PLANEGG/MUNICH, Germany – February 5, 2024 – MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced the company entered into a Business Combination Agreement with Novartis data42 AG and Novartis AG (hereinafter collectively referred to as “Novartis”) based on Novartis’ intention to submit a voluntary public takeover offer for all outstanding MorphoSys no-par value bearer shares at an offer price of € 68.00 per share in cash. As part of the Business Combination Agreement with Novartis, Novartis seeks to obtain exclusive, worldwide rights to develop and commercialize pelabresib, an investigational BET inhibitor, and tulmimetostat, an investigational next-generation dual inhibitor of EZH2 and EZH1, across all indications. Separately, MorphoSys entered into a Purchase Agreement to sell and transfer all rights worldwide related to tafasitamab to Incyte Corporation (“Incyte”). Currently, MorphoSys partners with Incyte on the development and commercialization of tafasitamab. MorphoSys’ Management Board and Supervisory Board unanimously approved both agreements.

“Novartis shares our steadfast commitment to develop and deliver transformative medicines that address the dire needs of cancer patients. Pelabresib – the investigational therapy at the forefront of our promising oncology pipeline – has the potential to shift the treatment paradigm in myelofibrosis and further expand into other indications. Novartis will provide ample resources currently unavailable to MorphoSys as a standalone biotech company to help accelerate the development opportunities and maximize the commercialization potential of pelabresib at a greater speed and scale,” said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. “We are also pleased that Incyte will assume full responsibility of tafasitamab. Given the proposed acquisition by Novartis and our long-standing partnership with Incyte, we know Incyte is best positioned to drive tafasitamab’s future growth opportunities forward successfully and more efficiently on its own at this time. We believe these agreements are in the best interest of MorphoSys, our shareholders and cancer patients.”

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December 19, 2023

SAN DIEGO — Treatment with a selective PIM1 kinase inhibitor showed positive clinical reactions in a sample of 23 patients with relapsed/refractory myelofibrosis, according to preliminary data presented at ASH Annual Meeting.

TP-3654, an oral investigational highly selective PIM1 kinase inhibitor, is the subject of the phase 1/phase 2 study evaluating monotherapy in relapsed/refractory myelofibrosis, according to results published by a team led by Lindsay A.M. Rein, MD, a hematologic oncologist at Duke Cancer Center.

Elevated circulating cytokines have previously been noted as having a strong association with myelofibrosis, and preclinical studies evaluating TP-3654 as both a monotherapy and in tandem with ruxolitinib (Jakafi, Incyte) displayed lowered cytokine response and other responses, such as spleen reduction and bone marrow fibrosis reduction.

As such, the phase 1/phase 2 study further examined TP-3654 monotherapy in a cohort of patients with intermediate or high-risk myelofibrosis, and who had been previously treated with or were ineligible for JAK inhibitor treatment.

The 23 patients — who had a median age of 73 years and all but one of whom had previously received JAK inhibitor treatment — were monitored for cytokine changes over 12 weeks of TP-3654 monotherapy. “Broad reductions” in cytokine levels were observed in as little as 24 hours, and over the course of 12 weeks, patients with higher cytokine reduction levels were found to have greater reduction in symptoms.

Twelve of 13 eligible patients saw a reduction in their total symptom score, with seven having their score reduced by 50% or more. Treatment-related adverse events, such as nausea and vomiting, were observed in over 20% of patients.

Rein noted that enrollment is still ongoing.

Reference:

Rein LAM, et al. Phase 1/2 study of TP-3654, a selective PIM1 kinase inhibitor: Preliminary data showed clinical activity and cytokine reductions in relapsed/refractory myelofibrosis patients. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2023; San Diego.

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June 5, 2023

Key points:

• New research links Agent Orange to an increased risk of blood cancers in veterans.
• Specifically, exposure could result in myeloproliferative neoplasms (MPNs), which are acquired stem cell disorders that can lead to overproduction of mature blood cells.
• Agent Orange has previously been associated with sarcomas and B-cell lymphomas, but not MPNs or leukemias.

Research conducted using a database of veterans exposed to Agent Orange found an association for an increased risk of developing myeloproliferative neoplasms (MPNs), which are acquired stem cell disorders that can lead to overproduction of mature blood cells complicated by an increased risk of blood clots in arteries and veins. When MPNs progress, they can become deadly leukemias.

The Agent Orange chemical has previously been associated with sarcomas and B-cell lymphomas, but not MPNs or leukemias.

For this study, researchers utilized the Veterans Affairs Informatics and Computing Infrastructure (VINCI) database and examined records of 93,269 MPN patients among 12,352,664 veterans over 17 years. The team used veterans from the state of Illinois as a control population since Illinois is highly representative of the United States, according to the U.S. Census Bureau.

According to the findings, the odds of Agent Orange exposure among MPNs are 1.63 times greater than the odds of exposure among controls. When comparing people with MPNs vs. age-, gender-, and race-matched controls, there was more clotting in the arteries (37% vs. 18.5%), more clotting in the veins (14.8% vs. 5.2%) and more bleeding events (39.1% vs. 13.5%), respectively.

Additionally, people with MPNs had more hypertension (75.5% vs. 43.2%), diabetes (31.2% vs. 19%), and more heart failure (26.1% vs. 11%) than age-, gender, and race-matched controls, respectively.

The odds of Agent Orange exposure among matched controls with arterial clots are 1.38 times greater than the odds of exposure among controls without arterial clots. The odds of Agent Orange exposure among MPNs with arterial clots are 1.49 times greater than the odds of exposure among MPNs without arterial clots.

Because the findings only point to possible associations and not causes, lead author Andrew Tiu said the researchers will need to dive more deeply into the biology of the disease. Specifically, they want to look at JAK2 mutations, which are one of the three driver mutations of MPNs that can cause uncontrolled proliferation of stem cells. JAK2 has also been associated with an increased risk of clotting.

“There are several associations between Agent Orange and health disorders that are not well understood and we hope our work helps uncover a few of these,” said Tiu.

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By Georgetown University Medical Center

Research conducted at Georgetown University’s Lombardi Comprehensive Cancer Center and the Washington DC VA Medical Center on a database of veterans exposed to Agent Orange found an association for an increased risk of developing myeloproliferative neoplasms (MPNs), which are acquired stem cell disorders that can lead to overproduction of mature blood cells complicated by an increased risk of blood clots in arteries and veins. When MPNs progress, they can become deadly leukemias.

Agent Orange is an herbicide that was utilized by the United States military in Korea and Vietnam to clear foliage during combat. It has been associated with sarcomas and B-cell lymphomas, but not MPNs or leukemias to date.

“MPNs are associated with serious cardiovascular events and people with this disease have decreased overall survival chances,” says Andrew Tiu, MD, a second-year hematology/oncology fellow with Medstar Georgetown University Hospital who conducts research at Georgetown Lombardi Comprehensive Cancer Center and is the lead author of this finding.

“But until now, we haven’t been able to fully ascertain whether Agent Orange exposure truly leads to the development of myeloproliferative neoplasms, which is why we’ve undertaken what is the biggest population-based study to date to try to answer this question.”

To explore associations between Agent Orange and MPNs in addition to blood clots, bleeding, and a number of cardiovascular factors, the researchers utilized the Veterans Affairs Informatics and Computing Infrastructure (VINCI) database and examined records of 93,269 MPN patients among 12,352,664 veterans over 17 years. The researchers used veterans from the state of Illinois as a control population since Illinois is highly representative of the United States according to the US Census Bureau.

Significant findings from the study include:

• The odds of Agent Orange exposure among MPNs are 1.63 times greater than the odds of exposure among controls.
• When comparing people with MPNs vs. age-, gender-, and race-matched controls, there was more clotting in the arteries (37% vs. 18.5%), more clotting in the veins (14.8% vs. 5.2%) and more bleeding events (39.1% vs. 13.5%), respectively.
• People with MPNs had more hypertension (75.5% vs. 43.2%), diabetes (31.2% vs. 19%), and more heart failure (26.1% vs. 11%) than age-, gender, and race-matched controls, respectively.
• The odds of Agent Orange exposure among matched controls with arterial clots are 1.38 times greater than the odds of exposure among controls without arterial clots.
• The odds of Agent Orange exposure among MPNs with arterial clots are 1.49 times greater than the odds of exposure among MPNs without arterial clots.

Because their findings only point to possible associations and not causes, Tiu notes that the researchers will need to dive more deeply into the biology of the disease. Specifically, they want to look at JAK2 mutations, which are one of the three driver mutations of MPNs (the other two being MPL and CALR mutations) that can cause uncontrolled proliferation of stem cells. JAK2 has also been associated with an increased risk of clotting.

“There are several associations between Agent Orange and health disorders that are not well understood and we hope our work helps uncover a few of these,” says Tiu. “We are proud of the fact that our work was selected for a 2023 Conquer Cancer Merit Award and we’ll be using those funds to further our research efforts.”

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By Rob Dillard

US veterans who were exposed to Agent Orange (AO) have an increased risk of myeloproliferative neoplasms (MPNs), bleeding, arterial thrombosis (AT), and venous thrombosis (VT), according to an analysis that will be presented at the 2023 American Society of Clinical Oncology Annual Meeting.

AO is a chemical herbicide that was weaponized and heavily used during the Vietnam War. The chemical is associated with the development of sarcomas and B-cell lymphomas, but, until now, less has been known about its link to MPNs, bleeding, AT, and VT.

To conduct their analysis, lead author Andrew Chua Tiu and colleagues used the VA Informatics and Computing Infrastructure database to identify 95,768 patients with MPN and any AT, VT, and bleeding events.

According to the results, there was a notable correlation between AO exposure and the development of MPNs (odds ratio, 1.61; 95% CI, 1.57-1.65; P<.0001). Specifically, the researchers observed that compared with patients with MPNs who were not exposed to AO, patients with MPNs who were exposed to AO had higher rates of AT (36.0% vs 28.2.%), higher rates of AT (28.7% vs 24.0%), and more bleeding events (41.2% vs 39.0%).

“This is the largest database evaluating MPNs, thrombosis, and bleeding in veterans exposed to AO. There is an association of increased risk of development of MPNs, increased AT, and increased bleeding with AO exposure,” the researchers concluded. They added that further studies “including JAK2 mutation, [clonal hematopoiesis of indeterminate potential], and cardiovascular risk factors will be needed to evaluate contribution to thrombosis and bleeding risk.”

Source: Tiu AC, McKinnell Z, Liu S, et al. Association of Agent Orange and myeloproliferative neoplasms, thrombosis, and bleeding among veterans. Abstract #7011. Published for the 2023 ASCO Annual Meeting; June 2-6, 2023; Chicago, Illinois.

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It has been said almost every family has been touched by cancer.  I developed AML/APL Leukemia in 2006 and suffered a horrible reaction to chemo that kept me hospitalized for almost 5 months.  It was a terribly difficult experience, but I made it through treatment and was so happy to reach the 5-year mark without other major issues.  Then, in 2017, a routine physical found elevated platelets and white cells, a
huge red flag.  Over the course of a short few months, the platelets rose to over one million.  Anxiety followed me, closer than my shadow.  Was AML back?  Were chemo and hospitalization in my future?  After a bone marrow biopsy, I was diagnosed with Essential Thrombocythemia.

For those living with illness, anxiety is simply a reality of life.  We constantly scan our bodies for any sign of something wrong.  We are nervous about blood test results because…what if…is always on our minds.  Something bad happened to us and it made a physical memory we don’t want repeated.  If illness has taught me anything, it is the importance of appreciating the present.

We have thousands of thoughts every day and most of them pass as background noise. The mind chatters away and we don’t engage with it too much. But let a scary thought come up, and we get carried away with worry that easily becomes all-consuming.  What can be done?

Watch your focus.  Treat disturbing thoughts as passing visitors.  Let them come and go, and certainly don’t invite them in for tea and conversation. Instead, be present. Breathe deeply, relax your shoulders, and do something tactile.  Gently change your focus to the here and now.  Don’t chase upsetting thoughts, don’t play with them, chew on them, or try to block them out.  Let them pass like clouds in the sky.  There is no need to respond.  You don’t have to react.

Experience has taught you life is short and can change in a moment.  Absolutely everything is temporary.  So, why are you wasting your precious time lost in thought, washed in worry?  It really doesn’t help anything.  You only have one precious life.  Live it.  Don’t wait.  Do whatever you find interesting and rewarding.  Your life will only have a deeper meaning when you do things that are meaningful to you.
Quit just getting by.  You are so much more than your illness. Take charge.  Don’t just survive – thrive.

Bob P.

Everyone has had good and bad experiences with physicians. When the experience is so bad, we never go back. When we need to see specialists, like those diagnosed with an MPN, it can be challenging when your connection with the physician is not what you had expected. All of us have different personalities and quirks and physicians are no different. Bedside manners are still very much a part of the conversations we hear when sharing stories about a doctor’s care. Those stories can influence others to either seek out care from a particular physician or go to someone else. What if the physician is one of the best doctors in the particular area of medicine you need and has a reputation for being rude, condescending, abrupt, and dismissive?

Dealing with difficult people is challenging for sure, but when it is someone you must rely on to be well there are other strategies that may help. Just like all of us, we have good days and bad days, days that are overwhelmingly busy, days dealing with home repairs, kids, financial issues, and so much more. Doctors deal with those same issues coupled with a patient load that sometimes exceeds the standard number. Their days never end if there is an emergency and some are available to their patients via texts to answer simple questions 24/7. That does not excuse poor manners and bad behaviors, it does, however, contribute to one’s demeanor at times. The question you must ask yourself is are you receiving the quality care, direction, and treatment you need, despite the differences in your personalities? That does not mean you should continue to see someone you don’t like, it is something you should weigh in your decision to make a change.

One of the best strategies I learned as a younger person to deal with difficult people was to empathize. It was the hardest thing to do but it did work most of the time. When it comes to a health provider, the last thing any of us needs is the extra stress of not wanting to go to our physician when we need to because we do not like them.

Things to consider:

• If you’re able, interview physicians –schedule a consultation. Very often, you will learn from that visit if there is a good fit.
• For MPN patients, the relationship with health providers is critical because it will last for years, therefore it is even more important to develop a great foundation at the onset of your care.

• A mutual respect and understanding should evolve during your long-term care. If it doesn’t, consider the pros and cons of changing physicians.

• Try to be prepared for each visit with any changes you’re experiencing and anything you’d like to discuss with your physician.

• If the care you receive outweighs the personality differences with a physician, carefully think about what’s important to you before making a change.

• Many of us do not have the luxury of changing doctors whether it is financial or geographical. If these are the issues you face, perhaps a conversation with a nurse or Physician’s Assistant may help. They can offer insights and ways to deal more effectively with the physician’s personality.

Finally, the MPN Community has some of the best specialists I’ve ever seen in my career. They are dedicated, considerate, kind, available, and willing to go above and beyond for the sake of their patient’s care. If you need to make a change and require some direction, let us know and we can direct you accordingly.

I’ve had ET for 32+ years and probably longer just undetected. I am a Vietnam Veteran who was exposed to Agent Orange from 1968 until my tour of duty ended. After my ET was diagnosed I filed a claim in 1990, and the VA handled it very poorly, especially back in the early 90s. After many years, the claim was officially denied, but I tolerated Hydroxyurea and got on with my life.

Fast forward to just 4 years ago and a phone conversation with a woman named Ann from an MPN advocacy group. What an education I received that day. I was enlightened and realized I was being fed bogus information regarding MPNs and veterans for too many years. In 3 short weeks, I was attending a conference at the Marriott in St. Petersburg, Florida, and discussing MPNs and my ET with a specialist from the Moffitt Cancer Center. I now see Dr. Kuykendall annually at Moffitt in Tampa supplementing my VA appointments.

Sincere heartfelt thanks to you MPN Advocacy and Education International for the warp-speed education and reigniting my motivation to reengage with the VA. I did a bunch of research, obtained new Nexus statements from the Oncologists linking Agent Orange (AO) exposure to my MPN, and found numerous medical journal articles regarding MPNs and toxins. I submitted a new claim in 2019 and provided a detailed 3+ decade medical summary with new supporting resource documentation. As expected, my new claim was summarily rejected and kicked to the curb. The VA indicated the reason for denial was that nothing new had been submitted with the claim, go figure!

I naturally appealed the case and finally had a hearing with an appeals board judge in July of this year, 3 years after my initial claim. The judge seemed irritated and appalled the VA claim’s reviewer totally dismissed and ignored all of my supporting documentation, including nexus statements from 2 oncologists supporting the link between AO exposure and my ET.

I just received this past weekend the official VA letter indicating my claim and appeal has been granted. Again, many thanks to MPN Advocacy and Education International for emboldening me to reengage the VA.

It is unfortunate the VA has all the leverage in the MPN cases. As I discovered, even though there are probably hundreds of successful claims for MPNs, every case is handled individually and goes back to square one. So, unlike a conventional court of law, precedent is not taken into account and the entire burden of proof is on the veteran. The level of a veteran’s persistence and determination, individual skills for record keeping, and obtaining all the appropriate documentation over many years, govern the outcome when battling the VA bureaucracy. Thank you for being a large part of helping me navigate the maze.

Sincerely,

Lawrence M.

By Mayra D.

My Primary Myelofibrosis journey started on a festive Cinco de Mayo in 2015 while I was at work. Without any warning, I started to feel sick to the point that I almost collapsed at my desk. I still remember this incident like it was yesterday. I was sweating and had an awful pain in my lower back that kept me out of my chair. I had very severe discomfort in my upper abdomen that was not an ordinary stomach pain. At that moment I knew I was struggling health-wise. I was feeling so weak and so out of balance, things I had never felt or experienced before in my life. After this scary episode, I was rushed to the ER. When I got to the hospital, I was not able to walk, and breathing was very difficult. Even holding my cell phone was a challenge. I was admitted right away due to the fact that my hemoglobin was very low among other things. After a bunch of blood transfusions, IV treatments, and everything in between, the doctors were able to stabilize my condition. After a week I was released from the hospital and started what I called ‘My Health Crisis Path’.

I started to see an Oncologist/Hematologist on a regular basis. One year later, I was rushed to the ER once again. At first the doctors thought I was pre-menopausal and that was the cause of the anemia.  No, it wasn’t!  The severe night sweats, the awful skin itching, especially after taking a shower, the painful feet, and leg cramps at night while in bed, and the severe anemia, were all part of a few of the new symptoms I was experiencing. Overall, my health was not improving, and I was feeling weaker every day. After a year and a half of trying new treatments with no diagnosis, the Oncologist/Hematologist team decided that the next step for me was a bone marrow biopsy. Everything became crystal clear with my ‘Jak 2 Mutation’ and the finding of Primary Myelofibrosis (MF).  

This health crisis of mine impacted me and my entire family.  My husband got so overwhelmed he even lost his job. I was forced to resign from my job and my husband losing his caused a great struggle financially. It was okay, and we managed together as a family, but having him by my side every step of the way was more important and something money can’t buy.

On the other hand, my daughter, who was only 14, felt like she was losing her mom. She reached rock bottom not only emotionally but academically.  Today I can say joyfully my daughter is now 21 years old and is a successful college student attending a State University. Through all of this, we saw a psychiatrist and had a few counseling sessions in order to help us individually and as a family cope with this unexpected health crisis. It has helped us with the healing and moving forward process.  Our daughter once said: “We are a family no one left behind.”

I used to donate blood and today I am on the other side of the chair. My driver’s license even says that I am an organ donor. Slowly but surely, I started to accept the fact that I suffered from a rare chronic blood disorder. I had two options in front of me, either feel sorry for myself and do nothing about it or go out there and make a difference. I chose the second option. It was not an easy task. In the beginning, I felt alone and confused, and I didn’t know where to go for help, support, and answers. When I heard the word ‘cancer’ for the first time it was a feeling I can’t explain. But this didn’t stop me. 

Being a former graphic designer, I was used to putting on a creative hat, so I knew what to do next. I began by researching about MPN in general. In the process, I came up with what I called ‘My 4 Daily Elements’: Chemo-Tablet Treatment, Anti-Inflammatory Nutritional Meal Plan, Routine of Exercise, and Mindfulness (I want to point out that when I started this health journey there was not much guidance like there is today). A few years ago, I received a couple of certificates in Modeling and Acting from a local school, so I decided to take advantage and use these tools. This knowledge and experience are my platform for cancer awareness. Today I’m proud to say I’m a member of a Cancer Support Community at the cancer institute in Orlando, FL. I’m also a member of MPN groups on social media. I was interviewed a couple of years ago and an article of my journey was published in Prevention Magazine. What an honor it was being able to speak about this rare and chronic blood disorder. We may be a small group, but our voices can make a big difference.

I am also the voice in the Latino community. I spoke on a local radio station where I was able to bring awareness to Central Florida. In my message I let the listeners understand that talking about cancer doesn’t make you a victim or a weak person, it makes us stronger by informing others. I even asked one of the CSC-Mental Health Therapist to join me for another live radio chat so we could talk about integrative medicine and what it offers the cancer community.

Next month, I’m going to attend my first meeting as part of the Patient and Family Advisory Council at Orlando Health. In December I’m also going to be participating in the Sea World 3 Mile Reindeer Run for pediatric cancer and bone marrow transplant programs at AdventHealth for the second year. Sharing my story is very important to me. If I can shed light, hope, and support to others then my mission is accomplished. “ME with a Purpose.”

In 1992, I was a Technical Service Representative for a major chemical company, working with clinical laboratories, when I learned through my yearly medical checkup that my platelet count was significantly elevated.  A CBC confirmed what I suspected, essential thrombocythemia (ET). “Enjoying” the first of many bone marrow biopsies proved the diagnosis to be correct.  I met with a pathologist friend and he explained the prognosis.  Except for the elevated platelets I had no other symptoms.

Fast forward to 2004.  I’m having bloodwork checked by a hematologist prior to minor surgery.  I still had no physical symptoms of a myeloproliferative disease.  He came back into the waiting room and announced, “You have morphed into myelofibrosis.”   I didn’t want to believe it, but I knew as a certified medical technologist, MT(ASCP), that the cells don’t lie!  Years of nervous waiting followed, until in 2009 I began to experience terrible pruritis and increasing fatigue.  It was time to move to the next step.

I checked with Mayo Clinic in Scottsdale, Dr. Reuben Mesa, and with M.D. Anderson in Houston, Dr. Srdan Verstovsek.  Sure enough, the myelofibrosis was progressing and I was positive for the JAK-2 mutation.  “Dr. V” told me that a new Phase III study was to start, and that an oncologist/hematologist in San Antonio was enrolling in the study.  That was good news.  San Antonio was much closer to home!

I found my hero, Dr. Roger Lyons, now retired.   After more bloodwork, more bone marrow biopsies, he thought I was a good candidate for the Comfort I study, the first Phase III ruxolitinib study.  It was of course a doubleblind study, but by the third week of the study I knew that I had not drawn a placebo!  The itching began to cease and I felt normal. I stayed in the study through completion, and continued on what came to be called Jakafi for quite a while after.  It was a miracle!  The first drug successfully developed to treat myelofibrosis!

Then there was a problem.  In 2018, I began to develop growths on my nose.  No one suspected it had anything to do with Jakafi. When every dermatologist had exhausted the list of probable diagnoses, Dr. Lyons gave permission to discontinue the Jakafi to see what would happen.  Again, as when I started ruxolitinib, I knew very quickly that Jakafi was the culprit.  Not good news, but the positive effects of the Jakafi stayed with me for over two years.  Luck is really on my side.

Pruritis began anew in 2020, my white blood count had begun to increase, and Dr. Lyons had retired, but fortune smiled again.  Dr. Mesa, who I’d seen years ago at Mayo Clinic Scottsdale, had come to the University of Texas Health Science Center San Antonio as the head of a new partnership with M.D. Anderson Cancer Center.  As my new doctor he suggested we try Jakafi again and adjust the dose as required.  Now I take 20 mg Jakafi daily.  I’m feeling well, considering my 82 years.