All 3 Proxy Advisors Urge Shareholders Vote FOR Change to Enzo Board

Harbert Discovery Fund, LP and Harbert Discovery Co-Investment Fund I, LP (collectively “HDF”), the beneficial owners of more than 11.8% of the outstanding shares of Enzo Biochem, Inc. (NYSE: ENZ) (“Enzo” or the “Company”), today announced that Egan-Jones Proxy Services (“Egan-Jones”) has recommended shareholders vote for both HDF nominees on the Blue proxy card. All three leading proxy advisors – Egan-Jones, Glass, Lewis and Co. (“Glass Lewis”) and Institutional Shareholder Services Inc. (“ISS”) – have now supported HDF’s case for change at Enzo.

In its report, Egan-Jones highlights the need for change at the Company, its track record of underperformance and corporate governance issues, as well as the qualifications of HDF’s nominees¹:

• “We believe that voting FOR the Harbert nominees is in the best interest of the Company and its shareholders.”

• “We believe that there is a validated need for change, as evidenced by the Company’s financial and operational underperformance, which have translated to value destruction for the past years.”

• “In our view, the shareholders have given the Company a considerable time to break the status quo of financial failure, however, the Board and management have engaged in misconstrued decisions, leading to broken promises to fix the Company’s current state.”

• “We believe that there is a compelling need to alter the Company’s corporate governance structure and practices in order to protect the interests of the shareholders in the future.”

• “We believe that the addition of the Harbert nominees will endow the Board not only with the right mix of skills, qualifications and experience, but will also bring forward fresh perspectives to execute the appropriate strategy to unlock and maximize shareholder value.”

• “Given the slate of nominees, the nominees appear qualified, and we recommend that clients vote FOR the nominees on the BLUE proxy card.”

Previously, ISS also recommended voting on HDF’s card, stating:

• “The dissident has made a compelling case that board change is warranted, as evidenced by operational deterioration, prolonged absolute and relative TSR underperformance, and substandard corporate governance.”

• “ENZ has a history of broken promises, as evidenced by the AmpiProbe development history.”

• “There are also board independence concerns, including the combined CEO/chairman role, the fact that 40 percent of the board is non-independent, and the family and professional relationships between Rabbani, Weiner, and Hanna.”

Glass Lewis found numerous reasons for urgent concern regarding the future of Enzo in its recommendation for both HDF nominees:

• “[W]e are ultimately inclined to conclude Harbert…submits the much stronger fundamental case.”

• “Disconcertingly, investors hoping to see a bold response steeped in critical measures of operational progress have instead been greeted by what we consider to be a fairly loosely structured narrative functionally ripped from Enzo’s last battle, including rehashed promises of pending value generation.”

• “On balance, we consider the yield on our review is fairly straightforward…the Company has underperformed every benchmark over every period, in all cases by no less than roughly 32%.”

• “[T]here remain a raft of other governance factors that we consider reflect poorly on Enzo and the board’s general willingness to undertake proactive — as opposed to reactive — change.”

Kenan Lucas, Managing Director and Portfolio Manager of HDF, commented on the news, stating: “We believe that unanimous recommendations for change from all three proxy advisory firms sends a clear message: the status quo is no longer acceptable at Enzo and fresh, independent voices are needed in the boardroom. Our nominees, Fabian Blank and Peter Clemens, have the right experience and skillsets to help Enzo become more than a story of broken promises, and to end the prolonged history of underperformance. We encourage any shareholder who cares about the future of their investment to vote today for both of HDF’s nominees.”

https://www.biospace.com/article/releases/all-three-proxy-advisory-firms-recommend-shareholders-vote-for-change-to-the-board-of-enzo-biochem-on-the-blue-card/

Takeda Eyes 12 New Drug OKs by 2024, Hemophilia Therapy May Not Compete

One year ago, Takeda wrapped up its acquisition of Shire plc, which created one of the largest drug developers focused on rare diseases. Over the past year, the company strived to transform itself into becoming a frontrunner in multiple areas, including cell and gene therapies.

During the company’s 2019 R&D Investor Day, Takeda highlighted the importance of gene and cell therapies as it moves forward in its continued transformation from the Shire deal, as well as other collaborations the company has forged since. However, in what might be considered a refreshing moment of real honesty, Andy Plump, Takeda’s head of R&D, recently noted that sometimes being on the cutting edge of treatments does not mean your treatment will be the top-selling preference. In an interview with the Boston Business Journal, Plump revealed that he did not believe the company’s hemophilia A gene therapy treatment would be a market leader. In fact, he went so far as to say the treatment would probably not even be a contender.

“I think the likelihood is that our hemophilia A gene therapy is not going to be a competitor in the market… But I don’t think you need to be a frontrunner in a field to really be effective. In fact, I think, sometimes in the world we live in, being the frontrunner can have disadvantages,” he told the Journal.

In its gene therapy pipeline, Takeda is developing TAK-754 for hemophilia A. The asset is currently in a Phase I study. The company also has TAK-748 in preclinical studies for treatment of hemophilia B. As the Journal reported, the company sees a strong future for its gene therapy programs and considers them a future driver of business. While the Journal’s article did not go into specifics as to why Plump feels that the company’s gene therapy won’t be a market driver in hemophilia, it’s likely due to the fact that it is still in the early stages of development. Spark Therapeutics, a division of Roche, is moving its gene therapy treatment into late-stages of study following highly impressive data that showed a one-time treatment yielded a 97% response rate in reduced bleeding events in hemophilia A patients. When Roche made its bid for Spark, the Swiss pharma giant saw that company’s gene therapies for hemophilia as a complement to its own products for the bleeding disorder, including hemophilia treatment Hemlibra.

While the hemophilia treatment may not be a competitor in the marketplace, Plump told the Journal that Takeda is looking at bringing nearly a dozen treatments to market by 2024. Those treatments are aimed at conditions such as “cytomegalovirus infections, a rare disease called Hunter Syndrome and complications of premature birth.” Takeda believes these therapies can drive a combined $10 billion in peak sales, the Journal said.

In September, Takeda published the results of a Phase II study of TAK-620 (maribavir) for cytomegalovirus (CMV). The drug is designed to target a specific CMV protein, which may lead to inhibition of CMV DNA replication and encapsidation.

Additionally, Takeda has remained busy inking collaborations with multiple companies to advance its drug development programs. Earlier this month, the company struck a multi-year drug discovery deal with Charles River Laboratories. The companies will develop potential drug candidates across Takeda’s four core therapeutic areas—oncology, gastroenterology, neuroscience and rare disease. Only weeks prior to the deal with Charles River, Takeda forged a collaboration worth up to $1 billion with Turnstone Biologics to tackle a number of cancer indications using that company’s vaccinia virus platform. The company and Cerevance teamed up to tackle diseases of the gastrointestinal tract that have their roots in the central nervous system.

https://www.biospace.com/article/takeda-r-and-d-head-doesn-t-see-a-blockbuster-in-its-hemophilia-a-gene-therapy-but-does-see-big-things-coming/

As its Drug Business Sees Growth in 2019, Lonza Continues to Search for New CEO

Swiss pharma and chemical company Lonza continues to hunt for a new chief executive officer following the abrupt departure of Marc Funk, who resigned from his position eight months after taking over for Richard Ridinger, who helmed the company for seven years.

In November, the company announced that Funk had resigned from his role due to personal reasons. Prior to serving as CEO of the company, Funk was its chief operating officer. When Ridinger announced his intention to retire at the beginning of 2019, Funk was the named successor. Funk remained with the company through the start of the year to support a transition of Lonza’s leadership. Albert Baehny, chairman of the board of directors, is serving as interim CEO.

This morning, Baehny said the company looks forward to the coming challenges of 2020, including the naming of a new CEO. However, in his brief announcement, Baehny did not provide an update or timeline for when a new Group CEO would be named.

Baehny made his comments as the company delivered its full-year financial results, which showed an 11% growth in the company’s pharma business. The company said its Pharma Biotech & Nutrition business achieved double-digit sales growth above its full-year guidance for 2019. The newly expanded segment now includes the nutritional hard capsules business (acquired with Capsugel), as well as a small portfolio of nutritional ingredients and formulation services. The section delivered annual sales of CHF 4.2 billion (about $4.34 billion) all while investing in strategic growth projects.

Some of the 2019 highlights for the division included the acquisition of a sterile drug product fill and finish facility from Novartis. The site became the company’s first for its Drug Product Services (DPS). The site will be the first Lonza DPS facility to cover sterile manufacturing for clinical production and commercial launches, the company said. The new facility will help Lonza Pharma & Biotech build on existing parenteral drug product development and testing capabilities, the company said. Also, the facility will provide its customers with end-to-end service for clinical supply and launch. It will be the first sterile drug product fill and finish facility in Lonza’s network, the company said this morning.

Also, in October, Lonza and Prevail Therapeutics entered into a strategic collaboration focused on the development of the baculovirus/Sf9 expression system for Prevail’s pipeline of gene therapy programs aimed at neurodegenerative diseases. PR001 is an AAV9-based gene therapy is in development for Parkinson’s disease patients with GBA1 mutations and neuronopathic Gaucher disease patients.

But, while Lonza’s Pharma Biotech & Nutrition business grew, the company noted that its Specialty Ingredients business saw a 3.2% decline to CHF 1.7 billion ($1.76 billion).

As it looks forward to this year, Lonza said in 2020, it will “focus on executing its growth projects in another major investment year, completing the carve-out of its Specialty Ingredients segment and reviewing future plans.”

https://www.biospace.com/article/as-its-drug-business-sees-growth-in-2019-lonza-to-continue-hunt-for-new-ceo/

Newly ID’ed T-Cells Have Potential to Become Universal Cancer Therapy

It’s something of the Holy Grail, a kind of immune cell that can attack all types of cancer cells. Researchers at Cardiff University in the UK appear to have discovered just that. They published their research in the journal Nature Immunology.

The researchers essentially identified a new T-cell and its receptor that appears able to search out and kill a broad range of cancer cells, including lung, skin, blood, colon, breast, bone, prostate, ovarian, kidney and cervical cancer cells. It left noncancerous cells alone.

“There’s a chance here to treat every patient,” Andrew Sewell, professor, Division of Infection and Immunity, School of Medicine at Cardiff, told the BBC. “Previously nobody believed this could be possible. It raises the prospect of a ‘one-size-fits-all’ cancer treatment, a single type of T-cell that could be capable of destroying many different types of cancers across the population.”

The T-cell they identified interacts with a cell surface molecule, MR1. MR1 is believed to flag the abnormal metabolism inside a cancer cell.

Immuno-oncology is a rapidly expanding field, leveraging the human immune system to fight the cancer itself. The best-known examples are CAR-T therapies, notably Novartis’ Kymria (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel). These therapies essentially take immune cells from the cancer patient, engineer them to specifically attack the patient’s cancer, then are reinfused back into the patient. They become living therapies, growing in the body to attack the cancer.

They are quite effective in blood cancers but haven’t been proven to be as useful for solid tumors. These types of therapies have also been limited to certain cancers where there is a clear target to engineer the T-cells to identify.

This new discovery has the potential to lead to a “universal” cancer therapy. The idea is the same. The T-cells would be extracted, genetically modified to identify the cancer cells, then injected back into the patient. However, the Cardiff group has only tested this approach in the laboratory animals and on cell cultures. More studies would need to be conducted before it could be tested in humans.

Daniel Davis, researcher at the University of Manchester, who was not involved in the study, told the BBC, “At the moment, this is very basic research and not close to actual medicines for patients. There is no question that it’s a very exciting discovery, both for advancing our basic knowledge about the immune system and for the possibility of future new medicines.”

The Cardiff group leveraged genome-wide CRISPR-Cas9 screening to identify the T-cell receptor by way of the monomorphic MHC class I-related protein, MR1 “while remaining inert to noncancerous cells.”

They tested the work in laboratory mice as well as in human melanoma cells. The research demonstrated that the melanoma patients’ T-cells could be modified to express this new TCR and kill their cancer cells in Petri dishes, but also other patients’ cancer cells. They hope to take the technique into clinical trials by the end of the year.

Sewell told the Irish Times, “We hope this new TCR may provide us with a different route to target and destroy a wide range of cancers in all individuals. Current TCR-based therapies can only be used in a minority of patients with a minority of cancers. Cancer-targeting via MR1-restricted T-cells is an exciting new frontier.”

https://www.biospace.com/article/researchers-id-immune-cell-that-can-attack-almost-all-cancer-cells/

Is Alzheimer’s Type 3 Diabetes? Novo Nordisk is Willing to Find Out

Danish company Novo Nordisk specializes in the diabetes market. The company appears to be making an entry into the Alzheimer’s market, which isn’t as unusual or unexpected as it initially sounds.

It has been postulated for some time that Alzheimer’s disease is related to blood glucose levels and has been dubbed type 3 diabetes. Type 1 is an autoimmune disease, sometimes referred to as insulin-dependent diabetes. Type 2 is typically acquired and appears more related to insulin resistance and is related to obesity.

Back in 2017, Mayo Clinic participated in a multi-institution clinical trial evaluating an insulin nasal spray on Alzheimer’s patients.

“This study has furthered our understanding of the gene that is the strongest genetic risk factor known for Alzheimer’s disease,” said Guojun Bu, a Mayo neuroscientist, at the time. “About 20% of the human population carriers this riskier form of [the gene] APOE, called E4.”

About 50% of Alzheimer’s cases are associated to APOE4 according to the study, which was published in the journal Neuron. And people with type 2 diabetes have a higher risk of Alzheimer’s disease, although the reasons for it are not completely clear. In fact, type 2 diabetes almost doubles the risk of developing Alzheimer’s disease. One possible reason is reduced blood flow to the brain because of damage to blood vessels caused by diabetes.

Now, Novo Nordisk is involved in a clinical trial using the company’s GLP-1 analogue diabetes drug Victoza to evaluate if the drug can improve brain function and cognition in Alzheimer’s patients. It is a Phase IIb clinical trial. In laboratory studies it has been shown to improve Alzheimer’s symptoms and decrease the amount of amyloid plaques in the brain, which are associated with the disease.

In an update on the trial site, it was noted that patients receiving the drug had a perceived change in their symptoms after they stopped taking it. As a result, at the end of the 12-month trial, all patients will be offered the opportunity to join a 12-month open-label extension trial.

Novo Nordisk shares recently popped, and Evaluate Pharma speculates that this was related to the company’s participation in the trial after the Danish newspaper Børsen made the link. They also cited a recent note by analysts at Bernstein titled “Is Alzheimer’s type 3 diabetes?” suggesting a role for GLP-1 drugs.

Despite the evidence, not a lot of clinical trials have been conducted testing the hypothesis. Evaluate Pharma notes, “Correlation does not equal causation, and a skeptical pharma sector has remained on the sidelines. Indeed, it is striking that the number of clinical trials testing the hypothesis can be counted on the fingers of one hand, and none has a corporate pharma company sponsor.”

These include studies by the University of Aarhus, which published data in 2016, the third Military Medical University, whose trial was completed last year but has not published the data yet, the trial mentioned earlier with the Imperial College London and Victoza, one by the Universitaria di Parma, with results expected last year, and an ongoing trial by the National Institute on Aging due in December 2022.

The trial of Victoza by the Imperial College London will enroll 204 patients with mild Alzheimer’s dementia and is a double-blind, placebo-controlled design that will last 12 months. Its primary endpoint is measuring rates of glucose metabolism in the brain. Secondary endpoints will look at various measures of cognition, including Adas, CDR-sum of boxes and ADSC-ADL.

The University of Aarhus study demonstrated that six months of Victoza was linked to an increase in glucose metabolism compared to placebo but was not deemed statistically significant.

https://www.biospace.com/article/novo-nordisk-quietly-enters-the-alzheimer-s-market/

Medicare to cover acupuncture for chronic low back pain

As part of CMS’ efforts to address the opioid crisis, the agency announced Jan. 21 that Medicare will cover acupuncture for people with chronic low back pain.

Under the decision, Medicare will cover up to 12 acupuncture session in 90 days. Medicare will cover an additional eight sessions for patients with chronic back pain who demonstrate improvement.

“We are dedicated to increasing access to alternatives to prescription opioids and believe that covering acupuncture for chronic low back pain is in the best interest of Medicare patients,” CMS Principal Deputy Administrator of Operations and Policy Kimberly Brandt said in a news release. “Over-reliance on opioids for people with chronic pain is one of the factors that led to the crisis, so it is vital that we offer a range of treatment options for our beneficiaries.”

For the purpose of its decision, CMS defined chronic lower back pain as lasting 12 weeks or longer, having no identifiable systemic cause and not associated with surgery or pregnancy.

Read the full decision here.

https://www.beckershospitalreview.com/finance/medicare-to-cover-acupuncture-for-chronic-low-back-pain.html

Progenics Pharma Updates on Reconstituted Board’s Strategic Review

The Board of Directors of Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, issued the following letter to shareholders:

January 21, 2020

To our shareholders:

On behalf of the Board of Directors, we are pleased to provide you with this update on our activities since you elected five new independent directors to the Company’s Board. With your clear mandate, we immediately took action to independently evaluate the business and prospects of Progenics, including the transaction with Lantheus Holdings, Inc. and to ensure that there is no interruption in the execution of the Company’s mission of developing and marketing products that improve outcomes for patients with cancer. We elected David Mims Interim Chief Executive Officer on November 15, 2019.

In recent weeks, the Progenics Board and management team have been conducting two separate reviews in parallel to evaluate the proposed Lantheus transaction as well as Progenics’ business operations and standalone prospects in the event the Lantheus transaction is not consummated.

Lantheus Transaction

Progenics and Lantheus entered into a definitive agreement on October 1, 2019, which is still in effect, under which Lantheus would acquire Progenics in an all-stock transaction. Since the Board’s reconstitution in mid-November, we have worked diligently to independently evaluate the merits and value to the Progenics shareholders of the proposed merger with Lantheus. Specifically, the Progenics Board has:

• Engaged new, independent financial and legal advisors to assist with its evaluation of the proposed merger.
• Worked with Progenics management, the Company’s existing lead financial advisor on the transaction, Jefferies LLC, and the two continuing directors to review the process that led to the Lantheus transaction, including the respective valuations of Progenics and Lantheus and the assumptions underlying those valuations, as well as other alternatives that were considered.
• Engaged in constructive discussions with Lantheus’ management and its financial advisors to review and discuss Lantheus’ business and products, and Lantheus’ view of expected strategic and financial benefits of the combination.
• While the Board continues to review the transaction, Progenics management under the Board’s oversight is engaged with Lantheus in integration planning.

Progenics’ Operations and Outlook

In parallel to the ongoing review of the Lantheus transaction, we are also conducting a thorough assessment, with the assistance of outside advisors, of Progenics’ business, products, operations, prospects and financial performance and condition. This review includes an assessment of each element of Progenics’ business, including its marketed products, each of its product candidates in development and other value creating assets with the goal of maximizing return on invested capital.

As a result of this ongoing review, the Board has already initiated or supported management in the following actions to enhance the commercialization of its pipeline:

• Working with potential new treatment centers to aid them in becoming comfortable dosing AZEDRA and providing reimbursement support prior to patients being identified for treatment; and resulting in dosing patients with AZEDRA at new centers.
• Working to ensure adequate clinical supply of AZEDRA and 1095 at U.S. sites, including the Somerset, NJ, facility.
• Enhancing radiopharmaceutical manufacturing relationships to ensure the Company’s 1095 program is progressing as planned.
• Ensuring that development plans for each product maximizes return on investment.
• Capitalizing on recently announced strong positive results of the Phase 3 CONDOR Trial of PyL™ in prostate cancer and furthering plans for filing and potential for FDA approval of PyL and for PyL’s commercial readiness.
• Capitalizing on the removal of the Centre for Probe Development & Commercialization (“CPDC”) import ban and expediting the initiation of US sites for participation in the 1095 phase 2 clinical trial.
• Reviewing the Company’s financing options as a stand-alone, taking into consideration the timing and magnitude of each option.
• Initiating a search process for a permanent CEO, with the assistance of Korn Ferry, a nationally-recognized search firm, with initial interviews with candidates commencing.

As we work to enhance the long-term interests of all Progenics shareholders, we are committed to transparency for all our stakeholders. These dual strategic reviews are actively ongoing. The entire Board is engaged in the oversight of Progenics and taking necessary steps to ensure the Company is well-positioned to generate value for all shareholders.

Sincerely,

Ann MacDougall, Interim Chair
On Behalf of the Board of Directors

https://www.streetinsider.com/Corporate+News/Progenics+Pharma+%28PGNX%29+Provides+Update+on+Reconstituted+Boards+Ongoing+Strategic+Review/16355686.html