From Exelixis

Gisela Schwab, M.D., President, Product Development and Medical Affairs, and Chief Medical Officer, Exelixis, explains, “The acceptance of our Investigational New Drug Application for XB002 gets us one step closer to our first biologic entering the clinic and learning more about its potential to help patients with difficult-to-treat cancers. Considering XB002’s promising preclinical data and potential differentiation from other tissue factor-targeting antibody-drug conjugates, we look forward to initiating our Phase 1 trial in patients with advanced solid tumors.”

The Encouraging Preclinical Data Demonstrated the Following:

• In contrast with prior therapies in antibody-drug conjugate, XB002 binds to tissue factor without affecting the coagulation cascade.
• Preclinical data demonstrated encouraging activity of XB002 in multiple solid tumor cancer models and improved tolerability compared with other tissue factor-targeting ADCs.
• The data demonstrated significant inhibition of tumor growth.
• The data demonstrated complete tumor regression in some cases.

So, there are many reasons for the scientists to expect XB002 having an in hand improved therapeutic index and favorable safety profile compared with earlier antibody-drug conjugates targeting tissue factors. 

Exelixis Discovery Efforts Resulted in Four Commercially Available Products:  

Exelixis Partnerships 

Exelixis’ leading pharmaceutical partners have helped to bring its products to patients all over the world. The revenues from Exelixis’ marketed products and from its collaboration overseas offer support for the firm’s plans and achievements. Exelixis reinvest prudently in its business in order to maximize its pipeline potential.

Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.

In November 2020, the company was named to Fortune’s 100 Fastest-Growing Companies list for the first time, ranking 17th overall and the third-highest biopharmaceutical company.

Prohost Observations 

We are sticking our conviction that Exelixis is undervalued by Wall Street, their negative investors and their followers. EXEL’s price does not reflect the good news the firm has received for the many approvals of cabozantinib – a product approved for the treatment of various cancers. It is in clinical trials for other malignancies.

Exelixis’ latest approval is of cabozantinib in combination with Bristol-Myers Squibb (BMY) immunotherapy Opdivo for the first-line treatment of renal cell carcinoma. Even this important news was incapable of boosting the stock that we believe will soon fiercely rebound.     

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Positive News for TransMedics Group

TransMedics Group (TMDX) – a medical technology company that is transforming organ transplant therapy for patients with an end-stage lung, heart and liver failure, announced that after the review of TransMedics’ clinical evidence from the OCS Heart EXPAND trial, the associated Continued Access Protocol (CAP) results, as well as the OCS Heart PROCEED II trial, the Circulatory Systems Device Advisory Panel convened by the U.S. FDA issued a favorable vote in support of approval of the OCS Heart System to the FDA’s Office of Health Technology 2 (Cardiovascular Devices).

The FDA Panel Voted as Follows:

• 12 to  5, with 1 abstaining, that the benefits of the OCS Heart System outweigh its risks.
• 10 to 6, with 2 abstaining, that there is reasonable assurance that the OCS Heart System is effective.
• 9  to  7, with 2 abstaining, reasonable assurance of the OCS Heart System’s safety.

The FDA Advisory committees provide the FDA with independent opinions and non-binding recommendations from outside medical experts.  While the FDA will consider the opinions and recommendations expressed at the Advisory Committee, the FDA will make a decision regarding whether to approve the premarket approval application for the use of the OCS Heart System for donor hearts currently utilized and unutilized for transplantation after completion of its review of the application.

From the President & CEO of TransMedics Group

Waleed Hassanein, MD, President and Chief Executive Officer of TransMedics, said, “This is a critical milestone for the OCS Heart technology on the path to a potential FDA approval, which I am confident would benefit patients in need of heart transplantation in the U.S. We are looking forward to working collaboratively with the FDA as it completes its review. We are grateful for the help and support of our investigators, the patients who enrolled in our trials, and the donor families who gave our patients the gift of life by supporting organ donation. In addition, we want to thank the respected members of the Advisory Panel and the FDA review team for their thoughtful discussion and deliberations on this important PMA. We are now laser-focused and looking forward to our next important business milestones planned for 2021: the scheduling the OCS Liver FDA Advisory Panel Meeting, the final readout of the OCS Heart DCD trial and the filing of the DCD Heart PMA supplement to eventually expand our OCS Heart indication into DCD heart transplantation in the U.S.”

From Duke and Columbia Universities

Dr. Jacob Schroder, surgical director of heart transplantation at Duke University Medical Center and the principal investigator for the OCS Heart EXPAND Trial, said, “For decades we have talked about heart transplant being supply limited. If approved by the FDA, with the use of OCS Heart System for extended criteria donors, and DCD hearts, we can access to a significantly greater suitable donor poll. As the donor pool expands, more patients can have access to this life-saving therapy. If the OCS Heart System is approved, I believe the industry will  reverse its thinking and open up the ‘demand’ to a greater patient population that never had a chance at a new heart and a better life.”

Dr. Maryjane Farr, medical director of the transplant program at Columbia University Irving Medical Center said, “The potential opportunity to expand the donor pool for our heart transplant candidates using the TransMedics device in select patients would be a major advance in the field of heart transplantation.”

The OCS Heart EXPAND Trial

The OCS Heart EXPAND trial met its primary effectiveness endpoint. It showed that the use of the OCS Heart System resulted in successfully transplanting 84% – more than 8 out of 10, of the extended-criteria donor hearts that are seldom used for transplant today in the U.S. using cold ischemic storage preservation. The post-transplant rate of severe Primary Graft Dysfunction was 8%, which is well below the rates reported in the literature, and there were no unexpected safety findings. Patient survival at 30-days post-transplant was 97%. All-cause survival was 92% at 6 months and 87% at 12 months. Importantly, cardiac-related survival was 96% at both 6 and 12 months, these survival rates are comparable to U.S. standard heart transplant outcomes.

TransMedics Group, Inc.

TransMedics Group is the world’s leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Massachusetts, the company was founded to address the unmet need for more and better organs for transplantation and has developed technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung, and liver failure.

TransMedics Group

Prohost Observations 

The voting by the FDA’s panel of experts is very encouraging news in our opinion. Heart Transplant is a serious and sensitive subject. We look forward to the FDA approval.

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