Biotech week ahead, Sept. 14

Biotech stocks continued to remain under pressure in the week ended Sept. 11, swayed by the volatility that was evident in the broader market.

The week also witnessed a flurry of news flow on the coronavirus vaccine front. Even as nine vaccine makers released a pledge to put safety first, AstraZeneca plc AZN 1.22% was forced to voluntarily stall the late-stage study of its coronavirus vaccine, citing an unidentified illness in one of the trial participants. Clinical trials were allowed to resume on Sept. 12.

Still, clinical trial readouts led to wild swings in some stocks.

Here are the key catalysts for the unfolding week:

Conferences:

• The International Parkinson and Movement Disorder Society, or MDS, Virtual Congress 2020: Sept. 12–16.
• H.C. Wainwright Virtual Healthcare Conference: Sept. 14-16
• 2nd RAS- Targeted Drug Development Summit 2020: Sept. 14-16
• 18th Annual Morgan Stanley Healthcare Conference: Sept. 14-18
• 2020 Cantor Global Virtual Healthcare Conference: Sept. 15-17
• European Society for Medical Oncology, or ESMO, Virtual Congress 2020: Sept. 14-21

PDUFA Dates

The FDA is set to rule on Bausch Health Companies Inc.’s BHC 1.6% NDA for EM-100, a ketotifen preservative-free ophthalmic solution that is being evaluated for allergic conjunctivitis. Bausch had in-licensed EM-100 from Eton Pharmaceuticals Inc. ETON 1.05% in Feb. 2019. The PDUFA date is set for Tuesday.

Clinical Trial Readouts/Presentations

Prothena Corporation PLC PRTA 0.41%: results from Part 1 of the Phase 2 PASADENA study of prasinezumab in early Parkinson’s disease (Tuesday)

2nd RAS- Targeted Drug Development Summit Presentations

Verastem Inc VSTM 0.83%: updated data from the LGSOC cohort of the Phase 1/2 FRAME study evaluating VS-6766 and defactinib in KRAS mutant solid tumors, and new preclinical data from studies investigating VS-6766 and defactinib in combination with KRAS-G12C inhibitors (Wednesday)

ESMO Congress Presentations

IMMUTEP LTD/S ADR IMMP 0.63%: initial results from a Phase 2 study of eftilagimod alpha and Keytruda as 2nd line treatment for PD-L1 unselected metastatic head and neck cancer patients and non-small cell lung cancer, or NSCLC, patients, and safety data from stratum D of the phase 1 trial evaluating feasibility of IMP321 combined with avelumab in advanced stage solid tumor (Thursday)

Clovis Oncology Inc CLVS 5.5%: initial data from the Phase 1b part of the LIO-1 trial of lucitanib in combination with Opdivo in advanced metastatic solid tumors, new data analyses for Rubraca from the Phase 2 TRITON2 and Phase 3 ARIEL3 studies in patients with metastatic castration-resistant prostate cancer and recurrent ovarian cancer, respectively, and preclinical data for FAP-2286 in a variety of cancers

Mersana Therapeutics Inc MRSN 1.25%: updated interim data from the ovarian cancer cohort of the ongoing Phase 1 expansion study evaluating XMT-1536 (Thursday)

Alkermes Plc ALKS 1.34%: Safety and anti-tumor efficacy data from the phase 1/2 ARTISTRY-1 study, evaluating ALKS 4230 as monotherapy and in combination with Keytruda in patients with refractory solid tumors (Friday)

Ayala Pharmaceuticals Inc AYLA 4.61%: interim results from the Phase 2 ACCURACY clinical trial of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma harbouring Notch activating mutations (Friday)

Agenus Inc AGEN 3.85%: data from two Phase 2 trials of balstilimab alone and in combination with zalifrelimab (Friday)

Autolus Therapeutics PLC AUTL 0.94%: Phase 1/2 data for AUTO3, its CAR T cell therapy being investigated in relapsed/ refractory diffuse large B cell lymphoma (Friday)

Arcus Biosciences Inc RCUS 1.75%: efficacy and safety data from a Phase 1/1b study of etrumadenant plus carboplatin, pemetrexed and anti-PD-1 therapy in patients with metastatic NSCLC

Beigene Ltd BGNE 4.76%: data from the Phase 3 trial of tislelizumab combined with chemotherapy for the first-line treatment of patients with advanced non-squamous NSCLC, and data from the Phase 1/2 trial of pamiparib in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer

Deciphera Pharmaceuticals Inc DCPH 1.56%: data from Part 2 of the ovarian cancer cohort of the Phase 1b/2 study in combination with paclitaxel, and updated data from the phase 3 INVICTUS study of ripretinib as fourth-line and above treatment in patients with advanced gastrointestinal stromal tumors

NuCana PLC NCNA 0.18%: Phase 1b data for NUC-3373 in colorectal cancer and Phase 1 study of NUC-7738 in advanced solid tumors

Immunomedics, Inc. IMMU 0.76%: data from a phase 3 study of sacituzumab govitecan versus treatment of physician’s choice in patients with previously treated metastatic triple-negative breast cancer and final results from a Phase 2 study of sacituzumab govitecan in metastatic urothelial cancer (Saturday)

ImmunoGen Inc. IMGN 3.75%: mature data from the triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin in patients with recurrent, platinum-sensitive ovarian cancer

MacroGenics Inc MGNX 0.33%: data from the Phase 1 dose escalation study of MGD019 in solid tumors

Veru Inc VERU 2.33%: results from Phase 1b/2 study of VERU-111 in castration-resistant prostate cancer

Fortress Biotech FBIO 3.37% and Checkpoint Therapeutics Inc CKPT 18.57%: updated interim safety and efficacy data for cosibelimab in cutaneous squamous cell carcinoma

Earnings

Champions Oncology Inc CSBR 3.83% (Monday, after the close)

IPOs

Waltham, Massachusetts-based Dyne Therapeutics, Inc. has filed to offer 10.30 million shares in an initial public offering, or IPO, at an estimated price range of $16-$18. The muscle disease company focused on therapeutics for patients with genetically driven diseases has applied for listing its shares on the Nasdaq under the ticker symbol DYN

Metacrine, Inc., a clinical-stage biopharmaceutical company focused on developing differentiated therapies for patients with liver and gastrointestinal diseases, is proposing to offer 6.54 million shares in an IPO. The company expects to price the offering between $12 and $14. The San Diego, California-based company has applied for listing its shares on the Nasdaq under the ticker symbol MTCR.

San Jose, California-based Outset Medical, Inc. is planning a 7.6-million IPO, to be priced between $22 and $24. The medical technology company expects to list its shares on the Nasdaq under the ticker symbol OM.

IPO Quiet Period Expiry

Harmony Biosciences Holdings Inc HRMY 0.56%
Inhibrx Inc INBX 0.35%
Nano-X Imaging Ltd NNOX 32.87%
Kymera Therapeutics Inc KYMR 6.71%

https://www.benzinga.com/general/biotech/20/09/17459482/the-week-ahead-in-biotech-decision-day-for-bausch-health-ipo-flow-resumes-oncology-conference

Coronavirus on campuses fueling nation’s largest outbreaks

A new analysis released on Friday by USA Today finds that college campuses are fueling the largest coronavirus outbreaks across the United States.

Of the 25 hottest outbreaks in the U.S., communities with dominant colleges and thousands of recently returned students represent 19 of them.

Harrisonburg, Va., home of James Madison University, topped the list with 1,562 COVID-19 cases per 100,000 people within the last two weeks.

The communities where Washington State University, Central Texas College, Georgia Southern University and Iowa State University are located round out the top five areas with large college populations that have seen a spike in cases.

Many schools, like the University of Mississippi, started the fall semester with a mix of in-person and online classes in an attempt to prevent an outbreak, the analysis noted. However, the wave of students who returned to Lafayette County in Mississippi has triggered 1,053 coronavirus cases, according to the analysis.

Washington State, located in the college town of Pullman, Wash., isn’t even having students take in-person classes yet, USA Today reported. The university asked students to remain home to continue virtual learning, but many students had already signed leases and would be required to pay.

“We don’t have the right to tell students where they can and can’t live,”  spokesman Phil Weiler told the outlet. “Our students are young adults. We need them to make the right decisions.”

Community spread is most likely occurring as students interact in apartments or crowded bars, according to officials. 

There were only 70 cases reported per 100,000 residents in Whitman County in late July before Washington State students returned to the area, according to the county public health director Troy Henderson.

“About 12,000 young adults pulled into a very small rural town,” Henderson said, and now the locality is reporting 1,295 cases in the last two weeks.

Despite the rise in cases, the Trump administration has pushed for colleges and universities to remain open.

President Trump on Thursday called for schools in the Big Ten Conference to play football this season and said it is “much safer for students to live on campus,” despite many schools reporting outbreaks on campuses and a number of them sending students home due to outbreaks. 

“The alternative is no good, going home, spreading the virus to high-risk Americans. They want to be on campus, they want to go back to school and the parents want them back to school, maybe more so than they want to be back in school,” Trump said.

The University of Wisconsin-Madison, a Big Ten school, announced Wednesday it is shifting to two weeks of remote instruction and quarantining all residents in residence halls due to an increase in positive test results.  

Penn State University, another Big Ten school, also said this week it would be pausing team activities indefinitely for several programs after 48 athletes tested positive. 

https://thehill.com/policy/healthcare/515979-coronavirus-on-college-campuses-fueling-nations-largest-outbreaks-analysis

China starts testing nasal spray coronavirus vaccine

China on Wednesday approved the first phase of human testing for a nasal spray vaccine, the first trial vaccine for the coronavirus that does not require a needle injection.

The spray vaccine was co-developed by researchers at Xiamen University and Hong Kong University with the aid of vaccine maker Beijing Wantai Biological Pharmacy Enterprise, Bloomberg reported.

Previously, the intranasal spray method has been used to administer flu vaccines for people seeking an alternative to injections. 

The latest vaccine marks the 10th candidate from China to enter human trials.

The announcement comes as the U.K.-headquartered company AstraZeneca was forced to pause late-stage human trials of a potential coronavirus vaccine after a spinal cord illness was detected in a patient who received the shot.

Advanced Chinese vaccine developers such as CanSino Biologics and state-operated China National Biotec Group have reassured their product’s efficacy amid setbacks experienced by AstraZeneca.

CanSino said its shot has been safe in trials and has not caused severe side effects.

An obstacle CanSino faces, however, is getting other nations to allow trials abroad. Critics are skeptical about the Chinese-made vaccine because it allegedly triggers fewer antibodies than other products currently under trial analysis, Reuters reported.

Zhu Tao, CanSino’s co-founder and chief scientific officer, defended the company’s vaccine against criticism, saying last week that the variation in antibody readings was due to different measuring methods.

https://thehill.com/policy/healthcare/public-global-health/516021-china-starts-testing-nasal-spray-coronavirus-vaccine

Business groups back pandemic insurance bill modeled on post-9/11 law

Business groups are throwing their support behind a pandemic insurance bill modeled after a post-9/11 law that created a federal backstop for claims related to acts of terrorism.

The Pandemic Risk Insurance Act, much like the 2002 Terrorism Risk Insurance Act (TRIA), would provide compensation for losses resulting from pandemics or public health emergencies.

But unlike TRIA, which had broad bipartisan support and was reauthorized as recently as 2019, the pandemic measure introduced by Rep. Carolyn Maloney (D-N.Y.) has garnered little to no support from Republicans, despite widespread backing from the business community.

“Congress needs to be proactive in helping businesses protect themselves from pandemic risk, which as we’ve seen can be devastating to businesses of all sizes,” Maloney, who is head of the House Oversight and Reform Committee, said Thursday at a briefing on the bill.

She said the goal of the legislation is “to better protect businesses across our country in the event of another pandemic.”

The legislation has support from the National Retail Federation, International Franchise Association, the U.S. Travel Association and several insurance industry groups.

Maloney’s measure, introduced May 26, would create a system of public-private compensation for pandemic-related losses. Unlike the COVID-19 liability shield sought by Senate Republicans, her bill would not be retroactive.

Businesses large and small have been forced to shutter or declare bankruptcy during the coronavirus pandemic. 

New York-based retailer Century 21 announced on Thursday it will file for bankruptcy and close all of its stores. The company’s co-CEO, Raymond Gindi, blamed the closures on its insurer, which he said had refused to pay out a $175 million claim the company made related to the pandemic.

Companies like Century 21 would have “absolutely” been able to be saved with a pandemic insurance risk bill, said Leon Buck, vice president for government relations, banking and financial services at the National Retail Federation. 

“They would have been able to keep their brick and mortar stores open; they would have been able to be saved. We just need champions to be concerned with not only the state of the economy, but the state of the retail business,” Buck told The Hill.

Maloney’s bill faces an uphill climb. The measure has just 25 co-sponsors — all Democrats — and it’s been awaiting action in the House Financial Services Committee for months. 

Maloney said she has spoken with Rep. Steve Stivers of Ohio, the top Republican on the Subcommittee on Housing, Community Development and Insurance, but his office said he isn’t backing the legislation. 

“Rep. Stivers does not support Rep. Maloney’s bill in its current form and needs to see substantial amendments before it is something he could vote in favor of. Nevertheless, he remains committed to bipartisan conversations and looks forward to continuing to work with Rep. Maloney to ensure that the final product best serves workers, businesses, and our economy,” his office said.

The main idea behind the Pandemic Risk Insurance Act (PRIA) stems from TRIA, which encouraged insurers to continue providing coverage after the 9/11 attacks by setting up a system of shared losses between the government and private insurers in the event of another catastrophic terrorist incident.

Maloney also played a role in TRIA by introducing a reauthorization of the measure in 2013 with former Rep. Michael Grimm (R-N.Y.) and Peter King (R-N.Y.).

King’s office did not respond to a request for comment on PRIA, nor did other congressional Republicans who co-sponsored reauthorizations of TRIA, which was extended for seven years in December.

“We need to create a degree of economic security and certainly for any business that is impacted by a pandemic,” Maloney said. “I hate to think what would have happened to New York if we didn’t have TRIA.”

Joe Wayland, general counsel at Chubb Ltd., the largest publicly traded insurance company, said at Thursday’s briefing that the disruption of social and economic life caused by the pandemic is “too great to be insurable by the private sector.” 

“We’re very gratified and excited by the recognition in PRIA that the ultimate responsibility of this kind of catastrophe lies with government,” Chubb said. 

PRIA would not require businesses to purchase the insurance policy but, similar to TRIA, it addresses a concern that some insurers might be discouraged from covering businesses in high risk areas.

“I think what we learned from TRIA is that terrorism was a very difficult risk to ensure, and if there is going to be a robust private market for insurance, some kind of public private partnership is needed, some kind of government involvement and backstop is needed,” said Lloyd Dixon, director of the Feinberg Center for Catastrophic Risk Management and Compensation at the RAND Corporation.

“Pandemics can be truly worldwide, huge numbers of policymakers affected at the same time. I do think it’s unrealistic to expect the private sector to really provide any kind of widespread coverage for pandemic risk without some kind of government backstop or government involvement,” he added. 

Birny Birnbaum, director of the Center for Economic Justice, said one of the main challenges to overcome in the near term is filling a major gap in the market.

“We want the insurance industry, which is in the business of assessing and managing risk, to be part of the solution. We want them to have skin in the game so they’re actively engaged with loss mitigation,” he said. “The reason that there’s no particular insurance market for this now is that the insurance industry hasn’t really developed coverage descriptions for this type of event. The exposure is sort of unlimited.”

https://thehill.com/policy/finance/516060-business-groups-back-pandemic-insurance-bill-modeled-on-post-9-11-law