On October 3, 2023 Iambic Therapeutics (formerly known as Entos), a biotechnology company developing novel therapeutics from its unique generative AI discovery platform, reported the closing of an oversubscribed $100 million Series B financing co-led by Ascenta Capital and Abingworth, and also including new investors NVIDIA, Illumina Ventures, Gradiant Corporation, Shanda, and independent board member Bill Rastetter (Press release, Iambic Therapeutics, OCT 3, 2023, View Source [SID1234637229]). Existing investors also participated, including Nexus Ventures, Catalio Capital Management, Coatue, FreeFlow, OrbiMed, Sequoia Capital, and Tao Capital. As part of the Series B, Iambic is delighted to welcome two new board members, Evan Rachlin, M.D., from Ascenta Capital and Kurt von Emster from Abingworth.

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"At Iambic, our world-class team has combined physics and AI to create a differentiated drug discovery platform that achieves a step-change in the speed and success rate for delivering best-in-class and first-in-class development candidates to clinic. With the Series B funding, we intend to advance multiple AI-discovered candidates into the clinic and expand our pipeline, demonstrating how the Iambic platform can deliver better therapeutics to patients in less time, with optimized target product profiles for greater likelihood of clinical success."
– Tom Miller, Ph.D., Co-founder and CEO of Iambic

"We were struck by the originality of these molecules, offering distinctive approaches in both deeply validated and more novel biological pathways," added Evan Rachlin, M.D., Co-founder and Managing Partner of Ascenta Capital. "Iambic’s platform enables a more creative and expansive exploration of how to treat diseases with profound unmet needs. We are delighted to partner with Tom and his extraordinary team in translating these thoroughly tested medicines into humans."

"Abingworth is proud to support the remarkably talented team at Iambic in its drive to revolutionize drug discovery and speed to the market with highly selective drugs" said Kurt von Emster, Managing Partner and Head of Life Sciences at Abingworth.

"AI-driven technologies, including methods that Iambic and NVIDIA researchers have built together, are charting a new path for researchers in the discovery of new therapeutic candidates," said Rory Kelleher, Director of Healthcare and Life Sciences at NVIDIA. "NVIDIA-accelerated computing and software are helping industry pioneers like Iambic drive scientific breakthroughs and our continued collaboration aims to speed innovation in drug discovery."

"We believe technology innovations powered by advanced computing and omics-derived data insights will transform drug discovery and pave the way for the next wave of groundbreaking medicines," said Ron Mazumder, Ph.D., MBA, Partner of Illumina Ventures. "Iambic’s physics-informed machine learning approach has yielded promising lead candidates with superior profiles in record time."

Since its 2021 Series A financing, Iambic has rapidly built its AI-driven discovery platform, which unifies state-of-the-art, physics-informed machine learning and experimental automation, and has demonstrated the platform’s success in identifying therapeutic candidates with differentiated drug profiles. In addition to building out a deep bench of AI and drug-discovery experts, Iambic has discovered two candidates to advance into the clinic: IAM-H1, a highly selective and brain-penetrant inhibitor of HER2 and its oncogenic mutants, and IAM-C1, a potential first-in-class selective dual CDK2/4 inhibitor to address unmet needs in terms of therapeutic window and treatment resistance in cell-cycle-driven cancers. Further, Iambic has extended its leadership position in the AI community, creating methods such as NeuralPLexer and OrbNet to drive its discovery platform.

With the funds raised in the Series B, Iambic intends to advance multiple candidates into clinical development, expand its pipeline with additional candidates with best-in-class and first-in-class potential, and continue to innovate and build next-generation AI and automation technologies for drug discovery. It plans to leverage NVIDIA technology such as the NVIDIA DGX Cloud AI supercomputing platform and the NVIDIA BioNeMo cloud service to accelerate discovery.

The company retains the technology created under its prior name of Entos Inc., adopting the new name of Iambic Therapeutics to reflect its transition to a company with the additional capability of clinical development of candidates identified through its AI-driven discovery platform.

About the Iambic Therapeutics Physics-Informed AI-Driven Discovery Platform

The Iambic Therapeutics AI-driven platform was created to address the most challenging design problems in drug discovery, incorporating the most current AI technologies and purpose-built tools from Iambic. The integration of physics principles into the platform’s AI architectures improves data efficiency and allows molecular models to venture widely across the space of possible chemical structures. The platform’s algorithms enable identification of new chemical mechanisms for engaging difficult-to-address biological targets, discovery of defined product profiles that optimize therapeutic window, and exploration of the chemical space to discover candidates for development with highly differentiated properties. Through close integration of AI-generated molecular designs with automated experimental execution, Iambic completes design-make-test cycles on a weekly cadence.

On October 3, 2023, Vaccinex, Inc. (the "Company") sold in a public offering an aggregate of 9,600,000 common share equivalents together with accompanying common stock warrants ("Common Warrants"), comprised of (i) 7,600,000 shares ("Shares") of the Company’s common stock ("Common Stock") together with Common Warrants to purchase up to 7,600,000 shares of Common Stock ("Warrant Shares") and (ii) in lieu of Shares, pre-funded warrants ("Pre-Funded Warrants" and together with the Common Warrants, the "Warrants") to purchase up to 2,000,000 Warrant Shares together with Common Warrants to purchase up to 2,000,000 Warrant Shares (the "Offering") (Filing, 8-K, Vaccinex, OCT 3, 2023, View Source [SID1234635650]). The Shares and accompanying Common Warrants were sold at a combined public offering price of $1.00 per Share and accompanying Common Warrant, and the Pre-Funded Warrants and accompanying Common Warrants were sold at a combined public offering price of $0.999 per Pre-Funded Warrant and accompanying Common Warrant. The Offering was made pursuant to the Company’s registration statement on Form S-1, as amended (File No. 333-274520), which was declared effective by the Securities and Exchange Commission (the "SEC") on September 28, 2023. In connection with the Offering, on September 28, 2023, the Company entered into a securities purchase agreement (the "Purchase Agreement") with some of the purchasers in the Offering.

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FCMI Parent Co., an entity controlled by Albert D. Friedberg, chairman of the Company’s board of directors (the "Board"), purchased 3,000,000 Shares and accompanying Common Warrants in the Offering for a purchase price of $3.0 million and Maurice Zauderer, the Company’s President, Chief Executive Officer, and a member of the Board (FCMI Parent Co. and Dr. Zauderer, together, the "Related Parties"), purchased 500,000 Shares and accompanying Common Warrants in the Offering for a purchase price of $500,000.

Each Pre-Funded Warrant sold in the Offering has an initial exercise price equal to $0.0001 per share, and each Common Warrant has an initial exercise price equal to $1.00 per share. The Warrants were immediately exercisable. The Pre-Funded Warrants may be exercised at any time until they are exercised in full, and the Common Warrants will expire five years from the date of issuance. No Warrant holder (together with its affiliates) may exercise any portion of its Warrants to the extent that the holder would own more than 4.99% (or, at the election of the purchaser, 9.99%) of the outstanding Common Stock immediately after exercise (the "Beneficial Ownership Limitation"), except that (i) upon at least 61 days’ prior notice from the holder to the Company, the holder may increase the Beneficial Ownership Limitation to a percentage not to exceed 9.99%, (ii) Dr. Zauderer is not subject to the Beneficial Ownership Limitation, and (iii) the Beneficial Ownership Limitation with respect to FCMI Parent Co. is 39.99%.

The Company has the right to "call" any portion of a holder’s Common Warrants by delivering a call notice to the holder within 30 days after Company publicly announces an increase in pepinemab-treated patients relative to placebo-treated patients, with statistical significance having a p-value of less than or equal to 0.05, in the change of the FDG-PET standard uptake value ratio for brain metabolism between baseline and month 18 as assessed by [18F]fluorodeoxyglucose (FDG)-PET in the resting state following administration of 40 mg/kg pepinemab or placebo, as applicable, as described in the protocol for the Company’s SIGNAL-AD Alzheimer’s disease study. After delivery of a call notice, the Common Warrants will continue to be exercisable. Each Common Warrant will be canceled and no longer exercisable to the extent the holder fails to timely exercise the Common Warrant for the called portion thereof within 20 trading days following the Company’s issuance of a call notice.

The net proceeds to the Company from the Offering are expected to be approximately $8.7 million after deducting placement agent fees and other estimated offering expenses, but excluding the proceeds, if any, from the exercise of Warrants issued in the Offering. The Company intends to use the net proceeds from the Offering to fund the ongoing development and clinical trials of its lead drug candidate, pepinemab, in Alzheimer’s disease and cancer and for working capital and other general corporate purposes.

The Purchase Agreement prohibits the Company, until January 1, 2024, from issuing, agreeing to issue, or announcing the issuance or proposed issuance of any Shares or common stock equivalents, other than (i) equity awards granted pursuant to an equity incentive plan, (ii) upon the exercise of Warrants or the exercise, exchange, or conversion of other securities outstanding on September 28, 2023, (iii) sales to employees, directors, consultants, or their affiliated entities in the ordinary course of business or pursuant to or in connection with commitments in place as of September 28, 2023, (iv) pursuant to acquisitions, joint ventures, strategic alliances, or other strategic transactions approved by the Company’s Board of Directors, and (v) the issuance of warrants to purchase Shares, or Shares underlying such warrants, to purchasers of Common Stock in private placements conducted by the Company between July 30, 2023 and September 27, 2023. The Purchase Agreement also prohibits the Company, until January 1, 2024, from filing any registration statement or amendment or supplement thereto, subject to certain exceptions. In addition, pursuant to the Purchase Agreement, the Company’s executive officers and directors and beneficial owners of 5% or more of the Company’s outstanding Common Stock entered into customary lock-up agreements pursuant to which they agreed until December 2, 2023 not to sell or transfer any shares of Common Stock beneficially owned by them or securities that are convertible into, or exchangeable or exercisable for, shares of Common Stock, subject to certain exceptions.

A.G.P./Alliance Global Partners ("A.G.P.") acted as the exclusive placement agent for the Offering on a reasonable best efforts basis pursuant to the terms of a placement agency agreement entered into between the Company and A.G.P. on September 28, 2023 (the "Placement Agency Agreement"). The Company agreed to pay A.G.P. an aggregate fee of 7.0% of the aggregate gross proceeds received in the Offering and to reimburse A.G.P. for up to $75,000 for A.G.P.’s legal fees and up to 1.0% of the aggregate gross proceeds of the offering for non-accountable fees and expenses, except that the Company agreed to pay an aggregate fee of 2.0% of the gross proceeds received from sales to the Related Parties and the parties agreed that A.G.P. will not be paid for non-accountable expenses with respect to such sales.

The descriptions of the terms and conditions of the Placement Agency Agreement, the form of Pre-Funded Warrant, the form of Warrant, and the form of Purchase Agreement are qualified by reference to the full text of such documents, which are attached hereto as Exhibits 1.1, 4.1, 4.2 and 10.1, respectively.

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.