Inceptua Medicines Access and Onconova Therapeutics Announce Pre-approval Access Collaboration for Rigosertib in Selected Countries Outside the US NEWTOWN, PA., and LUXEMBOURG

Inceptua Medicines Access and Onconova

Therapeutics Announce

Pre-approval Access Collaboration for

Rigosertib in Selected Countries Outside the US

NEWTOWN, PA., and LUXEMBOURG, Dec 6,

2019 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a Phase 3-stage biopharmaceutical

company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), and

Inceptua Medicines Access (a business unit of the Inceptua Group), a global pharmaceutical company and service partner, today announced

that they have entered into a collaboration to make available intravenous rigosertib via a Pre-approval Access Program in selected

countries around the world.

Pre-approval Access Programs (also known

as expanded access, early access, compassionate use, named patient supply) are regulatory-compliant processes permitting experimental

agents in development to be made available upon the request of a physician or a patient for appropriate patients for whom no alternative

treatment option exists in their country. Rigosertib is a small molecule that inhibits cellular signaling in cancer cells by acting

as a RAS mimetic. Current clinical development of rigosertib is centered upon the therapeutic management of MDS, a heterogeneous

group of bone marrow disorders characterized by ineffective hematopoiesis that often develop into acute myeloid leukemia (AML).

Rigosertib, in its intravenous formulation, is currently in Phase 3 clinical development for the treatment of higher-risk MDS.

The rigosertib Pre-approval Access Program

is expected to launch in first half of 2020 and will allow Inceptua to supply intravenous rigosertib within designated countries,

primarily and initially concentrated in selected countries in Europe, in response to physician requests for patients with higher-

risk MDS who have exhausted all available treatment options, and are not eligible for or have no access to the INSPIRE study. Under

the terms of this agreement, Inceptua will support Onconova through the pre-approval provision of intravenous rigosertib initially

into a number of countries including: Australia, Denmark, Finland, France, Ireland, Italy, the Netherlands, Portugal, South Africa,

"Inceptua Medicines Access is

delighted to be selected as Onconova's partner for the Pre-approval Access Program for rigosertib. Higher-risk MDS is a disease

with significant unmet need, and we are pleased to be able to support healthcare professionals seeking access to rigosertib, ahead

of its commercial launch," said Mark Corbett, EVP, Inceptua Medicines Access.

Steven M. Fruchtman, M.D., President and

Chief Executive Officer of Onconova, said, "The rigosertib Pre-approval Access Program is a key strategic initiative for

Onconova. We are pleased that intravenous rigosertib will be made compliantly available to suitable patients with higher-risk MDS

through their physcians in designated countries. The program will run alongside our ongoing Phase 3 INSPIRE Trial, and is expected

to continue until commercial launch in such countries. We are pleased to work with Inceptua, given their strong record of administering

such programs successfully."

Please note: Inceptua can only respond

to unsolicited requests from bona fide healthcare professionals. Healthcare professionals can obtain information about the rigosertib

Pre-approval Access Program by contacting Inceptua either by telephone +44 20 3910 7600 or by email: Access@inceptua.com.

About Onconova Therapeutics, Inc.

Onconova Therapeutics, Inc. is a Phase

3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with

an initial focus on Myelodysplastic Syndromes (MDS). Using a proprietary chemistry platform, Onconova has created a pipeline

of targeted agents designed to work against specific cellular pathways that are important in cancer cells. Advanced clinical

trials with the Company's lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients

with MDS. Onconova has conducted trials with two other research compounds and has a pre-clinical program with a CDK4/6 and

Ark5 inhibitor, ON 123300.

For more information, please visit http://www.onconova.com.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions

that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating

blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers

of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone

marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected,

although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress

to the development of acute leukemia.

Rigosertib, Onconova's lead candidate,

is a proprietary Phase 3 small molecule. A key publication in a preclinical model demonstrated rigosertib's ability

to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: "A Small Molecule RAS-Mimetic

Disrupts RAS Association with Effector Proteins to Block Signaling." Cell 165, 643). Onconova is currently in the clinical

development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk

MDS patients (pivotal Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS

patients (Phase 2). Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide

coverage until at least 2037.

About the INSPIRE Phase 3 Clinical Trial

The clinical trial INternational Study

of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the

U.S. Food and Drug Administration and European Medicines Agency. INSPIRE is a global, multi-center,

randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had

progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine

cycles over the course of one year after initiation of HMA treatment. This time frame optimizes the opportunity to

respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. Patients are randomized

at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive

Care. The primary endpoint of INSPIRE is overall survival. The trial continued beyond the pre-specified interim

analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well

as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).

The intravenous form of rigosertib has

been studied in Phase 1, 2, and 3 clinical trials involving more than 1000 patients, and is currently being evaluated in a randomized

Phase 3 international INSPIRE trial for patients with HR-MDS after failure of HMA therapy.

About Oral Rigosertib

The oral form of rigosertib was developed

to provide a potentially more convenient dosage form for use where the duration of treatment may extend to multiple years. This

dosage form may also support combination therapy modalities. To date, over 400 patients have been dosed with the oral formulation

of rigosertib in clinical trials. Combination therapy of oral rigosertib with azacitidine, the standard of care in HR-MDS,

has also been studied. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients

with higher-risk MDS who require HMA therapy. A Phase 1/2 trial of the combination therapy has been fully enrolled, and

the preliminary efficacy and safety data was presented at The American Society of Hematology (ASH) Annual Meeting in December 2018.

The data will be updated at the upcoming 2019 ASH Annual Meeting next week.

Inceptua is a pharmaceutical company

and service partner spanning throughout the product lifecycle - from comparator sourcing for clinical trials, through early

access programs to licensing and commercialization for products.

We partner with life science companies

of all sizes, drawing on over 20 years of industry experience. Our pharma and biotech offering includes registration and commercialization

of products through in-licensing and flexible partnerships. We have leading expertise in strategy and operational implementation

of pre-approval access programs making pharmaceutical products under clinical development available for patients and Inceptua's

clinical trial services business offers high quality clinical comparator sourcing and manufacturing services with an agile global

supply chain to ensure that products are delivered exactly when needed.

Inceptua Medicines Access is a business

unit of the Inceptua Group. It offers full access solutions for the design, implementation and delivery of Pre-approval and Medicines

Access Programs on behalf of biopharmaceutical companies.

Inceptua has global operations with

local offices across Europe, USA, and Asia.

Forward-Looking Statements