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.

On September 28, 2021 Diaprost reported that it has agreed terms for an exclusive Licensing Agreement with Radiopharm Theranostics (RAD); an Australian based biotech startup, focused on building an innovative and differentiated pipeline of radiopharmaceutical products for both diagnostic and therapeutic uses (Press release, Diaprost, SEP 28, 2021, View Source [SID1234590433]). RAD has recently raised A$20 million to progress a portfolio of radiopharmaceutical assets that have the potential to be first to market or best in class in their respective disease areas. The Diaprost asset is one of four distinct & clearly differentiated platform technologies.

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The Diaprost pipeline is focused on humanised antibodies for diagnostic and therapeutic radiopharmaceutical applications. The hu5A10 antibody enables non-invasive detection and therapy by delivering radionuclides to prostate cancer cells. The platform’s targeting mechanism utilizes binding to Prostate Specific Antigen (PSA), a well-established biomarker previously only applied for diagnostic blood tests.

The imaging modalities based on hu5A10, which were developed together with Lasker Award recipient Charles Sawyers, demonstrate superior specificities in diagnosing prostate cancer cell occurrence and an unparalleled ability to detect disease activity. When employing hu5A10 with a Therapeutic Isotope, results clearly demonstrate specific and effective prostate cancer cell eradication. The combination of imaging and radioimmunotherapy, based on the same antibody, enables a powerful tool for both diagnosis and treatment of prostate cancer.

Under the terms of the agreement RAD will have exclusive responsibility to manufacture, develop and commercialise hu5A10 worldwide. Upfront and near-term payments of US$10M are part of a financial package that over the life of the agreement could exceed US$125M, if all development and regulatory goals are met.

"We believe the Licensing Agreement with Radiopharm Theranostics, founded by the experienced Australian life sciences industry figure Paul Hopper, represents a focused route to maximizing the potential of both Diaprost and the hu5A10 program," said Johan Drott, the CEO of Diaprost. "RAD has established a strong management team with recognised experts to focus on the development of radiopharmaceutical products for diagnostic and therapeutic uses in areas of high unmet medical needs."

On September 28, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the Company has strengthened its leadership team with the appointments of Mark S. Berger, M.D. to the newly-created position of Chief Medical Officer and Hemant Kumar, Ph.D., CPM, EMBA to the newly-created position of Chief Manufacturing and Technology Officer (Press release, Genprex, SEP 28, 2021, View Source [SID1234590394]). Drs. Berger and Kumar will report to Rodney Varner, Chief Executive Officer of Genprex.

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"It is my privilege and pleasure to welcome Mark and Hemant to our management team. Their collective accomplishments and deep domain expertise in clinical development and gene therapy manufacturing, respectively, will be of great value as they help guide Genprex and advance our important Acclaim-1 and Acclaim-2 clinical trials in non-small cell lung cancer this year," stated Mr. Varner. "As we continue to make progress with these studies, and to expand our technology pipeline, it is more important than ever to have medical affairs and manufacturing in such capable hands."

"I am delighted to join the growing team at Genprex, confident that my experience designing and managing pivotal clinical trials in oncology will provide valuable insight and oversight for Genprex’ novel gene therapy pipeline," commented Dr. Berger. "Advancing the first systemic gene therapy in oncology is a uniquely exciting opportunity to transform cancer care for patients with limited treatment options and I am looking forward to working with Genprex’ leadership team to help develop this new approach to cancer treatment."

"I am excited to join the management team at Genprex and to work alongside this group of seasoned executives to realize the potential for its novel systemic gene therapy to improve outcomes for cancer patients," noted Dr. Kumar. "I am eager to apply my expertise and technical background in accelerated development of innovative biologics and advanced cell and gene therapies to support Genprex’ already impressive work and drive its technologies to commercialization."

About Mark S. Berger

Dr. Berger is an oncologist and senior executive with 25 years of biotech and pharmaceutical company experience in the development of oncology therapeutics. He has successfully brought two drugs through the regulatory process to approval and excels in strategic development, team management and collaborative leadership. Dr. Berger joins Genprex from Actinium Pharmaceuticals, Inc. where since January 2017 he served as Chief Medical Officer and was responsible for clinical strategy and development of radioisotope-labeled antibodies for therapy in oncology, including the Company’s Phase 3 SIERRA trial. Before that, Dr. Berger was Senior Vice President-Clinical Research at Kadmon Corporation from 2013 through 2017, where he led all aspects of the company’s new drug development, including clinical trial design and management of the oncology programs in non-small cell lung cancer and breast cancer, among others.

Prior to that, Dr. Berger was Chief Medical Officer of Deciphera Pharmaceuticals from June 2011 to September 2013. Before Deciphera, Dr. Berger was Vice President for Clinical Development at Gemin X Pharmaceuticals, where he led the clinical strategy, design and management of clinical trials for two novel oncology agents including obatoclax. Based on the results of a randomized Phase 2 clinical trial of obatoclax, Gemin X was acquired by Cephalon in March of 2011. Before his work with biotechnology companies, Dr. Berger held key positions in two global pharmaceutical companies. Dr. Berger previously served as Group Director, Medicine Development Centre-Oncology for GlaxoSmithKline. In this position Dr. Berger managed the development of Tykerb (lapatinib) in lung and breast cancer where he designed and led two Phase 2 clinical trials before planning and leading a 399 patient pivotal Phase 3 trial that resulted in the FDA approval of Tykerb in breast cancer. In addition, he managed the Lapatinib Expanded Access Program that enrolled over 4000 patients on a global basis. Dr. Berger began his career in drug development at Wyeth Research where he led the planning and execution of the pivotal Phase 2 trial for Mylotarg, which was the first antibody targeted chemotherapy agent. He presented the Mylotarg clinical data at the FDA’s Oncology Drug Advisory Committee meeting, after which Mylotarg received accelerated FDA approval for patients with relapsed AML.

Dr. Berger holds a B.A. in biology from Wesleyan University and a M.D. from the University of Virginia School of Medicine. He did his Hematology/Oncology fellowship at the University of Pennsylvania, where he was an Assistant Professor of Medicine, and also was a Research Fellow at the Ludwig Institute for Cancer Research and the Imperial Cancer Research Fund, both in London. Dr. Berger is board certified in internal medicine, hematology and medical oncology.

About Hemant Kumar, Ph.D., CPM, EMBA

Dr. Kumar is a recognized global expert in Chemistry, Manufacture and Controls (CMC) Technical Development and GMP manufacturing. He has a greater than 25-year track record leading global CMC and regulatory approval strategy for accelerated development of innovative vaccines, biologics, advanced cell & gene therapy drug process and product development (Ph1 to Ph3 and commercialization) under current GMP, and licensing processes. Dr. Kumar joins Genprex from Arcturus Therapeutics, Inc., where he served as Strategic Advisor and then Vice President, Global Head of Manufacturing, Supply Chain, and Strategy. Prior to that, Dr. Kumar was Vice President of CMC Technical Development & Manufacturing Operations at Oncoimmune Therapeutics, Inc., a private company that was acquired by Merck & Co. during his tenure there. Before that, he was Vice President, Head of Global Process Sciences and Clinical Manufacturing Operations at Rentscher BioPharma, SE. Previous to that, Dr. Kumar was with Anaptysbio, Inc., where he served as Senior Vice President, Head of Global CMC, Technical Development and Manufacturing Operations. Before that, Dr. Kumar held senior level positions of increasing manufacturing and technical operations leadership in global biopharmaceutical companies including Merck & Co., Inc., Sanofi Genzyme, Inc., Lonza Biologics, Inc., Sanofi Pasteur, Janssen Biotech ( a Johnson & Johnson company) and Wyeth Lederle Vaccines, Inc.

Dr. Kumar earned his Ph.D. in Biochemistry at J.N. Medical College, Aligarth India through a collaboration with the U.S. National Institutes of Health. He holds a graduate certificate in Project Management from Lehigh University School of Management. Dr. Kumar has conducted postdoctoral and research scientist fellowships at Yale University School of Medicine, the University of Rhode Island and the Center for Disease Control and Prevention’s Center for Infectious Diseases. He holds professional affilations with the American Chemical Society, American Association for the Advancement of Science, Americal Society for Microbiology and the International Society of Pharmaceutical Engineers.

Inducement Grants

The Company has granted 550,000 options to Dr. Berger at an exercise price equal to $2.85, the closing price of our common stock on September 27, 2021, the date of grant. While these options were not granted under Genprex’s 2018 Equity Incentive Plan (the "Plan"), the awards will incorporate the terms of the Plan. The options vest as to one-third of the shares over the next three years and are exercisable for a period of ten years subject to continued service to the Company.

The Company has granted 400,000 options to Dr. Kumar at an exercise price equal to $2.85, the closing price of our common stock on September 27, 2021, the date of grant. While these options were not granted under the Plan, the awards will incorporate the terms of the Plan. The options vest as to one-third of the shares over the next three years and are exercisable for a period of ten years subject to continued service to the Company.