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Message: Morphic Holding

Below is Chrispi's post that I removed from the main forum.....it belongs off-topic.

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Well whenever we or our partners (with our xB3) get into the clinic, look at what can happen for just reporting good phase 1 results (which should be very easy to do for nearly all biotechs).

Note: I have no idea how to insert images in Agoracom posts so I just included links. 

Nothing like adding about $1.5 Billion USD in market cap in one day for announcing:

·        Good phase 1 clinical trial results for IBD in 5 cohorts

·        getting $20m fee from a partner

·        an expanded research and development collaboration with Janssen through a third integrin program (no further details provided)

 

Note:

·        they ended the year 2020 with $228.3 million USD in cash and equivalents and marketable securities, providing runway into 2023

·        their pipeline is at the end of this post:

o   They have 5 pgms they are doing themselves with only one 1 clinical (phase 1).

o   They have 3 pgms that are partnered and all are pre-clinical.

Full details here https://finance.yahoo.com/news/morphic-announces-corporate-highlights-financial-115500688.html

 

 

https://finance.yahoo.com/quote/MORF?p=MORF&.tsrc=fin-srch 

Why Morphic Holding Stock Is Skyrocketing Today

A series of positive news is helping the biopharmaceutical company start the week on a strong note.

Mar 1, 2021 at 1:33PM

What happened?

Shares of Morphic Holding (NASDAQ:MORF) are soaring through the roof on Monday, following the company's release of its fourth-quarter and full-year 2020 earnings report. More important than its financial results, the biopharmaceutical company announced results from a clinical trial and other developments regarding collaboration agreements with big-name drugmakers. As of 12:50 p.m. EST, Morphic Holding's stock was up by 130.8%.

So what

Morphic Holding reported interim data from a phase 1 clinical trial for MORF-057, a potential medicine for inflammatory bowel disease (IBD). The trial was to test the safety, pharmacokinetics (the way the body processes the treatment), and pharmacodynamic (the way the drug affects the body) of MORF-057 in healthy participants. During the study, the drug was generally well tolerated with no recorded serious adverse events.

It also showed a "proportional and predictable pharmacokinetic profile" during the trial, according to Morphic Holding. Meanwhile, the company's long-standing partnership with pharma giant AbbVie is moving forward. Under the collaboration agreement between these two entities, which started more than two years ago, AbbVie initially paid $100 million up front to Morphic to acquire exclusive license options for some of Morphic's candidates. 

 

Morphic Holding would be responsible for conducting research and development for these products up to the completion of investigational new drug enabling studies. AbbVie would then be able to exercise its license option for a fee to take up the development of these programs. Today, Morphic Holding announced that AbbVie paid a $20 million fee to assume the responsibility to develop and commercialize a couple of Morphic's pipeline candidates.

Lastly, Morphic has a partnership with Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), which focuses on developing integrin therapeutics for conditions for which there are few adequate therapy options. Morphic announced that it has expanded this partnership with the pharma company.

Now what

For a drugmaker with no products on the market, lucrative deals with well-established pharmaceutical companies are important. Morphic Holding will be able to use the funds it received from AbbVie to fund the clinical development of some of its other candidates, while its partnership with Janssen could bear fruit in the form of promising clinical compounds. These factors explain why investors are bidding up shares of Morphic Holding today. 

 

Morphic Reports Positive Interim Results from Single Ascending Dose Phase 1 Clinical Trial of MORF-057

 

Morphic Therapeutic

Mon, March 1, 2021, 7:00 AM

 

MORF-057 well tolerated in all dose cohorts

MORF-057 achieved greater than 95% mean receptor occupancy of α4β7 integrin at three highest dose levels; demonstrates ability to saturate α4β7 receptor

Data provide early clinical proof of concept for MORF-057 as an oral, selective α4β7 inhibitor

Phase 1 multiple ascending dose and food effect trials ongoing

WALTHAM, Mass., March 01, 2021 (GLOBE NEWSWIRE) -- Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced positive interim results from its Phase 1 clinical trial of MORF-057, an oral small molecule inhibitor of the α4β7 integrin in development for the treatment of inflammatory bowel disease (IBD). α4β7 inhibition for the treatment of IBD is a clinically validated biologic mechanism but with no currently available oral treatment options. This single ascending dose (SAD) clinical trial was designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MORF-057 in healthy volunteers.

“MORF-057 was designed to be a potent and selective oral inhibitor of the integrin α4β7 and these data exceeded our expectations for the Phase 1 SAD trial of MORF-057. Importantly, the robust receptor occupancy data provide early clinical proof-of-concept for MORF-057 as a potential oral treatment option for those suffering from IBD,” commented Peter Linde, M.D., chief medical officer of Morphic Therapeutic. “We’re excited to present the totality of the Phase 1 trial data later this year and to leverage this emerging data set to inform the optimal study design for Phase 2 trials in ulcerative colitis and beyond.”

In the Phase 1 SAD trial, MORF-057 was well tolerated in all 5 cohorts receiving MORF-057 in single doses ranging from 25 mg to 400 mg with no serious adverse events (SAEs) and no significant lab abnormalities in any subject. In the study, MORF-057 exhibited a generally dose proportional and predictable pharmacokinetic profile. The key pharmacodynamic measurement in the trial was receptor occupancy (RO), which indicated the percentage of α4β7 bound by MORF-057 12 hours after the dose. MORF-057 achieved greater than 95% mean α4β7 RO across the three highest dose cohorts, including the observation of >99% RO in subjects in each cohort above 25mg. These single dose data demonstrate the potential that MORF-057 will be able to maintain saturating levels of receptor occupancy following twice daily oral administration. MORF-057 was specifically designed to be highly selective for α4β7 and not α4β1, a related integrin. Notably, we did not observe quantifiable levels of α4β1 RO in the study.

MORF-057 SAD Phase 1 Safety and Receptor Occupancy Data

 

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

MORF-057 Dose

25 mg

50 mg

100 mg

150 mg

400 mg

Safety Measures

Well tolerated

Well tolerated

Well tolerated

Well tolerated

Well tolerated

Mean α4β7 RO
12 hours Post-dose

>70%

>85%

>95%

>95%

>95%

“Morphic’s mission is to create new oral therapies to treat serious chronic diseases by modulating integrins, through our unique understanding of this critical, bi-directional receptor. To achieve this goal, Morphic built a talented team and invested heavily in the MInT Platform to mine the integrin family for new therapeutic opportunities and these data represent the first clinical realization of that ambitious founding strategy,” said Bruce Rogers, Ph.D., chief scientific officer of Morphic. “These results for MORF-057 further validate the MInT Platform’s ability to design small molecules that potently and selectively target this class of receptors with tremendous therapeutic potential.”

About the MORF-057 Phase 1 Trials

The clinical trial is currently enrolling two additional groups in the MORF-057 Phase 1 program: a multiple ascending doses (MAD) study evaluating three dose cohorts of MORF-057 as well as a concurrent food-effect study in both fed and fasting states. Morphic expects to present the full data set from the MORF-057 Phase 1 clinical trial at an appropriate medical meeting in mid-2021 after completion of the MAD and food effect portions of MORF-057’s clinical program.

About MORF-057

Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin for patients with inflammatory bowel disease (IBD). α4β7 has been clinically validated as a target for the treatment of IBD by the success of the approved injectable antibody therapeutic vedolizumab. MORF-057 is designed to block the interactions between α4β7 on the surface of lymphocytes and the mucosal endothelial cell ligand MAdCAM-1, substantially reducing lymphocyte migration from the bloodstream into intestinal mucosal tissues and causing inflammation that is associated with IBD.

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular, and metabolic diseases, fibrosis, and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary Morphic Integrin Technology (MInT) Platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

 

https://morphictx.com/pipeline/ 

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