On January 19, 2023 LG Chem, Ltd. ("LG Chem") (KOSPI: 051910) reported that it has completed its previously announced acquisition of AVEO Oncology ("AVEO"), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, in an all-cash transaction with an implied equity value of $571M on a fully diluted basis (Press release, LG Chem, JAN 19, 2023, View Source [SID1234626374]).

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"We are excited to complete LG Chem’s acquisition of AVEO, which will position us to deliver on our mission of becoming one of the world’s leading oncology companies with a robust clinical pipeline of innovative therapies," said Shin Hak-Cheol, Chief Executive Officer of LG Chem.

AVEO plans to accelerate the commercialization of new anti-cancer drugs developed by LG Chem Life Sciences. With strong capabilities in early-stage R&D and production process, LG Chem Life Sciences will be positioned to pursue promising anti-cancer therapies and commercial processes for pre-clinical and early clinical trials, while AVEO, with its broad expertise in clinical development and sales in the U.S. market, will oversee clinical development and commercialization.

"The merger extends LG Chem Life Sciences’ commercial footprint to the U.S., diversifies our pipeline and advances our combined capabilities with AVEO, accelerating our ability to develop, commercialize and acquire world-class cancer therapies," said Dr. Son Jeewoong, President of LG Chem Life Sciences. "We look forward to working closely with AVEO’s experienced and talented team as we welcome them to the LG Chem family."

"This transaction delivered significant value to our shareholders and AVEO is now positioned to benefit from the support and resources of LG Chem as we advance our mission of improving the lives of patients with cancer," said Michael Bailey, President and Chief Executive Officer of AVEO. "We look forward to our next chapter of growth as we realize the tremendous potential of our promising pipeline and leverage our combined capabilities to deliver continued progress across our clinical and pre-clinical stage anti-cancer therapies."

AVEO Leadership Updates

AVEO will continue to be led by President and Chief Executive Officer Michael Bailey, Chief Commercial Officer Mike Ferraresso, Chief Operating Officer Jeb Ledell and Senior Vice President, General Counsel Danielle Holland. AVEO is also welcoming Martin Birkhofer, M.D. as its Chief Medical Officer and will have Erick Lucera serve as its Chief Financial Officer during a temporary transition period. A new Chief Financial Officer is expected to be appointed by LG Chem.

While AVEO is now a wholly owned subsidiary of LG Chem Life Sciences Innovation Center, Inc., AVEO will continue to operate under the AVEO Oncology name. The combined company will fully maintain operations in Boston and Cambridge, Massachusetts, where both AVEO and LG Chem Life Sciences Innovation Center are based.

About Martin Birkhofer, M.D.

Dr. Birkhofer is an oncologist and seasoned business executive with more than 30 years of life sciences management experience. Dr. Birkhofer joins AVEO with proven leadership abilities and extensive global clinical development, business development, regulatory and medical affairs experience with both small molecules and biologics. Dr. Birkhofer most recently served as Senior Vice President and Chief Medical Officer of Taiho Oncology Inc. Prior to joining Taiho Oncology, he served as Chief Medical Officer of Gradalis, Inc. and NuCana BioMed Ltd. Between 1994 and 2013, he served in various leadership roles within Research and Development and Business Development at Bristol-Myers Squibb (BMS).

Dr. Birkhofer is Board Certified in Internal Medicine and Medical Oncology. He obtained his M.D. from New York Medical College in Valhalla, New York.

Advisors

BofA Securities served as exclusive financial advisor to LG Chem, and Latham & Watkins LLP served as LG Chem’s legal counsel. Moelis & Company LLC served as exclusive financial advisor to AVEO, and WilmerHale LLP served as AVEO’s legal counsel.

On January 19, 2023 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that it will present detailed results from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin 18.2 (CLDN18.2) targeted monoclonal antibody, plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (Press release, Astellas, JAN 19, 2023, View Source [SID1234626373]).

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In the study, investigational treatment zolbetuximab plus mFOLFOX6 demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to placebo plus mFOLFOX6. Specifically, zolbetuximab plus mFOLFOX6 reduced the risk of progression or death by 24.9% (n=565; Hazard Ratio [HR]=0.751; [95% Confidence Interval [CI]: (0.598-0.942)]; P=0.0066) compared to placebo plus mFOLFOX6, meeting SPOTLIGHT’s primary endpoint. Median PFS was 10.61 months (95% CI: 8.90-12.48) in the treatment arm and 8.67 months (95% CI: 8.21-10.28) in the placebo arm. The study also showed that zolbetuximab plus mFOLFOX6 significantly prolonged OS, reducing the risk of death by 25.0% (HR=0.750; 95% CI: 0.601-0.936; P=0.0053). Median OS was 18.23 months (95% CI: 16.43-22.90) and 15.54 months (95% CI: 13.47-16.53) for the treatment arm and placebo arm, respectively.

The incidence of serious treatment-emergent adverse events (TEAEs) was similar between both arms (44.8% versus 43.5% in the zolbetuximab versus placebo arms) and consistent with previous studies. The most frequent TEAEs in the SPOTLIGHT study were nausea (82.4% versus 60.8%), vomiting (67.4% versus 35.6%) and decreased appetite (47.0% versus 33.5%).

These new data from the SPOTLIGHT trial will be presented today at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium in an oral presentation (Abstract LBA292; January 19, 1:30 p.m. PT) by Kohei Shitara, MD, Primary Investigator for SPOTLIGHT Study and Chief, Department of Gastrointestinal Oncology, the National Cancer Center Hospital East in Kashiwa, Japan.

"For gastric and gastroesophageal junction cancer patients with disease that is locally advanced but inoperable or metastatic, to see a positive progression-free and overall survival response in SPOTLIGHT is very encouraging given the limited treatment options available," said Dr. Shitara.

"The investigational results from SPOTLIGHT are exciting and support the potential of zolbetuximab as a precision therapy for patients with CLDN18.2-positive gastric/GEJ cancer," said Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Development Therapeutic Areas, Astellas. "The SPOTLIGHT data, along with the positive topline results from the GLOW Phase 3 trial announced in December, build a strong foundation for our ongoing regulatory discussions for zolbetuximab and mark valuable progress towards our mission of turning innovative science into VALUE for patients."

The SPOTLIGHT and GLOW studies are a part of Astellas’ gastric cancer development program to investigate new treatment options such as zolbetuximab and address patient needs in locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. In both trials, approximately 38% of these patients have CLDN18.2-positive tumors (CLDN18.2 expression in ≥75% of tumor cells with strong-to-moderate staining intensity), as determined by a validated immunohistochemistry assay.1 Based on these findings, an estimated 82,000 patients globally may be eligible for zolbetuximab annually, if approved.1

About Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction Cancer
Gastric cancer, also commonly known as stomach cancer, is the fifth most commonly diagnosed cancer worldwide.2 Signs and symptoms can include indigestion or heartburn, pain or discomfort in the abdomen, nausea and vomiting, diarrhea or constipation, bloating of the stomach after meals and loss of appetite and sensation of food getting stuck in the throat while eating.3 Signs of more advanced gastric cancer can include unexplained weight loss, weakness and fatigue and vomiting blood or having blood in the stool.4 Risk factors associated with gastric cancer can include older age, male gender, family history, H. pylori infection, smoking and gastroesophageal reflux disease (GERD).4,5 Because early-stage gastric cancer symptoms frequently overlap with more common stomach-related conditions, gastric cancer is often diagnosed in the advanced or metastatic stage, or once it has spread from the tumor’s origin to other body tissues or organs.4 The five-year relative survival rate for patients at the metastatic stage is approximately six percent.6 Gastroesophageal junction (GEJ) adenocarcinoma is a cancer that starts at the area where the esophagus joins the stomach.7

About Zolbetuximab

Zolbetuximab is an investigational, first-in-class chimeric IgG1 monoclonal antibody (mAb) that targets and binds to CLDN18.2, a transmembrane protein. Zolbetuximab acts by binding to CLDN18.2 on the cancer cell surface of gastric epithelial cells. In pre-clinical studies, this binding interaction then induces cancer cell death by activating two distinct immune system pathways — antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).8 The safety and efficacy of zolbetuximab are under investigation in gastric, gastroesophageal junction and pancreatic cancers and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.

About SPOTLIGHT Phase 3 Clinical Trial

SPOTLIGHT is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab (IMAB362) plus mFOLFOX6 (combination regimen of oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6 as a first-line treatment of patients with CLDN18.2-positive, HER2- negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer. The study enrolled 565 patients at 220 study locations in the U.S., United Kingdom, Australia, Europe, South America and Asia. The primary endpoint is progression-free survival of participants treated with combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6. Secondary endpoints include overall survival, objective response rate, duration of response, safety and tolerability and quality-of-life parameters.

For more information, please visit clinicaltrials.gov under Identifier NCT03504397.

About GLOW Phase 3 Clinical Trial

GLOW is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab (IMAB362) plus CAPOX (a combination chemotherapy regimen which includes capecitabine and oxaliplatin) compared to placebo plus CAPOX as a first-line treatment of patients with CLDN18.2 positive, HER2- negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer. The study enrolled 507 patients at 165 study locations in the U.S., Canada, United Kingdom, Europe, South America and Asia. The primary endpoint is progression-free survival of participants treated with combination of zolbetuximab plus CAPOX compared to those treated with placebo plus CAPOX. Secondary endpoints include overall survival, objective response rate, duration of response, safety and tolerability and quality-of-life parameters.

On January 19, 2023 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, reported that it will participate in the 6th Annual DDR Inhibitors Summit, held in Boston, Massachusetts from January 24 – January 26, 2023 (Press release, Aprea, JAN 19, 2023, View Source [SID1234626371]).

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Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea, will participate in a panel discussion entitled "How Are Newer Targets Being Validated to Move Towards Clinical Trials?" and present in two sessions. In addition, Eric Brown, Ph.D., Scientific Consultant to Aprea and a member of the Scientific Advisory Board, will present on Repli-Biom, Aprea’s proprietary discovery platform of novel synthetic lethal targets and biomarkers.

Details for the panel and presentations are as follows:

Panel Discussion: How are Newer Targets Being Validated to Move Towards Clinical Trials?
Date & Time: Wednesday, January 25, 2023 at 5:30 pm ET
Session: Exploring Novel Targets on the Horizon & Discussing Their Potential as Monotherapy Agents
Presenter: Oren Gilad, Ph.D., President and Chief Executive Officer

Presentation: Understanding DDRi’s In the Clinic: Why is Toxicity Such a Big Issue?
Date & Time: Thursday, January 26, 2023 at 9:00 am ET
Session: Unpacking an Ongoing Clinical Challenge & DDR Inhibition’s Biggest Obstacle: Toxicity
Presenter: Oren Gilad, Ph.D., President and Chief Executive Officer

Presentation: Repli-Biom: a Novel Proteo-Genomic Approach to Identify Predictive Biomarkers of DDR Inhibitor Efficacy
Date & Time: Thursday, January 26, 2023 at 11:30 am ET
Session: Pondering Patient Selection: Improving Targeting Using Biomarkers & Screening Platforms
Presenter: Eric Brown, Ph.D., Scientific Consultant

Presentation: Adding On to Monotherapy: Combining DDR Inhibitors
Date & Time: Thursday, January 26, 2023 at 1:30 pm ET
Session: Conducting Combination Studies: A Two-Birds-One-Stone Approach to Tackling Toxicity & Resistance
Presenter: Oren Gilad, Ph.D., President and Chief Executive Officer

On January 19, 2023 Advaxis, Inc. (OTCQX: ADXS), a biotechnology company devoted to the discovery, development and commercialization of immunotherapies based on a technology which uses engineered Listeria monocytogenes (Lm), reported the completion of a previously reported merger with Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers (Press release, Advaxis, JAN 19, 2023, View Source [SID1234626370]).

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While the stock will continue to trade on OTC under the symbol ADXS, the merged company will operate under the name Ayala Pharmaceuticals. The merged company will be focused primarily on the development and commercialization of Ayala’s lead program AL102 for the treatment of desmoid tumors. As previously disclosed, the company is seeking to uplist to Nasdaq in the near future, but there is no guarantee that this effort will be successful.

Management and Board of Directors

Kenneth A Berlin, President and Chief Executive Officer of Advaxis, will be President, Chief Executive Officer and a Director of the company; Andres Gutierrez, M.D., Ph.D., will be the Chief Medical Officer; and Igor Gitelman will be the Interim Chief Financial Officer. The board of directors consists of David Sidransky, M.D., as chairman, Roni Appel, Samir Khleif, M.D., Vered Bisker-Leib, M.D., Murray A. Goldberg, Robert Spiegel, M.D., and Ken Berlin.

On January 19, 2023 Addex Therapeutics Ltd (SIX: ADXN, Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported a corporate update, including a review of its pipeline and financial guidance (Press release, Addex Therapeutics, JAN 19, 2023, View Source [SID1234626369]).

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"We ended 2022 with CHF7.0 million of cash and expect to be able to finance our operations until Q3 2023. We continue to focus on entering into collaborative arrangements across our pipeline to secure the financial resources to advance their development and strengthen our balance sheet," said Tim Dyer, CEO of Addex. "We also look forward to our Partner Janssen completing part 1 of the Phase 2 epilepsy study this quarter and reporting progress under our collaboration with Indivior."

Corporate Update:

Cash and cash equivalents at December 31, 2022 of CHF7.0 million

ADX71149, our mGlu2 PAM, licensed to Janssen Pharmaceuticals Inc., a Johnson and Johnson company: continues to advance in a Phase 2 study in epilepsy patients with completion of part 1 on track for Q1 2023. Under our agreement with Janssen, we are eligible to receive up to €109 million in success-based development and regulatory milestone, and low double-digit royalties on net sales.

Dipraglurant, our mGlu5 NAM: we continue discussions with potential strategic partners to reinitiate Phase 2 development of dipraglurant in PD-LID or an alternative indication, including pain, substance use disorders (SUD) and stroke recovery.

GABA B PAM strategic partnership with Indivior: we recently extended the research term of the agreement until March 31, 2023, securing CHF 850,000 (approx. US $900,000) of additional funding. The program is currently in clinical candidate selection phase, with IND enabling studies expected to be initiated in late 2023. Under the agreement with Indivior, in addition to research funding, we are eligible to receive $330 million in development, regulatory and sales milestones as well as the right to select drug candidates for development in certain exclusive indications outside of SUD. We plan to develop our selected drug candidate in chronic cough, pain and CMT1A.

mGlu7 NAM for the treatment of stress related disorders, including PTSD: lead drug candidate ready to start IND enabling studies.

mGlu2 NAM for the treatment of mild neurocognitive disorders and depression: drug candidates in clinical candidate selection phase.

M4 PAM for the treatment of schizophrenia and other psychotic disorders: novel series of compounds have rapidly progressed into lead optimization; scheduled to enter clinical candidate selection phase in H2 2023.