On February 22, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it has entered into a securities purchase agreement with an institutional investor, providing for the purchase and sale of 1,496,400 shares of common stock (or common stock equivalents) at a price of $2.80 per share, in a registered direct offering, resulting in total gross proceeds of approximately $4.2 million, before deducting the placement agent’s fees and other estimated offering expenses (Press release, Applied DNA Sciences, FEB 22, 2022, View Source [SID1234608792]). The Company has also agreed to issue to the investor unregistered warrants to purchase up to an aggregate of 1,496,400 shares of common stock in a concurrent private placement. The warrants will have an exercise price of $2.84 per share, be exercisable six months from the date of issuance and will expire five years from the initial exercise date.

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The offering is expected to close on or about February 24, 2022, subject to the satisfaction of customary closing conditions.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital, and to advance the adoption of its LinearDNA manufacturing platform.

Roth Capital Partners served as sole placement agent for the transaction.

The shares of common stock (or common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) are being made pursuant to a shelf registration statement on Form S-3 (File No. 333-238557) (including a prospectus) previously filed with the Securities and Exchange Commission (the "SEC") on May 21, 2020, and declared effective by the SEC on June 1, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

On February 22, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported it has entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals, Inc. ("CPP"), a private clinical stage company developing therapeutics to reduce the risk and recurrence of cancer and rare diseases, for a combination of stock and future milestone payments (Press release, Panbela Therapeutics, FEB 22, 2022, View Source;utm_medium=rss&utm_campaign=panbela-therapeutics-inc-to-acquire-cancer-prevention-pharmaceuticals-inc [SID1234608808]).

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Strategic Rationale and Benefits of the Transaction

The combined entity will have an expanded pipeline addressing an estimated aggregate $5 billion market opportunity for the areas of initial focus: familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs boast a steady cadence of catalysts with programs ranging from pre-clinical to registration studies, including CPP’s lead asset with a fully funded registration trial scheduled to begin this year. In addition, the transaction facilitates operational and commercial synergies, under the leadership of a highly experienced management team with a proven history of drug discovery, development, and commercialization expertise. "This transaction is an important step towards our goal of creating a diversified pipeline with an ability to hit multiple targets and thereby expanding the potential of the combined company," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "The combined platforms will be better positioned to treat more patients. This transaction is a tremendous strategic fit and we feel creates robust stockholder value."

CPP co-founder and CEO, Jeff Jacob, stated, "I strongly believe Panbela is the right choice to carry our efforts forward and continue the outstanding work our team has done to build our clinical stage orphan and oncology pipeline into what it is today and to continue the development of Flynpovi, our lead asset. Flynpovi, a combination of CPP-1X (eflornithine) and sulindac has a dual mechanism both inhibiting polyamine synthesis and increased polyamine export and catabolism. By leveraging the established infrastructure of Panbela, we expect to continue to expand our pipeline. After a full assessment of strategic alternatives, our Board of Directors believes the transactions signifies the best value opportunity for CPP stakeholders."

CPP is developing therapeutics designed to reduce the risk of cancer and other diseases. In addition to the fully funded FAP registration trial scheduled to begin by year-end, a phase 3 trial in colon cancer survivors is currently underway and is sponsored by the Southwest Oncology Group (SWOG). Additionally, clinical trials in neuroblastoma, gastric cancer, and early-onset type-1 diabetes are underway in collaboration with various nonprofit groups.

Transaction Details

Under the terms of the agreement and plan of merger, the holders of CPP’s outstanding capital stock immediately prior to the merger will receive shares of common stock of Panbela upon closing of the mergers. On a pro forma and fully diluted basis, holders of Panbela common stock are expected to own approximately 59% of the post-merger holding company and holders of CPP securities, including converted indebtedness, are expected to beneficially own approximately 41% of post-merger holding company. CPP stockholders will be eligible to receive contingent payments totaling a maximum of $60 million from milestone and royalty payments associated with the potential approval and commercialization of the lead asset.

The proposed mergers have been unanimously approved by the boards of directors of each company and the stockholders of CPP. A closing is expected to occur by the second quarter of 2022, subject to approval of the issuance of securities in the transactions by Panbela’s stockholders, and satisfaction of other customary closing conditions.

Additional Information

The combined company will be led by Jennifer Simpson, Chief Executive Officer of Panbela and will remain headquartered in Waconia, Minnesota. The board of the combined company is expected to optimize the value of this transaction and beyond and will include at least two members initially designated by CPP, CPP Chief Executive Officer, Jeff Jacob, and CPP Director, Dan Donovan.

Canaccord Genuity LLC is acting as the exclusive financial advisor to Panbela, and Faegre Drinker Biddle & Reath LLP is acting as its legal counsel. The Sage Group is acting as the exclusive financial advisor to CPP, and Blank Rome LLP is acting as its legal counsel.

About: SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.0 months which is not yet final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

On February 22, 2022 BeiGene (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 U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, BeiGene, FEB 22, 2022, View Source [SID1234608826]). CLL is the most common form of adult leukemia. The Prescription Drug User Fee Act (PDUFA) target action date is October 22, 2022.

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"While previously approved BTK inhibitors have been transformational for some patients with CLL, there continues to be unmet need as not all patients achieve a favorable clinical response while others are unable to tolerate currently approved BTKi therapies"

"We are pleased with the FDA’s acceptance of BRUKINSA’s filing in CLL. This is an important milestone in BRUKINSA’s global registration program. With superiority in investigator-assessed ORR over ibrutinib in ALPINE for relapsed or refractory patients and in PFS over chemoimmunotherapy in the SEQUOIA study for treatment-naïve patients, BRUKINSA has demonstrated its potential to improve treatment outcomes for CLL patients," commented Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene. "We look forward to furthering our discussions with the FDA on this filing and the potential to bring this important treatment option to the CLL community in the U.S."

The sNDA filing in CLL/SLL includes data from two pivotal randomized Phase 3 studies and eight supportive studies in B cell malignancies. The two global Phase 3 trials of BRUKINSA in CLL/SLL are: ALPINE (NCT03734016) comparing BRUKINSA to ibrutinib in relapsed or refractory (R/R) patients and SEQUOIA (NCT03336333) comparing BRUKINSA to bendamustine and rituximab in treatment-naïve (TN) patients. Additionally, the SEQUOIA study enrolled patients with deletion 17p in a non-randomized arm evaluating BRUKINSA monotherapy in this high risk population. ALPINE and SEQUOIA enrolled patients from a total of 17 countries, including the United States, China, Australia, New Zealand and multiple countries in Europe. Results from the ALPINE trial and the SEQUOIA trial were reported at the 26th European Hematology Association (EHA) (Free EHA Whitepaper) (EHA2021) Virtual Congress in June 2021 and at the 63rd American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021, respectively.

"While previously approved BTK inhibitors have been transformational for some patients with CLL, there continues to be unmet need as not all patients achieve a favorable clinical response while others are unable to tolerate currently approved BTKi therapies," said Jennifer R. Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute, and a principal investigator in the two studies. "As demonstrated in both the ALPINE AND SEQUOIA studies, BRUKINSA was generally well-tolerated in CLL patients with low rates of atrial fibrillation and showed strong efficacy compared to ibrutinib and chemoimmunotherapy, respectively."

About Chronic Lymphocytic Leukemia

Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults. CLL accounts for about one quarter of new cases of leukemia, and in 2021 there were more than 21,000 new cases diagnosed in the U.S.1 In 2018, there were an estimated 195,129 people living with chronic lymphocytic leukemia in the United States.1 CLL begins in cells that become certain white blood cells (lymphocytes) in the bone marrow but then go into the blood. Proliferation of cancer cells (leukemia) in the marrow result in reduced ability to fight infection and spread into the blood, which affects other parts of the body including the lymph nodes, liver and spleen.2,3,4 The BTK pathway is a known route that signals malignant B cells and contributes to the onset of CLL.5 Small lymphocytic lymphoma (SLL) is a non-Hodgkin’s lymphoma affecting the B-lymphocytes of the immune system, which shares many similarities to CLL but with cancer cells found mostly in lymph nodes.6

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA has previously been approved for three indications in the United States: for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (Nov. 2019)*; for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) (Aug. 2021); and for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (Sept. 2021)*.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the United States, China, the EU and Great Britain, Canada, Australia and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

* This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA (ZANUBRUTINIB)

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.4% of patients treated with BRUKINSA monotherapy. Hemorrhage events of any grade occurred in 35% of patients treated with BRUKINSA monotherapy.

Bleeding events have occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 27% of patients, most commonly pneumonia. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (26%), thrombocytopenia (11%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy. Grade 4 neutropenia occurred in 13% of patients, and Grade 4 thrombocytopenia occurred in 3.6% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer, reported in 8% of patients. Other second primary malignancies included malignant solid tumors (4.0%), melanoma (1.7%) and hematologic malignancies (1.2%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Atrial fibrillation and atrial flutter were reported in 3.2% of patients treated with BRUKINSA monotherapy. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher events were reported in 1.1% of patients treated with BRUKINSA monotherapy. Monitor signs and symptoms for atrial fibrillation and atrial flutter and manage as appropriate.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse reactions

The most common adverse reactions, including laboratory abnormalities, in ≥ 30% of patients who received BRUKINSA (N = 847) included decreased neutrophil count (54%), upper respiratory tract infection (47%), decreased platelet count (41%), hemorrhage (35%), decreased lymphocyte count (31%), rash (31%) and musculoskeletal pain (30%).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with moderate or strong CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

Please see full U.S. Prescribing Information at www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at www.beigene.com/PDF/BRUKINSAUSPPI.pdf.

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 United States, 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 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 February 22, 2022 Medtronic plc (NYSE: MDT), a global leader in healthcare technology, and the American Society for Gastrointestinal Endoscopy (ASGE) reported they are working to provide colorectal cancer screening technologies in low income and underserved communities across the United States through the Medtronic Health Equity Assistance Program for colon cancer screening, with support from Amazon Web Services (AWS) (Press release, Medtronic, FEB 22, 2022, View Source [SID1234608842]). The initiative will include the donation of 50 Medtronic GI Genius intelligent endoscopy modules to endoscopy centers across the country that can potentially improve the detection of polyps that can lead to colorectal cancer. Certain types of colorectal cancer, when caught early, can have a survival rate (five year) of up to 91%; however, it remains the third most common and third deadliest cancer among adults in the United States. With these placements, there is an opportunity to potentially impact more than 350,000 patients over three years.

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The goal of this program is to increase early detection and diagnosis in underserved communities.

"Addressing gaps in colorectal cancer screening is complex. We know that Black adults are more likely to be diagnosed and subsequently die from this disease. There are also disparities in screenings among different groups, including adults in rural communities," said Douglas K. Rex, M.D., MASGE, president, ASGE. "Colonoscopy is critical in preventing colorectal cancer and as the global leader in gastrointestinal endoscopy, ASGE is working together with Medtronic to ensure that providers receive screening technology and are able to use them in communities where they are most needed."

AWS has provided computing credits that have made the funding of this program possible and continues to work with Medtronic to support the ongoing development of GI Genius and innovative future Medtronic health screening technologies that will further support Medtronic’s health equity efforts. ASGE is independently leading the application and selection process to determine the facilities that otherwise would be unable to fund this innovative solution for underserved patient populations. Initial recipients will be announced in March 2022 during Colorectal Cancer Awareness Month.

"The crisis of health inequities cannot be solved without expanding access to healthcare technologies that put people first," said Geoff Martha, Medtronic chairman and chief executive officer. "We must begin with local efforts that consider the needs of the community. This program is an important step towards ensuring that our powerful technologies help reduce disparities, improve care and enhance patient outcomes."

The GI Genius intelligent endoscopy module, authorized by the FDA in April 2021, detects colorectal polyps of varying shapes and sizes automatically in real time which helps diagnose and prevent colorectal cancer. It is the first-to-market, computer-aided polyp detection system powered by artificial intelligence (AI) that provides physicians with a powerful solution in the fight to screen, detect and prevent colorectal cancer and an increase of up to 14.4% absolute detection rate (ADR). Each 1% increase in ADR decreases patients’ risk of colorectal cancer by 3%.

Earlier this month, Medtronic released its Global Inclusion, Diversity and Equity Annual Report, which maps out the Company’s Zero Barriers commitment to remove barriers to opportunity — including efforts to improve access to healthcare technology. As part of this work, Medtronic introduced several initiatives in 2021 to reduce health inequities among people of color living with diabetes, including supporting the American Diabetes Association’s Technology Access Project.

"This effort is part of Medtronic’s Zero Barriers approach to building equity within our healthcare system, accelerating our innovation and helping to bring our lifesaving technologies to more patients," said Giovanni Di Napoli, president of the Medtronic Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic. "The program represents a continuation of Medtronic’s commitment to health equity anchored in healthcare technology."

"Individual health outcomes should not depend on socioeconomic status, race, ethnicity, or neighborhood," said Maggie Carter, global lead for social impact at AWS. "We are pleased to support Medtronic and ASGE as part of AWS’s recently launched health equity program to help these organizations bring effective screening tools to the communities that need them most."

For more information and to apply, visit: ASGE’s program website.

About ASGE
Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence and innovation in gastrointestinal endoscopy. ASGE, with almost 15,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit Asge.org and ValueOfColonoscopy.org for more information.

On February 22, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies and AVEO Oncology (NASDAQ: AVEO) ("AVEO"), a commercial stage, oncology-focused biopharmaceutical company, reported that they have entered into a research collaboration to develop and study a first-in-class antibody radio-conjugate (ARC) targeting ErbB3, also known as HER3 (Press release, AVEO, FEB 22, 2022, View Source [SID1234608793]). Actinium will utilize its AWE technology platform and extensive radiotherapy know-how to conjugate one of AVEO’s ErbB3 targeted antibodies, with the potent alpha-emitting radioisotope Actinium-225 (Ac-225).

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"Actinium has amassed extensive clinical experience, technical know-how and research capabilities for the development of next-generation targeted radiotherapies that we are excited to bring to this collaboration with AVEO, which has a portfolio of high-affinity antibodies and is currently commercializing FOTIVDA (tivozanib) in advanced RCC. We believe ErbB3 is a validated and differentiated target that is aptly suited for radio-conjugate development. Using our AWE platform, we will harness the powerful Ac-225 payload to enhance targeted cell killing against a target that is overexpressed in a number of cancers that are difficult to treat with traditional oncology therapies. A member of the epidermal growth factor family of receptors, ErbB3 has been gaining increasing recognition as a validated targeted, we are committed to rapidly advance and evaluate this novel Ac-225 ErbB3 targeted radiotherapy together with AVEO," said Sandesh Seth, Chairman and CEO of Actinium.

"While we focus on the commercialization of FOTIVDA in advanced RCC,, we are pleased to announce this collaboration with Actinium in an effort to leverage our high-affinity antibody program to expand our robust portfolio with a potential first-in-class targeted radiotherapy ," said Michael Bailey, president and chief executive officer of AVEO. "We are excited to advance this ErbB3 targeted compound which is expressed in multiple solid tumors and is the third in the family of clinically validated ErbB targets."

Actinium’s AWE technology platform has created a Ac-225 CD38 targeting ARC using the blockbuster myeloma antibody daratumumab (Darzalex), in collaboration with EpicentRx for targeted radiotherapy CD47-SIRPα immunotherapy combinations and in collaboration with Astellas Pharma, to create theranostics for solid tumors. Actinium employs a multidisciplinary approach leveraging its team’s expertise and experience in cancer cell biology, radiochemistry, radiation sciences, immunology and oncology drug development to R&D and collaborations.

AVEO’s ErbB3 targeting antibodies are designed to inhibit both ligand-dependent and ligand-independent ErbB3 signaling. ErbB3 is a receptor that is typically expressed in many human cancers and has demonstrated preclinical activity in multiple tumor models.