On February 1, 2023 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer were updated to include an addition involving neratinib (NERLYNX) (Press release, Puma Biotechnology, FEB 1, 2023, View Source [SID1234626745]).

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The updated NCCN Practice Guidelines for Breast Cancer include neratinib combinations as category 2B potential targeted therapies for patients with ER+/HER2- or ER-/HER2- metastatic (stage IV) breast cancer and activating mutations in the HER2 gene as detected by next generation sequencing of tumor tissue or ctDNA. Neratinib is included 1) with or without fulvestrant, and 2) with or without trastuzumab/fulvestrant. The NCCN Guidelines’ Category of Preference is designated as "useful in certain circumstances" and for ER+/HER2- disease, "useful in certain circumstances in patients who have already received CDK 4/6 inhibitor therapy." This update is described in a table entitled, "Emerging Biomarkers to Identify Novel Therapies for Patients with Stage IV (M1) Disease."

This addition was based on results from the Phase 2 SUMMIT trial (NCT01953926), which enrolled a cohort of patients with locally assessed HR+/ HER2- metastatic breast cancer with activating HER2 mutations who had received prior CDK4/6 inhibitor therapy (Jhaveri KL, J Clin Oncol 2022; 40:1028-1028*), as well as results from the Phase 2 MutHER trial (NCT01670877), a single-arm, multi-cohort trial that evaluated neratinib in combination with fulvestrant in patients with HER2-mutated, non-amplified metastatic breast cancer (Ma CX, Clin Cancer Res 2022; 28:1258-1267**).

Additionally, in its recent update, NCCN included dose escalation in the neratinib dosing schedule for recurrent unresectable or metastatic breast cancer. The neratinib dose escalation schedule was previously included in the 2022 NCCN Guidelines for Breast Cancer under preoperative/adjuvant therapy regimens as an approach to improve the tolerability of neratinib in the treatment of adjuvant HER2-positive breast cancer. This latest update aligns with the labeling supplement to the U.S. Prescribing Information approved by the U.S. Food and Drug Administration in June 2021, which incorporated the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL study.

Alan H. Auerbach, Chief Executive Officer and President of Puma, said, "We are pleased with the additional inclusion of neratinib in the NCCN Guidelines for Breast Cancer for patients with HER2 activating mutations. Physicians use the NCCN Guidelines as the standard resource for determining the best course of treatment for patients. We believe the updated NCCN guidelines will increase awareness, which will help assist patients, their caregivers and their healthcare providers in making informed decisions while treating this significant unmet need in advanced breast cancer."

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information.

On February 1, 2023 The University of Texas MD Anderson Cancer Center and Federation Bio, a biotechnology company pioneering bacterial cell therapies, reported a strategic collaboration to design and manufacture a complex, synthetic microbial consortium with the goal of expanding the number of cancer patients who respond to immunotherapy (Press release, MD Anderson, FEB 1, 2023, View Source [SID1234626744]). The agreement pairs Federation Bio’s proprietary ACT (anerobic co-culture technology) platform with the expertise and capabilities of MD Anderson’s Platform for Innovative Microbiome and Translational Research (PRIME-TR).

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Immune checkpoint inhibitors and other forms of immunotherapy have dramatically improved outcomes for many with cancer, but many patients do not benefit from these treatments.i Previous work, including research led by MD Anderson, demonstrates the gut microbiome is a key mediator of individual response to checkpoint inhibitors.ii Further, early findings suggest that fecal microbiota transplants (FMT) from individuals who respond to checkpoint inhibitors may improve outcomes for those who did not previously benefit.iii,iv Unfortunately, the application of FMT in this setting has been hindered by the inability to scale up manufacturing or modify FMT for enhanced therapeutic benefit.

Under the agreement, MD Anderson and Federation Bio intend to rationally design a complex consortium of bacteria derived from a donor fecal sample that has a demonstrated ability to improve immunotherapy responses in cancer patients via FMT in a clinical trial. Federation Bio will use its proprietary ACT platform to manufacture the consortium from purified cell lines, generating a therapy that comprises the full metabolic complexity of the identified microbiome and is optimized for therapeutic benefit.

"Federation Bio’s demonstrated ability to engineer complex, synthetic bacterial consortia and produce them at scale offers an exciting avenue to potentially improve cancer immunotherapy responses," said Jennifer Wargo, M.D., professor of Genomic Medicine and Surgical Oncology and director of PRIME-TR at MD Anderson. "Published evidence supports the potential of this approach, and we believe this collaboration will enable us to accelerate the development and evaluation of microbial cell therapies for our patients."

Federation Bio’s ACT platform uniquely enables the production of highly controlled bacterial consortia that have been rationally designed to address a broad range of diseases and disorders. The company already has used the platform to design and manufacture FB-001, an investigational oral therapy consisting of 148 bacterial strains isolated from multiple healthy donors. Federation Bio currently is evaluating FB-001 in a Phase I clinical trial; it is the first rationally designed complex consortium at this scale to enter clinical studies.

"We are proud to be collaborating with MD Anderson, an institution that is leading the charge globally to advance microbiome-based approaches that could dramatically improve outcomes for cancer patients," said Emily Drabant Conley, Ph.D., chief executive officer at Federation Bio. "We’ve demonstrated that our ACT platform enables the manufacture of complex, rationally designed microbial consortia at scale through the manufacture of FB-001, and this collaboration enables us to explore its potential in oncology, where there is both high unmet need and evidence supporting the critical role of the microbiome in driving therapeutic response."

PRIME-TR is a novel institutional platform that aims to transform the landscape of cancer treatment, diagnosis and prevention through studying and targeting the microbiome at multiple different niches. Supported by MD Anderson’s Moon Shots Program, PRIME-TR works to advance microbiome-based applications as a complement to other foundational discoveries and cancer treatments, including immune-based strategies and other therapeutic approaches.

On February 1, 2023 HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for 2022 and provided business updates (Press release, HanAll Biopharma, FEB 1, 2023, View Source [SID1234626743]).

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Total revenues for 2022 were 110 billion won, an 8% increase year-on-year, mainly driven by continued strong sales from the key products and milestone revenues from the licensed partners, including $10 million milestone payment from Immunovant for the initiation of the MG Phase 3 trial. Net income for the year was 2 billion won, offset by increased R&D expenses.

"HanAll continued to transform into innovative global biopharma in 2022 by strengthening clinical development capability and expanding open collaboration network while continuing to deliver solid sales performance. We were able to launch a share buyback program to return value to our stakeholders," said Sean Jeong, M.D., CEO of HanAll Biopharma.

"Moving into the 50th years since our foundation, 2023 will be a pivotal year for HanAll with top-line data readout of tanfanercept and progress in anti-FcRn programs. We will continue to make our best efforts to contribute to the patients," he added.

Full-Year 2022 BUSINESS UPDATE

Pipeline Development Highlights

A comprehensive update on HanAll’s pipeline development below includes an overview of HanAll’s research along with the list of compounds, targeted indications, and developmental phase.

Autoimmune Diseases Programs

Batoclimab (Code name: HL161BKN)

A novel, fully human, subcutaneously administered antibody targeting FcRn, with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to and inhibit FcRn, which plays a role in recycling IgG, thus leading to a reduction in IgG antibodies.

In the second half of 2022, HanAll Biopharma received approval from the Pharmaceuticals and Medical Devices Agency to initiate a Phase 3 study of batoclimab in myasthenia gravis (MG) in Japan, and plan to initiate the study in the first half of 2023. HanAll is exploring the options of developing batoclimab in thyroid eye disease (TED) in Japan.
HanAll’s licensed partner, Immunovant is conducting global Phase 3 trials with batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED). The top-line results for the pivotal Phase 2b trial in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected in the first half of 2024. In Graves’ disease (GD), a Phase 2 trial is planned to be initiated in early 2023. Immunovant will finalize the trial design in warm autoimmune hemolytic anemia (WAIHA) in early 2023, based on recent FDA interaction.
Harbour BioMed, another licensed partner of HanAll who is developing batoclimab in China, signed a sub-licensing deal with CSPC NBP Pharmaceutical Co., Ltd. in October 2022. Under the agreement, CSPC was granted the rights to develop and commercialize batoclimab in Greater China. The company is developing batoclimab in an array of autoimmune disorders including myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), and immune thrombocytopenia (ITP). The top-line data for the ongoing Phase 3 study in MG are expected in the first half of 2023.
HL161ANS (Immunovant code name: IMVT-1402)

A second novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG, designed to deliver maximum lgG reductions while minimizing interference with albumin binding.

In September 2022, Immunovant unveiled a new FcRn inhibitor HL161ANS (Immunovant code name: IMVT-1402), originally discovered and developed by HanAll. Immunovant plans to start a Phase 1 trial for HL161ANS in early 2023 with the initial data read out expected in in mid-2023.
Eye Disease Programs

Tanfanercept (Code name: HL036)

A novel, topical biologic therapy for eye diseases including dry eye disease (DED) by inhibiting TNF alpha, which is a key mediator of ocular inflammation.

HanAll Biopharma and Daewoong Pharmaceutical are progressing with the second Phase 3 VELOS-3 study in patients with moderate to severe DED to examine the safety and efficacy of tanfanercept, at nine clinical sites in the US. The study enrollment is complete and the top-line results from the VELOS-3 study are expected in the first half of 2023.
Harbour BioMed, HanAll’s licensed partner in China, announced in October 2022, that they decided to close its Phase 3 study in DED without enrolling additional patients to the study, following the recommendation from the Independent Data Monitoring Committee (IDMC) upon review of the insufficient efficacy trend observed during the second interim analysis. The study in China is different from the ongoing US study (VELOS-3) in key inclusion criteria, primary endpoints, and patient demographics reflecting different medical practices and regulatory requirements. HanAll is in discussion with Harbour BioMed regarding the next steps for the development of tanfanercept in China.
Oncology Programs

HL187/ HL186

Monoclonal antibodies that respectively target TIM-3 and TIGIT, for the potential treatment of cancer, being developed in collaboration with Daewoong Pharmaceutical Co.

HanAll is continuing with the pre-clinical development of HL187 and is preparing for IND submission in 2023. HL186 is currently in the discovery phase.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)

Key Highlights

(KRW in billion)

2022

2021

% change

Sales

110

102

+8 %

Gross Profit

62

60

+3 %

Selling, marketing and administrative expenses

44

40

+11 %

Research and development expenses

16

10

+58 %

Operating income

2

10

-85 %

Net Income

2

9

-78 %

Sales recorded 110 billion won in 2022, an 8.3% increase compared to 2021. The sales in the pharmaceutical division remained strong with its major products including Normix, Eligard, and Biotop.
R&D expenses showed a 58% increase compared to 2021, with a record of 16 billion won.
Net income was 2 billion won, a 78% decrease, compared to the same period in the year of 2021, mainly due to increased investments in R&D.

On Februray 1, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in the 2023 Guggenheim Oncology Conference (Press release, Ideaya Biosciences, FEB 1, 2023, View Source [SID1234626742]).

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2023 Guggenheim Oncology Conference
Thursday, February 9, 2023 at 7:45 AM PT (10:45 AM ET)

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer and Michael White, Senior Vice President and Chief Scientific Officer, hosted by Charles Zhu, Ph.D. Vice President and Equity Research Analyst

A live audio webcast of the event will be available, as permitted by conference host, at the "Investors/ Events" section of the IDEAYA website at View Source A replay of the webcast will be accessible for 30 days following the live event.

On February 1, 2023 Beactica Therapeutics AB, the Swedish precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BEA-17 for the treatment of glioblastoma (GBM) (Press release, Beactica, FEB 1, 2023, View Source [SID1234626741]).

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BEA-17 is a first-in-class small molecule targeted degrader of the epigenetic enzyme LSD1 and its co-factor CoREST. Overexpression of LSD1 has been implicated in the pathogenesis of a variety of cancers, including GBM. There are currently no approved therapies for GBM that target this enzyme.

"The FDA’s decision to grant orphan drug status to BEA-17 marks an important milestone for the programme and highlights the significant need for novel therapies to treat these devastating brain tumours." said Dr Per Källblad, Co-Founder and CEO of Beactica Therapeutics. "The designation will facilitate our development of this agent which we believe has the potential to serve as a much-needed therapeutic option for patients affected by glioblastoma."

The FDA’s Orphan Drug Designation program supports the development of drugs that address rare diseases which affect fewer than 200,000 people in the United States. Incentives that come with the designation include eligibility for federal grants, tax credits for qualified clinical trials, prescription drug user fee exemptions, and a seven-year marketing exclusivity period upon FDA approval.

About BEA-17

BEA-17 is a first-in-class small molecule targeted degrader (non-PROTAC) of the epigenetic enzyme LSD1 and its co-factor CoREST. The compound has shown promising preclinical in vivo potentiation of immune-modulating treatments in several cancer forms, including standard of care (temozolomide and radiation) in state-of-the-art models of GBM. Pharmacokinetic studies of BEA-17 show good blood-brain-barrier penetration and oral availability. BEA-17 is investigational and not approved anywhere globally. Its efficacy and safety in humans have not been established.

About Glioblastoma (GBM)

GBM is the most common and most aggressive brain tumour. Approximately 35,000 people in the U.S. and Europe are diagnosed with GBM each year. The median overall survival is 15 months, and the five-year overall survival is only 5%.