Onxeo Launches a Rights Issue to accelerate its R&D programs

On March 10, 2021 Onxeo S.A. (Euronext Growth Paris: ALONX, First North Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, reported the launch of a capital increase through the issuance of new shares (the "New Shares") with shareholders’ preferential subscription rights (PSR) for a gross target amount of €9.3 million, which may be increased to €10.7 million through the exercise of the extension clause, at a price of €0.71 per share with a parity of 1 New Share for 6 existing shares (the "Right Issue) (the "Capital Increase") (Press release, Onxeo, MAR 10, 2021, View Source [SID1234580413]). The prospectus relating to the Rights Issue (the "Prospectus") has received approval no. 21-063 dated March 9, 2021 from the Autorité des marchés financiers ("the AMF").

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The proceeds from this issue of New Shares will be used to finance primarily the expansion and acceleration of the clinical development of AsiDNA, in particular in combination with other anti-cancer agents.

The Company also intends to:

continue the optimization and preclinical development of new candidates selected on the platON platform,
optimize pharmaceutical development and compound manufacturing operations, and
more generally, finance the Company’s operations.
Judith Greciet, Chief Executive Officer of Onxeo stated: "Our key asset, AsiDNA, is currently in clinical development in two ongoing trials. DRIIV-1b aims at showing an increased efficacy of reference chemotherapy treatments combined with AsiDNA in solid tumors while Revocan has been designed to demonstrate the ability of AsiDNA to overcome tumor resistance to targeted therapies such as a PARP inhibitor. With this new financing, our goal is to accelerate the clinical development of AsiDNA in the coming months and initiate additional trials to unlock the potential of this first-in-class candidate. A randomized Phase 2 study of AsiDNA in combination with platinum-based chemotherapies in a high medical need indication is already in preparation and should soon be followed by other proof-of-concept clinical trials. The raised amount will also support the optimization of a second candidate issued from our chemistry platform platON, as well as our activities related to pharmaceutical development and manufacturing operations.

We would like to warmly thank our two core shareholders, Financière de la Montagne and Invus, who are once again demonstrating their confidence in our long-term development strategy, as well as other shareholders who will support our acceleration plan through their participation in this operation. This capital raise will enable the Company to extend its financial visibility until the 4th quarter of 2022, taking into account the new preclinical and clinical programs that the Company intends to conduct as early as 2021 to accelerate its development."

EVOLUTION OF R&D PROGRAMS

The Prospectus in section 3 of the Amendment (page 13 & following) and in section 2 of the summary of the Securities note (pages 5 & 6) provides updated and enriched information on Onxeo’s programs under development (studies in progress, studies planned in the short term) and its strategy, as an extension of the information communicated to the market, including the letter to shareholders dated February 2, 2021.

MAIN TERMS AND CONDITIONS OF THE RIGHTS ISSUE

Nature of the operation

The fund raising proposed by Onxeo is a capital increase through the issuance of New Shares with preferential subscription rights (PSR). Prior to the proposed transaction, Onxeo’s share capital amounted to €19,579,452.50 divided into 78,317,810 shares with a par value of €0.25 each.

The operation will involve the issue of a maximum of 15,010,913 New Shares (in case of exercise of the extension clause) at a unit price of €0.71, on the basis of 1 New Share for 6 existing shares owned: 6 preferential subscription rights will allow to subscribe to 1 New Share. Each shareholder will receive one preferential subscription right for each share registered in his securities account at the end of the accounting day of March 16, 2021, according to the indicative timetable set out below.

The offering will be open to the public in France and Denmark only.

Share codes

Name: Onxeo

ISIN Code: FR0010095596

Listing locations: Euronext Growth Paris and Nasdaq First North Growth Copenhagen

Ticker Euronext Growth Paris: ALONX

Ticker Nasdaq First North Growth Copenhagen: ONXEO

LEI Code: 96950018AS30IUG0V528

Contributors

Invest Securities is acting as Lead Manager and Bookrunner for the transaction.
Invest Corporate Finance will act as Listing Sponsor.
Nordea Denmark, a subsidiary of Nordea Bank Abp, Finland, will act as Underwriting Agent in Denmark.
Legal framework of the offer

Pursuant to the delegation received under the 17th and 20th resolutions adopted by the Extraordinary Shareholders’ Meeting of June 19, 2020, the Board of Directors’ meeting of January 20, 2021, decided, inter alia:

the principle of a capital increase with preferential subscription rights, and
to sub-delegate the effective implementation of this resolution to the Chief Executive Officer of the Company, who decided on March 9, 2021 to implement the sub-delegation granted to him and to proceed with a capital increase by issuing New Shares with preferential subscription rights, under the following conditions:
Subscription price of the New Shares

The subscription price was set at 0.71 euro per share, including 0.25 euro par value and 0.46 euro additional paid-in capital to be fully paid up at the time of subscription, representing a 5.3% face discount compared to the closing price of Onxeo shares on March 8, 2021, i.e. 0.75 euro.

This subscription price is equivalent to DKK 5.287 for the public offering in Denmark on the Nasdaq First North Growth Copenhagen based on the euro/DKK exchange rate on March 9, 2021.

Subscription period

Subscription for the New Shares will be open

from March 19 to March 31, 2021 inclusive on Euronext Growth Paris, and
from March 19 to March 26, 2021 inclusive on Nasdaq First North Growth Copenhagen.
Number of shares offered

13,052,968 New Shares, which may be increased to a maximum of 15,010,913 New Shares in the event of full exercise of the Extension Clause.

Gross proceeds of the operation

9,267,607 euros, which may be increased to 10,657,748 euros if the Extension Clause is exercised in full and to approximately 7,000,000 euros if the offer is limited to 75.5% of the amount of the planned capital increase (corresponding to subscription commitments).

Preferential subscription right

The subscription of the New Shares is reserved:

to the holders of existing shares registered in their securities account at the end of the accounting day of March 16, 2021 who will be granted preferential subscription rights (hereinafter "PSR") at the rate of 1 PSR per share held,
to the assignees of preferential subscription rights.
Holders of preferential subscription rights will be able to subscribe:

on an irreducible basis at the rate of 1 New Share at 0.71 euro per share for every 6 existing shares owned. 6 PSR will allow to subscribe for 1 New Share at a price of 0.71 euro per share. Subscriptions on an irreducible basis will be allocated in full to enable the shareholder to maintain his participation in the capital; and
the number of New Shares, on a free basis, they would like in addition to the number of New Shares they are entitled to in respect of the exercise of their irreducible rights.
No reducible subscription is planned within the framework of the Rights Issue.

Listing period for preferential subscription rights

The preferential subscription rights will be listed on Euronext Growth Paris and Nasdaq First North Growth Copenhagen under ISIN code FR0014001YS4.

on Euronext Growth Paris: from March 17 to March 29, 2021 inclusive;
on Nasdaq First North Growth Copenhagen: from March 17 to March 24, 2021 inclusive.
Theoretical value of the preferential subscription right

0.006 euro (based on the closing price of Onxeo shares on March 8, 2021, i.e., 0.75 euro). The subscription price of 0.71 euro per share represents a discount of 4.6% compared to the theoretical ex-right value of the share.

The offer will be open to the public in France and Denmark only.

Subscription commitments

Financière de la Montagne and Invus Public Equities LP, core shareholders of the Company, have committed to participate in the transaction for a maximum total amount of approximately €7.0 million, of which approximately €2.23 million on an irreducible basis.

The New Shares that may not be absorbed by irreducible subscriptions will be allocated in priority to shareholders having signed subscription commitments, Invus Public Equities LP and Financière de la Montagne, and then to requests from institutional investors.

These commitments to subscribe represent thus 75.5% of the total amount of the central offering of the Rights Issue.

These commitments will at least allow to reach the completion threshold (75%) of the Offering if the subscriptions on an irreducible basis do not allow it and may be called beyond that threshold as free subscriptions, in order to reach the initial size of the issue, if again the subscriptions on an irreducible basis do not allow it.

Impact of the issue on the shareholding structure

As an indication, the theoretical impact of the issue, in the event that the transaction is completed at 100% (excluding the Extension Clause) and in the event that the subscription commitments of Financière de la Montagne and Invus Public Equities LP were to affect in their entirety the distribution of the Company’s capital and voting rights (as at March 9, 2021) is as follows:

% capital ownership Before the issue After the issue
Financière de la Montagne 13.36% 16.08%
Invus Public Equities LP 10.72% 15.36%
Guarantee

The issue is not subject to a guarantee contract.

DILUTION

For information purposes, the impact of the issue on the capital ownership of a shareholder holding 1% of the Company’s share capital prior to the issue and who does not subscribe to the issue (calculations based on a number of 78,094,959 shares making up the Company’s share capital at December 31, 2020 after deduction of treasury shares) would be as follows:

Shareholder’s interest (%)
(in euros per share) Non-diluted basis Diluted basis (1)
Before issue of 13,052,968 New Shares 1.00 0.95
After issue of 9,789,726 New Shares(2) 0.89 0.85
After issue of 13,052,968 New Shares (3) 0.86 0.82
After issue of 15,010,913 New Shares (4) 0.84 0.80
(1) Taking into account the 4,335,740 options and warrants giving access to the share capital granted and outstanding as of the date of this securities note.

(2) Capital increase up to 75.5% of the initial number of new shares to be issued.

(3) Capital increase up to 100% of the initial number of new shares to be issued.

(4) Capital increase up to 115% of the initial number of new shares to be issued (full exercise of the Extension Clause).

INDICATIVE TIMETABLE OF THE OPERATION

March 9, 2021 AMF approval of the Prospectus.
March 10,2021 Notification of a certificate of approval by the AMF to the Danish Financial Supervisory Authority ("FSA") (Finanstilsynet).
Distribution of a press release describing the main features of the operation and the means by which the Prospectus will be made available to the public.

March 11, 2021 Publication by Euronext Paris and Nasdaq First North Growth Copenhagen of a notice of issue.
March 12, 2021 Start of the suspension period of the right to transfer the Company’s current shares between Euronext Growth Paris and Nasdaq First North Growth Copenhagen.
March 16, 2021 Accounting day at the end of which the holders of current shares registered for accounting purposes in their securities account will be attributed preferential subscription rights.
March 17, 2021 Detachment and start of trading of preferential subscription rights on Euronext Growth Paris and on Nasdaq First North Growth Copenhagen.
March 18, 2021 Record date
March 19, 2021 Regaining of the right to transfer the Company’s existing shares between Euronext Growth Paris and Nasdaq First North Growth Copenhagen.
Opening of the subscription period on Euronext Growth in Paris and on Nasdaq First North Growth in Copenhagen.

March 24, 2021 End of preferential subscription rights listing on Nasdaq First North Growth Copenhagen.
March 26, 2021 Closing of the subscription period on Nasdaq First North Growth Copenhagen.
March 29, 2021 End of preferential subscription rights listing on Euronext Growth.
March 31, 2021 Closing of the subscription period on Euronext Growth Paris.
April 12, 2021 Possible exercise of the Extension Clause.
Distribution of a press release by the Company announcing the result of the subscriptions.

Distribution by Euronext Paris of the notice of admission of the New Shares indicating the final amount of the capital increase and indicating the allocation scale.

April 16, 2021 Issuance of New Shares – Settlement and Delivery.
April 19, 2021 Admission of the New Shares to trading on Euronext Growth Paris and Nasdaq First North Growth Copenhagen.
INFORMATION FOR DANISH SHAREHOLDERS

The subscription price of the New Shares is denominated in euros.

Any shareholder wishing to subscribe for the New Shares on the Nasdaq First North Growth Copenhagen must pay the subscription price of the New Shares (fixed in euros) in Danish kroner, i.e. DKK 5.287 (based on the exchange rate on March 9, 2021). The Company has entered into a hedging agreement with Nordea Denmark, a subsidiary of Nordea Bank Abp, Finland, to hedge against any potential change in the euro/DKK exchange rate.

The Company will not bear any costs related to the subscription of the New Shares other than those related to the currency hedging contract entered into with Nordea.

AVAILABILITY OF THE PROSPECTUS

The Prospectus, having received the approval n°21-063 dated March 9, 2021 from the Autorité des marchés financiers ("AMF"), consists of (i) the Universal Registration Document of Onxeo filed with the AMF on April 27, 2020 under number D.20-0362 (the "Universal Registration Document"), (ii) the Amendment to the Universal Registration Document, filed with the AMF on March 9, 2021 under number D.20-0362-A01, (iii) a Securities Note and (iv) a summary of the Prospectus (included in the Securities note).

Copies of the Prospectus are available free of charge at the registered office of Onxeo, 49, boulevard du Général Martial Valin – 75015 Paris. The Prospectus may also be consulted on the websites of the AMF (www.amf-france.org) and Onxeo (www.onxeo.com) and from the Lead Manager and Bookrunner.

In connection with the opening of the public offering in Denmark, an unofficial translation into English of all the documents constituting the prospectus has also been prepared by the Company. In the event of any discrepancy between the French prospectus and the English translation, the French version will prevail. These documents are also available free of charge at Onxeo’s registered office at 49, boulevard du Général Martial Valin – 75015 Paris and on Onxeo’s website (www.onxeo.com).

Risk Factors

Investors are invited to carefully consider the risk factors detailed in section 3 of the Universal Registration Document, section 2 of the Amendment to the Universal Registration Document and section 2 of the Securities Note. The occurrence of all or part of these risks may have an adverse effect on the Group’s business, financial position, results or ability to achieve its objectives.

Humanigen Announces $80 Million Loan Facility from Hercules Capital

On March 10, 2021 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported that it has obtained a term loan facility from Hercules Capital (NYSE: HTGC), a leader in customizing debt financing for companies in the life sciences market (Press release, Humanigen, MAR 10, 2021, View Source [SID1234576425]). Under the terms of the facility, Hercules will provide Humanigen up to $80 million of secured debt financing.

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"The term loan facility provides working capital to support the production of lenzilumab, strengthens our balance sheet and increases our financial flexibility as we prepare for the potential Emergency Use Authorization and commercial launch of lenzilumab in 2021," said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen.

The facility consists of a $25 million initial term loan, with up to an additional $55.0 million available for future draws subject to achievement of future milestones and satisfaction of other conditions. The facility provides for an interest-only period and the four-year term is extendable under certain conditions. Loans under the facility are secured by the company’s assets.

"Hercules is excited to be partnering with Humanigen as it advances lenzilumab for COVID-19 and other indications. This structured financing represents a significant commitment from Hercules, which is consistent with our goal of supporting innovative life sciences companies," said Himani Bhalla, Principal at the Life Sciences group at Hercules. "This is an example of the breadth of our platform and our ability to finance life sciences companies through all stages of development."

Alpine Immune Sciences Announces Poster Presentations at AACR Virtual Annual Meeting I

On March 10, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the planned presentation of two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, taking place April 10-15, 2021 (Press release, Alpine Immune Sciences, MAR 10, 2021, View Source [SID1234576394]). Dr. Mark Voskoboynik of Nucleus Network and The Alfred Hospital in Melbourne, Australia, will be presenting a poster in the Phase 1 Clinical Trials in Progress session on NEON-1, a Phase I study of ALPN-202 in advanced malignancies. Separately, Alpine researchers will present a preclinical poster describing the application of Alpine’s directed evolution platform to the development of fusion proteins capable of tumor antigen-dependent CD28 costimulation, as a distinctive immuno-oncology approach.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details of the presentations are as follows:

Presentation Title: NEON-1: A first-in-human phase I open-label study of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies

Session Category: Phase I Clinical Trials in Progress
Session Title: Phase I Clinical Trials in Progress
Date Poster Available: Saturday, April 10th
Session Type: E-Poster Session
Poster Number: CT213
Presentation Title: Engineered variant domain fusion proteins provide checkpoint inhibition and tumor antigen dependent CD28 costimulation resulting in potent anti-tumor immunity

Session Category: Immunology
Session Title: Immunomodulatory Agents and Interventions
Date Poster Available: Saturday, April 10th
Session Type: E-Poster Session
Poster Number: 1740
Titles and/or full abstracts are available on the AACR (Free AACR Whitepaper) Virtual Annual Meeting website. Posters for both presentations will be available on the Scientific Publications page of Alpine’s website on April 10th.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor designed to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling.

Affimed Announces Continuation of REDIRECT, a Registration-directed Study of AFM13 in PTCL, after Positive Preplanned Interim Futility Analysis

On March 10, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported its decision to continue enrollment in the REDIRECT trial, which is evaluating AFM13 as a monotherapy for the treatment of patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (Press release, Affimed, MAR 10, 2021, View Source [SID1234576410]).

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The decision to continue the trial followed a preplanned interim futility analysis. The interim analysis was triggered following enrollment of 20 patients in both Cohort A (³10% CD30) and Cohort B (>1% to <10% CD30). The futility boundary was derived from response rates for previous therapies that have received accelerated approval in relapsed or refractory (R/R) PTCL. The futility analysis demonstrated that the response rate in Cohort A achieved the predefined threshold for continuation of the study. The response rate in Cohort B was sufficiently comparable to allow merging of both cohorts into a single cohort for all patients with CD30 >1%, per the study protocol. Evidence of anti-tumor response was observed in both cohorts with complete and partial responses. The safety analysis was consistent with previously reported data from Affimed’s Phase 1 trials of AFM13, with infusion related reactions (IRRs) representing the main side effect. Following the introduction of mandatory premedication, IRRs were markedly reduced, resulting in fewer dose reductions and a trend towards better activity.

"We are very encouraged by the observed activity of AFM13 in this heavily pretreated patient population, where more than half of the patients had three or more lines of previous therapy. These data reinforce our strategy to broadly develop AFM13 across CD30-positive lymphomas both as monotherapy and in combination with other therapies," said Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. "Having successfully met the criteria for continuation, the trial will move forward by merging the CD30 high- and low-expressing PTCL cohorts for evaluation of the safety and efficacy of AFM13."

"We are excited by this progress and by AFM13’s potential as monotherapy for patients with PTCL," said Dr. Won Seog Kim, Principal Investigator of REDIRECT and Professor of Hematology and Oncology at the Samsung Medical Center, Sungkyunkwan University, Seoul, Korea. "PTCL is an aggressive and challenging cancer to treat in patients who relapse or do not respond favorably to current therapies, which often have high toxicity profiles, and new therapeutic approaches are needed."

AFM13 is also being evaluated in combination with cord-blood derived natural killer cells in CD30-positive lymphomas at MD Anderson Cancer Center (MDACC). Initial data from this investigator sponsored study will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021.

Investor Conference Call and Webcast Details Affimed will host an investor conference call and webcast today, Wednesday, March 10, at 8:30 a.m. EST, to review the REDIRECT study interim analysis. To access the call, please dial +1-646-741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference conference ID 6065008 approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section of the company’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

About AFM13-202 and the REDIRECT Trial Design

REDIRECT (also known as AFM13-202, NCT04101331) is a registration-directed phase 2 open-label, multicenter, global study investigating the efficacy and safety of AFM13 monotherapy in patients with R/R CD30-positive PTCL and Transformed Mycosis Fungoides (TMF).

The study enrolls patients who suffer from CD30 expressing PTCL or TMF and who have relapsed after an earlier standard of care treatment or have refractory disease. Dependent on their disease type and the magnitude of CD30 expression on their tumor cells, study participants are assigned to one of three study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The three cohorts are comprised of Cohort A, which includes PTCL patients with ³10% CD30 expression on tumor cells; Cohort B, which includes PTCL patients with >1% to< 10% CD30 expression on tumor cells; and, Cohort C, currently on hold, which includes TMF patients with ³1% CD30 expression on tumor cells.

The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of objective responses. Further goals of the study are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood.

The study began recruitment in October 2019 at sites in the United States, Australia, South Korea and seven European countries. The TMF arm of the study (Cohort C), which is exploratory only and not relevant to the potential consideration for accelerated approval, will remain paused, due to COVID-19 and the high number of assessments and site visits necessary for this group of patients. To date, no TMF patients have been recruited into the study.

Alpine Immune Sciences Announces Poster Presentations at AACR Virtual Annual Meeting I

On March 10, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the planned presentation of two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, taking place April 10-15, 2021 (Press release, Alpine Immune Sciences, MAR 10, 2021, View Source [SID1234576426]). Dr. Mark Voskoboynik of Nucleus Network and The Alfred Hospital in Melbourne, Australia, will be presenting a poster in the Phase 1 Clinical Trials in Progress session on NEON-1, a Phase I study of ALPN-202 in advanced malignancies. Separately, Alpine researchers will present a preclinical poster describing the application of Alpine’s directed evolution platform to the development of fusion proteins capable of tumor antigen-dependent CD28 costimulation, as a distinctive immuno-oncology approach.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the presentations are as follows:

Presentation Title: NEON-1: A first-in-human phase I open-label study of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies

Session Category: Phase I Clinical Trials in Progress
Session Title: Phase I Clinical Trials in Progress
Date Poster Available: Saturday, April 10th
Session Type: E-Poster Session
Poster Number: CT213
Presentation Title: Engineered variant domain fusion proteins provide checkpoint inhibition and tumor antigen dependent CD28 costimulation resulting in potent anti-tumor immunity

Session Category: Immunology
Session Title: Immunomodulatory Agents and Interventions
Date Poster Available: Saturday, April 10th
Session Type: E-Poster Session
Poster Number: 1740
Titles and/or full abstracts are available on the AACR (Free AACR Whitepaper) Virtual Annual Meeting website. Posters for both presentations will be available on the Scientific Publications page of Alpine’s website on April 10th.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor designed to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling.