On November 6, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Jannie Oosthuizen, president, Human Health U.S., and Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories, are scheduled to participate in a fireside chat at the UBS Global Healthcare Conference on Wednesday, Nov. 13, 2024, at 12:30 p.m. EST / 9:30 a.m. PST (Press release, Merck & Co, NOV 6, 2024, View Source [SID1234647822]).

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On November 6, 2024 Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported its financial results for the third quarter ended September 30, 2024, and provided business highlights (Press release, Tango Therapeutics, NOV 6, 2024, View Source [SID1234647867]).

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"We have made great progress with our PRMT5 development program, including positive data from the TNG462 phase 1/2 clinical trial that showcase the best-in-class potential of TNG462 in multiple tumor types, including pancreatic and non-small cell lung cancers (NSCLC). Based on these early data, we are advancing TNG462 into trials with multiple targeted and standard of care combinations, including two RAS(ON) tri-complex inhibitors from Revolution Medicines. Given that nearly all MTAP-deleted pancreatic cancer has a co-occurring RAS mutation, we believe this could be a powerful approach to changing the treatment landscape for this challenging cancer," said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. "As part of the expanded capabilities needed to rapidly move TNG462 development forward, Dr. Maeve Waldron-Lynch, M.D. is joining Tango as Senior Vice President, Head of Clinical Development. Dr. Waldron-Lynch has extensive late-stage oncology clinical development and regulatory experience and will be invaluable as we prepare to advance TNG462 to registration."

In a separate press release issued earlier today, Tango Therapeutics provided an update on its ongoing PRMT5 clinical development program:

Data from the ongoing phase 1/2 clinical trial of TNG462, a potentially best-in-class MTA-cooperative PRMT5 inhibitor, demonstrate clinical activity across multiple tumor types, including NSCLC and pancreatic cancer. Of note, this includes an ORR of 43% in cholangiocarcinoma (n=7). Substantive durability and a good safety and tolerability profile also were observed in this ongoing trial. The next clinical update is expected in 2025.
The Company plans to initiate multiple targeted and standard of care combinations with TNG462 including RAS(ON) multi-selective and RAS(ON) G12D-selective inhibitors (Revolution Medicines), osimertinib (AstraZeneca) and pembrolizumab (Merck). These studies are expected to begin enrolling in 1H 2025.
TNG908, an MTA-cooperative brain-penetrant PRMT5 inhibitor, is clinically active and well-tolerated across non-CNS cancers in the phase 1/2 clinical trial. In particular, there were a total of nine evaluable pancreatic cancer patients, two with partial responses (ORR 22%) and five with stable disease as best response to date. The five ongoing pancreatic cancer patients have been on study for an average of 24 weeks, the longest for 72 weeks.
TNG908 did not demonstrate activity in glioblastoma (n=23 at active doses) likely because CNS exposure did not meet the required exposure threshold for clinical efficacy.
TNG908 enrollment is being stopped to allow full resourcing of TNG462 as a potential best-in-class molecule. In particular, the notably longer time on treatment observed – 24 weeks and still increasing for TNG462 versus 16 weeks for TNG908 – the superior target coverage, and the safety and tolerability profile all support selection of TNG462 for further development.
TNG456 is a next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor that is 55X selective for MTAP deletion with 20 nM potency. Preclinical studies suggest TNG456 central nervous system exposure has the potential to be sufficient for meaningful efficacy in glioblastoma and brain metastases.
The Company expects to begin enrolling patients in the planned phase 1/2 trial during 1H 2025.
Business Highlights

Clinical collaboration with Revolution Medicines

In November 2024, the Company entered into a clinical collaboration with Revolution Medicines to evaluate the efficacy and safety of TNG462 in combination with RMC-6236, a RAS(ON) multi-selective inhibitor, and with RMC-9805, a RAS(ON) G12D-selective inhibitor.
The agreement provides that Revolution Medicines will supply RMC-6236 and RMC-9805 to Tango and that Tango will be the sponsor of any combination trials. Each company will retain commercial rights to their respective compounds and the agreement is mutually non-exclusive.
TNG260, a first-in-class, highly selective CoREST complex inhibitor

The TNG260 phase 1/2 clinical trial is ongoing, evaluating safety, pharmacokinetics, pharmacodynamics and efficacy of TNG260 in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors with an STK11 loss-of-function mutation. To date, safety, tolerability and pharmacokinetic profiles are favorable.
STK11 mutations occur in approximately 15% of non-small cell lung, 15% of cervical, 10% of carcinoma of unknown primary, 5% of breast and 3% of pancreatic cancers.
Upcoming Milestones

TNG462 clinical data update expected in 2025
TNG462 combination trial enrollment expected to begin 1H 2025
TNG456 phase 1/2 trial enrollment expected to begin 1H 2025
TNG260 clinical data expected in 2025
Additional Business and Pipeline Highlights

Leadership Update

Maeve Waldron-Lynch, M.D. will join Tango as Senior Vice President, Head of Clinical Development later this month. In this role, Dr. Waldron-Lynch will lead clinical development functions under Adam Crystal, M.D., Ph.D., President of Research and Development at Tango. Dr. Waldron-Lynch most recently served as VP and Global Clinical Program Head at MorphoSys, where she oversaw the clinical program for tafasitamab. Prior to MorphoSys, she was a Clinical Development Medical Director at Novartis. Dr. Waldron-Lynch also has served as Senior Clinical Director, Oncology at Roche, and as Associate Director of Medical Science, Oncology at Mundipharma. Dr. Waldron-Lynch graduated from the University College Cork School of Medicine and served as a Specialty Registrar Medical Oncology at the Royal College of Physicians of Ireland, and a Clinical Fellow in Medical Oncology at the Yale University School of Medicine.

Financial Results

As of September 30, 2024, the Company held $293.3 million in cash, cash equivalents and marketable securities, which the Company expects to be sufficient to fund operations into the third quarter of 2026, including for additional planned TNG462 and TNG456 clinical trials.

Collaboration revenue was $11.6 million for the three months ended September 30, 2024, compared to $10.7 million for the same period in 2023, and $25.9 million for the nine months ended September 30, 2024 compared to $26.1 million for the same period in 2023. Collaboration revenue increased due to changes to estimated costs expected to be incurred under the collaboration during the three months ended September 30, 2024.

License revenue was $0 and $12.1 million for the three and nine months ended September 30, 2024, respectively, compared to $0 and $5.0 million for the three and nine months ended September 30, 2023, respectively. The year-to-date increase is primarily due to licensing a drug discovery program to Gilead for $12.0 million during the second quarter of 2024 as compared to Gilead licensing a program for $5.0 million during the second quarter of 2023.

Research and development expenses were $33.3 million for the three months ended September 30, 2024, compared to $27.1 million for the same period in 2023, and $110.0 million for the nine months ended September 30, 2024 compared to $83.9 million for the same period in 2023. The change is due to increased spend related to the advancement of TNG462, preclinical programs and personnel-related costs to support our research and development activities.

General and administrative expenses were $11.2 million for the three months ended September 30, 2024, compared to $9.2 million for the same period in 2023, and $32.7 million for the nine months ended September 30, 2024 compared to $26.4 million for the same period in 2023. The change was primarily due to increases in personnel-related costs.

Net loss for the three months ended September 30, 2024 was $29.2 million, or $0.27 per share, compared to a net loss of $22.3 million, or $0.23 per share, in the same period in 2023. Net loss for the nine months ended September 30, 2024 was $92.6 million, or $0.85 per share, compared to a net loss of $71.0 million, or $0.78 per share, in the same period in 2023.

On November 6, 2024 Novo Nordisk reported Financial report for the period 1 January 2024 to 30 September 2024 (Press release, Novo Nordisk, NOV 6, 2024, View Source [SID1234648994]).

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On November 6, 2024 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the third quarter of 2024. For the quarter, revenue was $1.01 billion, a decrease of 1.6% from $1.03 billion in the third quarter of 2023 (Press release, Charles River Laboratories, NOV 6, 2024, View Source [SID1234647807]).

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The impact of foreign currency translation benefited reported revenue by 0.4%, and an acquisition contributed 0.9% to consolidated third-quarter revenue. A divestiture of a small Safety Assessment site reduced reported revenue by 0.2%. Excluding the effect of these items, revenue declined 2.7% on an organic basis. On a segment basis, organic revenue growth in the Manufacturing Solutions (Manufacturing) and Research Models and Services (RMS) segments were more than offset by lower revenue in the Discovery and Safety Assessment (DSA) segment.
In the third quarter of 2024, the GAAP operating margin decreased to 11.6% from 14.8% in the third quarter of 2023. This GAAP decrease was primarily driven by costs associated with the Company’s restructuring initiatives. On a non-GAAP basis, the operating margin improved in all three segments; however, the improvements were more than offset by higher unallocated corporate costs, which resulted in the third-quarter operating margin decreasing to 19.9% from 20.5%.

On a GAAP basis, third-quarter net income attributable to common shareholders was $68.7 million, a decrease of 21.4% from $87.4 million for the same period in 2023. Third-quarter diluted earnings per share on a GAAP basis were $1.33, a decrease of 21.3% from $1.69 for the third quarter of 2023. The GAAP net income and earnings per share decreases were driven primarily by lower revenue and operating income, which included higher costs associated with the Company’s restructuring initiatives. On a non-GAAP basis, net income was $133.7 million for the third quarter of 2024, a decrease of 4.8% from $140.5 million for the same period in 2023. Third-quarter diluted earnings per share on a non-GAAP basis were $2.59, a decrease of 4.8% from $2.72 per share for the third quarter of 2023. The decreases in non-GAAP net income and earnings per share were driven primarily by lower revenue and operating income.

James C. Foster, Chair, President and Chief Executive Officer, said, "Forward-looking demand indicators were relatively stable in the third quarter, contributing to third-quarter financial performance which exceeded our prior outlook. We are continuing to navigate through a challenging period as global biopharmaceutical clients reduce spending in conjunction with major restructuring and pipeline reprioritization activities, but overall demand trends do not appear to have deteriorated further. In addition, biotech funding has improved in 2024, and demand appears to be demonstrating early signs of stabilization. These factors resulted in a slight, sequential improvement in net book-to-bill and the cancellation rate in the Safety Assessment business."

"We remain laser focused during this period on our strategy, which includes aggressively managing our cost structure, enhancing our clients’ experiences to gain additional share, and protecting shareholder value. We will continue to distinguish ourselves through our exceptional science and preclinical focus, in order to extend our leading position as our clients’ preferred, global, non-clinical drug development partner. We expect to emerge from this period as a stronger, leaner, and more profitable company, and an even more responsive partner for our clients," Mr. Foster concluded.
Third-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $197.8 million in the third quarter of 2024, an increase of 5.9% from $186.8 million in the third quarter of 2023. The Noveprim acquisition in November 2023 contributed 4.9% to third-quarter RMS reported revenue, and the impact of foreign currency translation increased revenue by 0.4%. Organic revenue increased by 0.6%, due primarily to higher sales of small research models in all geographic regions, principally driven by higher pricing. This was largely offset by a revenue decline for research model services, particularly in the Insourcing Solutions business.

In the third quarter of 2024, the RMS segment’s GAAP operating margin decreased to 13.9% from 15.2% in the third quarter of 2023. The GAAP operating margin decline was driven primarily by higher amortization expense related to the Noveprim acquisition coupled with higher costs associated with the Company’s restructuring initiatives, including severance and site consolidation costs. On a non-GAAP basis, the operating margin increased to 21.0% from 18.9%. The non-GAAP operating margin increase was primarily driven by higher pricing for small research models, a favorable revenue mix related to the Noveprim acquisition, and the benefit of cost savings associated with the Company’s restructuring initiatives.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $615.1 million in the third quarter of 2024, a decrease of 7.4% from $664.0 million in the third quarter of 2023. The divestiture of a small Safety Assessment site reduced reported revenue by 0.3% and the impact of foreign currency translation increased DSA revenue by 0.3%. Organic revenue decreased by 7.4%, driven primarily by lower sales volume in both the Discovery Services and Safety Assessment businesses.

In the third quarter of 2024, the DSA segment’s GAAP operating margin decreased to 20.6% from 22.1% in the third quarter of 2023 primarily driven by lower revenue and higher severance costs related to restructuring initiatives. On a non-GAAP basis, the operating margin increased to 27.4% from 27.2% in the third quarter of 2023. The non-GAAP operating margin increase was primarily driven by the benefit of cost savings associated with restructuring initiatives.
Manufacturing Solutions (Manufacturing)
Revenue for the Manufacturing segment was $196.9 million in the third quarter of 2024, an increase of 12.0% from $175.7 million in the third quarter of 2023. The impact of foreign currency translation increased Manufacturing revenue by 0.2%. Organic revenue growth of 11.8% reflected higher revenue across each of the segment’s businesses.
In the third quarter of 2024, the Manufacturing segment’s GAAP operating margin increased to 20.4% from 15.0% in the third quarter of 2023, and on a non-GAAP basis, the operating margin increased to 28.7%, from 24.5% in the third quarter of 2023. The GAAP and non-GAAP operating margin increases were driven primarily by improved operating leverage from higher revenue in each of segment’s businesses, as well as the benefit of cost savings associated with restructuring initiatives.
Stock Repurchase Update
On August 2, 2024, the Company’s Board of Directors approved a new stock repurchase authorization of $1.0 billion. Following the new authorization, the Company repurchased 500,000 shares during the third quarter of 2024 for a total of $100.7 million. As of September 28, 2024, the Company has $899.3 million remaining on its $1.0 billion stock repurchase authorization.
Updates 2024 Guidance
The Company is updating its financial guidance for 2024, which was previously revised on August 7, 2024. Revenue and non-GAAP earnings per share guidance have been narrowed and slightly raised from the midpoint of the previous ranges to principally reflect the third-quarter financial performance, which exceeded the Company’s prior outlook. In addition, GAAP earnings per share guidance has been reduced due primarily to increased charges related to the Company’s additional restructuring actions.

On November 6, 2024 Oxford Vacmedix (OVM), the UK-based biopharma company developing vaccines to treat cancer reported the lead investment in its Series B fund of $3.0m from existing investors, Dx&Vx of Seoul, South Korea and Mr. Jin of Jia He Hui Investment of Beijing, China (Press release, Oxford Vacmedix, NOV 6, 2024, View Source;utm_medium=rss&utm_campaign=oxford-vacmedix-announces-lead-investment-for-series-b-fund [SID1234647823]). Dx&Vx is OVM’s largest shareholder, and Jia He Hui Investment is the second largest shareholder. The most recent investment has been made at the valuation for OVM of $54.0m, which reflects the substantial progress the company has made in developing the novel Recombinant Overlapping Peptide (ROP) technology. Funds will be used to accelerate the development of the lead cancer vaccine OVM-200 and support further research in the Professor Shisong Jiang’s labs in the Department of Oncology at the University of Oxford.

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OVM-200 targets survivin, a protein overexpressed by cancer cells that allow unregulated growth, and stimulates an immune response. The OVM-200 vaccine is in a Phase 1 clinical trial in the UK, which is focused on safety and on establishing an immune response in advanced cancer patients in three cancer indications: non-small cell lung cancer (NSCLC), prostate cancer and ovarian cancer. Initial results from the Phase 1a dose escalation study indicated good safety and a strong immune response. The ROP technology is unique in being suitable for all HLAs (human leucocyte antigen) and has potential to be used with mRNA technology. ROPs hold the promise of minimally invasive, cost effective and efficacious therapy that can also extend and enhance the effect of immunotherapy.

William Finch, CEO of OVM said:

We are delighted to have this support from our largest shareholders. It shows their confidence in OVM’s ROP technology and in the initial results with OVM-200. This funding will allow the completion of Phase 1 and preparation for Phase 2 trials of OVM-200 alone and in combination, to help patients with advanced cancer. We look forward to interest from other investors to complete Series B.

Kevin Kwon, CEO of Dx&Vx added:

We are very pleased to be supporting OVM through this investment. We look forward to completing licensing discussions for OVM-200 for S. Korea, China, and India. We plan to proceed with Phase 1b/ Phase 2 clinical trials and will try to launch OVM-200 through an accelerated approval that will allow patients to benefit early from these effective vaccines.