On April 29, 2024 Immix Biopharma, Inc. ("Immix Biopharma", "Company", "We" or "Us", Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, reported that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of multiple myeloma (Press release, Immix Biopharma, APR 29, 2024, View Source [SID1234642427]).

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"Frail patients, heavily represented in our NEXICART-1 clinical trial, remain an area of unmet medical need and are a significant portion of the relapsed/refractory multiple myeloma population," said Ilya Rachman, MD PhD, Chief Executive Officer, Immix Biopharma. "We believe EU orphan drug designation for NXC-201 affirms the potential clinical impact of NXC-201 in this sizable population."

Gabriel Morris, Chief Financial Officer, Immix Biopharma added, "We believe NXC-201’s observed favorable tolerability profile and ‘Single Day CRS’ across a robust clinical dataset could enable an attractive option for frail relapsed/refractory multiple myeloma patients in addition to our lead indication, relapsed/refractory AL Amyloidosis, and our active NXC-201 expansion into other autoimmune diseases."

According to Davis et al., 2023 Transplantation and Cellular Therapy, commercial CAR-Ts produced 6.9 months median progression free survival in frail relapsed/refractory multiple myeloma patients in a real-world setting. 61% of patients in the dataset were considered frail.

Orphan drug designation in the European Union (EU) is granted by the EC based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products. To qualify for orphan drug designation, a candidate therapy must be intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that occurs in not more than five in 10,000 people in the EU. The designation provides regulatory, financial and commercial incentives to develop therapies for rare diseases where there are either no satisfactory treatment options or significant benefit to those affected by the disease.

On April 29, 2024 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that it has entered into a definitive merger agreement with ONO Pharmaceutical Co., Ltd. (ONO), under which ONO will acquire all outstanding shares of Deciphera common stock for $25.60 per share in cash through a tender offer followed by a merger of Deciphera with a wholly-owned subsidiary of ONO (the "Acquisition"), for a total equity value of $2.4 billion (Press release, Deciphera Pharmaceuticals, APR 29, 2024, View Source [SID1234642426]). The boards of directors of both companies have unanimously approved the transaction.

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Together, ONO and Deciphera will accelerate their shared vision to deliver innovative new drugs and serve patients around the world. Deciphera brings specialized research and development capabilities in kinase drug discovery, well-established commercial and sales platforms in the United States and Europe, and global clinical development capabilities. In addition to QINLOCK – Deciphera’s switch-control inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST), which is approved in the United States and over 40 other countries, Deciphera also brings a mature, diverse pipeline of best-or-first in class potential medicines, including vimseltinib, DCC-3116 (an ULK inhibitor) and multiple additional oncology candidates. Vimseltinib is a highly selective switch-control kinase inhibitor with successful pivotal clinical data for the potential to be a best-in-class and first-in-class agent for the treatment of tenosynovial giant cell tumor (TGCT), and potentially other indications. The Acquisition is expected to enable ONO to build a robust presence in oncology, one of its key priority areas, and also support ONO’s efforts to become a Global Specialty Pharma company.

Steven L. Hoerter, President and Chief Executive Officer of Deciphera, said, "Deciphera and ONO share a deep commitment to improve the lives of people living with cancer, and the transaction announced today enables us to make even greater impact for patients. Together, we expect to advance and accelerate each organization’s important work through combined research and development capabilities and a global commercial footprint. Importantly, this acquisition delivers for all of Deciphera’s stakeholders. It provides immediate, compelling value for our shareholders, provides greater opportunities for our world-class team, and ultimately, greater hope for patients. I am excited about the future of the combined organization, and we are honored to contribute to the continued growth of ONO in the U.S. and around the world."

Gyo Sagara, Representative Director, Chairman of the Board and Chief Executive Officer of ONO, said, "We expect that this acquisition of Deciphera will not only expand ONO’s target oncology portfolio, but also accelerate ONO’s business development in the United States and Europe, and strengthen kinase drug discovery research. Deciphera’s mission statement ‘Inspired by Patients: Defeat Cancer’ is aligned with ONO’s corporate philosophy ‘Dedicated to the Fight against Disease and Pain.’ We respect the innovative culture of Deciphera and look forward to working together to drive further growth for both ONO and Deciphera."

Transaction Details

The Acquisition is structured as a tender offer and subsequent merger of Deciphera with a wholly-owned subsidiary of ONO. Under the terms of the definitive merger agreement, ONO will acquire all outstanding shares of Deciphera for $25.60 per share in cash for a total equity value of approximately $2.4 billion. The purchase price represents a premium of 74.7% to Deciphera’s closing share price of $14.65 on April 26, 2024, and a premium of 68.8% to Deciphera’s 30-trading-day volume weighted average price as of April 26, 2024.

ONO will promptly commence the tender offer, and it will expire 20 business days after its commencement, unless otherwise extended. If the tender offer conditions are not satisfied, ONO may be required to extend the tender offer under certain circumstances. Upon the successful completion of the tender offer, ONO’s wholly-owned subsidiary will merge with and into Deciphera, with Deciphera continuing as the surviving corporation and a wholly-owned subsidiary of ONO, and any shares of common stock of Deciphera not tendered into the offer will receive the same USD per share price payable in the tender offer. The Acquisition is expected to close in the third quarter of 2024, subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of Deciphera’s outstanding shares of common stock.

In connection with the execution of the merger agreement, certain stockholders of the Company owning approximately 28% of the outstanding shares of Deciphera Common Stock have entered into Tender and Support Agreements pursuant to which they will tender all of their owned shares in the offer.

Upon completion of the Acquisition, Deciphera will operate as a standalone business of ONO Group, from its headquarters in Waltham, Massachusetts.

In light of the Acquisition, Deciphera will not host a first quarter 2024 earnings call. The Company will file a Form 10-Q in the ordinary course.

Advisors

J.P. Morgan Securities LLC is serving as exclusive financial advisor to Deciphera and Goodwin Procter LLP is serving as legal counsel. BofA Securities is serving as financial advisor to ONO and Greenberg Traurig is serving as legal counsel.

On April 29, 2024 Bio-Techne Corporation (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities reported a significant milestone in its commitment to providing cutting-edge solutions to its customers (Press release, Bio-Techne, APR 29, 2024, View Source [SID1234642425]). Effective May 1, 2024, Bio-Techne will enter into a strategic distribution agreement with Thermo Fisher Scientific, a leading provider of laboratory products and services, in Europe.

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This partnership marks an important collaboration between two industry leaders in the fields of scientific research, diagnostics, and biotechnology. Under this agreement, Thermo Fisher, through the European arm of its Fisher Scientific Channel, will distribute Bio-Techne’s extensive portfolio of innovative products, including antibodies, proteins, Immunoassay kits, reagents and enzymes to laboratories and research institutions across Europe.

"We are excited to partner with Thermo Fisher to expand the reach of our products and services throughout Europe," said Kim Kelderman, Bio-Techne’s President and Chief Executive Officer. "By leveraging the Fisher Scientific Channel’s extensive European distribution network and industry expertise, we aim to enhance support for researchers and accelerate scientific discoveries that address some of the most pressing challenges in healthcare today."

Bio-Techne’s state-of-the-art products are designed to accelerate research and improve outcomes in areas including cell and gene therapy, immunology, neuroscience, and more. With this collaboration, Thermo Fisher reinforces its commitment to providing customers with access to the latest technologies and expertise, ultimately advancing scientific knowledge and improving human health.

"We are thrilled to forge this partnership with Bio-Techne, a company renowned for its pioneering advancements in the life sciences industry," said Claire Wallace, President Research and Safety Market, Europe at Thermo Fisher. "By adding Bio-Techne’s high-quality products to our comprehensive portfolio, we aim to further empower scientists and researchers with the tools they need to drive breakthrough discoveries and advancements in healthcare."

"Thermo Fisher is an ideal partner to accelerate our already strong presence in Europe," said Dr. Peter Schüßler, Vice President and General Manager EMEA. "We are looking forward to the positive impact this relationship will have on the research community, as expanded access to our portfolio of bioactive reagents enables scientific discoveries in the region."

This distribution agreement underscores Thermo Fisher’s dedication to fostering innovation and collaboration within the scientific community. Through strategic partnerships with leading companies like Bio-Techne, Thermo Fisher continues to strengthen its position as a trusted partner for researchers and laboratories across Europe.

For more information about Bio-Techne and its range of products and services, visit our Website.

For more information about the Fisher Scientific Channel in Europe and its comprehensive range of laboratory products and services, visit their Website.

On April 29, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that it has taken an essential step forward in testing the combination of AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of late-stage pancreatic cancer (the "DURIPANC" study) (Press release, AIM ImmunoTech, APR 29, 2024, View Source [SID1234642424]). See: ClinicalTrials.gov NCT05927142.

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Investigators at Erasmus Medical Center ("Erasmus MC") in the Netherlands have completed the safety evaluation of patients enrolled in the first dose level of the dose escalation design in the Phase 1b/2 study. The combination of Ampligen and Imfinzi was found to be generally well-tolerated with no severe adverse events ("SAE") or dose-limiting toxicities ("DLT").

Based on these positive results, escalation to the next dose will occur according to protocol design and AIM expects the next cohort of patients to begin dosing very soon. Subjects will be in treatment for up to 48 weeks, or until confirmed disease progression or another discontinuation criterion is met. They will be monitored for response according to Response Evaluation Criteria in Solid Tumors ("RECIST 1.1").

Learn more about the clinical collaboration between AIM, AstraZeneca and Erasmus MC.

On April 29, 2024 Astrazeneca reported positive high-level results from the DESTINY-Breast06 Phase III trial showed that Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy in the primary trial population of patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer following one or more lines of endocrine therapy (Press release, AstraZeneca, APR 29, 2024, View Source [SID1234642407]).

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A statistically significant and clinically meaningful improvement in PFS was also observed in the overall trial population (patients with HER2-low and HER2-ultralow [defined as IHC 0 with membrane staining; IHC >0<1+] metastatic breast cancer). A prespecified subgroup analysis showed the clinically meaningful improvement was consistent between patients with HER2-low and HER2-ultralow expression.

Overall survival (OS) data were not mature at the time of the analysis; however, Enhertu showed an early trend towards an OS improvement versus standard-of-care chemotherapy in patients with HER2-low metastatic breast cancer and in the overall trial population. The trial will continue as planned to further assess OS and other secondary endpoints.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "DESTINY-Breast06 shows that Enhertu could become a new standard of care for patients with HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy. These data underscore the potential for treatment with Enhertu across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "The topline results from DESTINY-Breast06 highlight the importance of continuing to challenge current treatment paradigms and established breast cancer classifications to evolve how we treat patients with HR-positive, HER2-expressing metastatic breast cancer. Building on the practice-changing data seen in DESTINY-Breast04, these results reinforce the potential for use of Enhertu earlier in the treatment landscape and in an even broader patient population."

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

It is estimated that approximately 60-65% of HR-positive, HER2-negative breast cancers are HER2-low and potentially an additional 25% may be HER2-ultralow.1,2 Endocrine therapies are widely used in the early lines of treatment for HR-positive metastatic breast cancer; however after two lines of treatment, further efficacy from endocrine therapy is often limited.3 The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes.3-6

The safety profile of Enhertu was consistent with previous breast cancer clinical trials with no new safety signals identified.

The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Notes

DESTINY-Breast06
DESTINY-Breast06 is a global, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) versus investigator’s choice of chemotherapy (capecitabine, paclitaxel or nab-paclitaxel) in patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) or HER2-ultralow (defined as IHC 0 with membrane staining; IHC >0<1+) advanced or metastatic breast cancer. Patients in the trial had no prior chemotherapy for advanced or metastatic disease and either experienced disease progression within 6 months of starting 1st-line treatment with an endocrine therapy combined with a CDK4/6 inhibitor or received at least two previous lines of endocrine therapies in the metastatic setting.

The primary endpoint is PFS in the HR-positive, HER2-low patient population as measured by blinded independent central review (BICR). Key secondary endpoints include OS in patients with HER2-low expression and PFS by BICR and OS in the overall trial population (HER2-low and HER2-ultralow). Other secondary endpoints include objective response rate, duration of response, time to first subsequent treatment or death, time to second subsequent treatment or death and safety. Analysis of the HER2-ultralow subgroup was not powered to demonstrate statistical significance.

DESTINY-Breast06 enrolled 866 patients (n=713 for HER2-low and n=153 for HER2-ultralow) at multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

Breast cancer and HER2 expression
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.7 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.7 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or progress to metastatic disease are expected to live five years after their diagnosis.8

HR-positive, HER2-negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers.8 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer.9 Patients with high levels of HER2 expression (IHC 3+ or 2+/ISH+) are classified as HER2-positive and treated with HER2-targeted therapies, representing approximately 15-20% of all breast cancers.10 Historically, tumours that were not classified as HER2-positive were classified as HER2-negative; however, many of these tumours still carry some level of HER2 expression.11 It is estimated that approximately 60-65% of HR-positive, HER2-negative breast cancers are HER2-low and potentially an additional 25% may be HER2-ultralow.1,2

Prior to the approval of Enhertu in HER2-low metastatic breast cancer post chemotherapy based on the DESTINY-Breast04 trial, there were no targeted therapies approved specifically for patients with HER2-low expression.12 There are no targeted therapies specifically approved for patients with HER2-ultralow expression.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4 mg/kg) is approved in more than 60 countries for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or 2+/ISH+) breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4 mg/kg) is approved in more than 60 countries for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4 mg/kg) is approved in more than 35 countries for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4 mg/kg) is approved in more than 40 countries for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 and/or DESTINY-Gastric02 trials.

Enhertu (5.4 mg/kg) is approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and who have no satisfactory alternative treatment options based on results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials.

Enhertu development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anti-cancer treatments, such as immunotherapy, also are underway.