No surprise then, that her first love was philosophy and remains so to this day, as evidenced by the well-thumbed Nietzsche classic “Thus Spoke Zarathustra” that lay between us as we talked over coffee.

At 18 and a philosophy major, Khatija had absolutely no interest in medicine or science and was content with lofty abstract ruminations. Yet life, as it often does, provided her with an unceremonious crash-landing back to reality when her dad was diagnosed with colon cancer.

After two rounds of chemotherapy and two years later he sadly passed away when she was 21. Taken aback by the suddenness of her dad’s deteriorating condition and the lack of treatment options available, she became hellbent on pursuing medicine to change the fate of future cancer patients.

At McMaster University, her curiosity led her to work with 3D-printed biodegradable blood vessels encapsulated with iPSCs (stem cells generated directly from adult tissue).

As fate would have it, she was also conducting a meta-analysis of antibiotic eluting beads when it suddenly occurred to her that by combining elements of the two technologies she could create an entirely new 3D-printed drug delivery mechanism.

After exploring the problems surrounding the current state of 3D printed designs, she found a novel biopolymer that was degradable, non-cytotoxic, long-lasting and had the unique ability to secrete a drug payload at a constant rate, thus ensuring the most efficacious and efficient therapy possible.

She immediately placed a patent on her discovery and with a $10K cheque from her ever-supportive OB-GYN attending she decided to take the plunge into founding her own biotech startup — Biosapien.

Now at RebelBio, she is recruiting a rockstar team, readying a seed round of fundraising, and preparing preclinical testing for her startups’ first design which intends to precisely deliver FDA approved chemotherapies directly to cancerous cells using only a fraction of the typically required dosage, significantly reducing costs and, crucially, mitigating against the debilitating side effects of the treatment.

On the potential of the technology, Khatija gestures skyward — “The possibilities are virtually unlimited. Anything that needs precise delivery into the body can be incorporated into Biosapien’s design. Therapeutics, nutrients, surgical nanorobots, you name it!”

Thinking back, she chuckles at how, when she was a child, she wanted to grow up to be an astronaut, charter boundless space and even dive into one of the cosmos’ greatest mystery— the black-hole. Where or when she would have liked to end up she paid little thought to.

It was the going into the unknown that so thrilled her imagination, and the chance that at the end of that journey we might find ourselves, and our species, further advanced along than we dared dream of at the start.

Source: https://medium.com/sosv/beyond-sapiens-1b6986d410e6

And for our eighth and latest cohort, we decided to invest in 10 new companies whose technologies exhibit potential for exciting advancements in their field. Read here.

BioSapien is a developer of 3D-printed biodegradable implantable devices intended to deliver FDA-approved drugs directly to cancerous cells.

The company’s device, MediChip®, is a novel 3D-printed biodegradable mesh that is intended to allow for chemotherapy to be delivered intravenously through a controlled drug release, with the aim of enabling physicians to reduce harmful side-effects and costs.

“As so many have witnessed or experienced first-hand, the effects of chemotherapy can take a tremendous toll on the immune system and body of patients undergoing treatment for cancer.

We are excited to be an early investor in BioSapien and their novel drug delivery system, which has the potential to revolutionize the delivery of chemotherapy through a targeted, personalized, and controlled approach to alleviate the unwanted side effects and toxicities of the treatment.” said Hamzeh Abdul-Hadi, Principal at Hikma Ventures.

“We are also strong supporters of BioSapien’s leadership team, led by CEO and Co-Founder Dr. Khatija Ali, and are proud to continue supporting female founders, who now comprise more than 20% of our investment portfolio.”

“Hikma Ventures is a strong addition to our investor syndicate and we are extremely pleased to have such an experienced partner supporting our work to transform patient care,” said Dr. Khatija Ali, CEO and Co-Founder of BioSapien. “The seed round funds will advance development of MediChip® and give access to global distribution channels and manufacturing.”

BioSapien, a biotech company has announced it has raised $1.8M in seed round funding led by global venture capital investor SOSV. Co-investors in the round include Hikma Ventures, Microventures, Infinity Capital Ventures, JPIN VCATS, Side Door Ventures, and other high-net worth angels and investors (Additional investors listed below)*.

In addition to the seed round funding, a non-dilutive grant of $256K from the National Science Foundation will accelerate the development of BioSapien’s patented product, MediChip: a 3D printed biodegradable mesh chip designed to deliver cancer drugs directly to the tumor site while reducing side effects.

“It’s great to have the support of these esteemed investors in BioSapien,” says Dr. Khatija Ali, CEO and co-founder of BioSapien. “The seed round funds will advance development of MediChip and give access to global distribution channels and manufacturing.

Chemotherapy can cause devastating side effects for patients. MediChip is designed to deliver cancer drugs straight to hard-to-reach tumor sites, for increased efficacy with reduced toxicity.”

MediChip is a novel biodegradable drug delivery platform designed to precisely administer any type of FDA-approved drug, locally and in a sustained manner. Pre-clinical research shows that in comparison to systemic chemotherapy, MediChip mitigates systemic side-effects through localized controlled release.

For cancer indications, it has the potential to improve the patient’s quality of care and life. It is designed to be a first-line treatment option for stage III locally advanced gastrointestinal cancer patients during surgery for adjuvant chemotherapy delivery. MediChip was granted its patent in February 2021 with a priority date of December 21, 2018.

Potential For Stage III, IV Pancreatic Cancer

The current clinical pipeline includes BioSapien’s lead indication of pancreatic cancer and others including lung cancer, esophageal cancer, and colorectal cancer. There are approximately 57,000 new cases of pancreatic cancer in the US every year.

Founded in 2018, in New York City, NY, BioSapien has already garnered global attention. In addition to the seed round funding and NSF grant which Inspiralia assisted in securing, BioSapien has been recognized in high profile biotech pitch competitions, winning the Pitch Night by Amazon and the Get in the Ring Start Up Competition.

The company is currently a semi-finalist in the PacBio 2021 conference. Now, with backing from SOSV, Hikma, and JPIN VCATS, MediChip has strategic partners, financial backing, and global reach to progress towards achieving the goal of impacting patient care worldwide.

• Additional investors include; SOSV, Hikma Ventures, Microventures, Infinity Capital Ventures, JPIN VCATS, Side Door Ventures, Harbr, Beni VC, Cedas Foundation, Kartik Garg – The Modern Nomad, George and Saul, and other angels

About BioSapien

BioSapien Inc. is a venture-backed biotechnology company focused on innovative therapies to transform patient care. The company invented MediChip: a patented treatment that early research has shown can reduce the system-wide side effects of cancer chemotherapy treatments.

The 3D printed biodegradable mesh is designed to allow for a more exact delivery of already approved FDA pharmaceuticals without the adverse effects. For more information, visit www.biosapien.tech.

About SOSV

SOSV is a global venture capital firm headquartered in Princeton, NJ. The firm has more $900 million in assets under management and more than 1,000 portfolio companies. 

SOSV operates the startup development programs HAX (hard tech), IndieBio (life sciences), Chinaccelerator and MOX (cross-border growth in Asia) and dlab (blockchain). Sean O’Sullivan, a serial entrepreneur and technologist, is the founder of SOSV. The firm has 8 general partners and a 130-person staff across seven locations in the US, Europe and Asia.

About Hikma

Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, Hikma has been creating high-quality medicines and making them accessible to the people who need them.

Headquartered in the UK, Hikma is a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and uses their unique insight and expertise to transform cutting-edge science into innovative solutions that transform people’s lives. 

Hikma is committed to their customers, and the people they care for, and by thinking creatively and acting practically, Hikma provides them with a broad range of branded and non-branded generic medicines.

Together, Hikma’s 8,600 colleagues are helping to shape a healthier world that enriches everyone’s communities. Hikma is a leading licensing partner, and through their venture capital arm, are helping bring innovative health technologies to people around the world.

For more information, please visit: www.hikma.com.

About Hikma Ventures

Founded in August 2015, Hikma Ventures operates as the corporate venture capital arm of Hikma Pharmaceuticals. Hikma Ventures invests in global start-ups where Hikma’s expertise can accelerate revenue growth and enhance value creation by providing ventures with access to the resources of a multinational pharmaceutical company.

For more information, please visit www.hikmaventures.com.

About BioSapien

BioSapien Inc. is a venture-backed biotechnology company focused on innovative therapies to transform patient care. The company developed MediChip®: a patented treatment that reduces the system-wide side effects of cancer chemotherapy treatments. The 3D printed biodegradable mesh allows for a more exact delivery of already approved FDA pharmaceuticals without the adverse effects

A personal loss in the life of BioSapien CEO Khatija Ali inspired her to embark on a completely new career path that just might benefit untold numbers of cancer patients in the future. When her father was diagnosed with colorectal cancer, Ali saw firsthand the ravages of chemotherapy side effects.

“It was the worst time in my life,” she said, in an interview with MD+DI, “and I didn’t understand what was going on. I didn’t understand why his hair was falling out. It sparked a curiosity in me.”

That curiosity drove her to leave behind her philosophy studies and apply to medical school, where she researched newer and better drug-delivery systems for chemotherapy.

And so began the idea for BioSapien, the company Ali founded in 2018 to develop a novel approach to delivering chemotherapy directly to tumors.

What started as a $10,000 graduation gift from her attending physician increased to $40,000 from a friends and family round of fundraising, to a recently closed $1.8 million last year. Another $15 million is expected to be raised by August this year for clinical trials.

BioSapien’s drug-delivery system is called MediChip. It is a 3D-printed biodegradable mesh that can release any type of cancer drug in a localized manner. “

She explained that the drug is encased within the polymer, remaining there until released at a targeted location. This slow, controlled release allows for application to various solid tumors.

“MediChip is designed with four corners, and those corners can be sutured onto the site of the tumor. The corners are designated as the north, south, east, and west compartments, and each compartment can release the drug at different rates (if desired), because it is a separate polymer, with a unique molecular weight,” Ali said.

Since MediChip delivers the drug directly to the tumor, it avoids the widespread effects seen in traditional IV chemotherapy. “With IV chemo, the medication travels through your bloodstream, reaching everything,” explained Ali. “This impacts sensitive areas like your digestive system and hair follicles, leading to nausea, hair loss, and weakened immunity.”

These effects have not happened in BioSapien’s animal studies, Ali said. “No weight loss. No hair loss. No problems with the GI. No nausea. No diarrhea. It’s as if there is nothing going on, except for tumor reduction, which is exciting,” she said.

The system is intended to be used in patients with Stage 3 localized cancer. “The reason we are targeting those patients is because they are already going in for some form of surgical procedure. The surgeon is already there and they are looking at the tumor and cannot take it out—what we call locally advanced unresectable cancers or residual markings,” Ali explained.

The first population for MediChip is expected to be rectal and anal cancer patients. “In patients with rectal and anal cancer, we are able to noninvasively or minimally invasively insert the MediChip without having to do an open procedure,” Ali said. In such cases, MediChip would be placed through either an endoscopy or colonoscopy.

BioSapien is on target to complete its IND application by Fall 2022 to start clinical trials in December 2022, with the goal of having the first patient enrolled by the first quarter of 2023.

Ali said that BioSapien has partnered with Memorial Sloan Kettering, Vanderbilt University Medical Center, and the University of California, San Diego Medical Center, and that those are the potential sites for the clinical trials.

“We are excited about our collaborations and hope to conduct our first-in-human Phase 1A/2B clinical trial with these Centers of Excellences and their experts” Ali said. “We aim to commercialize by Q4 of 2024.”

BioSapien is a US customer from California (Vista, just north of San Diego). They developed a 3D printed biodegradable mesh that delivers drugs in a localized sustained manner for cancer indications.

Doing it this way will reduce the systemic side effects compared to standard treatment. The product is called MediChip.

Having overseas customers means working at 05.00 am, during the weekends and evenings. Nine hours of time differences is sometimes a challenge. But the energy that is beaming off the CEO of BioSapien, Khatija Ali, and her team, is contagious.

Vosfox Medical will support this exciting project by further developing the production process, using 3D printers, designing and testing the packaging, performing the sterilization and packaging validation and producing the MediChips for clinical evaluations. 

Bioprinting is a form of medical 3D printing or medical additive manufacturing. It is an extrusion technology working with syringes. The syringes can be filled with polymers, gels, or solutions. At the end of the syringe is a nozzle and the material is pressed out of the syringe with air pressure.

In addition, she has successfully raised capital totaling $2.5M for MediChip. Khatija is passionate about science and has the ability to translate complex medical and scientific information into high-performance deliverables.

Skilled with medicine and powered by the logic of philosophy, she aims to provide patients with new and innovative products.

Khatija has a deep love for medical education, which is evident through her 4+ years as a medical educator (hybrid), where she has mentored and guided 10+ medical graduates into successful residencies.

In addition, Khatija has 2+ years of experience in building and launching companies at HB. Khatija has over 15+ years of professional experience holding various titles.

With a deep love for research, she has numerous peer-reviewed publications in the Journal of Vascular Surgery, Annals of Vascular Surgery, Annals of Oncology Surgery, and the Canadian Journal of Surgery.

Since the inception of BioSapien, she has won multiple awards, including Top 25 CEOs in Biotech from TechCEOs, Rising Star CEO at Boston LifeSci, and multiple pitch competitions worldwide, including Get in the Ring.

Khatija is also involved in non-profit work involving building water pumps in South Asia and volunteering at Habitat for Humanity in NYC to build homes globally. She has been involved in multiple builds around the world. Her recent build was in El Salvador.

In addition, Khatija sits on multiple non-profit boards, including Muslims Against Hunger, HAF, and Habitat for Humanity YP.