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Tuesday, December 3, 2024

Relay, Elevar Licensing Agreement for Lirafugratinib in Cholangiocarcinoma

 Global licensing agreement grants Elevar Therapeutics worldwide rights to develop and commercialize lirafugratinib (RLY-4008)

Lirafugratinib is a potential best-in-class FGFR2 inhibitor that has shown differentiated efficacy in FGFR2-driven cholangiocarcinoma and demonstrated durable responses across multiple other types of FGFR2-altered solid tumors

Relay Therapeutics has potential to receive up to $500 million in upfront, regulatory and commercial milestone payments, including $75 million in upfront and regulatory milestones, plus up to double digit royalties on global sales

https://www.globenewswire.com/news-release/2024/12/03/2990578/0/en/Relay-Therapeutics-and-Elevar-Therapeutics-Announce-Exclusive-Global-Licensing-Agreement-for-Lirafugratinib-in-FGFR2-Driven-Cholangiocarcinoma-and-Other-Solid-Tumors.html

Takeda Puts Up to $1.3B on the Line for Keros’ Blood Cancer Anemia Drug

 

Keros’ elritercept has shown promising efficacy signals in myelofibrosis and myelodysplastic syndromes and could pose a formidable challenge to Bristol Myers Squibb’s Reblozyl.

Takeda Pharmaceuticals on Tuesday inked an exclusive licensing deal with Massachusetts-based biotech Keros Therapeutics to advance a potential competitor to Bristol Myers Squibb’s blockbuster injection Reblozyl (luspatercept).

At the center of Tuesday’s deal is Keros’ elritercept, a late-stage activin inhibitor being assessed for the treatment of anemia in patients with hematologic cancers such as myelofibrosis and myelodysplastic syndromes (MDS). Elritercept previously won the FDA’s Fast Track designation for very low-, low- and intermediate-risk MDS.

For the worldwide rights to develop, manufacture and commercialize elritercept, Takeda is paying Keros $200 million upfront and is pledging development, approval and commercial milestone payments “with the potential to exceed $1.1 billion,” according to Keros’ news release. The biotech will also be entitled to tiered royalties on net sales of elritercept.

Tuesday’s agreement will give Takeda control over elritercept in international markets except mainland China, Hong Kong and Macau.

“The addition of elritercept further bolsters our oncology pipeline and introduces a potential future growth driver for Takeda,” Teresa Bitetti, president of Takeda’s Global Oncology Business Unit, said in a statement. “Elritercept has the potential to make a meaningful difference for patients with blood cancers, one of our key areas of strategic focus.”

Elritercept is currently being studied in two Phase II trials—one in myelofibrosis and the other in very low-, low-, or intermediate-risk MDS.

At the 29th Annual Hybrid Congress of the European Hematology Association in June 2024, Keros touted “durable transfusion independence” in patients with lower-risk MDS after treatment with elritercept, including in those who had high transfusion burdens. In the myelofibrosis study, presented at the same conference, elritercept addressed ineffective hematopoiesis and cytopenias, while also providing other clinical benefits such as easing symptoms and reducing spleen volume.

Takeda plans to take elritercept into late-stage development, with a clinicaltrials.gov page showing that an MDS study is scheduled to start by the end of this year.

Elritercept could potentially compete with BMS’s Reblozyl, a blockbuster erythroid maturation agent indicated for MDS and beta-thalassemia. In the third quarter, Reblozyl surged 80% to bring in nearly $450 million for the pharma.

For Keros, analysts see the Takeda deal to be a big positive. Truist Securities in a Tuesday note wrote that the agreement is “a strong indication for differentiated profile of elritercept in MDS and likely [myelofibrosis],” adding that Takeda’s upfront payment will put the biotech “in a strong capital position with runway expected into 4Q 2028.”

Guggenheim Partners agreed, noting that “today’s deal helps to shore up the company’s balance sheet,” which in turn should allow it to focus its resources into the development of its Phase II asset cibotercept, being developed for pulmonary arterial hypertension. A readout for this program is expected in the second quarter of 2025.

https://www.biospace.com/business/takeda-puts-up-to-1-3b-on-the-line-for-keros-blood-cancer-anemia-drug

Gilead Plots ADC Comeback With Potential $415M License Agreement

 

The deal with Tubulis will help Gilead regain its footing in the ADC space following the withdrawal of Trodelvy in bladder cancer and its late-stage fail in NSCLC.

Gilead Sciences on Tuesday put forth $20 million in an exclusive option and license agreement with Tubulis to advance novel antibody-drug conjugate therapies for solid tumors.

Aside from the upfront payment, Gilead is also on the hook for a $30 million option exercise fee if it decides to exclusively license the partnership program. Overall, including development and commercialization milestones, Tubulis will be entitled to up to $415 million, plus mid-single to low-double-digit tiered royalties if a product hits the market.

If Gilead exercises its exclusive licensing option, it will assume full responsibility for all further development and commercialization options for the antibody-drug conjugate (ADC) program.

Flavius Martin, vice president of research at Gilead, said in a statement that the Tubulis partnership will allow it to access “novel technologies” that are “critical to advancing our pipeline,” especially as the pharma works to develop “next-generation therapies and combinations.” Together, Gilead and Tubulis hope to “increase the therapeutic value of the ADC modality.”

The partners are planning to achieve this goal by leveraging Tubulis’ proprietary Tubutecan platform, which uses the biotech’s P5 conjugation technology to produce what it calls ultra-stable ADCs that can optimally deliver their topoisomerase-I payloads to their designated targets, while minimizing unwanted toxicities, according to Tubulis’ website.

In April 2023, Bristol Myers Squibb saw the promise in Tubulis’ platform and paid the biotech $22.75 million upfront—along with the promise of more than $1 billion—to use Tubutecan to develop safer and more effective ADCs. Like Gilead, BMS is looking to target solid tumors with Tubulis’ technology.

In March 2024, Tubulis announced that it had closed its nearly $140 million Series B2 funding round, which will help it advance its own pipeline of ADCs, including the ovarian and lung cancer hopeful TUB-040 and the solid tumor candidate TUB-030.

For Gilead, Tuesday’s partnership represents somewhat of an ADC comeback after a series of stumbles in recent months. In October 2024, the pharma announced that it was pulling Trodelvy from the bladder cancer market after disappointing findings in the confirmatory Phase III TROPiCS-04 trial. Data from that study, unveiled in June 2024, indicated that Trodelvy did not result in significant overall survival (OS) benefits versus a physician’s choice of treatment.

In January 2024, Gilead also announced that Trodelvy failed the Phase III EVOKE-01 study in non-small cell lung cancer. Compared with docetaxel, the ADC did not significantly improve OS in patients with advanced or metastatic disease who had progressed on or after platinum chemotherapy and treatment with a checkpoint inhibitor.

https://www.biospace.com/business/gilead-plots-adc-comeback-with-potential-415m-license-agreement

Coherus to Divest UDENYCA® Franchise for up to $558 m

 - Coherus to focus exclusively on innovative immuno-oncology programs that include LOQTORZI®, an FDA approved, next-generation programmed cell death protein 1 (PD-1) inhibitor -

- Proceeds to fund development of key combination programs with LOQTORZI, including casdozokitug, a first-in-class, clinical-stage interleukin-27 (IL-27) antagonist, and CHS-114, a highly selective chemokine receptor 8 (CCR8) antibody -

- Post-closing proceeds to repay the entirety of the company’s $230 million convertible notes due April 2026 -

- Coherus management to host investor conference call today, Tuesday, December 3, 2024, at 8:00 a.m. Eastern Time -

Conference Call Information

When: Tuesday, December 3, 2024, starting at 8:00 a.m. Eastern Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BId14c70118ce44561902dd39c791136fa

Please dial in 15 minutes early to ensure a timely connection to the call.

Webcast Link: https://edge.media-server.com/mmc/p/ypqpachc

A replay of the webcast will be archived on the “Investors” section of the Coherus website at http://investors.coherus.com

https://www.globenewswire.com/news-release/2024/12/03/2990450/33333/en/Coherus-Announces-Agreement-to-Divest-UDENYCA-Franchise-for-up-to-558-million-to-Intas-Pharmaceuticals-Ltd.html

Catalent gains amid report buyer working on contact extensions with drugmakers

 Catalent (CTLT) shares rise 1% as Novo Holdings explores contract extensions with concerned drugmakers post $16.5 billion sale.

https://seekingalpha.com/news/4360760-catalent-gains-amid-report-buyer-working-on-contact-extensions-with-drugmakers

Beigene resumed at Overweight by Morgan Stanley

 Target $300

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

Moderna shares could slump over 30% on negative CMV reading: Leerink

 Leerink analyst warned that Moderna (NASDAQ:MRNA) shares could fall more than 30% if interim results from its Phase 3 CMV vaccine trial, CMVictory gives negative readout.

In case of a negative readout, where data fails to show a statistically significant benefit, could drop Moderna’s stock below $30 as the company’s long-term revenue prospects would take a hit, potentially delaying its profitability timeline beyond the current 2028 estimate.

Whereas a positive interim result could trigger a relief rally, with shares potentially rising to the mid-$50 range, aided by short covering.

The CMV vaccine is a major focus for Moderna as it seeks to diversify its revenue beyond COVID-19 products, which have faced declining demand.

The company navigates concerns over COVID vaccine oversupply, falling prescriptions, and the appointment of Robert F. Kennedy Jr. to lead the U.S. Department of Health and Human Services, which has raised uncertainties for vaccine manufacturers.

Moderna completed enrollment for the CMVictory trial in September 2023, with the final dose administered in February 2024. As of earlier this year, the company reported 50 confirmed cases out of the required 81 for the interim analysis.

Investors are now closely watching for updates on the trial as Moderna’s next earnings driver hinges on the success of its CMV program.


https://finance.yahoo.com/news/moderna-shares-could-slump-over-143420774.html