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Monday, June 22, 2020

Altimmune on go with mid-stage study of HepTcell in hepatitis B

The FDA has signed off on a Phase 2 clinical trial evaluating Altimmune’s (NASDAQ:ALT) HepTcell, a peptide-based immunotherapeutic, for the treatment of chronic hepatitis B.
It has filed clinical trial applications in Canada, Spain, Germany and the UK. The study should launch in Q4.
The company says HepTcell is designed to restore antiviral T cell responses against the most conserved antigenic domains of the hepatitis B virus (HBV).
https://seekingalpha.com/news/3584846-altimmune-on-go-mid-stage-study-of-heptcell-in-hepatitis-b

Dosing starts in SpringWorks’ early-stage combination study in multiple myeloma

SpringWorks Therapeutics (NASDAQ:SWTX) doses first patient in a Phase 1b clinical trial evaluating its investigational gamma secretase inhibitor, nirogacestat, in combination with GlaxoSmithKline’s (NYSE:GSK) investigational anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, belantamab mafodotin, in patients with relapsed or refractory multiple myeloma.
The nirogacestat and belantamab mafodotin combination is being evaluated as a sub-study in GSK’s ongoing DREAMM-5 platform trial.
The Phase 1b combination trial is being advanced subject to a global clinical trial collaboration agreement that both the companies signed in June 2019.
The study will include two parts, a dose exploration phase and a cohort expansion phase.
https://seekingalpha.com/news/3584844-dosing-underway-in-springworks-early-stage-combination-study-in-multiple-myeloma

Sunday, June 21, 2020

Coronavirus is weakening, could disappear on its own: Italian doctor

An Italian infectious disease doctor believes the coronavirus has become less dangerous — and could disappear on its own without a vaccine.
Dr. Matteo Bassetti, the head of the infectious diseases clinic at the San Martino hospital, said the virus appears to have become less potent, possibly due to genetic mutations, the Sunday Telegraph reported.
“The clinical impression I have is that the virus is changing in severity,” Bassetti told the outlet.
“In March and early April the patterns were completely different. People were coming to the emergency department with a very difficult to manage illness and they needed oxygen and ventilation, some developed pneumonia.”
But he said in the past month, “the picture has completely changed in terms of patterns.”
“It was like an aggressive tiger in March and April but now it’s like a wild cat,” Bassetti said. “Even elderly patients, aged 80 or 90, are now sitting up n bed and they are breathing without help. The same patients would have died in two or three days before.”
He said one of the reasons for the virus becoming weaker could be that it has mutated in response to social distancing measures.
“I think the virus has mutated because our immune system reacts to the virus and we have a lower viral load now due to the lockdown, mask-wearing, social distancing,” he said. “We still have to demonstrate why it’s different now.”
It’s possible that the virus will be eradicated before researchers find a vaccine, he said.
“We have fewer and fewer people infected and it could end up with the virus dying out,” Bassetti said.
But another expert was less optimistic about the prospect of the virus disappearing soon, saying it could take years, the outlet reported.
“I don’t expect it to die out that quickly,” said Dr. Bharat Pankhania, a professor at the UK’s University of Exeter Medical School, according to the report.
“It will if it has no one to infect. If we have a successful vaccine then we’ll be able to do what we did with smallpox. But because it’s so infectious and widespread, it won’t go away for a very long time.”
https://nypost.com/2020/06/21/coronavirus-is-weakening-could-disappear-on-its-own-italian-doctor/

Germany’s coronavirus reproduction rate jumps, indicating rising contagion

Germany’s coronavirus reproduction rate jumped to 2.88 on Sunday, up from 1.79 a day earlier, health authorities said, a rate showing infections are rising above the level needed to contain the disease over the longer term.
The rise brings with it the possibility of renewed restrictions on activity in Europe’s largest economy – a blow to a country that so far had widely been seen as successful in curbing the coronavirus spread and keeping the death toll relatively low.
To keep the pandemic under control, Germany needs the reproduction rate to drop below one. The rate of 2.88, published by the Robert Koch Institute (RKI) for public health, means that out of 100 people who contract the virus, a further 288 people will get infected.
Chancellor Angela Merkel had favoured maintaining lockdown measures for longer but gradually eased restrictions in recent weeks following pressure from regional politicians to reboot the economy.
Already, the country is grappling to get people to adhere to isolation rules in places where they have been imposed. Over the weekend, authorities in Goettingen needed riot police to enforce quarantine measures.
In North-Rhine Westphalia, more than 1,300 people working at a slaugterhouse in Guetersloh tested positive for coronavirus, up from 803 infections on Friday.

As a result, North-Rhine Westphalia has put 7,000 people under quarantine and closed kindergartens and schools close to the abbatoir.
“I cannot rule out a broader lockdown,” North-Rhine Westphalia’s premier Armin Laschet told German television ZDF on Sunday.
Outbreaks in recent weeks have occurred in nursing homes, hospitals, institutions for asylum seekers and refugees, in meat processing plants and logistics companies, among seasonal harvest workers and in connection with religious events, RKI said.
The 2.88 rate is a jump from 1.06 on Friday, based on RKI’s moving 4-day average data, which reflects infection rates one to two weeks ago.
Based on a 7-day average, infection rates have risen to 2.03, RKI said, adding that an accurate reading for long-term patterns will take a couple of days.
The spike in infections is mainly related to local outbreaks including in North Rhine-Westphalia, RKI said. North-Rhine Westphalia was one of the regions most vocal about urging Merkel to ease lockdown restrictions.

A high 7-day incidence rate was observed in the towns of Guetersloh and Warendorf, North Rhine-Westphalia. Further outbreaks were detected in the cities of Magdeburg, in Saxony Anhalt and the Berlin district of Neukoelln, RKI said.
In total, Germany has reported 189,822 laboratory-confirmed COVID-19 cases and 8,882 deaths due to COVID-19 have been reported, RKI said.
In an interview published on Sunday, Bundesbank President Jens Weidmann told German newspaper Frankfurter Allgemeine Sonntagszeitung that the economy had passed the worst of the crisis caused by the coronavirus outbreak and was now expected to recover gradually.
https://www.reuters.com/article/us-health-coronavirus-germany/germanys-coronavirus-reproduction-rate-jumps-indicating-rising-contagion-idUSKBN23S0PJ

Remdesivir OK’d in India at $39 – 52 per dose

India’s Controller General has approved generic versions of Gilead Sciences’ (NASDAQ:GILD) remdesivir for the treatment of COVID-19.
Two domestic drugmakers, Hyderabad-based Hetero and Mumbai-based Cipla, plan to launch their offerings within a week at Rs 5,000 – 6,000 ($65 – 78) and Rs 3,000 – 4,000 ($39 – 52), respectively.
According to current Indian government guidelines, a COVID-19 patient may need five-to-six doses, implying a total treatment cost of the antiviral as low as $195.
Gilead has yet to announce the price in the U.S. but it’s safe to say it will be substantially higher. Drug cost watchdog ICER issued a report last month that the medicine would be cost-effective at $4,500 per course of treatment.
https://seekingalpha.com/news/3584771-remdesivir-okd-in-india-39-52-per-dose

Biotech week ahead, June 22

Biotech stocks rebounded along with the broader market in the week ended June 19. The week was a busy one from the perspective of PDUFA dates, with the FDA issuing approvals for Merck & Co., Inc. MRK 1.67% and Novartis AG NVS 1.61%, among others. The week also witnessed a flurry of activity on the IPO front.
The following are key biotech catalysts for the unfolding week.
Conferences
  • American Association of Cancer Research, or AACR, Virtual Annual Meeting II: June 22-24
  • BMO 2020 Prescriptions for Success Healthcare Conference: June 23
  • American Thoracic Society, or ATS 2020 Virtual: Clinical Trials Session: June 24
  • BofA Securities Napa Biopharma Conference: June 24
  • Cowen FutureHealth Conference: June 24-25

PDUFA Dates

The FDA is scheduled to rule on Karyopharm Therapeutics Inc’s KPTI 1.99% sNDA for Selinexor, which could expand the drug’s label to include adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who have received at least two prior therapies. (Tuesday)
Zogenix, Inc.’s ZGNX 1.61% NDA for Fintepla as a potential treatment candidate for seizures associated with Dravet syndrome is pending before the FDA, with the regulatory agency expected to rule on the drug by the June 25 PDUFA date.
Heron Therapeutics Inc HRTX 5.16% awaits an FDA nod for its HTX-011 as a treatment option for post-operative pain. (Friday)
The FDA is also expected to rule on Chiasma Inc’s CHMA 4.92% NDA for Mycapssa, which is being evaluated as a maintenance therapy for acromegaly. (Friday)
Intercept Pharmaceuticals Inc ICPT 1.68% has a PDUFA date of June 26 for its NDA for NASH drug candidate obeticholic acid.
An Adcom meeting scheduled for June 9 has been postponed, making it less likely an approval comes through by the PDUFA date.

Clinical Readouts

AACR Presentations

VBI Vaccines Inc VBIV 3.58% is due to present expanded immunologic and tumor response data from the ongoing Phase 1/2a study of VBI-1901, its cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma patients. (Monday)
BioNTech SE – ADR BNTX 0.82% will present data from the Phase 1 trial of BNT122 in multiple solid tumors.
DelMar Pharmaceuticals Inc DMPI 0.91% is due to present data from separate Phase 2 trials of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated glioblastoma as well as in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the recurrent or adjuvant setting.
Affimed NV AFMD 8.68% is scheduled to present two posters, one on AFM24, a bispecific EGFR/CD16A Innate Cell Engager with the potential to overcome resistance to current targeted treatments for EGFR-positive malignancies, and another on preclinical pharmacology and safety of RO7297089, a novel anti-BCMA/CD16a bispecific antibody for the treatment of multiple myeloma.

Presentations At ATS 2020 Virtual: Clinical Trials Session

AstraZeneca plc AZN 0.67%: Phase 3 ETHOS trial for triple-combination therapy Breztri Aerosphere, formerly PT010, in patients with moderate to very severe chronic obstructive pulmonary disease.
Insmed Incorporated INSM 1.76%: Phase 2 WILLOW study evaluating the efficacy, safety and pharmacokinetics of INS1007 administered once daily in adults with non-cystic fibrosis bronchiectasis.
United Therapeutics Corporation UTHR 2.34%: key data from the INCREASE study of Tyvaso inhalation solution in patients suffering from WHO Group 3 pulmonary hypertension associated with interstitial lung disease.

Other Presentations

Aridis Pharmaceuticals Inc ARDS 5.8% will participate in a Cantor Fitzgerald-hosted Virtual Fireside Chat on Thursday. The discussion is intended to provide a comprehensive profile of the company’s CRISPR-based platform technology APEX, with a particular emphasis on addressing how it can be rapidly customized to future COVID strains as well as any emerging viral or bacterial pathogens.

Earnings

  • Affimed (Tuesday, before the market open)
  • Aethlon Medical, Inc. AEMD 0.75% (Thursday, after the close)
https://www.benzinga.com/general/biotech/20/06/16304965/the-week-ahead-in-biotech-karyopharm-zogenix-heron-chiasma-on-the-radar-ahead-of-fda-decisions

New adjuvant successful in extending immunity against HIV

Researchers at the Yerkes National Primate Research Center and the Emory Vaccine Center (EVC) are first to show a new adjuvant, 3M-052, helps induce long-lasting immunity against HIV. The study results are published today in Science Immunology.
In this pre-clinical study that included 90 rhesus monkeys, the researchers showed 3M-052, a new, synthetic small molecule that targets a specific receptor (TLR 7/8), successfully induced vaccine-specific, long-lived bone marrow plasma cells (BM-LLPCs), which are critical for durable immunity. In a striking observation, 3M-052-induced BM-LLPCs were maintained at high numbers for more than one year after vaccination. This prolonged interval is not only feasible in monitoring pre-clinical effectiveness, it is also highly informative in down selecting vaccine candidates.
First author Sudhir Pai Kasturi, PhD, an assistant professor in the Department of Pathology and Laboratory Medicine and a research assistant professor at Yerkes and the EVC, says, “We have known adjuvants are critical immunity-boosting supplements that help improve the effectiveness of vaccines. Until now, however, it has been unclear which class of adjuvants can promote stable and long-lived immunity in nonhuman primate models. Our study provides that information.”
Co-senior author Rafi Ahmed, PhD, director of the Emory Vaccine Center, adds, “The key to a successful vaccine is durability of immune responses. Antibodies provide the first line of defense against pathogens, and antibody levels are maintained by the generation of long-lived plasma cells that reside in bone marrow. Our study identifies an adjuvant that is effective in generating such long-lived plasma cells in bone marrow. This finding has implications for developing successful vaccines against HIV, influenza and, especially important now, COVID-19.
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The research data from this study has prompted a phase 1 clinical trial to assess the potential of 3M-052 in the context of HIV Env antigens; see http://clinicaltrials.gov NCT04177355.
Research collaborators include Bali Pulendran, PhD, senior author and a professor at Stanford; Mohammed Ata Ur Rasheed, PhD, co-first author and a researcher in Dr. Ahmed’s lab at the time of the study and now with the CDC; Christopher Fox, PhD, Infectious Disease Research Institute, who prepared the clinical grade adjuvant formulation; and Mark Tomai, PhD, and his team at 3M Drug Delivery Systems in Minnesota, who discovered the novel 3M-052 adjuvant.
This study was funded by the Bill and Melinda Gates Foundation and the National Institutes of Health. Grant amounts (direct + indirect) are:
  • Bill and Melinda Gates Foundation: $2,738,195/over 3 years; and #OPP1055855, $9,778,596/over 3 years
  • NIH K01 OD023039-03, $346,266/yr; 8/8/16 – 7/31/20
  • NIH R01 AI125068, $841,574/yr; 2/1/16 – 1/31/21
  • NIH P30 AI050409, $2,249,998/yr; 8/1/17-7/31/22
  • NIH P51-OD011132, $10,540,602/yr
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  • https://www.eurekalert.org/pub_releases/2020-06/ehs-nas061920.php