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biosectinvestor Profile picture
@biosectinvestor
Mar 19, 2022 • 14 tweets • 4 min read • Read on X
Let's explore a new accelerated pathway to licensing for new drugs in the UK #MHRA #ILAP
The MHRA Innovative Licensing and Access Pathway is open for business

The Medicines and Healthcare products Regulatory Agency (MHRA) today, 1 January 2021, formally starts the Innovative Licensing and Access Pathway (ILAP). #MHRA #ILAP

gov.uk/government/new…
Innovative Licensing and Access Pathway (ILAP)

"A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access." #MHRA #ILAP

gov.uk/guidance/innov…
Geron Enters New Innovative Licensing and Access Pathway in the United Kingdom for Imetelstat #MHRA #ILAP $GERN [I am not an investor in $GERN]

finance.yahoo.com/news/geron-ent…
"The objective of this new licensing and access pathway is to reduce the time to market for innovative medicines.
Key benefits of being within ILAP include a 150-day accelerated assessment and rolling review of a Marketing Authorization Application (MAA), as well as opportunities for frequent interactions with the review staff at the MHRA and its partner agencies, including the National…
…Institute for Health and Care Excellence (NICE), to discuss imetelstat’s development, regulatory plans and reimbursement plans."
Further: "The Innovation Passport is awarded by the UK’s Innovation Licensing and Access Pathway Steering Group, which consists of representatives from MHRA, NICE, the Scottish Medicines Consortium (SMC) and the National Health Service (NHS) England.
To enter ILAP and receive an Innovation Passport, an experimental drug needs to meet the following public health and/or patient-centric criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program fulfills at least one of the following: innovative…
…medicine, clinically significant new indication or, it is intended for a special population; and (3) the medicine has the potential to offer benefits to patients.
The ILAP aims to accelerate the time to market and facilitate patient access to medicines through the development of a target development profile (TDP) that outlines a unique product-specific roadmap for regulatory and development milestones.
Other benefits provided by ILAP include the potential for a 150-day accelerated assessment of a Marketing Authorization Application (MAA) and rolling review.
The ILAP also provides opportunities for frequent interactions with the review staff at the MHRA and its partner agencies to discuss the drug’s development and regulatory plans, as well as reimbursement."

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More from @biosectinvestor

biosectinvestor Profile picture
Jun 23, 2023
I think one way to think of $NWBO's vaccine as DCVax being a platform, #DCVaxL and #DCVaxDirect are descriptions of instantiations of DCVax. the patient's dendritic cells, One w/a lysate, in vitro, the other in vivo to the inoperable or metastatic tumors, by direct application.
If #DCVaxL is approved, & #DCVaxDirect is a less complex expanded patient dendritic cell infusion of the same sort, processed but substantially not genetically or otherwise modified, one has to wonder how much complexity should be involved in its ultimate "approval"?
If $NWBO had funding to do a follow-on trial from their Phase 1, for very late stage patients who have exhausted their options, this time allowing for broader application of #DCVaxDirect, AND, if they show survival benefit & various biomarkers as they've identified previously,
Read 12 tweets
biosectinvestor Profile picture
Dec 21, 2022
$NWBO #DCVaxL

Interesting given some additional information in attached documents to that page, which I will include below this as a thread.

UK NICE updated status:

"DecisionAwaiting decision"

nice.org.uk/guidance/topic…
"Timing Issues...
Given the current absence of phase III trials for DCVaxL but the pending results of a phase III RCT trial, this NICE single technology appraisal would be better completed following publication of that study."
..."Comment noted. NICE aims to publish guidance on cancer drugs within 90 days of marketing authorisation. Any requirements for potential delays will be taken into account as appropriate."

nice.org.uk/guidance/gid-t…
Read 13 tweets
biosectinvestor Profile picture
Nov 25, 2022
Exploring Adjuvants with #DCVaxL: POLY ICLC TLR 3 Agonist adjuvant discussion, #DrLindaLiau, early trial P 1. Using adjuvants w/ #DCVaxL $NWBO #Murcidencel #DCVax

Survival Data w/Adjuvants, small early trial:
Fuller Discussion re early trial with #DCVaxL + adjuvants, including Poly ICLC:
Re single agent checkpoint inhibitors, without DCVaxL, in Glioblastoma:
Read 13 tweets
biosectinvestor Profile picture
Aug 12, 2022
Al Musella, President, Musella Foundation for Brain Tumor Research & Information, Inc., a 501(c)3 nonprofit, re #DCVaxL : “ The results are outstanding.
Over 200% increase in the 5 year survival rate for newly diagnosed Glioblastomas as well as in the 30 month survival for recurrent Glioblastoma. There has been some unfair criticism of the trial on the internet -but watch the video and get the details directly from the source!
The same criticism happened after every major trial for brain tumors this century.
Read 6 tweets
biosectinvestor Profile picture
Jun 22, 2022
Dendritic Cell Vaccine for Patients With Brain Tumors - Full Text View - ClinicalTrials.gov

#AdjuvantStimulus #PolyICLC

Ongoing #DCVaxL trial with Adjuvant stimulus, will likely further improve outcomes with #DCVaxL $NWBO clinicaltrials.gov/ct2/show/NCT01…
A trial with a combination #DCvaxL #PolyICLC and #Keytruda is already in process at UCLA. This is some of the early research on that combination $NWBO $MRK
Read 7 tweets
biosectinvestor Profile picture
Jun 21, 2022
Some quick thoughts on $NWBO and #DCVaxL. DCVaxL is designated an #OrphanDrug, for an #OrphanDisease, #Glioblastoma. This provides a bunch of benefits which are off topic for this thread.
My main point is to suggest that patients needing #DCVaxL may likely qualify for either of two funds in the UK, the #InnovativeMedicinesFund or the #CancerDrugsFund, which together have £640M allocated to provide early coverage to patients in the UK's NHS.
The UK charity, BrainTumorResearch.org recently put out a PR about the new program in the UK for rare diseases, which is modeled on an already existing program called the #CancerDrugsFund.
Read 32 tweets

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