Soleno Therapeutics' Upside Potential Much Higher Than Downside Risk: Cantor

 Cantor Fitzgerald has initiated coverage on Soleno Therapeutics Inc 

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 with an Overweight rating and a price target of $19. 

Soleno's lead program, diazoxide choline controlled-release (DCCR), is currently in Phase 3 development for Prader-Willi Syndrome (PWS), and the analyst expects the 3Q23 findings to be positive. 

PWS is characterized by insatiable hunger resulting in physical, mental, and behavioral problems.

The analyst notes that the company announced disappointing Phase 3 trial data and missed its primary endpoint on hyperphagia (excessive overeating) three years ago. It says that COVID-19 affected the trial due to impacts on patient routines. 

Statistical significance was reached for the 69% of study subjects who had completed follow-up by March 1, 2020, but top-line results after the pandemic set in did not reach statistical significance. 

Cantor analyst says that secondary endpoints and longer-term data cement DCCR's potential.

The analyst says it is encouraged to see that the changes correlate well with some behavioral manifestations observed with the condition. The company also reported physical changes over a year, which are critical, as excess weight could cause a significant health impact, Cantor writes. 

Considering that the valuation doesn't reflect potential in the PWS market, with no approved therapies, the Cantor analyst sees the upside potential as much higher than any downside risk heading into near-term binary events.

https://www.benzinga.com/general/biotech/23/07/33187822/keep-the-hunger-on-analyst-says-soleno-therapeutics-upside-potential-much-higher-than-downside-ri

Syndax Pharmaceuticals Set for Potential Breakthrough with Revumenib: Guggenheim

 Guggenheim Partners initiated coverage on Syndax Pharmaceuticals Inc 

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 with a BUY rating and a price target of $40.

SNDX's lead asset and principal value driver is revumenib, an inhibitor of menin in development for a genetically defined subset of leukemias that currently have no FDA-approved targeted therapies. 

The analyst says Syndax's revumenib is the most advanced and potentially best-in-class menin inhibitor in development for hematological and solid cancers in a crowded, competitive landscape. 

The analyst also writes that the ongoing investor debates around menin inhibitors provide meaningful upside opportunity as revumenib heads into a catalyst-rich ~12 months, which includes potentially stock-moving topline registrational data in late-line KMT2Ar (3Q23) and mNPM1 (2024) acute leukemias as well as initial proof-of-concept data in treatment-naïve AML (YE23) and solid tumors (MSS CRC in YE23). 

The company's second program axatilimab partnered with Incyte Pharmaceutical Inc INCY, is a partially de-risked and underappreciated asset.

The analyst says the price target reflects 80% PoS for revumenib in R/R acute leukemias and 75% PoS for axatilimab for 3L cGVHD, with additional contributions from probability-adjusted revenues in the frontline settings for both agents.

https://www.benzinga.com/general/biotech/23/07/33188619/syndax-pharmaceuticals-set-for-potential-breakthrough-with-revumenib-analyst-calls-it-potentially

Why Are Journey Medical Shares Trading Lower

 Journey Medical Corporation 

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 shares are trading lower after the company announced topline results from the two Phase 3 trials, evaluating Minocycline Hydrochloride Modified Release Capsules (DFD-29) for adult patients with moderate-to-severe papulopustular rosacea.

DFD-29 is being developed for rosacea in collaboration with Dr. Reddy's Laboratories Ltd 

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.

The company said the trials - Minocycline Versus Oracea in Rosacea-1 (MVOR-1) and Minocycline Versus Oracea in Rosacea-2 (MVOR-2), achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues.

In MVOR-1, In the DFD-29 group, 65.0% of subjects demonstrated IGA success, compared to 46.1% in the Oracea (Doxycycline) group and 31.2% in the placebo group. 

The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of 0.007, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. 

The DFD-29 group showed a mean reduction of 21.3 lesions vs. 15.9 in the Oracea group and 12.2 lesions from baseline to week 16. 

The difference between the DFD-29 and Oracea groups and the difference between the DFD-29 and placebo groups were statistically significant, each with a p-value of <0.001.

In MVOR-2, in the DFD-29 group, 60.1% of subjects demonstrated IGA success vs. 31.4% and 26.8%. 

The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of <0.001, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. 

The DFD-29 group showed a mean reduction of 18.4 lesions vs. 14.9 in the Oracea group vs. 11.1 lesions from baseline to week 16. 

Recently, Journey Medical announced topline data from the Phase 1 clinical trial assessing the impact of DFD-29 on the microbial flora of healthy adults. 

https://www.benzinga.com/general/biotech/23/07/33188770/why-are-journey-medical-shares-trading-lower-today

Ocean mRNA-based Vaccine Candidate Generates Over 90% Killing of Malaria Parasites in Primates

 Ocean Biomedical, Inc. (NASDAQ: OCEA), a biopharma company working to accelerate the development of compelling discoveries from top research scientists, announced today that it is focusing its multi-pronged malaria program to address the chronic malaria crisis in sub-Saharan Africa while recognizing newly emerging global malaria challenges.

Based on discoveries by Scientific Co-founder, Jonathan Kurtis, MD, PhD, Ocean Biomedical is working on a multivalent mRNA-based malaria vaccine with potential to target several stages in the malaria cycle. Additionally, the company has discovered a new therapeutic approach with the potential to launch a whole new class of anti-malarials. Promising results from the malaria program include: 1) an mRNA-based vaccine that generates >90% killing of malaria parasites in non-human primates, 2) a monoclonal antibody that kills 94%-99% of malaria parasites in culture, and 3) a small molecule drug that kills 100% of parasites at low nanomolar concentrations. Multiple U.S. and global patents are held by Ocean Biomedical for both the vaccine and therapeutic approaches.

“Inducing parasite cell death via targeting PfGARP is a novel approach that has potential to launch a whole new class of anti-malarial interventions, including mRNA-based vaccines, small molecule drugs and our current monoclonal antibody,” said Dr. Kurtis. “Our monoclonal antibody and small molecule drug comes at a critical time because malaria parasites are developing resistance to current frontline therapeutics, and the currently approved vaccine offers only very limited protection.”

https://www.biospace.com/article/releases/ocean-biomedical-s-nasdaq-ocea-mrna-based-vaccine-candidate-generates-over-90-percent-killing-of-malaria-parasites-in-non-human-primates-demonstrating-broad-potential-for-ocean-s-program-to-address-global-and-emerging-u-s-malaria-challenges/

ADC Therapeutics Halts Enrollment of Zynlonta Trial After Seven Patient Deaths

 ADC Therapeutics announced on Tuesday that it has ceased enrollment of new patients in a Phase II of Zynlonta along with rituximab for patients with previously untreated diffuse large B cell lymphoma (DLBCL), a type of blood cancer. The reason: seven patient deaths due to extreme respiratory events.

The LOTIS-9 trial has thus far enrolled 40 participants who received the combination of Zynlonta and rituximab. Almost one-third of these participants developed respiratory issues following the treatment. Among the 12 participants who experienced respiratory-related events, there were seven Grade 5 that led to the patients’ deaths and five Grade 3 or 4.

The cancer patients who passed away were 80 years of age or older and were suffering from existing comorbid conditions such as chronic obstructive pulmonary disease idiopathic pulmonary fibrosis or recent COVID-19 infection.

ADC assessed that 11 of 12 of the events, including six of the deaths, were “unlikely or unrelated to study drug.” The company said that it put a voluntary pause to investigate the data and determine the next steps.

“Our top priority is the safety of every patient who participates in our clinical trials,” Ameet Mallik, ADC Therapeutics CEO, said in the release.

For now, ADC has informed regulatory authorities, including the FDA and EMA, and doesn’t expect to report further data by the end of the year.

TD Cowen analyst Boris Peaker suggested that the safety concerns could be due to the combinations of Zynlonta along with rituximab. “A lower dose of Zynlonta may be worth exploring given the high efficacy,” Peaker wrote in a note to investors, according to Endpoints News.

Zynlonta received an accelerated approval in 2021 from FDA for the treatment of adults with DLBCL, after two prior lines of treatments. It was the first single-agent CD19-targeted antibody drug to be approved for DLBCL based on Phase II trial that showed it has positive effect on about 48.3% patients.

The LOTIS-9 clinical trial is a part of ADC’s attempt to grow Zynlonta’s label as a first option for patients with DLBCL. ADC is also running a separate clinical trial of Zynlonta as a second option for DLBCL patients. Peaker noted that it’s likely that the LOTIS-9 trial will need to be modified to a lower dose or exclude certain patients.

Last year, ADC Therapeutics entered into a partnership with Sobi in a deal worth $435 million. This partnership allows Sobi to manufacture and market Zynlonta outside of the U.S., except for certain countries in Asia. Additionally, ADC Therapeutics has collaborated with Avid Bioservices to increase the production of Zynlonta at a facility in Tustin, California, to meet the demand for the drug.

ADC Therapeutics shares sank 21% after the company released today’s news of the adverse events in the LOTIS-9 trial.

https://www.biospace.com/article/adc-therapeutics-halts-enrollment-of-zynlonta-trial-after-seven-patient-deaths-/

UAE, Saudia Arabia Serve as Gateway to International Markets for Biopharma

 Biopharma companies, including Sanofi, AbbVie and Virax Biolabs, are finding significant business opportunities in the Middle East, particularly in the United Arab Emirates and Saudi Arabia. These countries have emerged as attractive markets for novel therapies, driven by growing populations with increasing incidences of chronic diseases such as diabetes and cardiovascular diseases.

The Middle East is emerging as a key healthcare market, with an increasing demand for innovative healthcare solutions, particularly after the region struggled to meet the challenges brought on by the pandemic, said Cameron Shaw, chief operating officer for Virax Biolabs, which recently made a deal to set up a regional headquarters in the Dubai Science Park in the UAE.

“The UAE was hit very hard by the COVID pandemic, similarly to how everyone in the world was affected,” Shaw told BioSpace. This is partly due to the high prevalence of diabetes and obesity in Dubai and Saudi Arabia, he noted, adding that these diseases need addressing even in the absence of a global viral threat.

Strategic partnerships with local entities allow biopharmas to enhance research and development or market existing products, taking advantage of incentives offered by governments eager to house innovation hubs.

For example, the UAE has established several designated free economic zones that offer business-friendly environments for biotechs open to doing business abroad. These zones, like the Dubai Biotechnology and Research Park and Abu Dhabi Global Market, provide various incentives, including 100% foreign ownership, tax exemptions and streamlined administrative processes, according to analysts at PwC.

In addition, the UAE has a well-established healthcare system and high healthcare expenditure, offering a robust market for the life sciences, said Virax CEO James Foster. The country’s location is also a strategic advantage, he added, providing easy access to additional international markets.

“It's a massive growth opportunity,” Foster told BioSpace. “We see potential investment opportunities; they’re opening up capital markets, they’re opening up funding markets there. There’s all sorts of interest from all sorts of companies like ours to go over there and access funding, which is becoming more and more difficult to come by in Western countries for a variety of different reasons.”

Besides the commercial incentives, retired industry analyst Randolph Gordon, CEO of World Health Advisors, told BioSpace that the Middle East also offers unique clinical trial enrollment opportunities.

“These countries may also provide a population on which they can develop new interventions,” he said. “A certain country has a population that may have distinguishing types of illnesses or genetics, then that also provides a resource base . . . for developing interventions targeted towards that condition or that genetic condition.”

Here’s a look at a few recent collaborations.

Sanofi

Announced earlier this month, French pharma Sanofi will partner with Saudi Arabian drugmakers Arabio and Lifera, both of which are wholly owned by the kingdom's sovereign wealth fund, to enhance vaccine production in the country. The partners seek to explore potential preventive measures, including using Lifera as a contract manufacturer for Sanofi and setting up a new manufacturing plant.

Sanofi will initially share its biotechnological know-how to produce seven vaccines, all included in Saudi Arabia’s mandatory immunization schedule. Arabio plans to leverage its local and regional distribution network to supply vaccines and biopharmaceutical products to the Saudi market. The vaccine partnership underlines Lifera’s broader objective of strengthening the national healthcare system and expanding the biopharmaceutical industry in Riyadh as part of Saudi Arabia’s Vision 2030. The plan intends to decrease Saudi Arabia's reliance on oil, broaden its economic base and enhance various public service sectors such as healthcare, education, infrastructure, recreation and tourism.

AbbVie

In June, another partnership was inked by AbbVie and the UAE. Emirati government officials in the announcement said the deal aligns with the UAE’s vision to become a global leader in healthcare innovation.

Now, AbbVie has formed a strategic partnership with the Department of Health of Abu Dhabi and local healthcare company M42 to further personalized medicine and genomics. The group uses precision medicine to analyze individuals’ genetic makeup to understand diseases better and optimize treatment strategies.

Virax Biolabs

In May, Virax signed a deal to locate a regional headquarters in the UAE. By entering the region, Foster said he hopes to increase Virax’s distribution of in vitro diagnostics and the company’s proprietary T cell tests. Foster said he envisions Virax’s T cell testing as particularly effective in diagnosing and treating potential future pandemics.  

https://www.biospace.com/article/uae-saudia-arabia-serve-as-gateway-to-international-markets-for-biopharma/

US Introduces New Immigration Pathway For People From Central America, Colombia

  by Mimi Nguyen Ly via The Epoch Times (emphasis ours),

The Biden administration has introduced a new immigration program to allow some nationals of Central America and Colombia to enter the United States.

The U.S. Department of Homeland Security (DHS) announced on July 7 that it’s implementing “new family reunification parole (FRP) processes” for Colombia, El Salvador, Guatemala, and Honduras. The program was first announced in April.

The FRP processes allow certain migrants with U.S. relatives to enter and work legally while they await their U.S. immigration visas.

“Specifically, nationals of these [four] countries can be considered for parole on a case-by-case basis for a period of up to three years while they wait to apply to become a lawful permanent resident,” the DHS stated on July 7.

Potentially eligible migrants are those from the four countries who have family members who are U.S. citizens or lawful permanent residents in the United States.

The latest initiative, according to the DHS, is part of the comprehensive measures the DHS and State Department announced in April “to further reduce unlawful migration across the Western Hemisphere, significantly expand lawful pathways for protection, and facilitate the safe, orderly, and humane processing of migrants.”

The FRP processes were available to Cubans starting in 2007 and Haitians starting in 2014. The Trump administration had halted the programs, but the Biden administration later restarted them.

US ‘Intends to Welcome as Many as 100,000’

The U.S. family member must file Form I-30—also referred to as the Petition for Alien Relative—on behalf of their Colombian, Salvadoran, Guatemalan, or Honduran relative.

If the petition is approved, the State Department issues an invitation to the petitioning U.S. family member, who can then start the FRP process by filing a request on behalf of the migrant relative to be considered for advance travel authorization and parole.

The DHS said on July 7 that if the foreign national is granted parole status, which permits entry into the United States, that person can then request employment authorization while waiting for his or her immigrant visa to become available. When the immigrant visa is available, he or she may apply for permanent residency—also referred to as a green card.

The FRP process can be a faster pathway to enter the United States than the regular process of U.S. citizens’ and green-card holders’ applying and waiting for an immigrant visa for their relatives.

The Biden administration announced on May 2 that the United States “intends to welcome as many as 100,000 individuals from Honduras, Guatemala, and El Salvador” under the FRP processes. No time frame has been provided, however, and a numerical cap for Colombian migrants has also not been specified.

‘Lawful Pathways’

Homeland Security Secretary Alejandro Mayorkas said in a statement that the new processes “promote family unity and provide lawful pathways consistent with our laws and our values.”

“The Department has proven that the expansion of safe, orderly, and lawful pathways, combined with strong enforcement, is effective in reducing dangerous, irregular migration to the United States,” he said.

According to data from the U.S. Customs and Border Protection more than 126,200 Colombians, 40,700 Salvadorans, 115,100 Guatemalans, and 110,000 Hondurans have been processed at the southwest border so far in fiscal 2023.

The DHS stated that the new FRP processes “allow for parole only on a discretionary, case-by-case, and temporary basis upon a demonstration of urgent humanitarian reasons or significant public benefit, as well as a demonstration that the beneficiary warrants a favorable exercise of discretion.”

The above stipulations are in accordance with the Immigration and Nationality Act (INA), enacted in 1952. The INA authorizes the Homeland Security secretary—currently Mr. Mayorkas—to decide whether to parole a foreign national into the United States.

Parole Status Previously Granted Sparingly

An immigration expert told The Epoch Times in 2022 that parole should be a “very, very boutique thing” and should be used in only special cases, such as when a family member needs entry into the United States to donate a kidney to his brother, or if a witness to a criminal case is needed to testify.

https://www.zerohedge.com/geopolitical/us-introduces-new-immigration-pathway-people-central-america-colombia