A Houston health care company received the green light from the FDA to advance a treatment that's targeting a deadly cancer. Photo via Getty Images

The FDA has granted a Houston-based company a Fast Track designation.

Diakonos Oncology Corp. is a clinical-stage immuno-oncology company that has developed a unique dendritic cell vaccine, DOC1021. The vaccine targets glioblastoma multiforme (GBM), the most common and most lethal malignant brain tumor in adults. The aggressive tumors come with a life expectancy of about 15 months following diagnosis. About 7 percent of those diagnosed survive five years, while the 10-year outlook only sees a one-percent survival rate.

“The FDA’s decision acknowledges the potential of this new treatment approach for a very challenging disease,” Diakonos CEO Mike Wicks says in a press release. “Our protocol represents a first for cancer immunotherapy and could be viable for many types of cancers beyond GBM.”

FDA Fast Track designations are intended to expedite the haste with which drugs with early clinical promise are reviewed, likely taking them to market faster.

DOC1021 uses the body’s natural anti-viral immune response to fight GBM. The vaccine mimics viral infection with the patient’s cancer markers. Essentially, DOC1021 uses the body’s own natural ability to detect and eliminate infected cells.

The technology uses dendritic cells, white blood cells that are able to perceive threats, to its advantage. The unique cancer markers are loaded both internally and externally into the immune cells, just as they would simultaneously occur in a viral infection. The individualized treatment is administered through three precise injections that target deep cervical lymph node chains. By dosing this way, the immune responses are directed straight to the central nervous system.

The results have spoken for themselves: All of the patients who have tried the treatment have exceeded survival expectations. And just as importantly, DOC1021 appears to be extremely safe. No serious adverse effects have been reported.

“Because Phase I clinical trials are generally not statistically powered to demonstrate efficacy, detection of a statistically significant efficacy signal is very promising,” says William Decker, associate professor of immunology at Baylor College of Medicine and inventor of the DOC1021 technology.

The Phase 1 open-label trial of DOC1021 (NCT04552886) is currently taking place at both the University of Texas Health Science Center in Houston and at the MD Anderson Cancer Center at Cooper University Health Care in Camden, NJ. The trial is expected to complete this year.

Drs. Maria Elena Bottazzi and Peter Hotez got the green light to distribute their low-cost COVID-19 vaccine in Indonesia. Photo courtesy

Houston doctors get approval for low-cost COVID vaccine abroad

green light

A Houston-born COVID-19 vaccine has gotten the go-ahead to be produced and distributed in Indonesia.

PT Bio Farma, which oversees government-owned pharmaceutical manufacturers in Indonesia, says it’s prepared to make 20 million doses of the IndoVac COVID-19 vaccine this year and 100 million doses a year by 2024. This comes after the vaccine received authorization from the Indonesian Food and Drug Authority for emergency use in adults.

With more than 275 million residents, Indonesia is the world’s fourth most populous country.

IndoVac was created by the Texas Children’s Hospital Center for Vaccine Development and Baylor College of Medicine. Drs. Peter Hotez and Maria Elena Bottazzi lead the vaccine project. Bio Farma is licensing IndoVac from BCM Ventures, the commercial group at the Baylor College of Medicine.

“Access to vaccines in the developing world is critical to the eradication of this virus,” Hotez, co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, says in a news release.

Aside from distributing the vaccine in Indonesia, Bio Farma plans to introduce it to various international markets.

“The need for a safe, effective, low-cost vaccine for middle- to low-income countries is central to the world’s fight against the COVID-19 pandemic,” says Bottazzi, co-director of the Texas Children’s Hospital Center for Vaccine Development and associate dean of the National School of Tropical Medicine at Baylor.

“Without widespread inoculation of populations in the developing world, which must include safe, effective booster doses, additional [COVID-19] variants will develop, hindering the progress achieved by currently available vaccines in the United States and other Western countries.”

Bio Farma says it has completed Phase 1 and Phase 2 clinical trials for IndoVac and is wrapping up a Phase 3 trial.

IndoVac is a version of the patent-free, low-cost Corbevax vaccine, developed in Houston and dubbed “The World’s COVID-19 Vaccine.” The vaccine formula can be licensed by a vaccine producer in any low- or middle-income country, which then can take ownership of it, produce it, name it, and work with government officials to distribute it, Hotez told The Texas Tribune in February.

Among donors that have pitched in money for development of the vaccine are the Houston-based MD Anderson and John S. Dunn foundations, the San Antonio-based Kleberg Foundation, and Austin-based Tito’s Vodka.

“During 2022, we hope to partner with the World Health Organization and other United Nations agencies to vaccinate the world. We believe that global vaccine equity is finally at hand and that it is the only thing that can bring the COVID pandemic to an end,” Hotez and Bottazzi wrote in a December 2021 article for Scientific American.

Drs. Maria Elena Bottazzi and Peter Hotez at the Center for Vaccine Development. Photo courtesy of Texas Children's Hospital

2 Houston powerhouses deploy game-changing COVID-19 worldwide vaccine

a good shot

With the U.S. logging its highest single-day total of new COVID-19 cases (441,278 infections) and some 281, 808, 270 cases documented worldwide, new treatments worldwide are in major demand — especially in emerging nations.

To that end, Texas Children’s Hospital and Baylor College of Medicine announced a new COVID vaccine ready to deploy in India and soon, other underserved countries.

Corbevax, which is dubbed “The World’s COVID-19 Vaccine,” utilizes a traditional recombinant protein-based technology that will enable production at large scales, per a press release. That means the inoculation will be widely accessible to inoculate the global population.

This new vaccine was developed at Texas Children’s Hospital CVD and led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez — and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE).

After completing two Phase III clinical trials involving more than 3000 subjects the vaccine was found to be safe, well tolerated, and immunogenic. Current research shows Corbevax notably effective against the Ancestral-Wuhan strain and the globally dominant Delta variant, press materials note.

Safe, streamlined, low-cost vaccines for middle- to low-income countries are central to the world’s fight against the COVID-19 pandemic, the two Houston organizations note. Indeed, without widespread vaccination of populations in the Global South, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the United States and other Western countries, per research.

“This announcement is an important first step in vaccinating the world and halting the pandemic,” said Hotez in a statement. “Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant. Widespread and global vaccination with our Texas Children’s-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow.”

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This article originally ran on CultureMap.

Texas Children's Hospital and Baylor College of Medicine are working on a new COVID-19 vaccine candidate. Photo by Dwight C. Andrews/Greater Houston Convention and Visitors Bureau

Houston health care organizations team up for the 'people's vaccine'

COVID Collaboration

Two major health care institutions in Houston — Texas Children's Hospital and the Baylor College of Medicine — are a step closer to rolling out what they dub the "people's vaccine" for COVID-19.

The two institutions, along with India-based vaccine and pharmaceutical company Biological E Ltd., have gained approval to move ahead this month with Phase III clinicals trials in India of a COVID-19 vaccine candidate called Corbevax. The Texas Children's Hospital Center for Vaccine Development developed the vaccine's protein antigen, which was licensed from the Baylor College of Medicine's BCM Ventures commercialization arm.

Unlike COVID-19 vaccines in the U.S., Corbevax contains the so-called "spike protein" from the surface of the novel coronavirus. Once that protein is injected via a vaccine, the body is supposed to begin building immunity against the protein and thereby prevent serious illness.

Experts envision Corbevax being a readily available weapon in the global fight against the COVID-19 pandemic, thanks to the simple vaccine platform (like the one used to prevent Hepatitis B) and the ability to store the vaccine in normal refrigerated settings. The targets of this vaccine are children and mothers.

"In the midst of India's public health crisis, it is our hope that our Texas Children's and Baylor COVID-19 vaccine can be released for emergency authorization in India and in all countries in need of essential COVID-19 vaccinations," Dr. Peter Hotez, co-director of the Texas Children's Hospital Center for Vaccine Development, says in a June 9 news release.

India has reported more than 29 million cases of COVID-19, causing 354,000 deaths. The country's COVID-19 surge reached its peak in May.

"The vaccines currently available cannot be manufactured quick enough to meet supply shortages in low-income countries," Hotez says. "Our vaccine is truly 'the people's vaccine,' created to serve the most marginalized and underserved populations that are hardest hit by this pandemic. This is the vaccine that could be used to vaccinate the world."

In the Phase III trial, the two-dose Corbevax vaccine will be administered to about 1,200 people age 18 to 80 at 15 sites in India. A larger global study of Corbevax is in the works.

According to India.com, Corbevax could be the most affordable COVID-19 vaccine available in the nation of nearly 1.37 billion people, costing close to $7 for a two-dose regimen. The Indian government already has preordered 300 million doses of Corbevax, which has shown promise in Phase I and Phase II trials. The Phase II trial ended in April.

If the Phase III trial goes as planned, doses could be widely administered as soon as August. Biological E initially plans to produce 75 million to 80 million doses per month, according to media reports. The Indian company foresees manufacturing at least 1 billion doses by the end of 2022.

ClassPass, which recently opened a Houston location, has launched a new tool for users to find their closest vaccine location. Photo courtesy of ClassPass

Tech company launches COVID-19 vaccine finder in Houston

there's an app for that

A global tech company that recently opened a local office in Houston has announced a major upgrade to its app — and it's now available in Houston.

ClassPass, a network of fitness and wellness partners, now has Houston vaccine centers searchable within the app and website. Members can find their closest vaccine center and get important information — like hours and address — as well as how to contact the locations; however, users aren't able to book directly through ClassPass.

"We are in a global health crisis and every company should be helping to support relief and vaccination efforts however they can. Using the ClassPass platform to connect members with vaccine centers is a natural extension of our technology and a way that we can contribute to curbing the spread of COVID-19," says Jeff Bladt, vice president of pricing and inventory, in a news release.

"We have deep knowledge of how to help people find accurate and up-to-date information on local businesses after routing millions of users to fitness and wellness locations across 30 countries," he adds.

Users can search for COVID vaccine locations online or through the app. Photo courtesy of ClassPass

The new search option has been rolled out already in in Austin and Dallas, as well as Boston, Chicago, Denver, Miami, New York City and Washington, D.C.

"The process of finding a vaccination appointment can be challenging and many people don't know where to start," says Dr. Vin Gupta, a critical care pulmonologist, health policy expert, and NBC News Medical Analyst, in the release.

"I was thrilled to hear that ClassPass, a high touch app that has already trained people how to search for vital health information, is leveraging their platform to make it easier to identify vaccine sites and secure appointments," he continues. "Anything that can address this information gap is critical in getting more people vaccinated."

ClassPass quickly pivoted when the pandemic hit last year, and now all 41,500 fitness, wellness, and beauty partners on the app have been asked to provide updated details on their COVID policies. ClassPass also worked with 5,000 top studios around the world to add digital classes as an option.

In March, Houston-based ClassPass exec, Rachel Moctron, joined the Houston Innovators Podcast to discuss this pivot and the new Houston office. Listen to it below.


This new guide helps streamline vaccine sites and eligibility information in one place. Photo courtesy of CVS Health

New app gives good shot at finding COVID-19 vaccination in Houston

HELP WITH HEALTHCARE

Are you frustrated by the hoops you're jumping through to get a COVID-19 vaccination? The GoodRx drug-price-comparison app has stepped in to help.

GoodRx just rolled out a guide so you can learn about the COVID-19 vaccine, track its availability, and set up a vaccination appointment in Houston or elsewhere in Texas.

"Vaccine information has been fragmented and availability unclear, so GoodRx has built the go-to destination for all Americans to track the vaccine rollout locally," the company says in a statement.

GoodRx is collecting data from more than 15,000 vaccination sites and is monitoring the country's 70,000 pharmacies as well as state-specific sites to update appointment availability. New information is added as it becomes available.

Among other things, the GoodRx guide tells you who's eligible for vaccinations where you live, who's next in line, and how you can make a vaccination appointment. You can even sign up to receive text messages that alert you when vaccination eligibility changes in your area.

This news comes as Texas Gov. Greg Abbott has reopened the state and lifted the mask mandate — which could put Houstonians at even greater risk.

Meanwhile, throughout Texas, the recent winter storm, power outages, and water shortages hampered the ability to distribute COVID-19 vaccines. As of March 3, Harris County shows some 351,063 confirmed COVD cases, according to most-recent data, and 2,297,878 cases statewide. Information about the Texas vaccination plan is available on the Department of State Health Services website.

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This article originally ran on CultureMap.

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Early-stage accelerator returns to Houston, announces finalists

prepare for take-off

CodeLaunch, a traveling seed-stage accelerator, is returning to Houston for its latest cohort.

The startup competition sponsored by software development company Improving will have its ultimate showdown on February 28. The final competition pairs six startups with six startup consulting companies.

Jason W. Taylor, CodeLaunch president and founder, says CodeLaunch isn’t your typical startup showcase, as it incorporates music acts, comedy, and crowd networking. Mirroring the set-up of a TV show, the six finalists all present their working products in front of an audience amid these performances.

“I would describe CodeLaunch as the next generation of venture-tainment in North America and the greatest startup show on earth,” Taylor explains.

The 2024 Houston CodeLaunch participant startups — and their mentor partners — are as follows:

Prior to pitch day, all six teams will receive hands-on instruction from CodeLaunch mentors on how to construct their pitches and free professional software development from their partners. Taylor says the strong relationships between CodeLaunch and these developers played a major role in setting the competition in Houston.

“We love Houston and we’re back for a third year in a row because the Houston startup ecosystem works together better than other major startup ecosystems I’ve seen,” Taylor says. “We have some great software development partners in Houston that are building code for those startups.”

Last year, Houston-based startup Energy360, with the mentorship and help of Honeycomb Software, took home the Championship belt and a $100,000 investment offer from Cyrannus VC fund for their energy management system Matt Bonasera, Energy360’s enterprise architect, says he is grateful for the entrepreneurial community CodeLaunch provides, in particular the team’s mentor Oleg Lysiak, Honeycomb VP of Partnerships and Business Development.

“I happened along this great community of people who are really passionate about supporting each other,” Bonasera says.

Lysiak agrees that CodeLaunch is an ideal opportunity for young entrepreneurs looking to hone their skills and expand their product capabilities. Lysiak says he is looking forward to defending Honeycomb’s title as top consultant development team.

“My whole philosophy is to connect people and have different collisions and collaborations,” Lysiak says.

Houston startup completes testing, prepares biosimilar insulin drug for clinical trials

next steps

A Houston biotech startup is one step closer to releasing its marquee drug for the global insulin market, which is projected to break the $90 billion threshold by 2029.

rBIO says it recently completed testing of the properties of R-biolin, an insulin drug that’s biologically identical to Novo Nordisk’s Novolin drug. The patent for Novolin about two decades ago. In March 2023, the Dutch drugmaker announced it was slashing the list price of Novolin by 65 percent to $48.20 per vial and $91.09 per FlexPen.

Executives at rBIO are now pursuing a partnership with a contract research organization to manage clinical trials of R-biolin. If those trials go well, R-biolin will seek approval to supply its insulin therapy to diabetes patients around the world.

Washington University in St. Louis is rBIO’s academic partner for the R-biolin project.

The rBIO platform produces insulin at greater yields that traditional manufacturing techniques do. The company is striving to drive down the cost of insulin by 30 percent.

About 38 million Americans have diabetes, with the vast majority being treated for type 2 diabetes, according to the U.S. Centers for Disease Control and Prevention (CDC). Many people with diabetes must take insulin to control their blood sugar levels.

Research company iHealthcareAnalyst predicts the global market for insulin will surpass the $90 billion mark in 2029.

“There has been a lot of talk in the media about reducing the cost of insulin for diabetic patients, but what is often overlooked is that the domestic demand for insulin will soon outpace the supply, leading to a new host of issues,” Cameron Owen, co-founder and CEO of rBIO, says in a news release.

“We’re dedicated to addressing the growing demand for accessible insulin therapies, and … we’re thrilled to announce the viability of our highly scalable manufacturing process.”

Professionals from the University of California San Diego and Johns Hopkins University established rBIO in 2020. The startup moved its headquarters from San Diego to Houston in 2022.

CEO Cameron Owen and Chief Scientific Officer Deenadayalan Bakthavatsalam work on insulin purification in the Houston lab. Photo courtesy

How AI is changing product management and what you need to know

guest column

For the past 14 months, everyone has been talking about ways artificial intelligence is changing the world, and product management is not an exception. The challenge, as with every new technology, is not only adopting it but understanding what old habits, workflows, and processes are affected by it.

Product managers — as well as startup founders leading a product function — more than any other role, face a challenge of bringing new life-changing products to market that may or may not be received well by their users. A product manager’s goal is complex — bring value, stay ahead of the competition, be innovative. Yet, the "behind the scenes" grind requires endless decision making and trade offs to inspire stakeholders to move forward and deliver.

As we dive into 2024, it is obvious that AI tools do not only transform the way we work but also help product managers create products that exceed customer expectation and drive businesses forward.

Market research and trends analysis

As product managers, we process enormous amounts of market data — from reviewing global and industry trend analysis, to social media posts, predictions, competition, and company goals. AI, however, can now replace hours, if not days, of analyzing massive amounts of data in an instant, revealing market trends, anticipating needs, and foreseeing what's coming next. As a result, it is easier to make effective product decisions and identify new market opportunities.

Competitive analysis

Constantly following competitors, reviewing their new releases, product updates, or monitoring reviews to identify competitor strengths and weaknesses is an overwhelming and time consuming task. With AI, you can quickly analyze competitors’ products, pricing, promotions, and feedback. You can easily compare multiple attributes, including metrics, and identify gaps and areas for improvement — all the insights that are otherwise much harder to reveal quickly and efficiently.

Customer and product discovery

Of course, the most intuitive use case that comes to mind is the adoption of AI in product and customer discovery. For example:

  • Use AI for customer segmentation and persona creation to help visualize personas, prioritize user motivations and expectations, and uncover hidden behavior and needs. You can then create and simplify customer questionnaires for interviews and user groups and target customers more accurately.
  • Analyze quantitative and qualitative data from surveys, support tickets, reviews, and in-person interviews to identify pain points and unmet user needs and help prioritize features for future updates and releases.

Roadmap and sprint management

AI provides value in simplifying roadmap planning and sprint management. Resource optimization is often a gruesome task and AI can help with feature prioritization and resource allocation. It helps teams focus on critical work and increase their productivity. You can even analyze and manage dependencies and improve results across multiple sprints months in advance.

Prototyping and mockup generation

There is no product manager’s routine without multiple mockups, wireframes, and prototypes that explain concepts and collect feedback among stakeholders. AI has become a critical tool in simplifying this process and bringing ideas to life from concept to visualization.

Today, you can use textual or voice descriptions to instantly create multiple visuals with slight variations, run A/B tests and gather valuable feedback at the earliest stage of a product life cycle.

Job search and job interviews

Consider it as a bonus but one of the less obvious but crucial advantages of AI is using it in job search. With the vulnerable and unstable job market, especially for product roles, AI is a valuable assistant. From getting the latest news and updates on a company you want to join, to summarizing insights on the executive team, or company goals, compiling lists of interview questions, and running mock interviews, AI has become a non-judgmental assistant in a distressing and often discouraging job search process.

Use AI to draft cold emails to recruiters and hiring managers, compare your skills to open positions’ requirements, identify gaps, and outline ideas for test assignments.

We already know that AI is not a hype; it is here to stay. However, remember that customers do not consume AI, they consume your product for its value. Customers care whether your product gets their need, solves their problem, and makes their lives easier. The goal of a product manager is to create magic combining human brain capabilities and latest technology. And the best result is with a human at the core of any product.

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Natasha Gorodetsky is the founder and CEO of Product Pursuits, a Houston company that helps early stage and venture-backed startups build products and create impact.