BeiGene sets next-gen CTLA-4 to go with PD-1 pillar in new deal worth up to $270M

BeiGene is jumping on the bandwagon for PD-(L)1/CTLA-4 combos — with a twist.

Through a development and commercialization pact with San Diego-based BioAtla, BeiGene is pairing its PD-1 drug tislelizumab with BA3071, a CTLA-4 blocking “conditionally active biologic” that gets turned on or off based on whether it’s inside the tumor microenvironment.

San Diego-based BioAtla is responsible for early clinical work, while BeiGene will lead the joint efforts thereafter to develop the combo and deal with regulators around the world. The Chinese biotech, which is committing $20 million upfront and $249 million in biobucks as well as a cost-sharing scheme, is also picking up all costs in Asia (except Japan), Australia and New Zealand from here on out. It has a full license to commercialization rights.
CTLA-4 was the first checkpoint to hit the market, with Bristol-Myers snagging boasting rights with Yervoy. But while effective in unleashing a T cell response and improving survival rates, their significant toxicity has also made their use problematic and thus thwarted their prominence. In recent years, though, a crop of biotechs has risen up on the promise to target CTLA-4 with higher specificity as CTLA-4 remains the hottest add-on in PD-(L) combo studies.

It is this backdrop that BioAtla has entered with its platform, which designs drugs that only bind to the target when they sense the the unique physiology and metabolism of a tumor. In addition to antibodies like BA3071, the platform can also give birth to antibody drug conjugates, bispecifics and CAR-Ts.

BioAtla president Scott Smith (yes, the former Celgene COO) says the deal fits with its strategy for advancing CABs beyond clinical proof-of-concept, as BeiGene is “a recognized leader in China-inclusive global clinical development.”

The company is prepping an imminent first IND filing for both the BA3071 monotherapy and the combo with tislelizumab, with a Phase I/II expected to start in the second half of 2019.

For BeiGene, the deal marks another addition to the broad pipeline around tislelizumab, which spans a dozen solo indications as well as early combo studies with its own PARP and BTK inhibitors.

https://endpts.com/beigene-lines-up-a-next-gen-ctla-4-to-complement-its-pd-1-pillar-in-bioatla-deal-worth-up-to-270m/

Community Healthcare initiated at Baird

Community Healthcare initiated with an Outperform at Baird. Baird analyst Drew Babin started Community Healthcare Trust with an Outperform rating and $40 price target. The analyst says he’s looking beyond the company’s “premium valuation” on 2019 metrics given the accretion management’s “relationship-driven” acquisition strategy.
https://thefly.com/landingPageNews.php?id=2890475

Insmed granted additional U.S. patent for ARIKAYCE

Insmed Incorporated announced that the U.S. Patent and Trademark Office has issued patent No. 10,251,900 for certain uses of ARIKAYCE. The claims of the patent relate in part to methods for treating Mycobacterium avium complex lung disease via administration of ARIKAYCE to patients previously unresponsive to MAC therapy. This is the 10th patent issued by the USPTO for ARIKAYCE in MAC lung disease and the second with an expiry date of May 15, 2035. ARIKAYCE was granted accelerated approval by the U.S. Food and Drug Administration on September 28, 2018, for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options. “We are very pleased to receive another patent for ARIKAYCE that reinforces our exclusivity in the U.S. to 2035 for methods that align closely with our approved label, further strengthening our global patent portfolio,” said Will Lewis, Chairman and Chief Executive Officer of Insmed. “In addition, as we advance toward regulatory filings for ARIKAYCE in Europe and Japan, we are continuing to pursue intellectual property protection in these and other major markets worldwide.”
https://thefly.com/landingPageNews.php?id=2890489

Chimerix beefs up management team

Chimerix (NASDAQ:CMRX) announces following appointments:

Michael A. Sherman, former CEO of Endocyte, appointed as CEO of Chimerix, effective immediately.

Michael T. Andriole, former CFO of Endocyte, appointed to the newly created position of Chief Business Officer.

https://seekingalpha.com/news/3449234-chimerix-beefs-management-team-shares-13-percent-premarket

INmune Bio looks to help treat Alzheimer’s disease and cancer

Therapy candidate INB03, meant to inactivate a kind immunosuppressive cell called myeloid-derived suppressor cells (MDSCs) while boosting anti-tumor immune cells, may help overcome resistance to immunotherapies, including immune checkpoint inhibitors, INmune Bio’s co-founder Raymond J. Tesi, MD, said at a conference.

Tesi, CEO of INmune Bio, presented the potentialities of the company’s new therapy at the Cambridge Healthtech Institute’s 4th Annual Immuno-Oncology Summit Europe recently in London.

His presentation was titled “Targeting Myeloid-Derived Suppressor Cells to Overcome Resistance to Checkpoint Inhibitors.”

MDSCs appear in advanced forms of cancer and are at the heart of cancer resistance to the body’s immune system. MDSCs move to where tumors are and release cell signaling proteins called cytokines to form an immunosuppressive shield that protects tumors from immune system attacks.

The shield also neutralizes treatments that rely on anti-cancer immune responses, such as immunotherapy with checkpoint inhibitors. In fact, the higher the number of MDSCs in a patient’s blood, the more severe the cancer is predicted to be and the more likely it is to be resistant to immunotherapy.

“Experts agree that decreasing the number of MDSC may improve the response to immunotherapy such as checkpoint inhibitors and may improve the ability of the immune system to fight the cancer,” INmune Bio states on its website.

INB03 was designed to inactivate MDSCs and destroy the protective shield that prevents immune cells from coming in and fighting it. The treatment is expected to strengthen patients’ immunity to cancer and give immunotherapies a better chance at being effective.

Specifically, INB03 is a second-generation inhibitor of tumor necrosis factor (TNF). It targets only cell-free TNF without affecting other types of TNF that are attached to the membrane of cells.

Because of this selectivity, the therapy does not suppress the immune system, a known side effect of currently approved, first-generation TNF inhibitors, such as those used for autoimmune disorders including rheumatoid arthritis.

The new compound acts in three steps. First, it blocks the proliferation and function of MDSCs, breaking the protecting shield of immunosuppressive signals produced by those cells.

This promotes the infiltration of innate immune cells (part of the body’s first-line of defenae), specifically natural killer (NK) cells and dendritic cells, which recognize and attack the tumor and also cross-talk with other immune cell types to reinforce subsequent immune responses.

From this cross-talk, more cytokines are released that call in cytotoxic T-cells, immune cells able to directly attack and kill the tumor. In animal studies, treatment with INB03 resulted in smaller and fewer tumors, extending survival.

A video explaining INB03’s mode of action is available here.

The potential therapy is now being tested in patients with advanced, metastatic, solid tumors in a Phase 1 trial (ACTRN12618000675224). The study is intended to address if the treatment is safe and well-tolerated and collect initial data about its efficacy. Its target population are patients with increased biomarkers of inflammation and a high number of MDSCs in their blood.

Three different doses of the treatment will be tested, all given by under-the-skin (subcutaneous) injections once per week for nine months or until disease progression.

Primary outcome measures will be the occurrence of adverse events, the therapy’s pharmacokinetics (absorption, distribution, metabolism, and elimination) of single and multiple doses, and change in high sensitivity C-reactive protein serum levels, a biomarker of inflammation.

Participants may opt to continue on INB03 at any time if their doctor believes the therapy is beneficial in any way.

An interim analysis of the results will be conducted after three months of treatment, and an optimal dose for a subsequent Phase 2 trial will be determined.

“I am excited to have the opportunity to present and exchange ideas with some of the most influential members of the immuno-oncology community,” Tesi said in a press release. “We are committed to developing treatments that target the patient’s innate immune system and facilitating an understanding that chronic inflammation is a root cause and agitator of cancer and many other diseases. By exchanging ideas with top researchers, we can help further push developments that lead to effective patient responses at the bedside.”

https://immuno-oncologynews.com/2019/04/02/inmune-bios-inb03-may-help-reverse-cancer-resistance-immunotherapy/

Unilever’s Schmidt’s Naturals to launch hemp-oil deodorants in September

Anglo-Dutch consumer goods giant Unilever PLC will be taking its first step into the U.S. hemp market in September, when its subsidiary brand Schmidt’s Naturals launches a line of hemp-oil deodorants that will be available at certain retailers.

That line will be followed later in the fall by a separate range of CBD products, according to Schmidt’s Naturals CEO Michael Cammarata. That’s assuming that regulations for CBD, a non-intoxicating ingredient in the cannabis plant, have been clarified by then, he told MarketWatch.

“We are working with our supply chain to ensure that we comply with FDA and state rules,” Cammarata said.

CBD was expected to be fully legalized along with hemp as part of the December Farm Bill, but instead it was moved under the purview of the U.S. Food and Drug Administration from the Drug Enforcement Administration. That’s because the FDA views it as a drug.

CBD is an ingredient in the only cannabis-based drug that has won FDA approval as a treatment for severe forms of childhood epilepsy. The FDA has promised to hold talks on regulating the substance this month and outgoing commissioner Scott Gottlieb said he would seek pathways for approval. But until those have been created, the FDA is not allowing companies to add CBD to food, beverages or cosmetics, forcing many companies to put their plans on hold.

https://www.marketwatch.com/story/unilevers-schmidts-naturals-to-launch-hemp-oil-deodorants-in-september-2019-04-09

Amgen says FDA approves EVENITY for treatment of osteoporosis

Amgen and UCB announced that the U.S. Food and Drug Administration has approved EVENITY for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY is the first and only bone builder with a unique dual effect that both increases bone formation and to a lesser extent reduces bone resorption to rapidly reduce the risk of fracture. A full course of EVENITY therapy is 12 monthly doses administered by a healthcare provider. Since osteoporosis is a chronic disease, continued therapy with an anti-resorptive agent should be considered once EVENITY therapy is completed. “One in two women will experience a fracture due to osteoporosis in her lifetime. These fractures can be devastating, with many leading to hospital stays and life-altering consequences. The FDA approval of EVENITY represents an important therapeutic development for patients who need a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures within 12 months,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Postmenopausal osteoporosis is a significant women’s health issue that far too often gets overlooked. As a leader in bone health with more than 20 years of osteoporosis research experience, Amgen is as committed as ever to combatting this disease to help women at high risk for fracture reduce their risk of a first and subsequent fracture.”

https://thefly.com/landingPageNews.php?id=2890439