On December 8, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that in connection with the hiring, announced on December 5, 2022, of Steve M. Sabus as Chief Commercial Officer, Mr. Sabus received an inducement award to purchase up to 220,000 shares of common stock (Press release, Syndax, DEC 8, 2022, View Source [SID1234624961]). The stock option has an exercise price per share of $25.44, the closing price of the Company’s common stock on the Nasdaq Global Select Market on December 5, 2022 and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the vesting commencement date and 1/48th of the underlying shares vesting monthly thereafter over 36 months, subject to Mr. Sabus’ continued service relationship with Syndax through the applicable vesting dates. Syndax’s Board of Directors approved the award as inducement material to Mr. Sabus’ employment in accordance with NASDAQ Listing Rule 5635(c)(4).

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On December 8, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported that it will share a poster presentation at the 12th AACR (Free AACR Whitepaper)-JCA Joint Conference: Breakthroughs in Cancer Research — Translating Knowledge into Practice, which is being held December 10-14 in Maui, Hawaii (Press release, Sermonix Pharmaceuticals, DEC 8, 2022, https://sermonixpharma.com/sermonix-pharmaceuticals-announces-poster-presentation-on-phase-1-ethnobridging-study-of-lasofoxifene-at-the-12th-aacr-jca-joint-conference-breakthroughs-in-cancer-research-translating-know/ [SID1234624960]).

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The poster describes a Phase 1 single-dose ethnobridging study evaluating the safety, tolerability and pharmacokinetics (PK) of oral lasofoxifene (5 mg) in healthy Japanese and Caucasian women. A total of 16 women (eight Caucasian and eight Japanese) were enrolled, and patient/baseline characteristics were similar between both groups. Lasofoxifene was well tolerated, with two grade one adverse events considered not related to treatment (calf soreness in a Caucasian woman and upper right arm bruise in a Japanese woman).

The PK data are currently being analyzed and will be presented at the conference. Results of this analysis are expected to show similar lasofoxifene PK profiles between Caucasian and Japanese women.

"We believe targeted lasofoxifene holds great promise for ESR1-mutated metastatic breast cancer patients not only in the U.S. and Europe, but globally," stated David Portman, M.D., chief executive officer of Sermonix. "To that end, this analysis from this important ethnobridging study will potentially support the development of lasofoxifene for the treatment of ESR1-mutated metastatic breast cancer in Japan."

Poster presentation details:

Title: Phase 1, Open-Label, Single Dose, Ethnobridging Study Evaluating the Safety, Tolerability and Pharmacokinetics of Lasofoxifene in Healthy Japanese and Caucasian Women
Poster #: A83
Session: Poster session A
Date: Sunday, December 11, 2022
Time: 5:30 p.m. – 7:30 p.m. local time (10:30 p.m. Sunday – 12:30 a.m. Monday, EST)
About the AACR (Free AACR Whitepaper)-JCA Joint Conference
The American Association for Cancer Research (AACR) (Free AACR Whitepaper) and Japanese Cancer Association (JCA) are proud to offer this 12th AACR (Free AACR Whitepaper)-JCA Joint Conference. This meeting series has a long tradition of bringing together outstanding researchers from the United States, Japan and around the world to share their findings and present the latest advances in basic, translational and clinical cancer research. Formal and informal interactions as well as international collaborations are fostered through this unique forum. Just as its predecessors have done, this AACR (Free AACR Whitepaper)-JCA Joint Conference will take a broad view of contemporary cancer research and will be of interest to basic, translational and clinical investigators at all career levels.

About Lasofoxifene
Lasofoxifene is an investigational, targeted endocrine treatment, and next-generation nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On December 8, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the Independent Data Monitoring Committee (IDMC) for its Phase 3 REGAL study for galinpepimut-S (GPS) in acute myeloid leukemia (AML) performed its initial prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications (Press release, Sellas Life Sciences, DEC 8, 2022, View Source [SID1234624959]). The charter for the IDMC provides for periodic reviews by the IDMC for safety, efficacy and futility in addition to the interim and final analyses.

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The REGAL study is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival (OS). The IDMC is an independent group of medical, scientific and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for the REGAL trial, and for monitoring the quality and overall conduct to ensure the validity, scientific and clinical merits of the study.

"Following a prespecified review of unblinded data by the IDMC in accordance with its charter, its recommendation to continue the REGAL study as is, and with trial conduct and integrity intact, is outstanding news. As we have previously reported, we have seen, based on a blinded review of the data conducted this fall, that patients live longer than expected which triggered modifications to the statistical analysis plan (SAP), in particular to reduce the number of events for the interim and final analyses, which is very encouraging," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

On December 8, 2022 Oncolytics Biotech Inc.’s (NASDAQ: ONCY) (TSX: ONC) Chinese partner Adlai Nortye reported interim results from a multicenter, single-arm bridging clinical trial to evaluate the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced/metastatic HR+/HER2- breast cancer (Press release, Oncolytics Biotech, DEC 8, 2022, View Source [SID1234624957]). The data were featured in a poster presented yesterday at the San Antonio Breast Cancer Symposium (SABCS), which is being held at the Henry B. González Convention Center in San Antonio, Texas through December 10, 2022.

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Fifteen patients were treated in the trial as of the data cut-off date (September 26, 2022), with fourteen having had at least one post-baseline tumor assessment (i.e., evaluable for efficacy). All patients enrolled into the trial were previously treated with at least one endocrine therapy and no more than one line of chemotherapy for recurrent/metastatic disease. Data and conclusions presented in the poster are summarized below.

•Disease control, partial response (PR) or stable disease (SD), was achieved in thirteen of fourteen evaluable patients (93%), with twelve (86%) showing tumor shrinkage from baseline.
•Seven of fourteen evaluable patients achieved a PR (50%). Three of these patients achieved a confirmed PR (20%), while two patients are awaiting potential confirmatory scans.
•One patient achieving a PR at week 8 has maintained the PR through week 48 and remains on study.
•Evolving median progression-free survival (PFS) for trial participants as of the data cut-off date was 9.1 months (95% confidence interval: 3.8 – NA).
•The studied combination has been well tolerated, with no dose-limiting toxicities or serious adverse events (SAEs) reported to date.

"These impressive results have us well-positioned to leverage Oncolytics’ prior positive data and join pelareorep’s global development program," said Lars Birgerson, M.D., Ph.D., Adlai Nortye President and Chief Medical Officer. "With no SAEs reported, the data suggests the favorable safety and potent anti-cancer activity displayed by the studied combination in North American HR+/HER2- breast cancer patients extends to the Chinese population. There are also promising signs of pelareorep-paclitaxel combination therapy driving durable clinical benefit, with one patient notably still on study for nearly a year while maintaining a PR. We look forward to further characterizing the efficacy and durability of the studied combination as data from the trial mature and to continuing our collaboration with Oncolytics."

Data from the bridging trial are expected to accelerate Adlai Nortye’s development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics’ North American metastatic breast cancer trials, IND-213 and BRACELET-1. IND-213 is a previously completed randomized phase 2 trial that showed a statistically significant near doubling of median overall survival when HR+/HER2- metastatic breast cancer patients were treated with paclitaxel plus pelareorep vs. paclitaxel alone. BRACELET-1 is an ongoing randomized phase 2 trial in HR+/HER2- metastatic breast cancer patients with cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel plus pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 inhibitor avelumab. Oncolytics expects to report overall response rate, PFS, and evolving overall survival data from BRACELET-1 at a major medical meeting in the first half of 2023.

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "BRACELET-1’s upcoming readout represents a crucial catalyst for Oncolytics, as data from the trial are expected to pave the way for pelareorep’s advancement to a registrational breast cancer study. We believe Adlai Nortye’s latest data significantly de-risk this upcoming readout as they validate IND-213’s positive results by confirming the ability of pelareorep plus paclitaxel to drive durable clinical responses in HR+/HER2- breast cancer patients. I’d like to thank Adlai Nortye for the productive partnership that led to these results, providing us with added enthusiasm for the outlook of our breast cancer program."

A copy of the SABCS poster (P3-07-04), entitled, A Multicenter, Single-Arm, Open-Label Phase I Study of AN1004 (Pelareorep) Oncolytic Virus Plus Paclitaxel in Chinese Patients with Hormone Receptor-Positive and HER2-Negative Advanced/Metastatic Breast Cancer (REO 026-1), will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the symposium.

On December 8, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the CONTACT-01 study did not meet its primary endpoint of overall survival (OS) at the final analysis (Press release, Ipsen, DEC 8, 2022, View Source [SID1234624955]). CONTACT-01 is a phase III clinical trial evaluating Cabometyx (cabozantinib) in combination with atezolizumab (Tecentriq) versus docetaxel in patients with unmutated metastatic non-small cell lung cancer (NSCLC) who experienced disease progression on or after treatment with an immune checkpoint inhibitor and platinum-containing chemotherapy.

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Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen, said: "The results from the CONTACT-01 clinical trial have shown the challenge of treating NSCLC patients after prior lines of treatment have failed. While the findings of the study have not met the primary endpoint in this setting, we remain confident in the clinical efficacy of cabozantinib alone and in combination with another treatment in existing indications in difficult-to-treat tumor types. We wish to thank the patients, their families and healthcare teams for their participation in this clinical trial."

The safety profile of the combination of cabozantinib and atezolizumab observed in the trial was consistent with the known safety profiles for each single agent, and no new safety signals were identified. Detailed findings from CONTACT-01 will be submitted for presentation at a future medical meeting.

About CONTACT-01
CONTACT-01 is a global, multicenter, randomized, phase 3, open-label study that enrolled 366 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of docetaxel. The study enrolled patients with both squamous and non-squamous NSCLC who progressed during or following anti-PD-1/PD-L1 therapy administered either concurrently or sequentially with chemotherapy. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, objective response rate and duration of response. Results from cohort 7 of the phase 1b COSMIC-021 trial informed the CONTACT-01 trial design. CONTACT-01 was sponsored by Roche and co-funded by Exelixis. Both Ipsen and Takeda Pharmaceutical Company Limited (Takeda) opted in to participate in the trial and are contributing to the funding for this study under the terms of the companies’ respective collaboration agreements with Exelixis. More information about the trial is available at ClinicalTrials.gov.

About CABOMETYX (cabozantinib)

Cabometyx is a multi-targeted tyrosine kinase inhibitor (TKI) with targets including vascular endothelial growth factor receptor (VEGFR), c-MET and the TAM receptor family, which block the growth of cancer.

Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of Cabometyx outside of the U.S. and Japan. Exelixis granted exclusive rights to Takeda for the commercialization and further clinical development of Cabometyx for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize Cabometyx in the U.S.

In over 60 countries outside of the United States and Japan, including in the European Union (E.U.), Cabometyx is currently indicated as:

Monotherapy for advanced renal cell carcinoma:
as first-line treatment of adult patients with intermediate or poor risk
in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy
In combination with nivolumab for the first-line treatment of advanced renal cell carcinoma in adults
Monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy
Monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.