On July 13, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study evaluating BAT8006, an antibody drug conjugate (ADC) that targets folic acid receptor α (FRα) (Press release, BioThera Solutions, JUL 13, 2022, View Source [SID1234616652]). The clinical trial is a multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors to evaluate the safety and tolerability of BAT8006 and to determine the recommended phase 2 dose.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FRα is a folic acid-binding protein located on cell membranes that is overexpressed in a variety of solid tumors such as ovarian, lung, breast cancer, etc., but has a limited distribution and a lower level of expression in normal human tissues. Differences in expression levels make FRα an ideal target for ADC drug development. BAT8006 was developed using Bio-Thera’s anti-FRα antibody and Bio-Thera’s proprietary ADC linker-payload combination that includes a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. A series of preclinical studies have shown that BAT8006 has good stability and safety and has high anti-tumor activity. The small molecule topoisomerase I inhibitor payload carried by BAT8006 has a strong cell membrane penetration ability, so when the target cancer cells are killed, the payload can be released and further kill nearby cancer cells, producing a bystander effect and effectively overcoming the heterogeneity of the tumor. BAT8006 has demonstrated high anti-tumor activity and good safety in both in vitro and in vivo pharmacological studies and is a potential "best-in-class" ADC that targets FRα. BAT8006 is the first ADC drug using Bio-Thera’s proprietary new ADC platform administered to patients, representing another important milestone in the company’s research and development in the field of innovative oncology drugs.

The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT8006 is designed to assess the safety and tolerability of BAT8006. Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and to evaluate pharmacokinetics and preliminary efficacy in patients with advanced solid tumor. In addition, Bio-Thera Solutions is developing several additional ADCs targeting B7H3, Her2 and two other targets along with additional innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, and TIGIT, all in early-stage clinical studies.

On July 13, 2022 Orion Corporation reported that upgrades the full-year outlook for 2022, provided on 10 February 2022, both for the part regarding net sales and operating profit (Press release, Orion , JUL 13, 2022, View Source [SID1234616651]). Due to the collaboration agreement regarding ODM-208, announced at the same time with this release in a separate stock exchange release, and related significant upfront payment, Orion estimates net sales in 2022 to be clearly higher than in 2021. Operating profit is estimated to be clearly higher than in 2021. The upfront payment is USD 290 million of which approximately EUR 220 million is recognised in Orion’s 2022 net sales and operating profit.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

New full-year outlook, provided on 13 July 2022

Orion estimates that net sales in 2022 will be clearly higher than in 2021
(net sales in 2021 were EUR 1,041 million).

Operating profit is estimated to be clearly higher than in 2021.
(operating profit in 2021 was EUR 243 million).

Previous full-year outlook, provided on 10 February 2022

Orion estimates that net sales in 2022 will be at a similar level as in 2021
(net sales in 2021 were EUR 1,041 million).

Operating profit is estimated to be at a similar level as in 2021
(operating profit in 2021 was EUR 243 million).

On July 13, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data published today in PLOS ONE show that the company’s Percepta Genomic Sequencing Classifier (GSC) is highly accurate in re-classifying lung cancer risk among patients with lung nodules whose bronchoscopy results are inconclusive (Press release, Veracyte, JUL 13, 2022, View Source [SID1234616650]). The authors also conclude that, based on findings from the large, multi-cohort study, use of the genomic test could enable a significant portion of patients to avoid unnecessary and invasive diagnostic procedures and offer the potential for earlier diagnosis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Quickly and accurately determining whether lung nodules identified through screening or incidentally are benign or malignant is critical to improve patient outcomes, but is often challenging. Physicians frequently use bronchoscopy to evaluate potentially cancerous lung nodules because it is less invasive than surgery, however, many times this procedure produces inconclusive results, leaving physicians and patients without clear guidance about what to do next," said Bill Bulman, M.D., Veracyte’s medical director for lung cancer. "The findings from this study suggest that the Percepta GSC provides accurate, objective information that can help resolve this challenge."

Researchers evaluated the ability of the Percepta GSC to accurately classify risk of malignancy (ROM) in a blinded, independent set of 412 samples from lung nodule patients who were included in one of three, large study cohorts (AEGIS I/II and the Percepta Registry study). Each sample was classified pre-bronchoscopy as low, intermediate or high ROM and subsequently had a bronchoscopy result that was inconclusive.

Among patients with a pre-bronchoscopy intermediate ROM – which accounts for the largest group of lung nodules undergoing bronchoscopy – the Percepta GSC re-classified a total of 41% to either low or high risk. Patients in this cohort were re-classified to low risk with a 91% negative predictive value (NPV) or up-classified to high-risk with a 65% positive predictive value (PPV). Additionally, among pre-bronchoscopy low-risk nodules, the Percepta GSC down-classified 54.5% to very low risk with 100% sensitivity, indicating no false negatives, and a >99% NPV, and the test up-classified 27.3% of high-risk lesions to very-high risk with a specificity of 91.2% and 91.5% PPV. Across all pre-bronchoscopy risk groups, the Percepta GSC re-classified nearly 40% (39.1%) of patients into a different category of cancer risk.

The researchers also concluded that if the Percepta GSC results were used in this cohort of patients, 50% of those with low or intermediate pre-bronchoscopy ROM and benign lesions, as well as 29% of those with malignant lesions, who underwent additional invasive procedures could have avoided them.

"By accurately classifying lung nodules that have inconclusive bronchoscopy results, the Percepta GSC can help patients avoid unnecessary invasive procedures, and help ensure earlier diagnosis and more timely treatment for those at high risk of cancer," said Giulia C. Kennedy, Ph.D., Veracyte’s global chief scientific officer and chief medical officer.

The Percepta GSC stratifies the risk of primary lung cancer across all pre-bronchoscopy risk groups to guide patient management when bronchoscopy is inconclusive. Veracyte developed the second-generation genomic test using RNA whole-transcriptome sequencing and machine learning, and by leveraging novel "field of injury" science through which genomic changes associated with lung cancer can be found in the airways of current or former smokers. The Percepta GSC is performed utilizing a sample collected from a brushing of the patient’s main lung airway during a bronchoscopy. The test is covered by Medicare.

On July 13, 2022 Theratechnologies Inc. ("Theratechnologies" or "the Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has received a binding commitment with respect to a non-dilutive term loan with an affiliate of Marathon Asset Management for up to $100 million (Press release, Theratechnologies, JUL 13, 2022, View Source [SID1234616649]). All dollar amounts are expressed in U.S. dollars, unless otherwise stated.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Through this non-dilutive facility, we have gained a strong partner and supporter in Marathon Asset Management," said Paul Lévesque, President and Chief Executive Officer, Theratechnologies. "The term loan is a significant vote of confidence by a leading healthcare investor and serves to materially strengthen our ongoing execution capabilities. Our strategic priorities include the advancement of our clinical oncology pipeline, which is currently in a larger Phase 1b basket study, and the rapid growth of our existing marketed brands, EGRIFTA SV and Trogarzo. We are fortunate to have a strong commercial division with a refocused concentration on revenue growth in North America, our core market. We now have every element in place to ensure we can execute on our future plans and benefit from an extended cash runway," concluded Mr. Lévesque.

The facility is subject to the terms and conditions of a credit agreement. Highlights of the agreement are as follows:

Senior secured term loan of up to $100 million available across multiple tranches;
$40 million is expected to be funded on or before July 29, 2022 (Tranche 1);
$20 million to be made available through June 2023, subject to the satisfaction of defined milestones (Tranche 2);
$15 million to be made available through March 2024 subject to the satisfaction of defined milestones, (Tranche 3);
An additional $25 million will be available to Theratechnologies until December 2024 upon meeting certain defined milestones (Tranche 4);
The facility will have an initial term of five years (six years if Tranche 3 is drawn), provide for an interest-only period of 24 months (36 months if Tranche 3 is drawn prior to December 31, 2023), and bear interest at the Secured Overnight Financing Rate (SOFR) plus 9.50%, subject to a SOFR floor of 1.00%); and,
The Company has agreed to purchase $30 million of the principal amount of the Convertible Notes due June 2023, at a discount to par, in privately negotiated agreements with United States based noteholders, which are expected to close on or before July 29, 2022;
"We are strong believers in Theratechnologies’ portfolio of therapeutic assets, and we have been impressed with this management team’s commitment to addressing patients’ needs," said Evan Bedil, Head of Healthcare at Marathon. "We are pleased to offer this non-dilutive financing that will help fund the company’s growth well into the future."

Truist Securities acted as exclusive financial advisor to Theratechnologies on this transaction.

Covington & Burling LLP acted as external counsel to Marathon Asset Management LP on this transaction.

On July 13, 2022 Royalty Pharma plc (Nasdaq: RPRX) reported that it has agreed to acquire a royalty interest in TRELEGY ELLIPTA (Trelegy) from Theravance Biopharma, Inc. (Nasdaq: TBPH) and Innoviva, Inc. (Nasdaq: INVA) for $1.31 billion in cash up front and up to $300 million in additional payments contingent on the achievement of certain sales milestones (Press release, Royalty Pharma , JUL 13, 2022, View Source [SID1234616648]). The acquisition is expected to close within ten business days.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Trelegy, marketed by GSK, is a combination of an inhaled corticosteroid (fluticasone furoate) and two bronchodilators (umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting ß2 adrenoreceptor agonist) in a single delivery device administered once-daily for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and the maintenance treatment of asthma in patients aged 18 years and older(2). Many moderate to severe COPD and asthma patients still experience symptoms and Trelegy has been shown to meaningfully improve lung function and quality of life, as well as reduce exacerbations. In 2021, Trelegy generated sales of $1.68 billion, an increase of 57% at constant exchange rates versus the prior year.

"We are excited to acquire this royalty from Theravance and Innoviva," said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "Trelegy is the leading triple combination therapy for COPD and asthma and adds another important, rapidly growing blockbuster therapy to our royalty portfolio. Additionally, providing capital at scale positions Theravance and Innoviva to pursue important strategic initiatives. The transaction involves multiple parties with different motivations and goals and once again highlights how Royalty Pharma can facilitate complex transactions to create win-win solutions for its partners."

Transaction Terms

Royalty Pharma is acquiring from Theravance and Innoviva all of the equity interests in Theravance Respiratory Company, LLC, which is entitled to an upward tiering royalty of 6.5% to 10% on annual worldwide Trelegy sales, payable by GSK. Royalty Pharma will pay to Theravance 85% of the royalties in respect of ex-U.S. net sales after June 30, 2029 and 85% of the royalties in respect of U.S. net sales after December 31, 2030.

Royalty Pharma is also providing Theravance $25 million in upfront funding and a potential $15 million regulatory milestone to support the clinical development of ampreloxetine, an investigational once-daily norepinephrine reuptake inhibitor for the treatment of symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy. Neurogenic orthostatic hypotension is a rare disorder in which the autonomic system fails to regulate blood pressure properly, resulting in low blood pressure upon standing. In exchange, Royalty Pharma will receive a low- to mid-single digit royalty on worldwide sales of ampreloxetine.

Trelegy Financial Contribution

The purchase of royalties on Trelegy will further diversify Royalty Pharma’s portfolio with a premier, blockbuster therapy. Based on the current analyst consensus estimate, Royalty Pharma expects this transaction to add at least $200 million to Adjusted Cash Receipts(1) (non-GAAP) in 2025, resulting in enhanced long-term growth.

Royalty Pharma expects to fund this transaction with existing cash on the balance sheet and to maintain significant financial capacity to deploy capital in additional value-creating opportunities.

Advisors

Goodwin Procter, Jones Day and Maiwald acted as legal advisors to Royalty Pharma.