On September 21 2021 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the body, reported the issuance of two new United States Patents Nos. 11,117,945 and 11,104,712 from the United States Patent and Trademark Office (Press release, Cue Biopharma, SEP 21, 2021, View Source [SID1234608271]).

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U.S. Patent No. 11,117,945 covers Cue Biopharma’s first clinical drug candidate, CUE-101, and its use in treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers. CUE-101 is currently in a Phase 1b clinical trial in which second line and beyond patients are receiving CUE-101 as a monotherapy for HPV16+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). To date, CUE-101 has demonstrated monotherapy clinical activity by selective activation of targeted CD8+ T cells specific for HPV+ cancer cells with a 40% clinical benefit in the first 10 evaluable patients at the recommended Phase 2 dose of 4mg/kg. CUE-101 is also in a dose escalation study in combination with pembrolizumab in front-line patients with HPV16+ recurrent/metastatic HNSCC. A Phase 2 exploratory clinical trial in which CUE-101 will be administered in the neoadjuvant phase before standard of care (SOC) therapy in treatment-naïve, HLA-A*0201 positive patients with locally advanced, HPV-positive oropharyngeal squamous-cell carcinoma, is expected to begin enrolling patients this fall.

The second U.S. Patent, No. 11,104,712, covers the use of CUE-101 in combination with KEYTRUDA (pembrolizumab) for treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers. The combination of CUE-101 and pembrolizumab is being evaluated by Cue Biopharma in collaboration with Merck Sharp & Dohme Corp.

"The issuance of these patents represents an important development as we continue to build-up our IP portfolio and bolster patent protection for the novel protein engineering platforms we have enabled, particularly as we begin demonstrating clinical activity in what we believe will be a disruptive and transformational breakthrough in immunotherapy for addressing cancer and other debilitating and life-threatening diseases," said Daniel Passeri, chief executive officer of Cue Biopharma. "Furthermore, obtaining these patents early in the clinical development of CUE-101 enhances our ability to receive a Patent Term Extension from the United States Patent and Trademark Office if CUE-101 is approved by the FDA. We continue to make a substantial investment in protecting our intellectual property, and we look forward to the issuance of additional patents that cover our important platforms and pipeline products."

Cue Biopharma’s IP portfolio includes approximately 300 pending applications and issued patents that are either owned by Cue Biopharma or exclusively licensed from the Albert Einstein College of Medicine.

On September 21, 2021 Zenith Epigenetics Ltd. ("Zenith" or the "Company") and Newsoara BioPharma Co., Ltd. ("Newsoara") reported the initiation of a multi-national, randomized Phase 2b clinical trial testing the combination of ZEN-3694, a leading BET bromodomain inhibitor (BETi), with Astellas Pharma Inc. ("Astellas") and Pfizer’s androgen receptor signaling inhibitor (ARSI), enzalutamide, in patients with mCRPC who had a poor response to prior abiraterone treatment (Press release, Zenith Epigenetics, SEP 21, 2021, View Source [SID1234590199]). The study will evaluate the efficacy of ZEN-3694 + enzalutamide vs. single agent enzalutamide as measured by its primary endpoint, radiographic free progression.

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Abiraterone, also an ARSI, is frequently prescribed as a first line therapy for patients with metastatic prostate cancer. A significant fraction of these patients, whose tumors have low androgen receptor (AR) signaling activity, have a sub optimal response to abiraterone and their subsequent treatment options are limited to cytotoxic therapies. The rationale for this study design is supported by a recent publication in Clinical Cancer Research whose authors uncovered a potential mechanism explaining the role of BETi in sensitizing tumors with low AR signaling to ARSI by blocking a treatment-emergent neuroendocrine differentiation program. This mechanistic study built on a previous clinical trial conducted by Zenith where results suggested that ZEN-3694 + enzalutamide was most active in mCRPC patient tumors who had the lowest AR activity. Furthermore, patients in that trial that had a poor response to prior abiraterone therapy had the most durable response with ZEN-3694 + enzalutamide.

"We are delighted to initiate this study in collaboration with our partners Newsoara and Astellas to continue the development of ZEN-3694 in mCRPC patients," said Donald McCaffrey, President and Chief Executive Officer of Zenith. "We are pursuing a novel approach of treating mCRPC patients whose tumors are resistant to ARSI. Other therapies, either approved or in development, are either cytotoxic or mainly target AR signaling which resistant tumors are no longer dependent on," Mr. McCaffrey further commented.

Dr. Benny Li, Chief Executive Officer of Newsoara added, "with promising data from the completed Phase 1b/2a trial, the initiation of the multi-national, randomized Phase 2b clinical study in patients with mCRPC is a significant milestone for us to pursue a novel treatment through our partnership with Zenith."

About Prostate Cancer

Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide. Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay for over six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone and to ARSIs that block AR signaling, disease progression ultimately occurs leading to mCRPC. The treatment of prostate cancer patients has evolved rapidly over the past ten years with second generation ARSIs. Despite these advances, many patients with mCRPC fail or develop resistance to existing treatments, leading to continued disease progression and limited survival rates.

On September 21, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 10:40 a.m. Eastern Time (Press release, Kiniksa Pharmaceuticals, SEP 21, 2021, View Source [SID1234590166]).

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A live webcast of Kiniksa’s presentation will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

On September 22, 2021 SHINE Medical Technologies LLC reported that the company has changed its name to SHINE Technologies LLC (Press release, Shine Medical Technologies, SEP 22, 2021, View Source [SID1234590122]).

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SHINE’s new name highlights the company’s core technological competencies, skilled team and focus as a next-generation nuclear technology company. SHINE is pursuing a four-phase strategy for the development of nuclear fusion technology to achieve its ultimate goal: producing fusion energy. SHINE’s technology is currently being applied to advanced industrial inspection services and medical isotope production, phases I and II of the company’s four-phase approach, respectively.

"Our long-term goal is to create and deploy systems that produce clean fusion energy, and we are continuing to grow towards that goal by commercializing more near-term applications of fusion," said Greg Piefer, SHINE’s founder and CEO. "In addition, our merger with Phoenix earlier this year strengthened our position by enabling us to integrate a key technological capability that supports our near- and long-term plans."

Phoenix commercialized phase I, advanced industrial inspection services, over a decade ago by utilizing its fusion-based technology for nondestructive testing. These applications take neutron images or perform other assay measurements of modern materials in detail, ensuring that the quality and safety needs of clients in the aerospace, defense and energy industries are met.

SHINE’s phase II involves the application of fusion to the production of medical isotopes. The company expects to produce diagnostic isotopes for heart disease and other applications and is producing therapeutic isotopes for certain cancers. SHINE anticipates producing these isotopes at commercial scale at facilities on its campus in Janesville, Wis.

"The goal of each phase of our approach is to create social and economic value while building additional capacity and capability, and deepening our scientific understanding of fusion technology as we progress to clean energy production," Piefer said.

SHINE’s next step will be to explore the use of its technology to recycle nuclear waste in phase III. Carbon-free nuclear power currently faces a major political obstacle because it produces radioactive waste, some of which can last for millions of years. If successful, SHINE’s phase III is expected to help mitigate this problem by recycling a portion of this waste and using fusion to shorten the half-life on long-lived waste forms. Importantly, SHINE’s work in this phase could help fission power become a more sustainable form of carbon-free energy.

The goal of phase IV is to generate clean, abundant and affordable fusion energy. SHINE believes its achievement of this goal will be built on the strength of its skilled team, including their experience with challenging nuclear technology projects, the breadth of the company’s unique technological capabilities, and the experience expected to be gained from operating many powerful fusion systems in the field during phase III.

"We are excited that our new name more clearly reflects our core technological competencies, strong team and long-term ambitions," Piefer said. "SHINE was founded on differentiated technology, and a unique, lean and phased approach to developing nuclear technology. It’s great to be telling the world more about the company we’ve built, with an updated brand that reflects it."

On September 21, 2021 Eli Lilly and Company (NYSE: LLY) reported the early tender results of its previously announced cash tender offer for specified series of its outstanding debt securities (Press release, Eli Lilly, SEP 21, 2021, View Source [SID1234590111]). Lilly also announced that it has removed the previously announced note caps setting forth the maximum principal amounts of its 4.150% Notes due 2059 and its 3.950% Notes due 2049 that Lilly will accept for purchase pursuant to the tender offer. Except as described in this press release, all other terms of the tender offer as described in the Offer to Purchase, dated September 7, 2021 (the "Offer to Purchase"), and the related Letter of Transmittal remain unchanged.

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A total of $2,016,575,000 in aggregate principal amount of the notes listed in the table below were validly tendered and not validly withdrawn on or before 5:00 p.m., New York City time, on September 20, 2021, the early tender date for the tender offer. The table below sets forth the aggregate principal amount of each series of notes subject to the tender offer that was validly tendered and not validly withdrawn on or prior to the early tender date.

Title of Security

CUSIP No.

Acceptance Priority Level

Principal Amount Outstanding

Principal Amount Tendered

Approximate Percentage of Outstanding Amount Tendered

Anticipated Principal Amount to be Accepted for Purchase

4.150% Notes due 2059

532457 BU1

1(1)

$1,000,000,000

$408,714,000

40.87%

$408,714,000

3.950% Notes due 2049

532457 BT4

2(2)

$1,500,000,000

$541,847,000

36.12%

$541,847,000

7.125% Notes due 2025

532457 AM0

3

$229,692,000

$12,221,000

5.32%

$12,221,000

6.770% Notes due 2036

532457 AP3

4

$174,445,000

$15,880,000

9.10%

$15,880,000

5.950% Notes due 2037

532457 BC1

5

$284,112,000

$17,284,000

6.08%

$17,284,000

5.550% Notes due 2037

532457 BA5

6

$476,152,000

$31,420,000

6.60%

$31,420,000

5.500% Notes due 2027

532457 AZ1

7

$377,505,000

$13,181,000

3.49%

$13,181,000

4.650% Notes due 2044

532457 BG2

8

$43,016,000

$4,680,000

10.88%

$4,680,000

3.950% Notes due 2047

532457 BR8

9

$436,129,000

$89,177,000

20.45%

$89,177,000

3.875% Notes due 2039

532457 BS6

10

$360,745,000

$120,492,000

33.40%

$120,492,000

3.700% Notes due 2045

532457 BJ6

11

$412,467,000

$25,668,000

6.22%

$25,668,000

3.375% Notes due 2029

532457 BV9

12

$1,150,000,000

$369,771,000

32.15%

$219,436,000

3.100% Notes due 2027

532457 BP2

13

$401,450,000

$54,408,000

13.55%

$0

2.750% Notes due 2025

532457 BH0

14

$560,646,000

$146,108,000

26.06%

$0

2.350% Notes due 2022

532457 BQ0

15

$750,000,000

$165,724,000

22.10%

$0

(1)

Lilly has removed the previously announced note cap setting forth the maximum principal amount of 4.150% Notes due 2059 that Lilly will accept for purchase pursuant to the tender offer.

(2)

Lilly has removed the previously announced note cap setting forth the maximum principal amount of 3.950% Notes due 2049 that Lilly will accept for purchase pursuant to the tender offer.

Subject to the conditions in the Offer to Purchase, notes validly tendered and not validly withdrawn at or prior to the early tender date with Acceptance Priority Level 12 have been accepted for purchase using a proration factor of approximately 59.4%.

The settlement date for the notes accepted for purchase by Lilly in connection with the early tender date is currently expected to be September 22, 2021.

Lilly expects to determine the pricing terms of the tender offer at 10:00 a.m., New York City time, on September 21, 2021, unless extended. The tender offer is scheduled to expire at 11:59 p.m., New York City time, on October 4, 2021, unless extended or terminated earlier.

Holders of notes subject to the tender offer who validly tendered and did not validly withdraw their notes on or prior to the early tender date are eligible to receive the applicable total consideration, which includes an early tender premium of $30 per $1,000 principal amount of notes validly tendered by such holders that are accepted for purchase by Lilly. Accrued and unpaid interest from the last interest payment date for the applicable series of notes to, but excluding, the applicable settlement date will be paid in cash in respect of all validly tendered notes accepted for purchase by Lilly in the tender offer.

In accordance with the terms of the tender offer, the withdrawal date was 5:00 p.m., New York City time, on September 20, 2021. As a result, tendered notes may no longer be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

The tender offer is being conducted on the terms and subject to the conditions set forth in the Offer to Purchase and the related Letter of Transmittal, as supplemented by this press release.

Lilly has retained BofA Securities, Inc. and Citigroup Global Markets Inc. to serve as lead dealer managers for the tender offer, and Barclays Capital, Inc., BNP Paribas Securities Corp. and Deutsche Bank Securities Inc. to serve as co-dealer managers. Lilly has retained Global Bondholder Services Corporation to serve as tender agent and information agent for the tender offer.

Requests for documents relating to the tender offer may be directed to Global Bondholder Services Corporation by telephone at +1 (866) 470-3900, by email at [email protected] or in writing at 65 Broadway, Suite 404, New York, NY 10006. Questions regarding the tender offer may be directed to BofA Securities, Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. toll-free at +1 (800) 558-3745 or collect +1 (212) 723-6106.

This press release is for informational purposes only and is not an offer to purchase, the solicitation of an offer to sell any notes. The tender offer is being made only pursuant to the Offer to Purchase and the information in this press release is qualified by reference to the Offer to Purchase. In any jurisdiction where the laws require the tender offer to be made by a licensed broker or dealer, the tender offer will be deemed made on behalf of Lilly by the dealer managers, or one or more registered brokers or dealers under the laws of such jurisdiction. None of Lilly or its affiliates, their respective boards of directors, the Dealer Managers, Global Bondholder Services Corporation or the trustee with respect to any series of notes is making any recommendation as to whether holders should tender any notes in response to the tender offer, and neither Lilly nor any such other person has authorized any person to make any such recommendation. Holders must make their own decision as to whether to tender any of their notes, and, if so, the principal amount of notes to tender.

In addition, this press release is not an offer to sell or the solicitation of an offer to buy any securities. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any such securities will be offered only by means of a prospectus, including a prospectus supplement relating to such securities, meeting the requirements of Section 10 of the Securities Act of 1933, as amended.