On September 14, 2022 BioCryst Pharmaceuticals, Inc. reported that Dr. Bill Sheridan will become chief development officer and will focus on advancing the company’s significant pipeline of development candidates (Press release, BioCryst Pharmaceuticals, SEP 14, 2022, View Source [SID1234619541]). Dr. Ryan Arnold has been appointed as the company’s new chief medical officer.

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Dr. Arnold joins Dr. Sheridan and Dr. Helen Thackray, the company’s chief research and development officer, as physicians on the company’s leadership team.

"Our research and development platform continues to generate exciting opportunities across multiple rare disease targets and Bill’s deep knowledge of our portfolio and dedicated focus on our pipeline strategy will add efficiency and expertise as we advance these programs to the patients who are waiting for them. Combined with Ryan’s work with investigators and key opinion leaders to share our science and integrate their input to drive patient outcomes, we have outstanding medical leadership to help us achieve our goals," Thackray said.

Dr. Sheridan joined BioCryst from Amgen in July 2008 as chief medical officer. During his 15-year tenure at Amgen, Dr. Sheridan led the company’s medical affairs functions in the U.S. and Europe, making significant contributions to the successful launch of many compounds, including Aranesp, Enbrel, Kineret, Neulasta, and Sensipar. He organized the global health economics and outcomes research function, supervised product development team leaders and led several clinical development phase product development teams. Dr. Sheridan earned his MB BS degree (MD equivalent) at the University of Melbourne in Victoria, Australia. He is a board-certified Fellow of the Royal Australasian College of Physicians, with a subspecialty in medical oncology, and a Fellow of the American College of Physicians.

Dr Arnold joined BioCryst in March 2022 as senior vice president of global medical affairs. He has more than 20 years of industry experience, including prior roles with increasing levels of responsibility in the medical affairs function at multiple companies, including Amgen (where he worked on Dr. Sheridan’s team), Genzyme, Biogen, Sage Therapeutics and Annexon Biosciences. Throughout his career, Dr. Arnold has helped build and lead medical functions, including support for the development and launch of multiple products in specialty and rare disease indications across neurology, hematology, immunology, oncology and other specialty areas. He has a doctorate of osteopathic medicine from the Michigan State University College of Osteopathic Medicine and completed residency training including clinical responsibilities in otolaryngology and facial plastic surgery.

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.