Hangzhou Adlai Nortye Biopharma Co. Ltd.

Takeda's Exkivity market withdrawal, Kyowa Kirin's acquisition of Orchard Therapeutics and Biogen's Actemra biosimilar approval made our news this week. Takeda will withdraw lung cancer drug Exkivity after a confirmatory trial failure. Kyowa Kirin is buying gene therapy biotech Orchard Therapeutics. Biogen's biosimilar version of Roche's Actemra, bought from Bio-Thera Solutions, won an FDA nod. And more. 1. Takeda to pull lung cancer med Exkivity around the world after confirmatory trial flop Takeda will pull Exkivity from the market in the U.S. and beyond. The drug won an accelerated approval in 2021 for previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations. But the phase 3 EXCLAIM-2 confirmatory trial in the first-line setting was a blunder. Exkivity failed as a monotherapy, just as Johnson & Johnson’s rival therapy Rybrevant succeeded in a combination with chemotherapy. 2. Orchard lands $387M Kyowa buyout, reaping harvest of US gene therapy progress Kyowa Kirin is paying $387.4 million upfront to purchase Orchard Therapeutics, which has a gene therapy for early-onset metachromatic leukodystrophy approved in Europe and under review at the FDA. Orchard investors will get an additional $1 per share if the FDA approves the med. After some clinical setbacks, Kyowa CEO Masashi Miyamoto recently said the company was working on acquisitions. 3. Biogen nabs FDA nod for biosimilar version of Roche's blockbuster Actemra The FDA has approved the first biosimilar to Roche’s blockbuster autoimmune drug Actemra. The copycat, now branded as Tofidence, will be marketed by Biogen. The company got the drug in 2021 from Chinese company Bio-Thera Solutions by paying $30 million upfront. The approval comes as Biogen conducts a strategic review of its biosimilar franchise. 4. Adlai, building on the ashes of Novartis' failure, raises $57.5M IPO to run phase 3 cancer trial Chinese-American biotech Adlai Nortye has raised $97.5 million through a Nasdaq IPO and private placement, and traded down 33% on its first day. The company has a Novartis castoff, a PI3K inhibitor called buparlisib, serving as its lead candidate. The drug is in pivotal testing in head and neck cancer. Novartis sold the drug for just $9.5 million upfront after seeing safety issues in a phase 3 breast cancer study. 5. In selling 3 businesses, Viatris bids adieu to 10 manufacturing plants, 6,000 employees Viatris is shedding some over-the-counter, women’s health and active pharmaceutical ingredient assets for more than $3 billion. In one deal, Viatris has agreed to sell its API business in India to IQuest Enterprises. The deal features six manufacturing sites and an R&D lab. Other News of Note 6. Flooding halts manufacturing at Alembic Pharmaceuticals plant in India 7. Lokavant snares $8M investment to expand its presence in Asia-Pacific region

Adlai Nortye is aiming to file for accelerated FDA approval next year. Adlai Nortye has established the financial foundation to show whether its bet on an ex-Novartis asset will pay off, securing $97.5 million through an IPO and private placement to fund a phase 3 trial in head and neck cancer. The Chinese-American biotech paid Novartis $9.5 million for the candidate, a PI3K inhibitor now called AN2025, in 2018. Novartis offloaded the asset after concluding that the safety profile in a phase 3 breast cancer trial was too bad to support further development. But Adlai sees a future for the therapy, leading it to strike a deal worth up to $74 million in regulatory milestones and start a 483-subject study. With $60 million to its name as of the end of June, the biotech needs more money to support plans for a pipeline that features AN2025 and an EP4 antagonist in-licensed from Eisai for $6 million upfront. The IPO and concurrent private placement meet the need for money. Adlai is selling 2.5 million shares at $23 apiece, positioning it to gross $57.5 million from the IPO. The private placement will add a further $40 million to the biotech’s coffers. Adlai plans to use $46.7 million of the money to fund a registrational trial of AN2025, plus milestone payments and launch preparations. The biotech has earmarked another $29.7 million to fund the rest of its pipeline.  The phase 3 trial is testing AN2025 in patients with recurrent or metastatic head and neck squamous cell carcinomas who have progressed after taking a PD-1/L1 drug. Adlai is aiming to file for accelerated FDA approval of the drug candidate in the second half of next year and to follow up with submissions in China, Europe and Japan. If Adlai pulls off the plan, it will have a shot at addressing an unmet need. The biotech believes AN2025 is the only drug candidate in active phase 3 development in its target indication. AstraZeneca and Innate Pharma had an anti-NKG2A antibody in development, but it failed a late-phase trial last year. Other assets such as Aveo Oncology’s ficlatuzumab are trailing AN2025 in the race to market.

FN Media Group Presents USA News Group News Commentary VANCOUVER, British Colombia , Nov. 30, 2022 /PRNewswire/ -- USA News Group - A new study has revealed that women diagnosed with benign breast disease through screening have an almost double risk of acquiring breast cancer. The findings come ahead of this year's San Antonio Breast Cancer Symposium (SABCS), known as one of the largest breast cancer symposiums in the world. This year's SABCS is already shaping up to contain some big developments, including data and presentations from biotech companies such as O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Eli Lilly and Company (NYSE: LLY), NeoGenomics, Inc. (NASDAQ: NEO), Zymeworks Inc. (NYSE: ZYME), and G1 Therapeutics, Inc. (NASDAQ: GTHX). Ahead of the SABCS, which is scheduled for December 6-10, 2022, analysts at ReportLinker are projecting that the Global Breast Cancer Therapeutics Market is expected to grow by US$13.85 billion during 2022-2026, accelerating at a CAGR of 8.95% during the forecast period. Set to present two new abstracts at the SABCS is O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) through a pair of poster presentations, including interim results from a bridging clinical trial being conducted with partners Adlai Nortye, to evaluate Oncolytics' flagship asset pelareorep in combination with paclitaxel in patients with advanced or metastatic HR+/HER2- breast cancer in one poster. The second poster will include data from a collaboration with SOLTI-Innovative Cancer Research from the AWARE-1 window-of-opportunity study in early-stage breast cancer patients. Full texts of the abstracts are available on the SABCS website. Data published in the SABCS abstract indicates that pelareorep in combination with paclitaxel was safe, well tolerated, and showed anti-tumor activity in Adlai Nortye's single-arm bridging clinical trial in Chinese patients with advanced or metastatic HR+/HER2- breast cancer. As of the abstract's cut-off date, 10 patients were treated, with 4 achieving a partial response (PR) (2 confirmed, 2 unconfirmed), and 5 showing stable disease (SD). This bridging trial is designed 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. Results from IND-213 showed a statistically significant near doubling of median overall survival in HR+/HER2- breast cancer patients treated with pelareorep plus paclitaxel compared to those treated with paclitaxel monotherapy. BRACELET-1 remains ongoing, with a readout on overall response rate, progression-free survival, and evolving overall survival data from the randomized phase 2 trial expected in the first half of 2023. As for the AWARE-1 abstract, Oncolytics will be presenting results of gene expression analyses from cohorts 1 and 2, which exclusively enrolled patients with the HR+/HER2- breast cancer subtype who were treated with pelareorep and anti-cancer drug letrozole—with cohort 2 being with the PD-L1 checkpoint inhibitor atezolizumab and cohort 1 being without it. Results published in the abstract showed that the studied combinations altered tumor microenvironments to induce and enhance anti-tumor immunity. Biotech giant Eli Lilly and Company (NYSE: LLY) also announced that study investigators will present data from the company's breast cancer portfolio and pipeline at the SABCS, including new results from studies of Verzenio® (abemaciclib; a CDK4/6 inhibitor), imlunestrant (an investigational oral selective estrogen receptor degrader [SERD]), and LOXO-783 (an investigational mutant-selective allosteric PI3Kα H1047R inhibitor). For the Verzenio oral and poster presentations, LLY will provide updated clinical data from ongoing studies in early and advanced forms of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Eli Lilly's oral presentation will provide results from a pre-planned overall survival (OS) analysis from the Phase 3 monarchE study in HR+, HER2-, node-positive, high-risk early breast cancer, including four-year efficacy outcomes. In another spotlight poster discussion, combination therapy results with imlunestrant will also be presented from the Phase 1 EMBER trial of imlunestrant in combination with Verzenio, with or without an aromatase inhibitor, in patients with estrogen receptor positive (ER+), HER2- advanced breast cancer. In addition, pharmacodynamic data from the preoperative EMBER-2 trial evaluating imlunestrant in ER+, HER2- early breast cancer will be provided. Preclinical data with LOXO-783 in combination with standard-of-care breast cancer agents will also be presented at the meeting. Oncology testing and global contract research services provider NeoGenomics, Inc. (NASDAQ: NEO) and its liquid biopsy-focused subsidiary, Inivata Limited are set to present new data at the SABCS that supports the use of their personalized, highly-sensitive sequencing test RaDaR®Assay across all types of early breast cancer in both the adjuvant and surveillance settings. "The data being presented at SABCS adds to the growing body of evidence demonstrating the accuracy of RaDaR in detecting minimal residual disease and early disease relapse," said Vishal Sikri, MBA, President and Chief Commercial Officer, Inivata, and President, Pharma Services, NeoGenomics. "We believe RaDaR offers great promise in breast cancer care as the detection of MRD and recurrence provides critical insights that can significantly impact patient care." RaDaR detects minimal residual disease (MRD) and recurrence, which are the trace amounts of circulating tumor DNA (ctDNA) that remain after surgery or other cancer treatment. One study being presented compared the use of RaDaR to digital PCR (dPCR) in the surveillance setting in 161 patients with early-stage triple-negative breast cancer (TNBC). Among ctDNA-positive patients, more than half (55.2%) were first detected by RaDaR versus 5.2% by dPCR. Clinical stage biopharmaceutical company Zymeworks Inc. (NYSE: ZYME) announced the publication of an abstract for their bispecific antibody zanidatamab, that can simultaneously bind two non-overlapping epitopes of HER2. In combination with palbociclib and fulvestrant, zanidatamab was well tolerated, with encouraging and durable anti-tumor activity in heavily pretreated patients with HER2-positive HR+ breast cancer. As per the trial, 34 heavily pretreated patients with HER2-positive HR+ breast cancer were treated with the zanidatamab+Palbociclib+fulvestrant combination, which resulted in a 34.5% confirmed objective response rate, with a 93.1% disease control rate in 29 response-evaluable patients. Commercial-stage oncology company G1 Therapeutics, Inc. (NASDAQ: GTHX) will also be presenting at SABCS with initial results from its Phase 2 Trilaciclib Mechanism of Action (MOA) Trial, which is a 24 patient trial in early-stage TNBC. G1 Therapeutics's primary endpoints will assess the immune-based MOA, including the impact of Trilaciclib on CD8+ T cells and regulatory T cells, or Tregs, in the tumor microenvironment. Secondary endpoints will include pathological complete response (pCR), immune response, and profiling measures. G1 will present initial results from the primary endpoint as a poster presentation during the 2022 SABCS. For more information please visit: Article Source: USA News Group [email protected] DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. 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