On July 13, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported plans to focus on its emerging pre-clinical and early clinical pipeline and to realign its capital resources to drive these efforts (Press release, CytomX Therapeutics, JUL 13, 2022, View Source [SID1234616642]).

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"With the Probody therapeutic platform, CytomX has pioneered a new and strategic field of biologics drug discovery and development. Our leadership position will continue as we incorporate learnings from our broad clinical experience and advance our next wave of innovative product candidates," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics. "In the context of the challenging current investment climate for biotechnology, we are making a series of changes to ensure CytomX remains well positioned for the future. We are restructuring the organization to focus on our earlier stage capabilities and programs, as well as our partnerships, leveraging our multi-modality Probody platform to accelerate the development of next-generation therapeutics to destroy cancer differently," continued Dr. McCarthy.

Business & Strategy Updates

Strategic realignment to accelerate early-stage pipeline development, including partnered programs, and extend cash runway:
The Company is restructuring its business to prioritize internal investments in its emerging pre-clinical and early clinical pipeline, resulting in a reduction to its workforce, primarily development and general and administrative staff, by approximately 40%.
These changes are expected to extend the Company’s cash runway into 2025.
CytomX is maintaining its robust research, translational, and early development organizations to support ongoing internal pipeline efforts with two Investigational New Drug Applications (INDs) planned for 2023.
CytomX remains committed to its current alliances with AbbVie, Amgen, Astellas, and Bristol Myers Squibb, which include the clinical-stage programs CX-2029, CX-904, and BMS-986249.
The Company will continue to emphasize future business development and new alliance formation as an integral part of its corporate strategy.
Dr. McCarthy continued, "This difficult decision to restructure CytomX regrettably leads to the departure of many valued team members who have been dedicated to our vision and mission and whose contributions have been critical to the Company’s success to date. On behalf of myself and the Board of Directors, we thank them for their efforts and wish everyone the very best in their future endeavors."

Overview of CytomX Pipeline of Conditionally Activated Product Candidates:
New Emerging INDs

Interferon alpha-2b (IFN alpha-2b) program – CX-801 is a wholly-owned IFN alpha-2b Probody. Based on preclinical activity and tolerability studies, CX-801 demonstrated a wide therapeutic index with an enhanced tolerability profile versus unmasked IFN, without compromising its potent antitumor effects. CX-801 has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. An IND submission is planned in 2023.
EpCAM-directed ADC program – CX-2051 is a wholly-owned conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. An IND submission is planned in 2023. CX-2043, CytomX’s DM21-conjugated EpCAM-directed ADC, is being deprioritized.
Current Clinical Programs

T-cell-engaging bispecific (TCB) EGFRxCD3 program – CX-904 is designed to target both the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells. CX-904 is currently in a Phase 1 dose-escalation study and is part of CytomX’s partnership with Amgen.
CD71-directed antibody-drug conjugate (ADC) program – CX-2029 has shown encouraging activity in patients with squamous non-small cell lung cancer in a Phase 2 expansion study. Enrollment in this cohort is complete and a data update is expected in the second half of 2022. CX-2029 is part of CytomX’s partnership with AbbVie.
Ipilimumab Probody program – BMS-986249 and BMS-986288 are Probody versions of the CTLA-4-targeting antibodies, ipilimumab and non-fucosylated ipilimumab, respectively – both being developed by Bristol Myers Squibb. BMS-986249 is being evaluated in a randomized Phase 2 study in combination with nivolumab in patients newly diagnosed with advanced melanoma. This novel combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer. BMS-986288 is being evaluated as monotherapy and in combination with nivolumab in a Phase 1 study in advanced solid tumors.
CD166-directed ADC program – Praluzatamab ravtansine demonstrated single-agent activity in a Phase 2 study in heavily-pretreated patients with advanced hormone receptor-positive, HER2-non-amplified breast cancer. As announced on July 6, 2022, based on results of a three-arm Phase 2 study, CytomX is deprioritizing internal investment in this program and will be seeking a partnership to further advance the asset.
Anticipated Future Pipeline Milestones

2022

Data update for CX-2029 from the ongoing Phase 2 expansion study in patients with squamous non-small cell lung cancer
Updated data from the Phase 2 study of praluzatamab ravtansine in advanced breast cancer
2023 – second half

IND submissions for CX-801 and CX-2051
Conference Call & Webcast
CytomX management will host a conference call and a simultaneous webcast today at 6:00 pm ET (3:00 pm PT) to discuss these updates. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. A live webcast of the call can be accessed via the Events and Presentations page of CytomX’s website at View Source

On July 13, 2022 Myovant Sciences (NYSE: MYOV), reported it will host a webcast and conference call to discuss corporate updates and financial results for its first fiscal quarter, ended June 30, 2022 (Press release, Myovant Sciences, JUL 13, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-host-first-fiscal-quarter-2022-earnings [SID1234616641]). The webcast and conference call will be held at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time on July 27, 2022.

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Investors and the general public may access the live webcast here. The live webcast can also be accessed by visiting the company’s investor relations page of Myovant’s website at: https://investors.myovant.com/.

The webcast will be archived on the company website for approximately one year.

On July 13, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the China National Medical Products Administration (NMPA) has conditionally approved COSELA (trilaciclib hydrochloride for injection), which was jointly developed for use in Greater China by Simcere and G1 Therapeutics (Press release, G1 Therapeutics, JUL 13, 2022, View Source [SID1234616640]). COSELA is now indicated in China to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen for extensive-stage small cell lung cancer. As a result of receiving approval in China, G1 will receive a $13 million milestone payment. In total, G1 may receive up to $156M in total milestones. G1 may also receive double-digit royalties on annual net sales of COSELA in China.

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"G1 congratulates our partner Simcere on rapidly progressing the development of COSELA in Greater China and successfully obtaining marketing approval from the National Medical Products Administration," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "China is one of the largest markets globally and there remains a great unmet medical need for an effective solution to prevent or reduce the debilitating myelosuppressive side effects of chemotherapy. We are excited Simcere will now be able to make COSELA available to ES-SCLC patients in Greater China, which represents a critical initial milestone in our mission of improving the lives of those impacted by cancer globally."

It is predicted that, by 2040, the number of new cancer patients requiring chemotherapy in China will reach 4.2 million. While chemotherapy remains the cornerstone of treatment for many cancer types, its toxic side effects have widespread impact on patients and can lead to dose reductions or delays, both of which diminish its therapeutic effect. According to Chinese statistics, myelosuppression is associated with more than 80% of chemotherapy drugs. G1 has partnered with Simcere to jointly conduct clinical trials of trilaciclib in colorectal cancer and triple negative breast cancer.

About COSELA (trilaciclib) for Injection

This is intended for U.S. audiences.

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

On July 13, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Orion Corporation ("Orion") reported a global development and commercialization agreement for Orion’s investigational candidate ODM-208 and other drugs targeting cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production (Press release, Merck & Co, JUL 13, 2022, View Source [SID1234616638]). ODM-208 is an oral, non-steroidal inhibitor of CYP11A1 currently being evaluated in a Phase 2 clinical trial for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

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Under the terms of the agreement, Orion and Merck, acting through its subsidiary, Merck Sharp & Dohme LLC, will co-develop and co-commercialize ODM-208. Merck will make an upfront payment to Orion of USD 290 million, which will be expensed by Merck in the third quarter of 2022 and included in non-GAAP results. Of this upfront payment, Orion recognizes approximately EUR 220 million as income at the time of signing and approximately EUR 60 million is reserved to cover Orion’s share of ODM-208 development cost to be accrued in the future. Orion will be responsible for the manufacture of clinical and commercial supply of ODM-208.

In addition, the contract provides both parties with an option to convert the initial co-development and co-commercialization agreement into a global exclusive license to Merck. If the option is exercised, Merck would assume full responsibility for all accrued and future development and commercialization expenses associated with the program. Orion would be eligible to receive milestone payments associated with progress in the development and commercialization of ODM-208 as well as tiered double-digit royalties on sales if the product is approved. The total amount potentially accrued from multiple regulatory and sales milestone events represents a substantial opportunity for Orion.

"Targeting CYP11A1 provides a compelling approach to suppressing the production of steroid hormones, a key driver of prostate cancer," said Dr. Dean Y. Li, president, Merck Research Laboratories. "We believe ODM-208 has the potential to complement our existing program in prostate cancer and look forward to working with the team at Orion."

"We are delighted to enter this collaboration with Merck, which is committed to extend and improve the lives of patients with cancer and has a strong commercial presence globally," said Timo Lappalainen, president and chief executive officer, Orion. "This agreement positions Orion to harness the potential of ODM-208 for the good of patients while continuing to invest in our other programs without compromising our financial targets."

About ODM-208

ODM-208 is an oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as prostate cancer. By inhibiting CYP11A1 enzyme activity, ODM-208 is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.

About Metastatic Castration-Resistant Prostate Cancer

Globally, prostate cancer is the second most common cancer in people assigned male at birth, with an estimated 1.4 million patients diagnosed worldwide in 2020. Approximately 10-20% of patients with advanced prostate cancer are estimated to develop CRPC within five years, and at least 84% of these patients may develop metastases at the time of CRPC diagnosis. Patients with advanced prostate cancer have a particularly poor prognosis, and the five-year survival rate remains low.

On July 13, 2022 IntegraGen (FR0010908723 – ALINT ), an OncoDNA Group company specializing in the decryption of the human genome which performs interpretable genomic analyzes for academic and private laboratories and develops diagnostic tools for oncology, reported its non-audited revenue of 6,439 k€ for the first half of 2022, representing an increase of 34% compared to H1 2021 (Press release, Integragen, JUL 13, 2022, View Source [SID1234616637]). This sales growth across all of the company’s businesses reflects the strong rebound of the general economic business climate compared to H1 2021 which was significantly impacted by the global pandemic.

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R&D sequencing activities have resumed the pre-pandemic growth trend and were fueled by several significant projects realized on the company’s sequencing platform in Évry. The growth was primarily a result of the strong demand for projects that were initiated in Q2 2021. The sequencing platform also benefited from a pandemic-related microbiology project during H1 which resulted from site specific sequencing capacity limitations experienced by one of the company’s partners, representing c. 7% of the company’s revenue in H1. In parallel with the above, sequencing activities associated with external platforms operated by IntegraGen continued to experience increased output with new clinical research projects for oncology also driving revenue growth.

The company’s cash position as of end of June 2022 was 4,489 k€, a decrease of 0.3 M€ compared to December 31, 2021. This was in line with the company’s expectations and 2022 budget. This decrease was primarily due to change in working capital requirement. This position includes a State guaranteed loan (Prêt Garanti par l’État, PGE) totaling 1,763 k€, received at the beginning of 2020, that the Company started to reimburse in June.

Despite a temporary slowdown in the booking orders as of end of June, the company confirms its growth perspectives based on the current sales dynamics and existing long-term contracts along with the synergies now in place with the other entities of the OncoDNA Group.

Bernard Courtieu, IntegraGen CEO, said "The revenue generated during the first half of 2022 confirms the resilience of IntegraGen’s business across each and every line of the company’s business. The company is now well-positioned for the future with rebound in the growth of our business seen in 2022 demonstrating our growth potential. The company’s business remains driven by long term contracts for the operation of external sequencing platforms with additional benefits derived from solid commercial dynamics, including the synergies we are now experiencing as a result of being fully integrated into the OncoDNA Group."

Full financial results for H1 2022 will be published on October 18, 2022.