Bicycle Therapeutics to Present Interim BT8009 Phase I Results at 2022 AACR

 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that interim Phase I results from the Phase I/II trial of BT8009, a second-generation BTC™ targeting Nectin-4, will be presented at the 2022 American Association for Cancer Research Annual Meeting, being held April 8-13, 2022 in New Orleans, LA. The Company will host a conference call to discuss the data from the presentation on Monday, April 11, 2022 at 8:30 a.m. ET.

Oral Presentation Details

Title: BT8009-100 Phase I/II Study of Novel Bi-Cyclic Peptide and MMAE Conjugate BT8009 in Patients with Advanced Malignancies Associated with Nectin-4 Expression

https://finance.yahoo.com/news/bicycle-therapeutics-present-interim-bt8009-170000238.html

Buyout Firms GTCR, CD&R Circle Merit Medical

  GTCR LLC and Clayton, Dubilier & Rice (CD&R) are among private equity firms that have expressed interest in acquiring U.S. medical device manufacturer Merit Medical Systems Inc, according to people familiar with the matter.

GTCR has informed Merit Medical it would be willing to pay $72 to $75 per share, one of the sources said. Merit Medical shares were trading at around $61 before Reuters reported on March 9 that the company was exploring a sale.

Other private equity firms could also express interest in Merit Medical and there is no certainty that any deal will be reached, the sources said. Should there be a deal, it could come as early as May, the sources added, asking not to be identified because the matter is confidential.

Spokespeople for GTCR and CD&R declined to comment. A Merit Medical spokesperson did not immediately respond to requests for comment.

Merit Medical manufactures and sells devices and instruments used in cardiology, radiology, oncology, critical care and endoscopy.

The South Jordan, Utah-based company previously attracted the interest of activist hedge fund Starboard Value LP, which clinched an agreement in 2020 to shake up Merit's board of directors.

Both GTCR and CD&R are prolific investors in health and medical device businesses and have been seeking to capitalize on a wave of consolidation sweeping the industry.

One of GTCR's portfolio companies, vaccine reagent provider Maravai LifeSciences Holdings Inc, turned down an $11 billion acquisition offer from laboratory supplies vendor Sartorius AG in February, sources told Reuters at the time. It remains possible that the companies will negotiate a deal.

https://money.usnews.com/investing/news/articles/2022-04-08/exclusive-buyout-firms-gtcr-cd-r-circle-merit-medical-sources

COVID-19 cases rise rapidly in New York City, DC

 Coronavirus cases are rapidly rising in New York City and Washington, D.C. amid the spread of the dominant omicron subvariant, BA. 2.

The New York Times’ coronavirus tracker for New York City showed that cases had risen over 50 percent in the last two weeks while the newspaper’s tracker for D.C. showed cases had doubled. 

Still, cases in both cities are relatively low to where they were just earlier this year in January. 

The number of new infections on Wednesday for D.C. was over 700 compared to compared roughly 9,200 reported in early January, according to the Times’ tracker. The number of new infections on Wednesday for New York City was roughly 800 cases compared to close to about 40,000 near mid-January.

In New York City, hospitalizations and deaths related to COVID-19 have both declined over the last 14 days—17 percent and 53 percent respectively, according to the Times’ tracker. In D.C., while COVID-19 deaths have risen five percent in the last two weeks, hospitalizations have declined 39 percent.

The uptick in cases is in part due to the contagious BA.2, according to the newspaper. The data suggests that the current phase of the pandemic in both cities is seeing a more contagious variant but one that may not be as severe.

The development comes as states weeks ago became lifting indoor mask mandates and other COVID-19 protocols in response to lowered case numbers and other indicators. 

Cases have generally flatlined in the United States, though some states like New York, Alaska and Colorado are noticing increases in caseloads, according to the newspaper. The pandemic has already surpassed two years.

https://thehill.com/policy/healthcare/3262687-covid-19-cases-rise-rapidly-in-new-york-city-dc/

C4 falls after Phase 1/2 myeloma trial data

 – Single Agent CFT7455 Induces Deep and Durable Degradation of IKZF1/3 and Meaningful Decreases in Serum Free Light Chain at Doses Lower than Expected Based on Pre-clinical Studies –

– CFT7455 Exhibits Differentiated Pharmacokinetics (PK) and Potency Relative to Approved and Investigational IKZF1/3 Degraders –

– On-Target Dose Limiting Toxicity Observed; Modeling Suggests Differentiated Activity and PK Profile Provides Pathway to Increase Therapeutic Index with Alternative Dosing Schedule –

– Company to Host Conference Call and Webcast Today at 2 pm ET –

Investor Webcast Information
C4T will host an investor webcast today, Friday, April 8, 2022, at 2 PM ET, with Sagar Lonial, M.D., FACP to discuss the CFT7455 clinical data being presented at AACR. To access the call, please dial 866-374-5140 or 404-400-0571 and provide the conference ID: 66856580. The webcast can be also accessed under “Events & Presentations” in the Investors section of the company’s website at www.c4therapeutics.com. A replay of the webcast will be available on C4T’s website for 30 days following the event.

https://finance.yahoo.com/news/c4-therapeutics-presents-clinical-data-170000407.html

Viz AI passes the $1bn valuation mark

 Companies working on diagnostic systems using artificial intelligence and machine learning are having a bit of a moment, with the FDA recently clearing products intended to detect colon polyps and triage aneurysms. It is appropriate, then, that medtech’s newest unicorn is an AI company. The $100m series D round closed by Viz AI yesterday, from investors including Google’s venture arm GV, gives the group a valuation of $1.2bn. Viz AI has already launched products designed to help detect and triage stroke, aortic disease, pulmonary embolism and cerebral aneurysms, and US clearance is pending for a system looking at subdural haematoma. The new cash will go partly towards expanding into yet more disorders. The company is itself expanding too, having nearly doubled in size over the past year in terms of headcount, and it plans to hire a further 200 employees in the coming year. It has stayed quiet on what the future might hold beyond that; it extended its partnership with Medtronic last year, but neither a trade sale nor an IPO appear to be on the horizon. 

Viz AI's VC funding
Date	Round	Investment ($m)	Investors
Apr 7, 2022	Series D	100.0	Tiger Global; Insight Partners; Scale Ventures; Kleiner Perkins; Threshold; GV; Sozo Ventures; CRV; Susa
Mar 17, 2021	Series C	71.0	CRV; Greenoaks Capital; Innovation Endeavors; Insight Partners; Kleiner Perkins; Scale Venture Partners; Susa Ventures; Threshold Ventures
Oct 23, 2019	Series B	50.0	CRV; Greenoaks Capital; GV; Kleiner Perkins; Threshold Ventures
May 24, 2018	Series A	21.0	GV; Kleiner Perkins
May 24, 2017	Seed capital	7.5	Ame Cloud Ventures; DHVC (Danhua Capital); Innovation Endeavors
Source: Evaluate Medtech & company release.

Deals

https://www.evaluate.com/vantage/articles/news/deals-snippets/viz-ai-passes-1bn-valuation-mark

It’s official: expect near-zero Aduhelm sales for the foreseeable future

 Any glimmer of hope Biogen might have had to reverse the fortunes of Aduhelm, at least in the near term, has been extinguished. The US Centers for Medicare & Medicaid Services (CMS) yesterday upheld the tough proposed restrictions on reimbursing the controversial Alzheimer’s drug that it had laid out in January.

As Vantage Analysis had argued at the time, the CMS’s draft national coverage determination was so severe that the agency had left itself very little room to loosen its proposed stance. The bigger question now is what US reimbursement could look like for gantenerumab, lecanemab and the like, as the final document makes it clear that it will apply to these too.

The final determination remains, as in the draft, coverage with evidence development; it applies to all MAbs targeting amyloid-beta for treating Alzheimer’s, meaning not only those with accelerated approval, like Aduhelm, but also any that receive a traditional full green light from the FDA.

In the near term this will affect Biogen/Eisai’s lecanemab, Roche’s gantenerumab and Lilly’s donanemab, each of which is in a phase 3 study designed to demonstrate a benefit on a cognition endpoint. The first two read out in the second half of this year, while the last is expected to yield data in mid-2023.

For Aduhelm itself Biogen expects to begin patient screening next month for a confirmatory trial, Envision. Donanemab is additionally expected to yield data this year from a biomarker study comparing it against Aduhelm, but this will at best provide a means of handicapping its chances rather than backing approval per se.

Any positives?

For Biogen the only positive takeaway is that the CMS, in its requirement that Medicare cover Aduhelm only when given as part of approved clinical trials, relaxed its stance and said these could be carried out beyond the hospital-based outpatient setting stipulated in the draft. In reality this probably makes little difference.

The harshness of the wording confirms the CMS’s coverage determination as a slap on the FDA’s wrists for approving Aduhelm on the basis of flimsy data. The Baird analyst Brian Skorney, long a critic of Aduhelm, tweeted: “Right decision by the wrong agency.”

Notably, the CMS states that its coverage determination relates also to amyloid-beta drugs that secure full approval backed by a cognition benefit. These will similarly be subject to the restrictive “coverage with evidence development” requirement.

One concession versus drugs under accelerated approved is that coverage will not be restricted to the clinical trial setting, but would also encompass a patient registry. “Registry data may be used to assess whether outcomes seen in carefully controlled clinical trials are reproduced in the real world and in a broader range of patients,” the CMS says.

In a statement Biogen bemoaned an “unprecedented CMS decision” that it said could “limit coverage for any future approved treatment in the class. These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas.”

Stifel analysts said the proposed restrictions for fully approved drugs represented a literal reading of the guidance. Instead, they suggested that the CMS was just creating a “bar” for hard clinical outcomes, writing: “We still think if an amyloid drug clearly succeeds CMS would not be in a realistic position to deny coverage.”

Either way, those follow-on drugs still have something to play for. The same cannot be said for Aduhelm, which sold a grand total of $3m in the more than six months that followed its US approval last June.

Evaluate Pharma data suggest that sellside consensus taken before the CMS’s draft decision saw Aduhelm revenues breaching $4bn in 2026. The actual figure now looks set to be rather closer to 2021’s full-year number.

https://www.evaluate.com/vantage/articles/news/policy-and-regulation/its-official-expect-near-zero-aduhelm-sales-foreseeable

KALEIDO BIOSCIENCES, INC. : Notice of Delisting

 On April 8, 2021, Kaleido Biosciences, Inc. (the "Company") delivered formal notice to The Nasdaq Stock Market, Inc. that the Company intends to voluntarily delist its common stock, par value $0.001 per share (the "Common Stock"), from the Nasdaq Global Select Stock Market ("Nasdaq") in connection with the Company's cessation of all operations as described in Item 8.01 below.

The Company expects to file a Form 25 with the Securities and Exchange Commission (the "SEC") on or about April 18, 2022 to effect the voluntary delisting of the Common Stock under Section 12(b) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and that the delisting will be effective on or about April 28, 2022 - ten days after the filing of the Form 25. Following the effectiveness of the delisting, it intends to file a Form 15 with the SEC to suspend the Company's Exchange Act reporting obligations.

https://www.marketscreener.com/quote/stock/KALEIDO-BIOSCIENCES-INC-55288611/news/KALEIDO-BIOSCIENCES-INC-Notice-of-Delisting-or-Failure-to-Satisfy-a-Continued-Listing-Rule-or-St-40004410/