Kite To Acquire Tmunity Therapeutics To Pursue Next Generation CAR T-Cell Therapy Advancements In Cancer

On December 20, 2022 Kite, a Gilead Company (Nasdaq: GILD), and Tmunity Therapeutics (Tmunity), reported that the companies have signed an agreement in which Kite will acquire Tmunity, a clinical-stage, private biotech company focused on next-generation CAR T-therapies and technologies (Press release, Kite Pharma, DEC 20, 2022, View Source [SID1234625458]). The acquisition of Tmunity complements Kite’s existing in-house cell therapy research capabilities by adding additional pipeline assets, platform capabilities, and a strategic research and licensing agreement with the University of Pennsylvania (Penn).

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The acquisition will provide Kite with pre-clinical and clinical programs, including an ‘armored’ CAR T technology platform, which potentially could be applied to a variety of CAR T’s to enhance anti-tumor activity, as well as rapid manufacturing processes. Tmunity’s prostate-specific membrane antigen (PSMA) and prostate stem cell antigen (PSCA) assets are not part of the Kite acquisition and will be spun-out by Tmunity as part of the transaction.

As part of the acquisition, Kite will assume responsibility for continuing the research and development collaboration between Tmunity and Penn, also known as the Amended Research License Agreement (ARLA), which includes research funding to Penn along with options and licenses to certain cell engineering and manufacturing technologies invented and developed in certain Penn laboratories. Upon closing, the ARLA will be extended until 2026 with an option to extend further.

"Kite has demonstrated an ability to globally scale cell therapy and address the unique challenges and opportunities that cell therapy represents, which are quite different in material ways than traditional pharmaceutical or biotech approaches," said Tmunity Founder Carl June, MD, who is also the Richard W. Vague Professor of Immunotherapy in Penn’s Perelman School of Medicine and director of Penn’s Center for Cellular Immunotherapies. "Kite’s singular focus on cell therapy makes them unique and particularly nimble."

Tmunity was formed in 2015 by some of the early innovators in the cell therapy field, the University of Pennsylvania’s Dr. June, Bruce Levine, PhD, James Riley, PhD and Anne Chew, PhD. The company was formed to rapidly advance early-stage cell therapy research and innovation done in academia into the clinic, to produce new treatments for patients with unmet needs.As part of Kite’s acquisition, the Tmunity founders will become senior scientific advisors for Kite.

"We believe that the impact cell therapy is making for patients today is just the start of what is possible," said Christi Shaw, Chief Executive Officer of Kite. "The Kite team is thrilled to be joining forces with the researchers at Tmunity who are rapidly advancing cell therapy research from the labs into the clinic through their unique partnership with the University of Pennsylvania. Together, we bring a deep understanding of cell therapy as an effective platform, and combined with Kite’s industry-leading global scale, we collectively have a singular focus: to use cell therapy to develop potential cures, and to get them to patients as quickly as possible."

Dr. June, a visionary researcher who helped shape the development of innovative cell therapies beginning in the 1980s, leads a team at Penn which, working across basic and clinical research settings, helped ignite the promise of cell therapy.

"The Tmunity team is excited by the potential to become part of Kite and see what we can accomplish together to write the next chapter on what cell therapy is capable of," said Beth Seidenberg, MD, Non-Executive Chairwoman of Tmunity and Founding Managing Director of Westlake Village BioPartners. "This acquisition is about unlocking ways to help more patients, and do so more quickly, than either team could do alone."

The transaction is expected to close in the first quarter of 2023, and after closing, Tmunity’s employees will join Kite. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

The financial terms of the agreement were not disclosed. Kite will acquire all outstanding shares of Tmunity other than those already owned by Kite. Beginning in the first quarter of 2022, consistent with guidance from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures and expects the transaction with Tmunity to reduce Gilead’s GAAP and non-GAAP 2023 EPS by approximately $0.18-$0.22.

Drs. June, Levine, Riley, and Chew are all individual equity holders in Tmunity and as part of this agreement will become paid scientific advisors to Kite. Penn receives sponsored research funding from Tmunity, and as inventors of some of the licensed technology, Drs. June, Levine, Riley, and Chew, along with Penn, may receive additional financial benefits under the license in the future. Penn is also an investor in Tmunity and holds equity interests.

The other major investors in Tmunity include Westlake Village Biopartners, Andreessen Horowitz (also known as "a16z"), Parker Institute for Cancer Immunotherapy, Gilead Sciences, Kleiner Perkins, Resilience, Lilly Asia Ventures, Crystal South, Be The Match, and BrightEdge, the philanthropic impact fund of the American Cancer Society.

Cowen is acting as financial advisor to Kite. Centerview Partners is acting as financial advisor and Cooley and Ropes & Gray are acting as legal advisors to Tmunity.

POINT Biopharma Announces Closing of Agreements with Lantheus Holdings

On December 20, 2022 POINT Biopharma Global Inc. ("POINT") (NASDAQ: PNT), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported that the closing conditions, including Hart-Scott-Rodino antitrust clearance, have been met for the previously announced agreements with Lantheus Holdings Inc. (NASDAQ: LNTH) (Press release, Point Biopharma, DEC 20, 2022, View Source [SID1234625457]).

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Under the terms of the agreements, POINT will receive the initial $260 million in upfront payments from Lantheus in the upcoming week. The agreements also include the potential for several future payments to POINT. For PNT2002, these include:

– an additional payment up to $250 million upon U.S. FDA regulatory approval

– royalties of 20% on all net sales once certain financial thresholds have been achieved

– profit from the manufacturing and supply of commercial drug product to Lantheus

– up to an additional $1.3 billion in various net sales milestone payments

For PNT2003, these include:

– up to an additional $30 million upon U.S. FDA regulatory approval

– royalties of 15% on net sales

– profit from the manufacturing and supply of commercial drug product to Lantheus

– up to an additional $275 million in various net sales milestone payments

Proceeds from this transaction will be used to accelerate the expansion of POINT’s next-generation radioligand platform. POINT will make a number of key investments in 2023, including the commercial scale up of its production facility, completion of the SPLASH trial, expansion of POINT’s R&D infrastructure, and acceleration of pipeline development. By the end of 2023, POINT expects to have two next-generation programs in the clinic including the pan-cancer PNT2004, which is currently in Phase 1, and the actinium-225 labeled PNT2001, expected to enter Phase 1 in late 2023, along with multiple new chemical entities advancing through discovery and preclinical validation. POINT expects that its cash, cash equivalents, and short-term investments, combined with the upfront payments, will fund its current operating plan into 2026.

Additional information regarding the POINT & Lantheus’ strategic collaboration and exclusive license agreements can also be found at POINT’s investor relations website, located at pointbiopharma.com/investors.

Atara Biotherapeutics Announces $31 Million Royalty Interest Financing Agreement with HealthCare Royalty

On December 20, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that it has entered into a royalty interest financing agreement totaling $31 million with HealthCare Royalty (HCRx) for Ebvallo in Europe and other territories covered by Atara’s commercialization agreement with Pierre Fabre (Press release, Atara Biotherapeutics, DEC 20, 2022, View Source [SID1234625456]).

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"This strategic deal with HCRx, a top-tier investment firm, contributes to Atara’s financial position and reflects our positive momentum following the recent European Commission approval of Ebvallo as the only approved therapy for EU patients with a rare and potentially deadly cancer," said Pascal Touchon, President and Chief Executive Officer of Atara. "We share HCRx’s confidence in Ebvallo and a vision of bringing a first ever allogeneic T-cell therapy to market in collaboration with our European commercialization partner Pierre Fabre."

Under the terms of the agreement, Atara will receive a $31 million upfront payment from HCRx. In exchange, HCRx will receive rights to specified royalties and milestones under the Pierre Fabre commercialization agreement for Europe and other territories. The total royalties and milestones payable to HCRx are capped between 185 percent and 250 percent of the total investment amount by HCRx, dependent upon the timing of such royalties and milestones.

Additionally, Atara retains existing milestone payments from Pierre Fabre of $10 million for Ebvallo approval in Europe and $30 million for Atara’s initiation of the EU Marketing Authorization Application transfer to Pierre Fabre from the previously announced commercialization agreement and subsequent update announced in September 2022.

"We are proud to support Atara and have strong confidence in their mission of helping transform the lives of cancer and autoimmune patients through pioneering innovative science, proven by rigorous data," said Clarke Futch, Chairman and Chief Executive Officer of HCRx. "Atara is a differentiated allogeneic T-cell immunotherapy company, and we are pleased to support their efforts at this pivotal moment for tabelecleucel development."

Seagen to Present at the J.P. Morgan Healthcare Conference

On December 20, 2022 Seagen Inc. (Nasdaq:SGEN) reported that management will present at the 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023 at 3:00 p.m. Pacific Time (Press release, Seagen, DEC 20, 2022, View Source [SID1234625450]). The presentation will be webcast live and available for replay from the investor section of Seagen’s website at investor.seagen.com.

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NanOlogy Publishes Results From a Clinical Trial of Intracystic LSAM-PTX in Mucinous Pancreatic Cysts

On December 20, 2022 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported publication of a research article entitled Early Phase Trial of Intracystic Injection of Large Surface Area Microparticle Paclitaxel (LSAM-PTX) for Treatment of Mucinous Pancreatic Cysts in Endoscopy International Open (Press release, NanOlogy, DEC 20, 2022, View Source;utm_medium=rss&utm_campaign=nanology-publishes-results-from-a-clinical-trial-of-intracystic-lsam-ptx-in-mucinous-pancreatic-cysts [SID1234625448]).

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Nineteen subjects completed the multicenter open-label dose escalation/confirmation study (NCT03188991), which followed subjects for 6 months to evaluate safety, tolerability, plasma paclitaxel concentration, and change in cyst volume.

No dose limiting toxicities, treatment-related serious adverse events, or clinically significant laboratory changes were reported. Systemic paclitaxel concentration did not exceed 3.5 ng/mL at any timepoint measured supporting the lack of systemic toxicity. By Week 24 a cyst volume reduction (10-78%) was seen in 71% of subjects.

Certain mucinous pancreatic cysts are at high risk for progression to pancreatic cancer. Such cysts are particularly worrisome in nonoperable patients who currently have limited options beyond active surveillance. Results from the trial are intended to support future research in this patient subset to evaluate whether intracystic LSAM-PTX can decrease the rate of progression. The treatment is covered by a recently issued US patent (11,523,983) entitled Treatment of Epithelial Cysts by Intracystic Injection of Antineoplastic Particles. The patent is valid until July 2038 with corresponding filings globally.

Enrollment is also complete (n=54) in a NanOlogy-sponsored clinical trial of intratumoral (IT) LSAM-PTX with systemic chemotherapy in locally advanced pancreatic cancer (LAPC). IT LSAM-PTX was well tolerated with encouraging signals of activity. Results are pending publication.

Pancreatic cancer remains an elusive target for pharmaceutical drug research. NanOlogy views LSAM-PTX as a potential therapeutic platform across the disease spectrum aimed at both stopping progression of high-risk lesions and offering meaningful clinical benefit to pancreatic cancer patients without adding to systemic toxicity.

In all, NanOlogy clinical programs have advanced tumor directed LSAM investigational drugs in multiple solid tumors including pancreas, lung, bladder, peritoneal, ovarian, prostate, and dermal cancers. More than 170 patients have been treated to date across its clinical trials with preliminary signals of tumor and immune response and no confirmed drug-related serious adverse events. Review articles of preclinical and clinical studies supporting LSAM-PTX and another investigational drug, Large Surface Area Microparticle Docetaxel (LSAM-DTX), have been published previously.