On October 3, 2023 BPGbio, Inc., a leading AI-powered biopharma that focuses on oncology, neurology, and rare diseases, reported that review of the Phase 2a trial in advanced, refractory pancreatic cancer patients by a Medical Advisory Board for its BPM 31510IV for Pancreatic Cancer recommends advancing the asset into a Phase 2b trial following a comprehensive analysis of data observed from a Phase 1 and completed Phase 2a clinical studies (Press release, BPGbio, OCT 3, 2023, View Source [SID1234635622]).

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As a result, the Advisory Board recommends the drug candidate be further assessed as a potential first-line therapy in advanced pancreatic cancer patients in the Phase 2b trial design. BPGbio submitted their findings for presentation to a major cancer meeting in January 2024 and embarked on the necessary diligence to assess the most appropriate next steps for development.

In the Phase 2a clinical trial, BPM 31510 IV demonstrated a tolerable safety profile in advanced refractory pancreatic cancer patients with an early indication for potential clinical benefit. Prior to commencement of the Phase 2a trial, the mechanism of action of BPM 31510 was first validated by data from BPGbio’s NAi Interrogative Biology multi omics AI platform, which suggested that there is a hallmark shift in the tumor microenvironment (TME) wherein a Warburg shift is induced by BPM 31510 to modulate mitochondrial oxidative phosphorylation in highly aggressive tumors, with a direct effect on the BCL-2 protein family.

"We are extremely encouraged to observe that BPM 31510 has demonstrated an early indication of potential clinical benefit for patients with advanced refractory pancreatic cancer," said Niven R. Narain, Ph.D., President and CEO of BPGbio. "Pancreatic cancer is the fourth leading cause of death of all cancers with only a 10% survival rate, we are focused on assessing further development of this drug for patients and their families affected by this devastating disease."

"Advanced pancreatic cancer patients have limited treatment options and lack of early detection often leads to advanced diagnosis in most cases, resulting in devastating impacts on the family unit," said Madappa Kundranda, M.D., Ph.D., Chief of Division of Cancer Medicine, Banner MD Anderson Cancer Center. "Early indication from BPM 31510 data, which targets the tumor microenvironment (TME), thus far supports further study in late-stage trials with the goal of offering hope for more effective treatment for the pancreatic patient community."

Moreover, in an ambitious commitment to changing the treatment paradigm of pancreatic cancer, BPGbio has identified biomarkers for early disease diagnoses in pancreatic cancer through Project Survival, a bold seven-year study led in collaboration with Beth Israel Medical Center/Harvard Medical School, among others. This initiative holds the promise of earlier disease diagnoses which may result in better outcomes, thereby potentially saving more lives. Project Survival has been supported by the Alliance for Families Fighting Pancreatic Cancer (AFFPC).

On October 3, 2023 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that it will host a conference call and live webcast to share initial data from Module 1 and 2 of its ongoing Phase 1 MYTHIC clinical trial that will be presented in a plenary session at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC conference, being held October 11-15, 2023 in Boston, MA (Press release, Repare Therapeutics, OCT 3, 2023, View Source [SID1234635621]). The data that will be presented at AACR (Free AACR Whitepaper)-NCI-EORTC will be based on a later cutoff date than what is included in the abstracts, which are released on Wednesday, October 4, 2023 at 12:00 p.m. ET. Repare’s executive management team will be joined by Dr. Timothy A. Yap, MBBS, PhD, FRCP, Principal Investigator, Professor in the Department of Investigational Cancer Therapies (Phase 1 Program) and Vice President, Head of Clinical Development in the Therapeutics Discovery Division at the University of Texas MD Anderson Cancer Center in Houston, Texas.

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Conference Call and Webcast Details:

To access the call, please dial (877) 870-4263 (U.S. and Canada) or (412) 317-0790 (international) at least 10 minutes prior to the start time and ask to be joined to the Repare Therapeutics call. A live video webcast will be available in the Investor section of the Company’s website at View Source A webcast replay will also be archived for at least 30 days.

On October 3, 2023 Exscientia plc (Nasdaq: EXAI) reported an update on its pipeline prioritisation strategy designed to further strengthen the Company’s focus, investment and infrastructure on programmes of greatest potential for differentiation and value creation (Press release, Exscientia, OCT 3, 2023, View Source [SID1234635620]).

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Exscientia has built a highly efficient and versatile AI-led drug discovery platform. To date, its platform has yielded eight differentiated clinical development candidates across a variety of therapeutic areas, and at a pace that is substantially faster than current industry standards. The Company anticipates its capabilities will continue to grow, driven by recent investments in automation as well as other leading technological and scientific advancements which may further accelerate pipeline growth. In this context, the Company intends to prioritise its internal development efforts and focus its resources on the most differentiated, highest value oncology targets within its portfolio, such as LSD1 and CDK7. This strategic focus is designed to allow Exscientia to maximise its pipeline value and output while continuing to develop novel technologies to transform drug discovery and development. In addition, it will enhance operational and financial efficiency with a cash runway well into 2026.

"Exscientia creates value by using technology to solve previously unsolved discovery challenges and achieving great data-driven operating efficiency," said Professor Andrew Hopkins FRS FMedSci, founder and Chief Executive Officer of Exscientia. "Our oncology programmes like LSD1 and CDK7 focus on well-understood development challenges where our platform can have a clear impact that, if successful, would lead to significant therapeutic benefit. Beyond a focused number of high-value internal programmes in areas where we have deep expertise and strong differentiation, we believe the best way Exscientia can create an abundance of novel medicines for patients is by pairing our platform with strong partners in existing and future collaborations."

Prioritising CDK7 and LSD1 advancement:

GTAEXS617 (CDK7):
‘617 is a potential best-in-class, reversible, candidate designed for improved potency, selectivity and pharmacokinetics compared to other molecules in development
Patient enrolment continues in the ELUCIDATE Phase 1/2 adaptive trial in patients with advanced solid tumours including head & neck cancer, HR+/HER2- breast cancer, non-small cell lung cancer, pancreatic cancer, ovarian cancer and colorectal cancer
The model-driven adaptive trial is studying ‘617 as monotherapy and in combination with standard of care, where Exscientia’s precision medicine platform is expected to play a critical role in determining the best combinations
EXS74539 (LSD1):
The Company will further prioritise the advancement of its LSD1 inhibitor into the clinic
IND submission expected in the first quarter of 2024
‘539 is highly differentiated in predicted human pharmacokinetics, pre-clinical safety and flexibility of dosing. Based on the unique combination of reversible mechanism of action and CNS penetration it has the potential to be first and best-in-class for small cell lung cancer (SCLC) and acute myeloid leukaemia (AML)
The Company intends to initiate a Phase 1 healthy volunteer trial in the first half of 2024 that could support more efficient development of ‘539 in multiple indications and in combination with other therapies
LSD1-related data from Exscientia’s precision medicine technology will be presented at ESMO (Free ESMO Whitepaper) in October, including data in primary AML tissues
Potential programmes for partnering or out-licensing

EXS21546 (A2A):
In addition to a validated patient selection strategy, the Company believes a prolonged, high level of target coverage is necessary for therapeutic effect, which has been supported by recently announced peer data. Based on modelling of the clinical and preclinical data, it will be challenging for ‘546 to reach a suitable therapeutic index
The Phase 1/2 trial will be wound down and internal research around the target will be discontinued
Exscientia believes in the A2A mechanism and its value for a potential partner with an existing immunotherapy pipeline. Exscientia will evaluate potential partnerships for its next-generation compounds and precision medicine capabilities
Additional ongoing clinical, IND-enabling and discovery programmes

EXS73565 (MALT1):
Exscientia’s MALT1 inhibitor is progressing through IND/CTA enabling studies and the Company expects to be able to provide further updates in the first half of 2024. Exscientia believes that ‘565 is highly differentiated due to reduced UGT1A1 inhibition combined with potency and selectivity
Data will be presented at ESMO (Free ESMO Whitepaper) in late October highlighting ‘565’s precision design and its potential for low drug-drug interaction
Discovery programmes:
The Company will continue to identify targets and design novel compounds internally and for partners, where there is strong differentiation. Exscientia intends to advance a small number of new candidates for internal clinical development that demonstrate clear differentiation and market need while also utilising Exscientia’s existing infrastructure. A majority of the future pipeline will be advanced through high-value partnerships or outlicensing
New collaboration with Merck KGaA initiated, with 3 programmes
First milestone achieved in the Sanofi collaboration
Other clinical programmes:
EXS4318 (PKC-theta), DSP-0038 (5-HT1A agonist/5-HT2A antagonist) and DSP-2342 (dual 5-HT2A/5-HT7 antagonist) all are continuing in Phase 1 studies by partners Bristol Myers Squibb and Sumitomo Pharma
The Company ended the second quarter of 2023 with $508.6 million of cash, equivalents and short-term deposits. With today’s announcement, the Company expects to remain well capitalised through the potential achievement of multiple clinical and partnership milestones.

On October 3, 2023 PharmaEssentia Corporation, (TPEx:6446), a global biopharmaceutical innovator headquartered in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that it has entered into a license agreement with WuXi Biologics Ireland Limited to obtain the global exclusive rights to research, develop, manufacture and commercialize a myeloid immune checkpoint antibody candidate (Press release, PharmaEssentia, OCT 3, 2023, View Source [SID1234635619]). PharmaEssentia will take over responsibility for the subsequent preclinical and clinical development efforts.

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"We are excited to expand our pipeline, which reflects our dedication to growing our research capabilities and delivering transformative healthcare solutions," said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer, PharmaEssentia. "Entering into this agreement with WuXi Biologics perfectly aligns with our commitment to accelerate priority development programs across oncology, hematology and immunology. We’re poised to pioneer breakthrough therapies and bring renewed hope to patients worldwide."

"PharmaEssentia’s mission is to create best-in-class or first-in-class therapies by expanding our expertise to new drug modalities where we can have the greatest impact on patient lives," said Lih-Ling Lin, Ph.D., Chief Scientific Officer, PharmaEssentia. "As one of the first programs that will be advanced by our global research and business development team, we are eager to apply our deep biopharmaceutical capabilities to better understand the clinical potential of this novel approach. We are committed to working urgently to advance this candidate, which has the potential to apply a new scientific breakthrough to create a treatment that helps alleviate the incredible medical burdens faced by patients living with solid tumors."

As part of the agreement, PharmaEssentia will pay license fees to WuXi Biologics, including an upfront payment upon signing, future research, development, regulatory and sales milestones payments, and sales royalties.

On October 3, 2023 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that it has completed its previously announced merger with Morphimmune (Press release, Immunome, OCT 3, 2023, View Source [SID1234635618]).

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"This merger is an essential step in establishing a preeminent oncology company," said Dr. Siegall. "We believe that we are well positioned to advance our current oncology pipeline into the clinic, build upon the pipeline through our technology platform and proprietary toolbox, and expand our portfolio through strategic transactions focused on clinical and preclinical assets."

Dr. Siegall previously served as the CEO and President of Seagen, Inc., which he co-founded in July 1997. Under his nearly 25 years of leadership, Seagen became an industry leader in antibody drug conjugate (ADC) therapeutics, a field he innovated, earned FDA approvals for four cancer therapies, and grew to over $2 billion in annual revenue. During his tenure, he raised well over $1 billion of equity financing for Seagen from public and private markets and oversaw the company’s acquisition of Cascadian Therapeutics. In March of 2023, Pfizer, Inc. agreed to purchase Seagen for $43 billion.

The oversubscribed private placement investment of $125 million includes participation from Enavate Sciences, EcoR1 Capital, Redmile Group, Janus Henderson Investors, Avidity Partners, Woodline Partners LP, and other leading institutional investors.