon our broad development program for tislelizumab, a potentially differentiated checkpoint inhibitor and explore additional opportunities with our new partner Novartis."

RATIONALE 303 Trial of Tislelizumab Compared to Docetaxel in Patients with Locally Advanced or Metastatic NSCLC Who Progressed on Prior Platinum-Based Chemotherapy

The sBLA is supported by clinical results from the Phase 3 RATIONALE 303 trial, a randomized, open-label, multicenter global Phase 3 clinical trial (NCT03358875) designed to evaluate the efficacy and safety of tislelizumab compared to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on a prior platinum-based chemotherapy. The primary endpoint of the trial is OS in all patients (the ITT population) and in patients with high PD-L1 expression; key secondary endpoints include objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), and safety. A total of 805 patients in 10 countries across Asia, Europe, the Americas, and Oceania were randomized 2:1 to either the tislelizumab arm or the docetaxel arm.

As announced in November 2020, RATIONALE 303 met the primary endpoint of OS at the planned interim analysis, as recommended by the independent Data Monitoring Committee (DMC). The safety profile of tislelizumab was consistent with the known risks with no new safety signals identified. BeiGene expects to present results from the RATIONALE 303 trial at an upcoming medical conference in the first half of 2021.

About Non-Small Cell Lung Cancer

In China, the lung cancer incidence rate is increasing.i There were approximately 815,563 new cases of lung cancer in China in 2020, and it is the leading cause of cancer-related death in both men and women, with approximately 714,699 deaths in China in 2020.ii Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 80 to 85 percent of all cases.iii

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody 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.

The China National Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, for the second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and two pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

About the Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed/refractory classical Hodgkin Lymphoma (NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).