On March 11, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology and inflammatory diseases, reported its VP of Business Development, Dr. Sari Fishman, will present data from the pancreatic and liver cancer programs during numerous partnering meetings at the BIO-Europe Spring 2024 in Barcelona, Spain, on Mar 18-27, 2024 (https://informaconnect.com/bioeurope-spring/) (Press release, Can-Fite BioPharma, MAR 11, 2024, View Source [SID1234641010]).

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Can-Fite’s pipeline of indications includes Namodenoson for the treatment of advanced liver cancer and pancreatic cancer; both indications have been licensed to the Swiss company Ewopharma for Eastern Europe. The liver cancer indication has been licensed as well to CMS in China and CKD in South Korea. Piclidenoson has been out-licensed to Cipher in Canada; Gebro Pharma for Swiss, Spain, Austria; CMS for China; and Kyongboo for South Korea. Each of the deals include upfront and milestone payments. The Company’s growing slate of indications and advanced pipeline are attracting increased interest from additional potential partners. Focusing on its core expertise in clinical development, Can-Fite pursues a strategy of partnering with companies in specific geographic markets that specialize in pharmaceutical distribution and regional regulatory approval.

"Advanced liver cancer and pancreatic cancer are Can-Fite’s clinical-stage indications for Namodenoson and am delighted with the interest that Namodenoson is raising with companies that will participate in the Bio Europe Conference and are experts in drug development and distribution in the oncology arena. The conference provides us with the opportunity to present our other developments to lead pharmaceutical companies," stated Dr. Sari Fishman, VP Business Development at Can-Fite.

On March 11, 2024 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will present clinical trial data for selected candidates from its oncology pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2024 in San Diego, California, from April 5-10, 2024 (Press release, BioNTech, MAR 11, 2024, View Source [SID1234641008]). The oral and poster presentations will feature BioNTech’s investigational mRNA-based cancer vaccine and novel investigational antibody-drug conjugate ("ADC") approaches.

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"This year’s AACR (Free AACR Whitepaper) presentations feature candidates from our individualized and off-the-shelf mRNA cancer vaccine platforms, including a late-breaking presentation of longer-term follow-up data with our individualized mRNA-based candidate autogene cevumeran in patients with pancreatic cancer," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Our investigational mRNA cancer vaccine approaches are an important pillar in our oncology portfolio, aimed at eliminating residual tumor foci and reducing the tumor burden by targeting multiple antigens at once. The data we will be sharing at AACR (Free AACR Whitepaper) show how we’re delivering on our commitment to patients through investigating novel treatment approaches."

Highlights of BioNTech’s clinical stage programs to be presented at AACR (Free AACR Whitepaper) Annual Meeting 2024:

Longer-term follow-up data of activity and immune responses of the investigator-initiated first-in-human Phase 1 trial (NCT04161755) with the mRNA-based individualized neoantigen-specific immunotherapy ("iNeST") candidate autogene cevumeran (BNT122, RO7198457) in patients with resected pancreatic ductal adenocarcinoma ("PDAC") will be presented. The results of the Phase 1 trial were published in Nature. The candidate is currently being evaluated in an ongoing randomized Phase 2 trial (NCT05968326) in PDAC and is jointly being developed by BioNTech and Genentech, a member of the Roche Group.
BioNTech will present preliminary results on the LuCa-MERIT-1 Phase 1 trial (NCT05142189) with its off-the-shelf, shared tumor-associated-antigen-based mRNA therapeutic cancer vaccine candidate BNT116 in combination with docetaxel in patients with advanced unresectable or metastatic non-small cell lung cancer ("NSCLC"). The data show antitumor activity, consistent induction of immune responses in heavily pre-treated patients with advanced NSCLC, and a manageable safety profile.
A trial in progress poster will inform on the global Phase 1/2a trial (NCT05914116) of the topoisomerase-1 inhibitor-based ADC candidate BNT324/DB-1311 targeting the immune checkpoint protein B7H3 in patients with pretreated advanced or metastatic solid tumors. The candidate is being jointly developed by BioNTech and Duality Biologics.
BioNTech has established a diversified clinical oncology pipeline of more than 20 clinical programs along mRNA-based therapeutic cancer vaccines, targeted therapies comprising cell therapies and ADCs, and novel immunomodulators in unmet medical need solid tumor indications. These candidates are currently being evaluated in more than 30 clinical studies, including nine programs in advanced Phase 2 trials and two candidates in pivotal Phase 3 trials. BioNTech is advancing the Company’s key programs into late-stage development with the aim to have ten or more potentially registrational trials in its oncology pipeline by the end of 2024.

The full abstracts are available on the AACR (Free AACR Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline candidates.

Full presentation details:

Late-breaking presentation
Candidate: Autogene cevumeran (BNT122, RO7198457)
Session Title: "Cancer Vaccines: Ready for Prime Time?"
Abstract Title: "Personalized RNA neoantigen vaccines induce long-lived CD8+ T effector cells in pancreatic cancer"
Abstract Number: CT025
Date: Sunday, April 7, 2024
Time: 3:00 PM – 5:00 PM PST

Posters
Candidate: BNT116
Session Title: Phase I Clinical Trials
Abstract Title: "Preliminary results from LuCa-MERIT-1, a first-in-human Phase I trial evaluating the hexavalent TAA-encoding mRNA vaccine BNT116 + docetaxel in patients with advanced non-small cell lung cancer"
Location: Poster Section 48
Poster Number: CT051
Date: Monday, April 8, 2024

Candidate: BNT324/DB-1311
Session Title: Phase I Clinical Trials in Progress 2
Abstract Title: "A phase 1/2a, multicenter, open-label, first-in-human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1311 (a B7-H3-targeting ADC) in patients with advanced/metastatic solid tumors"
Location: Poster Section 50
Poster Number: CT165
Date: Monday, April 8, 2024

On March 11, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that it has entered into a securities purchase agreement with new and existing healthcare focused institutional investors and certain Company insiders to raise up to $34.0 million in gross proceeds, including initial upfront funding of $16.0 million and up to an additional $18.0 million upon cash exercise of accompanying warrants at the election of the investors (Press release, Aprea, MAR 11, 2024, View Source [SID1234641007]).

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The financing is being led by Sphera Healthcare and includes participation from new and existing healthcare-focused investors, including Nantahala Capital, DAFNA Capital Management, Exome Asset Management and Stonepine Capital Management, among others, as well as certain Company insiders.

"This meaningful financing led by high quality healthcare institutions will support Aprea in our goal to be a leader in the field of Synthetic Lethality (SL) and DNA Damage and Response (DDR)," said Dr. Oren Gilad, President and CEO of Aprea. "It will provide the capital to fund our Phase 1 ACESOT-1051 clinical trial evaluating a highly potent, oral WEE1 inhibitor for Cyclin E over-expressing cancers including breast and ovarian cancers as well as continuation of patient enrollment in the dose expansion portion of the Phase 1/2a clinical trial (AR-276-01) evaluating ATR inhibitor, ATRN-119, in patients with advanced solid tumors having mutations in defined DDR-related genes."

Maxim Group LLC is acting as the sole placement agent for the private placement.

Pursuant to terms of the securities purchase agreement, Aprea will issue an aggregate of 2,194,788 shares of its common stock (or pre-funded warrants in lieu thereof) and accompanying warrants to purchase up to an aggregate of 2,194,788 shares of its common stock at a combined purchase price of $7.29 per share and accompanying warrants, in accordance with the "Minimum Price" requirement as defined in the Nasdaq rules. The accompanying warrants will consist of two tranches:

Tranche A warrants to purchase up to 1,097,394 shares of common stock at an exercise price of $7.29 per share for an aggregate of up to $8.0 million and will expire at the earlier of (i) 30 days following the announcement of the recommended Phase 2 dose for the Company’s ATR inhibitor program for ATRN-119 and the daily VWAP of the Company’s common stock equaling or exceeding $14.58 per share for 30 consecutive trading days following the announcement and (ii) three years from the date of issuance.
Tranche B warrants to purchase up to 1,097,394 shares of common stock at an exercise price of $9.1125 per share for an aggregate of up to $10.0 million and will expire at the earlier of (i) 30 days following the announcement of the recommended Phase 2 dose for the Company’s WEE1 inhibitor program for APR-1051 and the daily VWAP of the Company’s common stock equaling or exceeding $18.225 per share for 30 consecutive trading days following the announcement and (ii) five years from the date of issuance.
In lieu of shares of common stock, certain investors are purchasing pre-funded warrants at a combined purchase price of $7.289 per pre-funded warrant and accompanying warrants, which equals the purchase price per share of common stock and accompanying warrant, less the $0.001 per share exercise price of each pre-funded warrant. The private placement is expected to close on or about March 13, 2024 subject to satisfaction of customary closing conditions.

Aprea intends to use the upfront net proceeds from the private placement for general corporate purposes and to fund clinical development of APR-1051, the Company’s WEE1 inhibitor product candidate which recently received IND clearance. The aggregate net proceeds (assuming the cash exercise of all accompanying warrants) are expected to be sufficient to fund the Company into 2026.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering, and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock purchased in the private placement and shares of common stock underlying the warrants.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

On March 11, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (IND 169359) for APR-1051 (Press release, Aprea, MAR 11, 2024, View Source [SID1234641006]).

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"APR-1051 is a next-generation inhibitor of WEE1 kinase and, based on its unique characteristics, we believe it will be best in class," said Dr. Oren Gilad, President and CEO of Aprea. "The FDA’s clearance of our IND is a critical step in the APR-1051 development program. We look forward to evaluating therapeutic activity in patients, focusing on Cyclin E overexpressing cancers, including ovarian and breast cancers."

Based on preclinical studies, APR-1051 is differentiated from other WEE1 inhibitors in its:

Molecular structure;
Selectivity for WEE1 versus off-target inhibition of the polo-like kinase, or PLK, family of kinases;
Potentially superior pharmacokinetic (PK) properties;
Potential absence of QT prolongation at doses that significantly inhibit WEE1*
APR-1051 was discovered and preclinically evaluated by Aprea’s team of chemists and scientists. Aprea has conducted extensive pre-clinical studies with APR-1051, which have demonstrated that the molecule has potent anti-tumor activity, along with a favorable pharmacokinetic (PK) profile. Additionally, pre-clinical data show that APR-1051 may demonstrate less toxicity than other WEE1 inhibitors.*

Clearance of the IND application will allow Aprea to initiate the Phase 1 ACESOT-1051 dose escalation trial to evaluate the safety, tolerability, and preliminary efficacy of APR-1051. Enrollment of the first patient in this study is expected in the first half of 2024 with an update expected in the fourth quarter of the year.

* No head-to-head studies have been conducted with APR-1051

On March 11, 2024 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the fourth quarter and year ended December 31, 2023 and provided a business update.

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"2023 was a remarkable year for Anaptys as we implemented a multi-year development plan investing across our best-in-class immune cell modulators (ICMs) to bring transformational medicines to patients living with heterogeneous, systemic autoimmune and inflammatory diseases, with the goal of restoring immune balance," said Daniel Faga, president and chief executive officer of Anaptys. "Enrollment is ongoing in three global Phase 2 trials for ANB032, our BTLA agonist, in atopic dermatitis and rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ulcerative colitis. Additionally, we expanded our portfolio by acquiring the rights to ANB101, a BDCA2 modulator, which targets plasmacytoid dendritic cells, known to be key drivers of interferon secretion and antigen presentation."

"We will have a number of important events in 2024 including the top-line data readout of ANB032’s Phase 2b trial in atopic dermatitis by year end," adds Faga. "We also plan to move our third and fourth ICMs — ANB033, our anti-CD122 antagonist, and ANB101 — into the clinic this year, with IND filings planned for Q2 and H2, respectively."

Updates on Wholly Owned Immune Cell Modulator Pipeline

ANB032 (BTLA agonist antibody)

Enrollment ongoing for global Phase 2b trial in moderate-to-severe atopic dermatitis (AD)
160-patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI75 and IGA 0/1
Reiterating top-line Week 14 data anticipated by year-end 2024
Presented poster on ANB032 preclinical data supporting the modulation of dendritic cell (DC) maturation and function, representing one of the mechanisms to address atopic dermatitis pathophysiology, at the 2024 AAD Annual Meeting in March 2024
Poster presentation is available here
Rosnilimab (PD-1 agonist antibody)

Enrollment ongoing for global Phase 2b trial in moderate-to-severe RA
420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI<=10, are eligible to be dosed for an additional 16-week all-active treatment period and then followed for a three-month off-drug follow-up period
Reiterating top-line Week 12 data anticipated by mid 2025
Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC
130-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission
Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period
Reiterating top-line Week 12 data anticipated by H1 2026
Presented posters on previously reported rosnilimab Phase 1 data and membrane proximal binding epitope to optimize PD-1 agonist signaling at the American College of Rheumatology (ACR) Convergence 2023 in November 2023 and at the 19th Congress of the European Crohn’s and Colitis Organisation (ECCO) in February 2024
Poster presentations are available here
Hosted a virtual Rosnilimab (PD-1 Agonist) R&D Event in October 2023
Replay of the audio webcast is available here
ANB033 (anti-CD122 antagonist antibody)

Plan to submit an Investigational New Drug (IND) application in Q2 2024
ANB101 (BDCA2 modulator antibody)

Announced exclusive global license of ANB101 in November 2023
Anaptys also received the same rights to ANB102, an extended half-life BDCA2 modulator with the potential to enable quarterly or less frequent dosing
License from Centessa Pharmaceuticals in exchange for a one-time upfront cash payment of $7 million, inclusive of $3 million for manufactured and released GMP supply of ANB101
Plan to submit an IND application in H2 2024
Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing

Announced positive top-line GEMINI-1 Phase 3 clinical trial results of imsidolimab (IL-36R) in generalized pustular psoriasis (GPP) in October 2023
Plan to submit comprehensive data abstract for GEMINI-1 and top-line GEMINI-2 results to a medical meeting in H2 2024
Intend to out-license imsidolimab in 2024
Updates on GSK Immuno-Oncology Financial Collaboration

GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
GSK anticipates top-line data in H1 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer
Cash Position

Year end 2023 cash and investments of $417 million and reiterating cash runway through year-end 2026
Fourth Quarter and Full Year 2023 Financial Results

Cash, cash equivalents and investments totaled $417.9 million as of December 31, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $166.3 million. The decrease relates primarily to cash used for operating activities and the $50 million stock repurchase program.
Collaboration revenue was $9.0 million and $17.2 million for the three and twelve months ended December 31, 2023, compared to $6.8 million and $10.3 million for the three and twelve months ended December 31, 2022. The change is due primarily to increased royalties recognized for sales of Jemperli offset by one development milestone achieved for cobolimab in 2022.
Research and development expenses were $33.5 million and $132.3 million for the three and twelve months ended December 31, 2023, compared to $23.4 million and $88.8 million for the three and twelve months ended December 31, 2022. The increase was due primarily to manufacturing and development costs for rosnilimab, ANB032 and ANB033. The R&D non-cash, stock-based compensation expense was $2.5 million and $10.2 million for the three and twelve months ended December 31, 2023 as compared to $1.8 million and $6.8 million in the same period in 2022.
General and administrative expenses were $10.3 million and $41.9 million for the three and twelve months ended December 31, 2023, compared to $9.4 million and $36.6 million for the three and twelve months ended December 31, 2022. The G&A non-cash, stock-based compensation expense was $5.6 million and $23.0 million for the three and twelve months ended December 31, 2023 as compared to $4.9 million and $20.6 million in the same period in 2022.
Acquired in-process research and development of $7.3 million for the three and twelve months ended December 31, 2023 related to the exclusive licensing agreement with Centessa Pharmaceuticals.
Net loss was $42.2 million and $163.6 million for the three and twelve months ended December 31, 2023, or a net loss per share of $1.59 and $6.08, compared to a net loss of $26.4 million and $128.7 million for the three and twelve months ended December 31, 2022, or a net loss per share of $0.93 and $4.57.