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Wednesday, November 1, 2023

Ligand Acquires Royalty on Sanofi’s TZIELD® for $20 Million

 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that it has acquired Tolerance Therapeutics, Inc. (“Tolerance Therapeutics”) for $20 million in cash. Tolerance Therapeutics is a holding company, owned by the inventors of TZIELD (teplizumab-mzwv), that is owed a royalty of less than 1% on worldwide net sales. The transaction will be immediately accretive to Ligand’s royalty revenue.

TZIELD is the first disease-modifying therapy in type 1 diabetes (“T1D”). It is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and children aged 8 years and older with Stage 2 T1D. TZIELD was granted Breakthrough Therapy Designation in 2019 and was approved by the U.S. Food and Drug Administration in November 2022. TZIELD is marketed by Sanofi, following its acquisition of Provention Bio, Inc., the owner of TZIELD, in 2023 for $2.9 billion. Sanofi recently announced new data from TZIELD’s PROTECT Phase 3 trial which showed TZIELD’s potential to slow the progression of Stage 3 T1D in newly diagnosed children and adolescents. TZIELD met the study’s primary endpoint, significantly slowing the decline of C-peptide levels, compared to placebo.

https://www.businesswire.com/news/home/20231101846503/en/

vTv Therapeutics Sell Shares in Reneo Pharmaceuticals for $4.4 M

 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today announced that it has entered into a common stock repurchase agreement with Reneo Pharmaceuticals, Inc. through which Reneo has purchased all of its common stock that was granted to vTv under the Reneo License Agreement for total proceeds to vTv of approximately $4.4 million.

“The proceeds from the sale of our Reneo stock will provide vTv with important financial support as we continue our preparations for the launch of the cadisegliatin Phase 3 program in T1D. We remain in active discussions related to the financing, partnering and/or licensing of cadisegliatin,” said Paul Sekhri, President and Chief Executive Officer of vTv Therapeutics. 

https://www.globenewswire.com/news-release/2023/11/01/2771100/0/en/vTv-Therapeutics-Announces-Sale-of-Shares-in-Reneo-Pharmaceuticals-for-Proceeds-of-4-4-Million.html

G1 cuts outlook

 As a result of the ongoing shortage of platinum-based chemotherapy, G1 today lowered its full year 2023 net revenue guidance. The Company expects to generate between $44 million and $47 million in COSELA net revenue in 2023. G1's product revenue guidance is based on expectations for continued acceleration of sales performance of COSELA in the U.S.

Webcast and Conference Call

G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the third quarter ended September 30, 2023.

Please note the following process to access the call via telephone: To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended to join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the Company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

https://www.globenewswire.com/news-release/2023/11/01/2770927/0/en/G1-Therapeutics-Provides-Third-Quarter-2023-Financial-Results-and-Operational-Highlights.html

Ocular Therapeutix: FDA OKs First Pivotal Clinical Trial of OTX-TKI in Wet AMD

 The first subject expected to be dosed by year-end

Company announces OTX-TKI trade name AXPAXLI

https://www.globenewswire.com/news-release/2023/11/01/2771115/0/en/Ocular-Therapeutix-Receives-FDA-Agreement-Under-Special-Protocol-Assessment-SPA-for-its-First-Pivotal-Clinical-Trial-of-OTX-TKI-in-Wet-AMD.html

FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death

 The FDA has lifted its full clinical hold on Mersana Therapeutics’ Phase I study of XMT-2056, its investigational STING-directed antibody-drug conjugate, the company announced Tuesday.

The clinical hold came in March 2023, following a patient death that was deemed related to XMT-2056. At the time, Mersana was assessing the candidate in a Phase I trial, enrolling previously treated patients with HER2-positive recurrent or metastatic solid tumors.

The fatality occurred in the second patient enrolled in the dose-escalation phase of the early-stage study, pushing the biotech to voluntarily suspend the trial and report the incident to the regulator.

In Tuesday’s announcement, Mersana indicated that it was lowering the starting dose of XMT-2056 in its study and that it has “aligned with FDA on the path forward” for the investigational therapy.

Mersana rose 7% in late morning trading following the news, according to Seeking Alpha.

Discovered and developed using Mersana’s proprietary Immunosynthen platform, XMT-2056 is an investigational antibody-drug conjugate (ADC) that targets a novel HER2 epitope and activates the STING signaling cascade in tumors and tumor-resident immune cells, according to the company’s website.

This mode of action allows it to boost the anti-tumor action of the innate immune response, and has the potential to treat cancers with high or low HER2 expression levels. In August 2022, GSK bought into the promise of XMT-2056 in a global collaboration deal worth $100 million upfront and the promise of up to $1.36 billion in development, regulatory and commercial milestones.

Under the agreement, GSK will have the exclusive option for global commercialization rights over XMT-2056, while Mersana will retain the option for profit-sharing and co-promotion in the U.S.

On Wednesday, however, GSK announced in a pipeline update that it was dropping an early-stage in-house STING agonist, dubbed 3745417. The British pharma has not yet exercised its option in the Mersana deal, and it remains unclear whether the discontinuation of 3745417 will affect the prospects of XMT-2056. 

In January 2023, Mersana kicked off the Phase I trial for XMT-2056, with an estimated enrollment target of around 170 patients with advanced or recurrent HER2-expressing solid tumors, including breast, gastric, non-small cell lung and colorectal cancers.

Mersana has two other trials under regulatory pause. In June 2023, the FDA placed the company’s UP-NEXT and UPGRADE-A studies on partial clinical hold following an aggregate safety report from some 560 patients showing a higher rate of serious bleeding events in patients treated with the investigational ADC upifitamab rilsodotin (UpRi).

Most of the bleeds were low-grade, according to Mersana’s announcement at the time, but five were ultimately fatal. UP-NEXT and UPGRADE-A are assessing UpRi in platinum-sensitive ovarian cancer.

https://www.biospace.com/article/fda-lifts-hold-on-mersana-s-antibody-drug-conjugate-following-patient-death/

Humana Shares Fall as Forecast for 2024 Profit Disappoints

 

Humana Inc. shares fell sharply at the US market open after executives said the initial outlook for 2024 profit growth would be at the low end of its forecast.

Adjusted earnings per share for 2024 will be at the lower end of the company’s 11% to 15% long-term growth target, executives said Wednesday on a call with analysts. The shares tumbled as much at 6.1%, the most intraday since June, before paring most of those losses.

https://www.bloomberg.com/news/articles/2023-11-01/humana-shares-fall-as-forecast-for-2024-profit-disappoints

Hundreds Of Foreigners, Including Americans, Allowed To Exit Gaza Into Egypt For 1st Time

 The Israel Defense Forces has said it is in close quarters combat with Hamas as troops push further into Gaza, resulting in an announced Tuesday death toll of eleven. By early Wednesday that figure rose to 13 Israeli soldiers killed, after Israel's defense minister warned of the "heavy toll" which would be paid by troops in the operation to eradicate Hamas.

As the death toll among Gazans approaches 9,000, the EU’s top diplomat Josep Borrell has lashed out at Israel's airstrikes and massive civilian casualties. Borrel says he is "appalled by the high number of casualties following the bombing by Israel of the Jabalia refugee camp." Jabalia camp has reportedly been struck again, a day after the initial massive attack which had killed at least 52 Palestinians, according to the Gaza Health Ministry.

But Israel's military said that its Jabalia strike had taken out a top Hamas commander and other Hamas officers, and said Israeli decision-makers took into account the harm to civilians in the densely populated urban area.

On Wednesday Prime Minister Benjamin Netanyahu expressed condolences for the IDF's fallen soldiers along side other leaders. He said "We are in a tough war. This will be a long war. We have important achievements, but also painful losses."

According to more from his message: "We know that every one of our soldiers is an entire world. All of Israel embraces you, the families, from the bottom of our hearts. All of us are with you during this time of mourning. Our soldiers fell in a war where there was no justice, a war for our home," he said. "I promise you, the citizens of Israel: we will complete the task - we will continue until victory."

IDF troops have begun the slow process of going door to door as they search for the missing Israeli and foreign hostages, which is up to 240, according to new military statements. Hamas has issued new statements claiming Israeli airstrikes killed a group of hostages. "Seven detainees were killed in the Jabalia massacre yesterday, including three holders of foreign passports," said a Hamas statement issued from its military wing.

But the "painful losses" are mounting in much greater numbers for the Palestinian side, and civilians are bearing the brunt of suffering. International outrage and pressure has mounted on Tel Aviv, which has voiced that has warned Gaza civilians they must move to the southern half of the Strip if they want to escape the bombs. According to a fresh Gaza health ministry update as republished in Al Jazeera:

  • The number of people killed in Israeli attacks on Gaza has gone up to 8,796, including 3,648 children and 2,290 women.
  • At least 22,219 people have been wounded.
  • There are 2,030 reports of people missing including 1,020 children buried under the rubble.
  • 130 paramedics and medical crew have been killed, 28 ambulances have been destroyed, and there have been more than 270 attacks on the healthcare system in Gaza.
  • 16 hospitals out of 35 are out of operation, and 51 out of 72 primary healthcare clinics have shut down.
  • In the occupied West Bank, 128 Palestinians have been killed and at least 1,980 have been wounded.

There has meanwhile been a rare positive development on the humanitarian front. For the first time since the start of the war, foreigners and wounded Palestinians have been allowed to exit Gaza through the Rafah crossing into Egypt. 

Some 500 foreign passport holders had reportedly been stuck at Rafah crossing for weeks since the start of the conflict after Oct.7. The area near the crossing had also been bombed by Israeli jets on several occasions. Ambulances have been observed Wednesday ferrying the wounded into Egypt. 

Hundreds are foreign passport holders are also belatedly being let through, among them Americans. "At least five NGO workers who have been confirmed as Americans are listed as approved to cross on Wednesday but it remains to be seen how many of at least 400 American citizens the U.S. State Department says are stuck in Gaza will be able to cross in coming days," CBS News reports. Some have lashed out at Washington over the lack of serious evacuation efforts in place for those dual nationals stuck in Gaza: 

"They started letting foreigners out today but it's not Americans because I guess we're not as important as we thought," Utah resident Susan Beseiso told CBS News on Wednesday.  

"The American Embassy and the State Department haven't called us since the last time we went to the border and got bombed four times. They haven't been communicating with us or doing anything to get us out," Beseiso said.

"It's like they're holding us hostages — not Hamas holding us hostages — it's the IDF soldiers, Egypt and America. They're using us as a human shield in a way."

The fresh evacuees are undergoing security checks on the Egyptian side. Among those exiting include Palestinians holding Austrian, Bulgarian, Indonesian, Japanese Jordanian, Italian, Greek, Australian and Czech citizenships, and many others. Various nationals working for several NGOs are also on the departure list.

According to The Times of Israel, "A source briefed on the development told Reuters that the evacuations were agreed on in a deal mediated by Qatar between Egypt, Israel and Hamas in coordination with the US."

https://www.zerohedge.com/geopolitical/hundreds-foreigners-including-americans-allowed-exit-gaza-egypt-1st-time