2024-05-16

Q: How does Sen-Jam Pharmaceutical differentiate its pain relief solutions from traditional opioid-based treatments?

I founded Sen-Jam Pharmaceu­tical because I had a vision around pain management when I studied the topic intensely during my research fellowship at Memorial Sloan Kettering in New York City. It was during that time, decades ago, that I first became fascinated by how the medical community treated pain after the fact or reactively instead of considering means of preventing or mitigating it proactively.

From the start, we have Sen-Jam consistently aim to develop drugs that are extremely safe as well as efficacious and from the beginning for us, that meant a non-opioid solution would be paramount. We are proud to have developed a line of revolutionary anti-inflammatories that are non-steroidal, non-opioid, non-toxic yet arguably the most effectively potent with the least side effects. From a mechanis­tic or scientific perspective, the Sen-Jam portfolio of products harness small mol­ecules that have synergistic effects via a dual mechanism of action. Addition­ally, our mission is to improve the lives of billions by providing safe, efficacious, and accessible products to all. What that translates to us is that affordability for the patient is another driving force be­hind our repurposing of small molecules that are already proven and likely widely available.

Q: Can you describe Sen-Jam Pharmaceutical’s approach to repurposing small molecules for new therapeutic uses?

Sen-Jam Pharmaceu­tical strategically focuses on repurpos­ing small molecules to effectively treat inflammation at its root cause, offering a promising alternative to conventional products with potentially dangerous side effects. As a deeply experienced pharmacist and thought leader, I rec­ognized early on the untapped potential of long-standing, overlooked drugs, which big pharma often avoids due to lower profit margins compared to designer or dis­covery drugs. We identified promising repurposing opportunities and validated them through in vitro studies using novel combination therapies.

After successful preclinical studies as­sessing efficacy, safety, and pharma­cokinetics in animal models, we pro­gressed to designing and conducting expedited clinical trials to evaluate the repurposed small molecules in humans. Simultaneously, we secured intellectual property rights for the new therapeutic uses, filing over 60 patent applications in the past six years.

By repurposing existing small mole­cules, Sen-Jam has reduced the time, cost, and risk associated with traditional drug discovery and development, lever­aging prior knowledge to identify new therapeutic opportunities and accelerate the delivery of treatments to patients in need.

Q: What is the accelerated 505(b)2 pathway, and how does it benefit Sen-Jam’s drug development strategy?

The accelerated 505(b)(2) pathway offers significant advantages for start-up pharmaceutical companies like Sen-Jam Pharmaceutical. By leveraging existing data from previously approved drugs, the company saves time and money on massive clinical trials, focusing only on generating data for the unique aspects of their drug. This pathway reduces the risk of failure, enables faster market entry, and provides opportunities for securing patent protection for new formulations, indications, or routes of administration. Overall, this streamlined, de-risking and cost-effective route to bring new drugs to market helps make Sen-Jam Pharmaceutical pursuing the 505(b)(2) pathway more attractive to investors.

Q: What makes the SJP-100 injectable anti-inflammatory therapeutic a revolutionary product in your portfolio?

Sen-Jam is developing an immunomodulator drug with a unique, dual mechanism of action. SJP-100’s formulation can provide individualized, precision, drug delivery. We believe there are many use cases for the drug, and we see it being used primarily in hospitals to combat cytokine storm. SJP-100 is a dual-action therapeutic that can reduce the rate at which inflammatory proteins are released into the body from the immune system while reducing intracellular inflammation. Approximately thirty years of safety data show that immunosuppression would not be a side effect of this injectable.

Sen-Jam Pharmaceutical’s drug, SJP-100, holds promise for scientific research into aging and efforts to maintain a longer and healthier lifespan. Its precise delivery mechanism suggests a potential for preventing diseases and extending individuals’ periods of good health. We are conducting a Phase 2 study on COVID-19 patients using SJP-002C, an oral combination product. This study aims to explore how SJP-100, one of the agents contained in SJP-002C, could help restore the immune system’s balance. The Phase 2 clinical trial is set to finish this summer and will provide valuable insights into SJP- 100’s potential benefits.

Q: How does the partnership with KVK-Tech enhance Sen-Jam’s capabilities in drug development?

The partnership with KVK-Tech is a massive accelerant to our drug development activities. By working closely and early with our incredibly capable colleagues (and now friends) at this world-class manufacturing and controls outfit, we are able to produce the highest quality product in the most efficient means possible. Founded in 2004, KVK has fast become a trusted leader in specialty pharmaceutical manufacturing. KVK is a leader in the development and manufacture of high-quality, FDA-approved medicines that address unmet patient needs. KVK and Sen-Jam are aligned in their missions to advance medical care and offer low-cost alternatives in response to today's healthcare challenges. The dedicated team is composed of individuals with the technical, clinical and business expertise that is necessary for innovation that results in the development of a diverse range of life- changing medicines for patients of all socio-economic levels. One final interesting note is that a founding advisor and many current employees, while living in America now, have proud family roots in India. Learn more at https://kvktech.com/

Q: What were the key findings from the Phase 2 study of SJP-002C in COVID patients?

We are very proud of all our assets in our pipeline, including SJP-002C. This therapy did extremely well in our earlier studies which can be reviewed here. Our Phase 2 Clinical Trial, however, is not yet completed but we are anticipating that the study will finish mid-summer this year and we are awaiting what we hope to be great news on the heels of that analysis and data read. Perhaps we can do a follow up story with you at that time as we would certainly welcome that opportunity.

Q: How does Sen-Jam Pharmaceutical foster a culture of continuous improvement and innovation?

In this vibrant life sciences company, innovation is not just a buzzword but a way of life. Our leaders are encouraged to think outside the box, challenge conventional wisdom, and explore new frontiers in their respective fields. Sen-Jam provides ample resources and support for experimentation, recognizing that breakthroughs often come from unexpected places. Failures are not seen as setbacks but as valuable learning experiences that contribute to the collective knowledge and growth of the organization. The high value placed on strategic partnerships and rich collaborations further fosters our abilities to embrace new ideas quickly and comprehensively.

Transparency and open communication are the bedrock of Sen-Jam’s culture. All executives maintain an open-door policy, welcoming ideas, thoughts, and concerns within regular meetings and cross- functional collaborations to ensure that knowledge and perspectives are freely exchanged, breaking down silos and promoting a sense of unity.

We actually have an all-team huddle every Wednesday at 5pm EST and the first few minutes is a gratitude share from each of the members of the team. This will be our 7th year of these weekly meetings and we start them this way, without fail. Sen-Jam places a high value on curiosity and continuous learning. Each of us are encouraged to stay up-to-date with the latest scientific advancements and industry trends, and the company invests heavily in their development through training programs, conferences, and partnership opportunities. Diversity and inclusion are celebrated, as the company recognizes that different backgrounds and experiences contribute to innovative thinking.

Throughout all its operations, from research and development to marketing and sales, our company maintains the highest ethical standards, providing clear guidelines and support for employees to navigate any ethical dilemmas that may arise. This culture of innovation, transparency, and curiosity creates an environment where groundbreaking discoveries like the ones discussed in this article are made, and patient outcomes are continuously improved.