On September 14, 2022 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that the Aptose will be participating in the Cantor Oncology, Hematology & HemeOnc Conference on September 28, 2022 (Press release, Aptose Biosciences, SEP 14, 2022, View Source [SID1234619540]).

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Dr. Rafael Bejar, Chief Medical Officer of Aptose, will participate in a panel, "Leukemia & MDS," and with Mr. Fletcher Payne, CFO of Aptose, will be hosting one-on-one meetings during the conference. To schedule a one-on-one meeting with the Aptose management team, please contact your conference representative.

Cantor Oncology, Hematology & HemeOnc Conference

On September 14, 2022 Apollomics Inc. ("Apollomics" or the "Company"), a late-stage clinical biopharmaceutical company, and Maxpro Capital Acquisition Corp. ("Maxpro") (Nasdaq: JMAC, JMACU, JMACW) reported a definitive agreement for a business combination (the "Transaction" or the "Business Combination") that would result in Apollomics becoming a publicly traded company on the Nasdaq Global Market ("Nasdaq") (Press release, Apollomics, SEP 14, 2022, View Source [SID1234619539]). The business combination is expected to close in the first quarter of 2023 and Apollomics is expected to be listed on Nasdaq under the ticker symbol "APLM."

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Apollomics’ broad pipeline of drug candidates includes late-stage clinical assets for the treatment of patients with difficult-to-treat cancers. Apollomics’ mission is to develop assets in critically important areas of unmet need. The Company’s leading drug candidates address certain subpopulations within lung cancer and leukemia. Globally, both lung cancer and leukemia affect over 2 million people annually.

The Company is dedicated to discovering and developing oncology therapies of different mechanisms of action to inhibit cancer. Its diverse portfolio of innovative drug candidates for treating difficult-to-treat cancers includes precision therapy targeting tumors with specific mutations, as well as assets addressing broader cancer conditions. The Company’s pipeline of nine clinical, preclinical and discovery drug candidates has the potential to improve treatment of a number of tumor types.

Upon the closing of the transaction, Apollomics will continue to be led by current Chairman and CEO, Dr. Guo-Liang Yu, Ph.D., a serial entrepreneur, and his team. Dr. Yu is a pharmaceutical researcher with more than 300 patents.

"Apollomics’ announcement represents the next major milestone on our journey to provide solutions for patients with difficult-to-treat cancers," Dr. Yu said. "We anticipate that the funds available to us from this transaction will help us accelerate development of our oncology pipeline."

Apollomics expects results from its global Phase 2 multi-cohort clinical trial of vebreltinib in NSCLC and other solid tumors with cMET dysregulation in 2023, which the Company believes may support its first New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") while generating clinical data for different indications. In addition, the Company expects to complete patient recruitment of its uproleselan Phase 3 study in China in 2023.

"Our goal was to find an exciting company with a growing pipeline of innovative product candidates that could positively affect the lives of millions of people," said Moses Chen, CEO of Maxpro. "Our team is excited to combine with Apollomics as it has met and exceeded all our key selection criteria. Together with Apollomics, Maxpro will do everything we can to support the Company’s vision of treating patients with difficult-to-treat cancers."

Apollomics Inc. Investment Highlights:

Headquartered in Foster City, Calif., the dedicated team at Apollomics has been developing its innovative pipeline of drug candidates addressing unmet needs in oncology since the beginning of its operations in 2016.
The Company has a strong pipeline of oncology assets with nine drug candidates – small molecule targeted drugs as well as biologics – at different stages of development, including two in late-stage clinical trials.
Vebreltinib is in Phase 2 targeting multiple indications of NSCLC and other solid tumors with cMet dysregulations globally, the data from which is expected to support filing NDA/sNDAs in the U.S.
The Company’s uproleselan asset is in Phase 3 in China to support an NDA in relapsed or refractory AML.
Transaction Overview

Upon the closing of the Transaction, Apollomics will become a publicly traded company under the name "Apollomics Inc." The Transaction reflects an implied pre-money equity value of approximately $899 million.

Upon the closing of the Transaction and assuming no redemptions by Maxpro’s public stockholders, Apollomics plans to retain up to $105 million of cash, being expected proceeds from realization of marketable securities held in the Trust Account, on its balance sheet, which would provide financial flexibility and facilitate internal and external growth opportunities.

At the closing of the Business Combination and assuming no redemptions by Maxpro’s public stockholders, approximately 10% of the outstanding shares of the combined company are expected to be held by public investors, with existing Apollomics shareholders owning approximately 87%.

The Transaction has been unanimously approved by the boards of directors of Maxpro and Apollomics. The completion of the Transaction is subject to customary closing conditions, including the approval of Maxpro’s stockholders and the satisfaction of a $20 million minimum cash condition. The Transaction is expected to close during the first quarter of 2023. Additional information about the proposed Transaction, including a copy of the business combination agreement and an investor presentation, will be provided in a Current Report on Form 8-K to be filed by Maxpro with the U.S. Securities and Exchange Commission ("SEC") and available at www.sec.gov.
Advisors

ARC Group Limited is acting as financial advisor to Maxpro. EF Hutton is acting as capital market advisor to Maxpro. White & Case LLP is acting as legal counsel to Apollomics. Nelson Mullins Riley & Scarborough LLP is acting as legal counsel to Maxpro. Marshall & Stevens Transaction Advisory Services LLC is acting as the fairness opinion provider to the board of directors of Maxpro.

On September 14, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported a poster presentation on the OPTIMIZE-1 Phase 1b/2 trial of mitazalimab in combination with modified FOLFIRINOX in first-line metastatic pancreatic cancer with the company’s lead asset mitazalimab (CD40 mAb) at the 2022 AACR (Free AACR Whitepaper) (American Association for Cancer Research) Special Conference on Pancreatic Cancer, being held in Boston September 13-16 (Press release, Alligator Bioscience, SEP 14, 2022, View Source [SID1234619538]).

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The presentation, entitled "Mitazalimab (CD40 agonist) in combination with mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC); Safety data and recommended dose of phase 2 (RP2D) from OPTIMIZE-1, a phase 1b/2 study", outlines additional results from the Phase 1b dose escalation part of the study that were announced in March, 2022 (press release).

The results presented at AACR (Free AACR Whitepaper), demonstrate that mitazalimab is safe and tolerable at 900 µg/kg, the highest dose tested in OPTIMIZE-1. Most of the mitazalimab related AEs at both dose levels (fever, muscle pain, loss of apetite and fatigue) were mild to moderate (grade 1 or 2) severity and manageable. Only one patient out of the 6 patients in the 900 µg/kg cohort experienced a grade 3 treatment-related adverse event (TRAE) of headache. There were no grade 4 TRAEs or treatment related death reported. Pharmacodynamic markers in peripheral blood confirmed immune activation, in accordance with mitazalimab’s mode of action.

Overall, the data showed that mitazalimab combined with mFOLFIRINOX is safe and well tolerated. The 900 µg/kg dose of mitazalimab was selected as the recommended dose for the Phase 2 study. Enrollment for the Phase 2 is ongoing at sites in Europe with an interim efficacy and safety read-out expected in Q4 2022.

"The AACR (Free AACR Whitepaper) Special Conference on Pancreatic Cancer is an extremely well-regarded scientific forum for Alligator to be presenting additional data from our OPTIMIZE-1 trial," said Søren Bregenholt, PhD, CEO of Alligator Bioscience. "Mitazalimab’s differentiated efficacy and tolerability profile allows for the higher and more frequent doses which, when combined with chemotherapy like mFOLFIRINOX, increases the chances of demonstrating clinical benefit in the treatment of metastatic pancreatic cancer. We are very pleased with the successful completion of the Phase 1b section of the trial and we continue to make great progress with the enrollment for Phase 2."

The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CEST on September 14, 2022.

On September 14, 2022 Phost’in Therapeutics (Montpellier, France), a clinical stage company focused on the discovery and development of N-glycosylation inhibitors for the treatment of cancer and other serious diseases, reported dosing of the first three patients in the Dose Escalation phase of the PhAST trial, an adaptive Phase I/II study in patients with advanced solid tumors evaluating the First-In-Class selective N-glycosylation inhibitor, PhOx430 (Press release, Phost’in, SEP 14, 2022, View Source [SID1234619532]). The study is operated with the scientific contribution of the Gianni Bonadonna Foundation which collaborated to the conception of the research protocol.

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PhAST trial will evaluate safety and pharmacodynamic effects of PhOx430 in patients. Additional objectives will include a preliminary evaluation of efficacy and the identification of biomarkers. The current dose escalation phase will eventually enroll two dozen of patients with non-selected tumour types. It will be followed by three expansion cohorts gathering patients with selected tumour types, including Glioblastoma multiforme (GBM), Triple-negative breast cancer (TNBC) and a selection of other solid tumour types, for which few therapeutic options exist.

Dr. Alain Herrera, CMO of Phost’in Therapeutics, said: "Dosing of first three patients marks an important milestone in the development of PhOx430. And beyond any scientific achievement, as a selective N-glycosylation inhibitor is administered for the 1st time in patients, it is a step ahead in the fight to overcome cancer and immune resistance with disrupting approaches". Dr. Luca Gianni, President of The Gianni Bonadonna Foundation, added "With the activation of both sites involved in the Dose Escalation Phase, a further step has been taken in this innovative first-in-human clinical trial, that could open new avenues for solid tumors therapy. With this in mind, Fondazione Gianni Bonadonna will continue collaborating with the PhAST Trial Team to achieve the best results for cancer patients’ benefit.".

First patients have been enrolled at the I.R.C.C.S. Ospedale San Raffaele in Milan, Italy, and at the Institute of Cancer of Montpellier (ICM), France. Dr. Diego Tosi, head of the Early Clinical Trial Unit-Medical Oncology Department and Principal Investigator at ICM, has been entrusted with the international direction of the first-in-human clinical trial.

The contract research organization ("CRO") Michelangelo Tech Srl (Milan, Italy) has been appointed by Phost’in to coordinate the PhAST trial. Owned by the Michelangelo Foundation with the aim of contributing to progress in cancer research and improving treatment options for tumors, Michelangelo Tech Srl provides extensive expertise in early phase clinical development, precisely to favor the rapid clinical application of new therapies. In parallel, Phost’in Therapeutics has selected Leads to Development (Paris, France), an agency with a strong reputation across Europe and the United States for regulatory and development expertise, to support product development strategy definition, operations and filings

About PhOx 430 treatment
The aberrant, complex and hypersialylated glycosylation of tumor cells is now recognized as a novel immune checkpoint, affecting key membrane receptors and masking tumor cells to the immune system, via the formation of complex abnormal glycan patterns operating as a shield. PhOx430 targets this aberrant glycosylation directly to the source through selective inhibition of a specific enzyme for a double antitumor effect, inducing simultaneously an anti-cancer immune response and the down regulation of the main receptors implicated in cancer progression. The program has demonstrated a significant antitumoral efficacy in several animal models, associated with a promising safety profile in regulatory preclinical studies. It is the first program from the Phost’ScreenTM platform that combines unique and patented chemical libraries with cutting-edge screening tools to produce selective nglycosylation inhibitors.

On September 14, 2022 Capstan Therapeutics, Inc., a biotechnology company dedicated to developing and delivering precise in vivo cell engineering to patients, reported that launched with $165 million in financing to build on the foundational insights of world-renowned leaders in mRNA and cell therapy, combining the power of cell therapy with the precision of genetic medicines to help bring safer, first-in-class medicines to more patients in multiple indications (Press release, Capstan Therapeutics, SEP 14, 2022, View Source [SID1234619529]).

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Capstan’s foundational precision in vivo engineering technology builds on research conducted in the laboratories of world-renowned mRNA and cell therapy scientists at the University of Pennsylvania.

Capstan’s funding includes a recently closed $102 million Series A financing led by Pfizer Ventures and joined by Leaps by Bayer, Eli Lilly and Company, Bristol Myers Squibb, Polaris Partners, Alexandria Venture Investments, and all existing investors, which follows a $63 million seed financing led by Novartis Venture Fund and OrbiMed and joined by RA Capital, and Vida Ventures in November 2021.

Advancing Breakthrough Therapies through Precision in vivo Engineering

The company plans to use the funds to further its mission of advancing the clinical promise of cell-based therapies by enabling precise in vivo engineering of cells with payloads necessary to benefit patients across multiple disease categories. Capstan’s modular platform leverages the biological and technological expertise of its founding scientists and includes proprietary targeted lipid nanoparticles (tLNP) technology, a suite of targeting moieties to mediate cell type-specific uptake, and disease-specific mRNA payloads aimed at directly engineering, or ablating pathogenic cells through in vivo generated CAR T cells.

Capstan is prioritizing programs based on the potential to transform clinical standards of care. The company’s initial efforts will focus on developing first-in-class in vivo CAR therapies, with the goal to deliver treatments in an outpatient setting, for patients who have diseases for which there are no effective treatments. Capstan also plans to leverage its precision delivery and engineering technology to advance new therapies for certain monogenic blood disorders.

Visionary Team of Accomplished Executives Poised to Deliver a Transformational Approach

Capstan is also pleased to announce that Laura Shawver, Ph.D., has joined the company as President and Chief Executive Officer. Dr. Shawver brings more than 20 years of experience in executive leadership positions in oncology and other serious diseases to this role, most recently serving as CEO of Silverback Therapeutics and President and CEO of Synthorx.

"Our ambition at Capstan is to invent new clinical paradigms through targeted in vivo reprogramming of cells," said Dr. Shawver. "Our founding scientific and operational team is purpose-built to advance programs to the clinic that unite decades of combined experience in groundbreaking CAR therapies with the latest advances in mRNA delivery technology. We are also fortunate to have a distinguished investor syndicate that understands the cell therapy landscape and recognizes the potential of this innovative approach. I am thrilled to lead this team as we work toward making this vision a reality for patients."

"Laura is an exceptional leader with a well-established track record in drug development and passion for addressing unmet needs in oncology and other serious diseases," said Michael Baran, Ph.D., Partner, Pfizer Ventures. "We are delighted to have someone of Laura’s caliber captain this exciting next chapter for Capstan to help unlock the potential of this transformative approach for patients."

Dr. Shawver joins an accomplished leadership team of industry veterans who have been at the forefront of cell and gene therapy, including Adrian Bot, M.D., Ph.D., Chief Scientific Officer, formerly Global Head and Vice President of Translational Medicine at Kite, a Gilead Company and previously Chief Scientific Officer at Kite Pharma; and Priya Karmali, Ph.D., Chief Technology Officer, who has over two decades of experience in the field of lipid nanoparticle mediated nucleic acid delivery technologies.

Building on Pioneering Work of World-Renowned Scientific Founders

"Capstan builds on a deep history of collaborative research in mRNA-enabled and CAR-based medicines by our incredible group of scientific founders," said Christian Homsy, M.D., MBA, Capstan’s founding CEO. "The company was established to deliver on the promise of cell-based medicines, and with Laura at the helm, is well-positioned to make rapid progress towards clinical evaluation."

The company’s scientific founders include several of the experts from the University of Pennsylvania who authored two landmark studies establishing preclinical proof-of-concept for non-viral, in vivo CAR-T therapy that Capstan plans to develop and advance toward the clinic. A 2019 Nature publication demonstrated the preclinical use of ex vivo CAR-T cell therapy against FAP, a fibrosis-related target. A follow-on study published in Science earlier this year built on these earlier results and demonstrated the production of functional CAR-T cells in vivo in a mouse model following a single IV administration of an mRNA encoding an anti-FAP CAR packaged in CD5-targeted-LNPs. The scientific founders span diverse areas of research expertise:

Preclinical translation – Jonathan Epstein, M.D. and Haig Aghajanian, Ph.D. (Dr. Aghajanian is now a Capstan employee.)
Cell engineering – Carl June, M.D. and Bruce Levine, Ph.D.
mRNA and targeted LNP technologies – Drew Weissman, M.D., Ph.D. and Hamideh Parhiz, Pharm.D., Ph.D.
Immunology and Fibrosis – Ellen Puré, Ph.D. and Steven Albelda, M.D.
"Capstan is uniting several recent life science technological advances in a manner that can hopefully unlock the potential of these technologies to develop new medicines for patients across a wider range of diseases," said Drew Weissman, M.D., Ph.D., Co-Founder of Capstan, who serves as the Roberts Family Professor in Vaccine Research and Director of the Penn Institute for RNA Innovation in the Perelman School of Medicine at the University of Pennsylvania, and co-recipient of the 2021 Lasker-DeBakey Clinical Medical Research Award.

"Research conducted at Penn demonstrates the tremendous promise of harnessing mRNA and targeted LNP delivery to train a patient’s body to make CAR-T cells in vivo, potentially creating new treatment options," said Jonathan Epstein, M.D., Chief Scientific Officer at Penn’s Perelman School of Medicine. "We believe this approach has the potential to make an important impact not only in oncology, but also in fibrosis and many other diseases. My fellow scientific co-founders and I all look forward to actively partnering with Capstan in our collaborative effort to develop medicines that may benefit patients around the world."