Target $19
Tuesday, September 7, 2021
Defence Therapeutics to develop a novel HPV-targeting vaccine
Defence Therapeutics Inc. ("Defence" or the "Company"), a biotechnology company working on ADC therapeutics for cancer targeting with its Accum^TM technology and cancer vaccine therapeutics and infectious disease vaccines, is pleased to announce the establishment of a high priority program to develop a novel HPV-targeting vaccine for cervical cancer with it's Accum^TM technology.
Currently there are more than 40 types of HPV strains capable of affecting the genital areas, mouth and throat of both males and females. This makes HPV one of the most common sexually transmitted disease worldwide. Just in the USA, 79 million Americans are currently infected with the virus, and 14 million will roughly become newly infected each year according to the center for disease control. Although most people with HPV never develop symptoms or health problems, HPV infections will persist resulting in life-threatening health issues such as genital warts, cervical, oropharyngeal, anal, vulvar, vaginal and penile cancer. "Even though current HPV vaccines produce high antibody titers, they do not protect against all types of HPV. Additional efforts are therefore required to develop more efficacious vaccines that can not only trigger a good antibody and cellular response but provide in addition an excellent memory response to ensure good long-term protection over at least 20 years post-vaccination" says Mr. Sebastien Plouffe, the CEO of Defence Therapeutics. "Defence's Accum^TM technology is highly versatile and can be applied to any protein for potential enhancement. Accum^ TM has shown from our past vaccine studies that the use of this platform can design novel protein-based vaccines that will amplify the immune response and can generate amplification in current vaccines," he added.
The global Human Papillomavirus (HPV) Vaccine market size was valued at USD 3.8 billion in 2019 and is projected to reach USD 12.69 billion by 2027, exhibiting a CAGR of 16.3% during the forecast period according to Fortune Business Insights.
Biopharma and medtech half-year review 2021
Evaluate Vantage’s latest half-year report, free to download now, examines the emerging trends shaping the biopharma and medtech sectors. Winners and losers on the stock market are identified; developers that brought pandemic treatments or vaccines to market are reaping the benefits, while in medtech those making devices used in orthopaedics or cardiovascular procedures are surging back. The financing climate remained strong in the first half, with some record-setting numbers emerging. Biotech flotations raised $9bn, while private start-ups raised $15bn in venture cash, according to Evaluate Pharma, the data source for this report. In medtech mergers are happening at a healthy pace: deals worth $31.5bn were closed in the first six months of 2021, outstripping the total for all of 2020. A quiet six months for M&A in biopharma, though, suggests that high valuations are hindering deal-making. But biopharma remains a highly active in-licensor of innovation, and for the first time this report contains insights from BioSciDB, acquired by Evaluate Ltd earlier this year. For a deeper dive into these insights and more download the report for free: Biopharma and medtech half year review 2021.
Biopharma and medtech half year report 2021.
Biopharma and medtech half year report 2021.
Download report: https://www.evaluate.com/node/17181/pdf
Pliant 'win' still leaves a lot to prove
Pliant Therapeutics claims to have gone some way towards validating its approach in idiopathic pulmonary fibrosis, but it still has a lot to prove. The group opened up 17% this morning on four patients’ worth of data from an ongoing PET imaging trial of its oral integrin inhibitor PLN-74809. The results so far exceeded Pliant’s target of at least 50% receptor occupancy, measured by lung PET imaging. But now the group has to show that this translates into a clinical benefit. A phase 2a trial is set to complete enrolment by year end; however, during a conference call today, Pliant’s chief executive officer, Bernard Coulie, played down the chance of the group seeing an improvement in forced vital capacity, given the study’s small size and short duration. Another reason to be cautious is the track record of integrin inhibitors in IPF, with both Biogen and Glaxosmithkline discontinuing projects in recent years, the former on a toxicity signal. Meanwhile, preclinical oral assets from Morphic, partnered with Abbvie, are still in play. Pliant is “looking forward” to full results from the 12-patient PET study, but Mr Coulie declined to say when these might come.
| Selected developments with integrin inhibitors in IPF | |||
|---|---|---|---|
| Project | Company | Description | Status |
| PLN-74809 | Pliant Therapeutics | Oral αvß6 & αvß1 integrin inhibitor | Interim data from ph2 PET trial reported; ph2a Integris-IPF ends Mar 2022 |
| MORF-720 | Morphic Therapeutic/ Abbvie | Oral αvß6 integrin inhibitor | Preclinical |
| MORF-627 | Morphic Therapeutic/ Abbvie | Oral αvß6 integrin inhibitor | Preclinical |
| BG00011 | Biogen | Subcutaneous αvß6 integrin inhibitor | Ph2 Spirit study stopped due to safety concerns, Sep 2019 |
| GSK3008348 | Glaxosmithkline | Inhaled αvß6 integrin inhibitor | Discontinued in ph1, Feb 2019 |
| Source: Evaluate Pharma & clinicaltrials.gov. | |||
% target engagement in interim analysis of phase 2 PET imaging trial of PLN-74809
Source: Company release
Roche Polivy to hit $2.4B as doctors expect 'significant switching' in lymphoma
Roche Pharmaceuticals CEO Bill Anderson recently pegged lymphoma drug Polivy’s potential expansion into newly diagnosed patients as a multibillion-dollar opportunity. Now, at least one analyst is backing up that estimate.
Polivy could hit $2.4 billion in peak sales, with $2.1 billion coming from its use in front-line diffuse large B-cell lymphoma (DLBCL), Jefferies analyst Peter Welford said in a Tuesday note to clients.
Welford’s estimate is up from a prior projection of $1.6 billion for the CD79b-directed antibody-drug conjugate. The increase comes after Roche touted a phase 3 win in front-line DLBCL that looks like it may change the standard of care after nearly two decades of stagnant innovation.
While Roche has yet to share detailed results from the phase 3 Polarix study, the company said a regimen of Polivy plus a Rituxan-containing R-CHP combo beat the longtime standard R-CHOP treatment at staving off cancer progression or death in previously untreated DLBCL.
Welford reached his new sales estimate after surveying 50 U.S. oncologists following the Polarix news. The survey results support “significant switching” to Polivy in the front-line use, in as many as 55% of patients, if the drug shows an over 25% reduction in the risk of disease progression or death and if it shows a higher cancer eradication rate than R-CHOP, Welford noted.
Even if Polivy only shows a modest but statistically significant advantage on the progression-free survival marker and a similar complete remission rate, doctors expect to reach for the Roche drug for 39% of front-line DLBCL patients, the analyst wrote.
Over the next five years, even with the possible entrance of new treatments, doctors generally expect to treat 36% of front-line patients with Polivy. Based on that finding, Welford figured Polivy can generate $1.2 billion in peak sales in front-line DLBCL from the U.S. alone.
Thanks to a 2019 FDA approval, Polivy is currently approved to treat relapsed or refractory DLBCL after at least two prior therapies. The drug currently gets some off-label use in the second-line setting.
Among patients who aren’t eligible to undergo stem cell transplant, Polivy is currently used in about 37% of second-line DLBCL patients, Jefferies’ survey suggests. Its use in third and later lines represents about 29% of the market, according to the analysts.
Five years from now, Polivy’s second- and third-line use could decrease to 20% and 17%, respectively. That’s why Welford only projected $300 million in peak sales for its r/r DLBCL indication.
While Polivy may lose share in the second-line-plus market over the long term, Roche has two CD20xCD3 bispecific antibodies, mosunetuzumab and glofitamab, in the pipeline, Welford noted. Given mosunetuzumab’s better safety profile, Welford argued Roche may target the community setting with the drug and leave the more aggressive glofitamab to specialist hospitals.
Overall, Welford put down $2 billion in peak sales for each of the two bispecifics with a 60% chance of success.
After Moderna contamination, Takeda in deal with Japan to supply Novavax COVID vax
As Moderna faces questions about contaminants found in its COVID-19 vaccines in Japan, the company’s distribution partner in the country, Takeda, is moving forward on its plans with another COVID vaccine developer.
On Monday, Takeda said the Japanese government has agreed to purchase 150 million doses of the Novavax shot that it will produce. Takeda and Novavax previously struck a licensing and production deal covering the country.
The Novavax shot remains in development, and the partners aim to start the rollout in Japan early next year. The government's purchasing agreement is subject to regulatory approvals.
While Takeda and Novavax struck their COVID vaccine partnership more than a year ago, the latest announcement helps to clarify timelines and plans.
Under the agreement, Novavax is transferring technologies to allow Takeda to manufacture the vaccine antigen. The partners will combine the antigen with an adjuvant, Matrix-M, provided by Novavax, in the fill/finish stage of production.
In the original pact, the companies said they hoped to have the capacity to produce 250 million doses per year. Takeda is handling clinical trials, regulatory submissions and distribution in Japan.
The news comes as Takeda is embroiled in controversy as the country’s distribution partner of the Moderna vaccine. Over the past two weeks, contaminants have been discovered in Moderna vaccine vials in Japan, forcing the suspension of batches of the shot.
Last week, Moderna identified the foreign material as stainless steel, which likely entered through friction from two pieces of machinery incorrectly installed on a production line. Moderna traced the problem to Rovi Laboratories, the Spanish manufacturer which does fill/finish work for the vaccine.
Other contaminants, such as rubber stopper material, also have been discovered recently in Moderna vials in Japan. This material also could have entered during manufacturing, Takeda said.
Two Japanese men, aged 38 and 30, died after receiving their second Moderna doses from a lot later discovered to be contaminated. Health officials in Japan and the U.S. don’t believe that the contaminants found in the vials could have caused the fatalities. There have been no other reports in Japan of unusual side effects among others who have received the Moderna vaccine from the lots in question.
By taking control of a large portion of the manufacturing of Novovax’s COVID-19 vaccine, Takeda could build confidence in the shot in Japan, giving it a better chance for widespread adoption.
Novavax had hoped to secure FDA approval for its shot this summer. But manufacturing and supply issues have pushed its target for regulatory submission from May to the fourth quarter of this year. Last month, Novavax hired industry veterans Nasir Egal, from Sanofi, and Jim Kelly, from Supernus, to help push the shot to the finish line. Egal is the new head of quality control while Kelly has taken over as CFO.
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