I-Mab hits the deal table with biopharma majors to talk partnerships and investments

 I-Mab has had a big 12 months, landing an $180 million upfront from AbbVie and delivering a series of readouts from clinical trials. Now, the Chinese biotech is reportedly seeking to build on its progress by talking to global biopharma companies about partnerships and investments.

Bloomberg broke news of the “early talks” with global biopharma companies in an article based on anonymous sources. I-Mab is reportedly conducting a strategic review that could lead to cooperation on clinical development in China or the sale of an equity stake. Unnamed large U.S. and European drugmakers are on the other side of the deal table. 

The article, which says I-Mab is also talking to potential financial advisers, follows a report in June that the biotech is seeking a partner for its anti-CD73 antibody uliledlimab. Work on an uliledlimab deal is continuing, with the goal being to replicate the success of the 2020 agreement with AbbVie.

AbbVie paid $180 million and committed to almost 10 times as much in milestones for the rights to anti-CD47 antibody lemzoparlimab outside of greater China, moving it into a space that has caught the attention of peers including Gilead Sciences and Pfizer.  

Big biopharma companies have also shown an interest in CD73, the target of the drug I-Mab is now seeking to partner. AstraZeneca and Bristol Myers Squibb have taken anti-CD73 prospects into the clinic in recent years, attracted by evidence of the role the enzyme plays in the production of an immunosuppressive molecule in the tumor microenvironment. 

I-Mab, which posted early clinical data on uliledlimab in May, sees its candidate as a differentiated molecule that can overcome resistance to drugs such as checkpoint inhibitors. The biotech is testing uliledlimab in combination with Roche’s PD-1 drug Tecentriq.

Uliledlimab is part of I-Mab’s global portfolio. I-Mab’s goal with the global portfolio is to quickly take assets to clinical proof of concept and then out-license them. The strategy is the mirror image of I-Mab’s approach in China, where it is seeking to in-license assets that have reached clinical proof of concept and bring them to market. 

https://www.fiercebiotech.com/biotech/i-mab-hits-deal-table-biopharma-majors-to-talk-partnerships-and-investments-report

Amicus spins off gene therapy unit in $600M SPAC deal as CEO becomes chief at Caritas

 Amicus has endured a tough few years of pipeline flops and a roller coaster stock ride, but now it’s riding the special purpose acquisition company wave, spinning off its gene therapy unit in a $600 million deal.

The pact sees Amicus’ gene therapy business bought out by ARYA Sciences Acquisition Corp IV, a SPAC sponsored by Perceptive Advisors. Caritas gets around $400 million in funding to start with, while Amicus adds about $200 million in private funding from “leading biotechnology investors.”

While being spun out, it still remains on a string for Amicus: The biotech will become the largest shareholder in Caritas with around a 36% stake as current John Crowley will lead Caritas as chairman and CEO. In his place, Amicus’ president and chief operating officer Bradley Campbell climbs up the ladder to chief of the biotech.

Caritas, from the Latin word for compassion, will focus on gene therapies, with much of the earlier pipeline from its 2018 $100 million buyout of Celenex. The pipeline is led by two Batten disease programs with clinical proof of concept in CLN6 and CLN3, which it snapped up in that deal three years ago.

It also has six active preclinical programs tackling targets including Fabry disease, Pompe disease and CDKL5 deficiency disorder. Through a collab with Jim Wilson, M.D., Ph.D., and a University of Pennsylvania team, it will also help work on broad range of early rare diseases including Angelman syndrome, Duchenne muscular dystrophy, Rett syndrome, myotonic dystrophy and select other muscular dystrophies. Wilson also becomes a senior scientific and strategic adviser to Caritas.

"This transaction will transform Amicus into a premier rare disease global commercialization and late stage product development company that we believe will benefit all of our stakeholders," said Campbell.

"The separation strengthens the financial profile of Amicus and accelerates our path to profitability, while preserving significant equity ownership in the gene therapy pipeline and commercial rights to the innovative and important Fabry and Pompe gene therapy programs.

“We will be laser focused on maintaining the growth of Galafold and executing on the anticipated global launch of AT-GAA, as we build Amicus into a leading global rare disease biotechnology company and bring our medicines to as many patients as quickly as possible."

This comes after a series of setbacks from the pipeline. Back in February, a phase 3 clinical trial of Amicus’ late-onset Pompe disease prospect missed its primary endpoint.

Yet Amicus looked past the failure of AT-GAA to improve statistically on Sanofi’s market incumbent Lumizyme, zeroing in on details of the data to justify forging ahead with plans to seek approval of the candidate.

And, back in 2017, a drug for rare skin disease epidermolysis bullosa that Amicus spent $847 million on ago failed a key phase 3 trial, throwing a lot of money down the drain.

Things are, however, looking up in Pompe disease: Alongside the SPAC deal, Amicus also announced it has been given FDA standard reviews for its Pompe hopefuls. The biologics license application for cipaglucosidase alfa and the new drug application for the already approved Galafold (miglustat) for AT-GAA, the company’s investigational two-component therapy for the treatment of Pompe disease, have both been handed reviews, with the BLA set for an end of July decision and the NDA for end of May next year.

https://www.fiercebiotech.com/biotech/amicus-spins-off-gene-therapy-unit-600m-spac-deal-as-ceo-moves-over-to-caritas-therapeutics

CytoDyn Comments on Rosenbaum/Patterson Activist Group 'Plan'

 Company Is Successfully Executing on Multi-Faceted Strategy to Bring Leronlimab to Market

Activist Group Offers No New Compelling Strategic Direction and its "Plan" Includes Numerous Misrepresentations and Misleading Statements

Activist Group’s Continued Attempts to Link CytoDyn to IncellDx Are Troubling, Given Connections Between IncellDx and Group’s Nominees

Shareholders Do Not Need to Take Any Action at this Time

CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today responded to the "plan" put forward by an activist group led by Paul Rosenbaum and Bruce Patterson (the "Rosenbaum/Patterson Group" or the "Activist Group"):

CytoDyn is highly focused on the expeditious development of leronlimab to help patients with critical needs. Clinical development of any product is a multi-year endeavor. Within this context, the Company has acted as quickly as possible – bringing leronlimab from the Phase 2b stage to successfully completing a pivotal Phase 3 (p=0.0032) in seven years, which was significantly faster than leronlimab’s progress with its prior owner. CytoDyn is exploring several different indications for leronlimab. These include COVID-19 critical and severe hospitalized patients as well as long-haulers, HIV and 22 different cancer types. The Company strongly believes in the drug’s potential – especially given that it is variant agnostic when it comes to treating COVID-19.

The Activist Group’s missive is not a "plan"; it appears to be a misguided and misleading attempt to discredit the significant efforts of CytoDyn to bring leronlimab’s lifesaving potential to market to help patients and drive value for shareholders. The success of these efforts is clearly demonstrated by the increasingly long list of positive developments that CytoDyn has announced recently, including the clearance from Brazil’s regulatory authority, ANVISA (Agência Nacional de Vigilância Sanitária), to begin an additional Phase 3 CD16 clinical trial of leronlimab with IV treatment, which the Company believes will have an enormous advantage over treatment via subcutaneous (SQ) injections. CytoDyn will continue to work tirelessly towards approvals for leronlimab and are laser focused on doing what is best for all shareholders.

https://finance.yahoo.com/news/cytodyn-comments-rosenbaum-patterson-activist-120000271.html

Lilly upped to Buy from Neutral by Citi

 Target to $265 from $210

https://finviz.com/quote.ashx?t=lly&ty=c&ta=1&p=d

GeoVax Higher On Gedeptin In-Licensing Pact For Solid Tumors

 

• GeoVax Labs Inc (NASDAQ: GOVX) entered into a license agreement with PNP Therapeutics Inc to develop and commercialize Gedeptin for solid tumors.

• The transaction's detailed financial terms were not disclosed but include a combination of upfront payments, milestone fees, and royalties on net sales.

• A cycle of therapy consists of three intra-tumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days.

• A Phase 1 dose-ranging study, evaluating the safety of a single cycle of Gedeptin therapy, found the treatment to be well-tolerated, with evidence of a reduction in tumor size in patients with solid tumors.

• A Phase 1/2 trial, evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options, is currently enrolling.

https://finance.yahoo.com/news/geovax-stock-trading-higher-gedeptin-112225718.html

Why Shares of Editas Medicine Are Lower

 Shares of gene-editing company Editas Medicine (NASDAQ:EDIT) are down today after the company shared the first clinical data for its CRISPR-based treatment EDIT-101.

Unlike many other companies using CRISPR to try to cure a genetic disease, Editas chose an inherited form of rapid vision loss as its target. The defect impacts the retina's ability to sense light and is estimated to affect a few thousand people in the U.S. and Europe. Most of those people are effectively blind in infancy or early childhood.

EDIT-101 is also an in vivo -- or inside the body -- treatment. While some gene-editing therapies for blood disorders require a transfusion, in vivo treatments can be injected directly into patients where they find and edit the target genes.

The company shared data from the first six patients who received the sub-retinal injections. Three doses of the therapy were tested. Although none showed serious side effects, the cohorts had mixed results with respect to efficacy.

Two patients with the lowest dose did not show meaningful improvement in a test of functional sight. The middle-dose cohort contained one patient who had improvements sustained six months after treatment. There was another patient who had some indicators of improvement but not sight. 

The results might not have been the overwhelming success that investors got from the in vivo treatment by Intellia Therapeutics and Regeneron in June, but there is progress and more data on the horizon.

In the middle-dose cohort, the patients who did not experience as much improvement were treated more recently. They could see better results over time. Enrollment is ongoing for a high-dose and a pediatric group.

After two years of waiting -- much of it because of disruptions related to the pandemic -- chief medical officer Lisa Michaels was refreshingly transparent in her reason why the company presented data that was somewhat incomplete. She said, "At the end of the day, I'll be honest with you, it was a calculus of: 'this trial has been going on for so long and we haven't been communicating,' I thought it was important to come out with data." At least for today, shareholders might disagree.

https://www.fool.com/investing/2021/09/29/why-shares-of-editas-medicine-are-lower-this-morni/

Evolent Health stock jumps after report of possible Walgreens takeover

 Evolent Health’s stock jumped as much as 18% in afternoon trading Wednesday after Bloomberg reported that Walgreens Boots Alliance was considering buying the health-care IT services company.

In trading, Evolent shares hit a 52-week high of $31.88, but the stock closed at $28.94, up more than 7%. Shares of Walgreens finished the day up more than 1%.

Evolent Health was founded in 2011 and went public just four years later, but it has been under pressure from activist investor Engaged Capital to sell the firm. The company’s shares have risen 80% this year, bringing its market value to $2.53 billion.

For Walgreens, the potential takeover could give the pharmacy chain an edge over the competition in the drugstore space as its retail business sees more sales of basic items like shampoo and makeup shift online. Rival CVS bought insurance provider Aetna in 2018 and has since leaned more into providing health-care services.

Earlier this year, former Starbucks executive Roz Brewer took the reins at Walgreens. On Sept. 21, the company announced it would invest nearly $1 billion in specialty pharmacy company Shields Health Solutions.

https://www.cnbc.com/2021/09/29/evolent-health-stock-jumps-after-report-of-possible-walgreens-takeover.html