On September 28, 2021 Acceleron Pharma reported that it is in advanced talks to be acquired in a deal estimated to be worth $11 billion (Press release, Acceleron Pharma, SEP 28, 2021, View Source [SID1234590535]).

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Merck & Co.. has now emerged as the frontrunner in the race, apparently having beaten out Bristol Myers Squibb, which currently owns more than 11.5% of Acceleron in company stock. BMS picked up the shares as part of its 2019 purchase of Celgene.

The Wall Street Journal reported Monday that Merck is in advanced talks to acquire Acceleron, citing sources familiar with the matter. Merck appears to be looking to diversify a portfolio that is largely dominated by blockbuster cancer drug Keytruda.

The same people said that an announcement could come this week, providing talks do not fall apart. In its original report, WSJ said that the pricepoint for Acceleron would be about $180-a-share in cash.

Merck previously went on a buying spree that spread from late in 2020 into 2021, acquiring OncoImmune in November, and picking up autoimmune disease drug developer Pandion Therapeutics in February in a 1.85 billion deal. Other acquisitions ncluded VelosBio and Themis.

If the deal for Acceleron goes through, it would be one of Merck’s largest and signal an increasing focus on the rare disease space, particularly in the treatments for respiratory and blood diseases where Acceleron focuses.

The rumors had already been percolating as Acceleron’s stock has risen over the past 10 days from $130-a-share in mid-September to $167.65 as the market closed on Friday. The company currently has a market value of $10.2 billion. Shares of the company have climbed 60% in the past year.

The biotech, which went public in 2013, is focused on developing protein therapies to treat certain types of cancer and rare diseases. Of prime attraction value is sotatercept, an investigational reverse-remodeling agent in phase III development for the treatment of pulmonary arterial hypertension (PAH).

In May, Acceleron presented preliminary interim data from its Phase II study of sotatercept at the American Thoracic Society 2021 International Conference showing that the drug was associated with improvements in resting and exercise hemodynamics at week 24. The outcomes were obtained from the first 10 patients evaluated among a total of 21 trial participants.

On Monday, Raymond James analyst Danielle Brill wrote that she thinks most investors would prefer Acceleron wait until Phase III data is available, which is due later in 2022, rather than accept a deal at the $180-per-share pricepoint.

According to Ziad Bakri, a vice president and health care investor at T. Rowe Price, the drug has "a ton of value in it." Acceleron was recently highlighted by Barron’s as one of "5 biotech names ready for a comeback."

Acceleron has been on an upward trend the past two years. The company’s one approved drug, Reblozyl, which is part of a global collaboration with BMS, was authorized by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of anemia in adults with beta thalassemia who require regular red blood cell (RBC) transfusions. This was followed just months later in April 2020 by an approval for the drug in the treatment of anemia in adults with lower-risk myelodysplastic syndromes. Reblozyl netted Acceleron approximately $25.6 million in royalty revenue for Q2 2021 from approximately $128 million in net sales.

A third candidate, ACE-1334, is being developed to treat fibrotic disease. The drug has been granted FDA Fast Track designation in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a rare, progressive autoimmune connective tissue disorder, and Orphan Drug designation for the treatment of systemic sclerosis.

For Merck, the acquisition of Acceleron would be another part of its transition to focus on growth areas that include cancer, vaccines and animal health. The pivot was enabled by the spinoff of slower-growth assets including women’s health products and cholesterol treatments into Organon & Co.

On September 28, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported the publication of research titled "Peptide-HLA-based immunotherapeutics platforms for direct modulation of antigen-specific T cells" in the peer-reviewed Nature journal, Scientific Reports (Press release, Cue Biopharma, SEP 28, 2021, View Source [SID1234608270]). The article describes Cue Biopharma’s IL-2 based CUE-100 series technology platforms, Immuno-STAT (Selective Targeting and Alteration of T cells) and Neo-STAT, being leveraged for the development of first-in-class biologics that enable selective activation of cancer-killing immune T cells within the patient’s body.

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"We believe our platforms address a significant challenge in immunotherapy of ensuring selective targeting of activation signals to anti-tumor T cells in the patient while sparing the indiscriminate systemic activation of the immune system," said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. "Adoptive cell therapy such as chimeric antigen receptor T-cell (CAR-T) therapies have demonstrated highly encouraging results for some patients but remain limited by the need of cellular ex-vivo manipulation and manufacturing challenges. Similarly, systemic approaches with immunostimulatory molecules, such as interleukin 2 (IL-2) or bispecific molecules, activate T cells indiscriminately and are associated with common severe adverse events, significantly limiting clinical benefit and applicability. Cue Biopharma’s approach and resulting platform, represents a potential breakthrough in the ability to selectively and safely modulate the immune system in a highly controlled and targeted manner directly in the patient’s body with the potential to create life-changing therapeutics with demonstrated improved efficacy and reduced toxicities."

Key aspects of Cue Biopharma’s technologies discussed in the article include:

The Immuno-STAT platform enables development of first-in-class off-the-shelf biologic molecules designed to selectively engage and activate disease-relevant T cells via the T cell receptors (TCR), mimicking the natural immune process, through the presentation of complimentary and synergistic signals, or "cues." An Immuno-STAT is engineered to include:
A first signal, or "cue" involving the presentation of a targeted and specific epitope, via a major histocompatibility (MHC)-peptide complex, to T cell receptors, or TCRs, of disease-specific T cells, to selectively engage a repertoire of T cells relevant to a particular disease such as cancer.
A corresponding second signal, or "cue" comprising the immunostimulant IL-2 molecule engineered with particular modifications for activation and expansion of CD8+ cytotoxic T cells, the relevant type of T cells with cancer-killing activity and minimize off-target binding and activation.
The Immuno-STAT is constructed upon a portion of a human antibody (the "Fc portion") that serves as the molecule’s backbone or scaffold and provides manufacturability and structural stability.
Through this design, Immuno-STATs enable disease specificity, targeted selective activation of CD8+ T cells and a larger therapeutic window for IL-2 effectiveness.
Neo-STAT is a plug-and-play variation of the Immuno-STAT platform designed with an empty "pocket" for the peptide presentation signal, enabling easy integration of disease-specific antigens a-posteriori to target a variety of cancers and infectious diseases.
The modular Immuno-STAT framework is compatible with diverse co-modulators, including immuno-suppressive molecules, with potential to address a variety of autoimmune diseases.
Ken Pienta, M.D., acting chief medical officer of Cue Biopharma, added, "We have identified a potential solution to safety and scalability challenges based on natural signals governing T cell function: peptide-HLA and costimulatory ligands, embodied in the Immuno-STAT and Neo-STAT immunotherapy platforms. The versatility and modularity of the platform as described in the paper, in addition to the clinical data to date supports the premise that our approach could be the next-generation solution to utilizing IL-2 as a targeted and selective immune activator for treating multiple cancers."

Cue Biopharma’s lead Immuno-STAT asset, CUE-101 has already shown encouraging results as a monotherapy in a Phase 1 dose escalation trial in late stage second line and beyond patients with HPV+ recurrent/metastatic head and neck cancer, which included a confirmed partial response with approximately 65% durable and ongoing tumor reduction and eight confirmed stable disease responses, controlling tumor growth for at least 12 weeks.

The Company is preparing for an Investigational New Drug filing for their next Immuno-STAT clinical candidate, CUE-102, which targets Wilms Tumor 1 (WT1), expressed in numerous solid tumors and hematological cancers.

On September 28, 2021 Artios Pharma Limited (Artios), a leading biotech company pioneering the development of novel small molecule therapeutics that target the DNA Damage Response process in order to treat patients suffering from a broad range of cancers, reported it has dosed the first patient in its Phase 1/2a study with its polymerase theta (Polθ) inhibitor, ART4215 (Press release, Artios Pharma, SEP 28, 2021, View Source [SID1234590357]). The Polθ project was originally in-licensed from Cancer Research UK in 2016 as part of the initial formation of Artios.

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The open label, multi-center study will assess the safety, tolerability, pharmacokinetics, and clinical activity of ART4215 administered orally as a monotherapy and in combination with other anticancer medicines in patients with advanced or metastatic solid tumors. The study will enroll up to 206 patients and will be conducted at multiple oncology centers across the USA and Europe. The trial is led by principal investigators Erika P. Hamilton, M.D., Director of the Breast Cancer and Gynecologic Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology, and Timothy Yap, M.B.B.S., Ph.D., Associate Professor of Investigational Cancer Therapeutics and Medical Director of the Institute for Applied Cancer Science at The University of Texas MD Anderson Cancer Center. Interim safety and tolerability data is expected in 2022. Full details can be found at www.clinicaltrials.gov under the identifier NCT04991480.

Dr. Niall Martin, Chief Executive Officer at Artios, said: "The initiation of our Phase 1/2a study is an important milestone for Artios and the DNA Damage Response field in general, launching the first evaluation of a specifically designed Polθ inhibitor in the clinic. Polθ is an important tumor-specific DDR target which we believe has the potential to exploit certain genetic vulnerabilities of cancer cells with defective DNA repair processes, while sparing healthy tissue. We have brought forward to the clinic a new and exciting inhibitor class where preclinical data shows the possible clinical utility that a potent, selective Polθ inhibitor may have as a single agent in patients who have progressed on PARP inhibitors, in combination with PARP inhibition in PARPi naïve patients and in combination with DNA damaging therapies such as ionizing radiation and cytotoxic chemotherapy. The progress of ART4215 supports Artios’s approach to leverage our internal expertise in identifying promising new DDR targets, developing novel molecules, working with our collaborators at Cancer Research UK, and advancing these molecules into the clinic. It has been a very productive year at Artios with the execution of our $153M Series C financing in July and now the expansion of our clinical pipeline, building upon our ongoing clinical development of ART0380, an ATR inhibitor, and our collaborations with Merck KGaA and Novartis."

Principal Investigator for the trial, Dr. Erika P. Hamilton, Director of the Breast Cancer and Gynecologic Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology, said: "I am encouraged by the preclinical data for ART4215 that demonstrates the molecule’s potential to address areas of high unmet need such as overcoming de novo and acquired resistance to PARP inhibitors and DNA damaging therapy. We look forward to advancing these important studies for an entirely new class of inhibitors for patients who need more effective treatment options."

ART4215 is the first selective, orally bioavailable, small molecule inhibitor of the Polθ polymerase domain to enter the clinic. Polθ, a DNA polymerase, is a tumor-specific DDR target involved in microhomology mediated end joining (MMEJ) that is overexpressed in many tumors and found in low levels in healthy tissue. Extensive preclinical studies have demonstrated that ART4215 has broad potential clinical utility, as described in Artios’s recent Nature Communications publication, Zatreanu et al., 2021.

On September 28, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy (Press release, Regeneron, SEP 28, 2021, View Source [SID1234590393]). The target action date for the FDA decision is January 30, 2022. The sBLA is also being reviewed under the FDA’s Project Orbis initiative, which will allow for concurrent review by participating health authorities in Australia, Brazil, Canada and Switzerland. Additional global regulatory submissions are planned, including in the European Union (EU) by the end of 2021.

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The sBLA is supported by results from a Phase 3 trial that enrolled patients irrespective of
PD-L1 expression status and is being conducted with The GOG Foundation, Inc. (GOG), the European Network for Gynaecological Oncological Trial groups (ENGOT) and NRG Oncology-Japan. Detailed results were first presented as part of a European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary in May 2021.

Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed in those between the ages of 35 and 44. Almost all cases are caused by human papillomavirus (HPV) infection, with approximately 80% classified as squamous cell carcinoma (SCC; arising from cells lining the bottom of the cervix) and the remainder being largely adenocarcinomas (arising from glandular cells in the upper cervix). Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages.

It is estimated that approximately 570,000 people are diagnosed with cervical cancer worldwide each year, with deaths exceeding 250,000. In the U.S. there are 14,500 new cases diagnosed annually and approximately 4,000 die each year.

Libtayo, which was invented using Regeneron’s proprietary VelocImmune technology, is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. The use of Libtayo in advanced cervical cancer is investigational, and its safety and efficacy have not been fully evaluated by any regulatory authority.

About the Phase 3 Trial

The Phase 3, open-label, multi-center trial, known as EMPOWER-Cervical 1, is the largest randomized clinical trial in advanced cervical cancer. The trial investigated Libtayo monotherapy versus an investigator’s choice of chemotherapy in patients with recurrent or metastatic cervical cancer who had progressed on platinum-based chemotherapy. Patients were enrolled regardless of tumor PD-L1 expression status or histology in 14 countries, including the U.S., Japan, Taiwan, South Korea, Canada, Russia, Poland, Spain, Brazil, Australia, the UK, Italy, Greece and Belgium.

Patients (median age: 51 years) were randomized to receive Libtayo monotherapy (350 mg every three weeks) or commonly used chemotherapy regimens (pemetrexed, vinorelbine, topotecan, irinotecan or gemcitabine). The primary endpoint for the trial was overall survival, analyzed first among patients with SCC histology, then in the total population.

About Libtayo

Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

About Regeneron’s VelocImmune Technology

Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved and authorized fully human monoclonal antibodies currently available. This includes REGEN–COV (casirivimab with imdevimab), Dupixent (dupilumab), Libtayo (cemiplimab-rwlc), Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb) and Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn).

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is Libtayo?

Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

Libtayo is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog inhibitor (HHI), or cannot receive treatment with an HHI.

Libtayo is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that has spread (metastatic BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.

Libtayo is a prescription medicine used to treat people with a type of lung cancer called non-small cell lung cancer (NSCLC). Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1" and your tumor does not have an abnormal "EGFR"," ALK "or "ROS1" gene.

It is not known if Libtayo is safe and effective in children.

What is the most important information I should know about Libtayo?

Libtayo is a medicine that may treat certain cancers by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, or chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Libtayo. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling.
Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Libtayo. Your healthcare provider will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Libtayo if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. Libtayo can harm your unborn baby
Females who are able to become pregnant:

Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo include muscle or bone pain, tiredness, rash, and diarrhea. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at
1-877-542-8296.

On September 28, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported that Derek Maetzold, president and chief executive officer, will deliver the keynote presentation during Arizona Bioscience Week, taking place from Oct. 3-9, 2021 (Press release, Castle Biosciences, SEP 28, 2021, View Source [SID1234590410]). Arizona Bioscience Week is presented by the Arizona Bioindustry Association (AZBio) and the Arizona Commerce Authority.

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As demonstrated through Arizona Bioscience Week, Arizona’s bioscience industry is committed to discovering, developing and delivering innovative medicines, medical devices and healthcare technologies that make life better for people in Arizona and around the world.

"As we continue to grow the bioscience industry in Arizona, we are grateful for companies like Castle Biosciences, who are committed to patient care and supporting the future business leaders of tomorrow," said Joan Koerber-Walker, president and chief executive officer of AZBio. "Derek’s and Castle’s success are a testament to the power and importance of having a strong vision from the beginning – keeping patient care at the forefront of business – and we are excited to hear Derek share his story with other up-and-comers in the life science industry."

"I am honored to have the opportunity to keynote Arizona Bioscience Week," said Derek Maetzold, president and CEO of Castle Biosciences. "This event benefits AZAdvances, part of the Opportunity Through Entrepreneurship Foundation that is providing not only funding but also mentorship for the life science innovators of tomorrow. Castle is proud to support this organization, future innovation and the Arizona bioscience community."

Maetzold’s keynote presentation will take place during the AZAdvances Innovation Showcase on Oct. 6. To register or learn more about the events taking place during Arizona Bioscience Week, visit View Source

About Arizona Bioindustry Association

The Arizona Bioindustry Association (AZBio) is a not-for-profit, 501(c)(6) trade association supporting the growth of Arizona’s life science sector. AZBio member organizations in the fields of business, research and education, health care delivery, economic development, government and other professions involved in the biosciences are the key drivers of the growth of Arizona’s life science sector. As the unified voice of our industry in Arizona, AZBio strives to make Arizona a place where bioscience organizations can grow and succeed.

AZBio works nationally and globally with the Advanced Medical Technology Association (AdvaMed), the Biotechnology Innovation Organization (BIO), the Medical Device Manufacturers Association (MDMA), the Pharmaceutical Research and Manufacturers of America (PhRMA) and leading patient advocacy organizations.

Through these relationships, AZBio has access to information, contacts, resources, cost saving programs and the global bioscience and medtech community.