On January 11, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported a business update reviewing 2020 achievements and outlining the Company’s key business objectives for 2021 (Press release, Cyclacel, JAN 11, 2021, View Source [SID1234573834]). The Company will present at Biotech Showcase Digital 2021 taking place virtually from January 11 to 15 with a prerecorded session of the company presentation. Spiro Rombotis, President & Chief Executive Officer, will provide an overview of the Company and progress in key programs. Cyclacel will host one-on-one meetings with investors and industry stakeholders during the event. Registered Biotech Showcase Digital 2021 attendees may request one-on-one meetings with Cyclacel through the partneringONE system.

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"With the recent appointment of Dr. Mark Kirschbaum as our CMO and the December 2020 strategic investment from Acorn Bioventures, we are well resourced to progress fadraciclib and CYC140, our two internally discovered molecules," said Spiro Rombotis, President and Chief Executive Officer. "Fadraciclib, a CDK2/9 inhibitor, has shown promising clinical activity and tolerability in patients with advanced cancers and CYC140, a PLK1 inhibitor, is in a first-in-human study. As the next step in our clinical development program we will evaluate both agents, dosed orally, across a broad spectrum of solid tumors and hematological malignancies as part of our strategy of identifying clinical activity which may lead to registration-enabling studies."

2020 Key Achievements

Data from Phase 1 study of fadraciclib as a single agent reported at the Plenary Session of the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium
• Radiographically confirmed partial response (PR) after a month and a half on i.v. fadraciclib: MCL1-amplified endometrial cancer; failed seven lines of prior therapy; continuing treatment for more than 16 months with 96% reduction in target tumor lesions
• High bioequivalence observed in 5 patients treated with oral fadraciclib
Enrolled 19 patients evaluating i.v. fadraciclib in combination with venetoclax in patients with relapsed or refractory AML/MDS and CLL with evidence of antileukemic activity
Enrolled five patients evaluating i.v. CYC140 in patients with advanced leukemias
Enrolled 12 patients in Phase 1/2 study evaluating an oral regimen of sapacitabine in combination with venetoclax in patients with relapsed or refractory AML/MDS
Announced peer-reviewed publication of a fadraciclib review in PLOS ONE. Authored by scientists from Cyclacel and The Institute of Cancer Research, London, the publication describes the discovery of fadraciclib and shows that its targeting of CDK2 and CDK9 leads to broad therapeutic potential
Appointed Mark Kirschbaum, M.D. as Senior Vice President and Chief Medical Officer. Dr. Kirschbaum is a highly experienced hematologist/oncologist with over 30 years of experience in molecular medicine, new drug development, clinical trial design and patient care
Appointed Brian Schwartz, M.D, formerly CMO at ArQule, Inc., and Karin L. Walker, Chief Accounting Officer of Prothena Corporation plc, to the Board of Directors
Raised approximately $30 million in net cash in two equity financings and related warrant exercises providing estimated capital to early 2023
In 2021, Cyclacel will commence streamlined Phase 1/2 clinical studies, initially of oral fadraciclib and subsequently of oral CYC140, in a broad range of solid tumors and hematological malignancies. These studies are supported by fadraciclib’s Phase 1 clinical data and its transcriptional mechanism of action enabling apoptosis of cancer cells and the extensive preclinical data of CYC140 demonstrating its antimitotic mechanism and broad therapeutic potential in several solid tumors and hematological malignancies.

The clinical development plan for these studies calls for parallel evaluation of different schedules of the two agents in multiple cohorts defined by cancer histology and collection of biospecimens for translational analysis. The aim of these studies is to identify clinical activity which may lead to registration-enabling studies.

Key Business Objectives for 2021

First patient dosed with oral fadraciclib in Phase 1/2 advanced solid tumor study
First patient dosed with oral CYC140 in Phase 1/2 advanced solid tumor study
Manufacture clinical supplies of fadraciclib and CYC140 for registration-enabling studies
Data on safety and antileukemic activity from the i.v. fadraciclib-venetoclax Phase 1 study in relapsed/refractory AML and CLL
Data from the sapacitabine-venetoclax Phase 1/2 study in relapsed/refractory AML or MDS
Initial data from the CYC140 Phase 1 First-in-Human study in patients with advanced leukemias
Data from the Phase 1b/2 IST of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators

On January 11, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported 2021 milestone targets for its pipeline of four drug candidates, including data updates from multiple clinical studies and the initiation of new clinical studies (Press release, Turning Point Therapeutics, JAN 11, 2021, View Source [SID1234573833]). The company also updated its cash position as of Dec. 31, 2020.

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"Following a pivotal year in 2020, we believe we have even greater opportunities in 2021 to further advance our pipeline by potentially modifying our SHIELD-1 study to a registrational Phase 1/2 design, adding three new clinical trials, including two anticipated combination studies and a Phase 1 study of our fourth drug candidate, our novel ALK-inhibitor TPX-0131, and reporting initial or updated data from our three clinical stage drug candidates," said Athena Countouriotis, M.D., president and chief executive officer. "At the same time, we have continued to invest in our discovery engine and look forward to the second half of the year when we plan to outline our focus and goals to further expand the pipeline."

2020 Achievements and 2021 Milestone Targets

Repotrectinib, ROS1 and TRK Inhibitor

In 2020, repotrectinib was granted breakthrough-therapy designation (BTD) and received its second and third fast-track designations. In addition, the company signed an exclusive license agreement with Zai Lab to develop and commercialize repotrectinib in greater China and reported early interim data from the Phase 2 TRIDENT-1 registrational study.

2021 Milestone Targets:

Present updated data from the TRIDENT-1 study in TKI-naive patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) in a mini-oral presentation on Jan. 31 at the World Conference on Lung Cancer

Provide an update on the overall Phase 2 TRIDENT-1 registrational study timeline in the first quarter

Initiate the Phase 2 TRIDENT-2 combination study in patients with KRAS mutant NSCLC mid-year

Provide clinical data updates from certain cohorts of the Phase 2 TRIDENT-1 study in the second half
TPX-0022, MET/SRC/CSF1R Inhibitor

In 2020, Turning Point advanced its clinical development of TPX-0022 and reported initial data from the Phase 1 SHIELD-1 study in an oral presentation during the plenary session at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) medical symposium.

Earlier today, the company announced the broadening of its collaboration with Zai Lab to include an exclusive licensing agreement for TPX-0022 in greater China.

2021 Milestone Targets:

Initiate the Phase 2 portion of SHIELD-1, pending FDA feedback, in the second half

Initiate the Phase 2 SHIELD-2 study of TPX-0022 in combination with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor in the second half

Provide a clinical data update from the Phase 1 portion of the SHIELD-1 study in the second half
TPX-0046, RET Inhibitor

In 2020, Turning Point presented preclinical data highlighting the potent inhibition of TPX-0046 against wildtype RET and RET mutations, and continued its ongoing Phase 1 study of TPX-0046.

2021 Milestone Target:

Report early interim data from initial patients enrolled in the dose finding portion of the TPX-0046 Phase 1 study in the first half
TPX-0131, ALK Inhibitor

In 2020, Turning Point nominated TPX-0131 as its ALK inhibitor drug candidate, advanced its IND enabling studies, and presented preclinical data highlighting its ability to overcome ALK resistant mutations refractory to approved ALK inhibitors.

2021 Milestone Targets:

Submit the IND for TPX-0131 in the first quarter
Initiate a Phase 1 clinical study of TPX-0131 in the first half
Early Discovery Pipeline

In 2020, Turning Point named Siegfried Reich as chief scientific officer and made investments to advance its research strategy.

2021 Milestone Target:

Outline research strategy, focus and milestones for future development candidates in the second half
Financial

In 2020, Turning Point completed follow-on stock offerings generating gross proceeds of $374 million and $460 million. The company enters 2021 with approximately $1.1 billion in cash, cash equivalents and marketable securities as of Dec. 31, 2020, which is expected to fund operations into 2024.

On January 11, 2021 Strand Therapeutics, a privately held developer of next-generation, programmable mRNA therapeutics for cancer and other diseases, and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) reported that they have entered into an option and license agreement aimed at developing and commercializing Strand’s innovative, multi-functional mRNA treatments for solid tumors (Press release, Strand Therapeutics, JAN 11, 2021, View Source [SID1234573832]). BeiGene has secured an option to an exclusive license to develop and commercialize in Asia (excluding Japan), Australia, and New Zealand up to two immuno-oncology programs using Strand’s intratumoral or systemic delivery mechanism, which is designed to deliver a tumor microenvironment-modifying mRNA directly to the tumor site.

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Strand has developed the first platform for the creation of programmable, long-acting mRNA therapeutics capable of delivering multi-functional treatments for deadly diseases, with an initial aim of developing potentially curative treatments for solid tumor cancers. The company’s self-replicating mRNAs are bioengineered to enable precise control of the location, timing, intensity, and duration of therapeutic protein expression for improved efficacy and lower toxicity.

"BeiGene is a recognized global leader in the development and commercialization of innovative, high-quality cancer therapeutics," said Jacob Becraft, Ph.D., Co-founder and Chief Executive Officer of Strand. "This collaboration between our two companies provides strong validation of Strand’s next-generation mRNA platform and our work to advance mRNA-based medicines beyond vaccines into potentially curative therapies."

"We look forward to working closely with BeiGene’s unsurpassed clinical team to accelerate the development of our solid tumor immuno-oncology therapies," said Tasuku Kitada, Ph.D., Co-founder, President, and Head of R&D of Strand. "The aim of both our companies is to increase patient access to cutting-edge therapeutics by providing safe and effective treatments that are more easily administered, cost-effective, and scalable."

"Strand’s programmable mRNA technology is incredibly exciting as a cutting-edge therapeutic platform and is expected to help us build novel mRNA-based immuno-oncology therapeutics for the treatment of cancer. We look forward to exploring this technology further and to collaborating with Strand as we advance up to two development programs with this new approach," said Lusong Luo, Ph.D., Senior Vice President of External Innovation at BeiGene.

Under the terms of the agreement, Strand will receive an upfront cash payment of $5 million and will also be eligible to receive additional near-term payments totaling up to $28 million, inclusive of BeiGene’s exercise of its options to the two programs following initial proof-of-concept studies. Additionally, Strand is eligible to receive payments from BeiGene based upon the achievement of certain development, regulatory, and sales milestones for a total deal value of up to $277 million, together with tiered royalties on any product sales in the licensed territory. In connection with the agreement, Strand also received investments of $10 million, including $5 million from BeiGene.

On January 11, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that its Chief Executive Officer, Dr. Adi Hoess, will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 7:30 a.m. Eastern Standard Time (Press release, Affimed, JAN 11, 2021, View Source [SID1234573831]).

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A live webcast of the presentation may be accessed on Affimed’s website at View Source and will be available for 30 days following the event. For more information or to schedule a one-on-one meeting with Affimed management, please contact Alex Fudukidis via email at [email protected] or phone at +1 (917) 436-8102.

On January 11, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported its strategic priorities and expected upcoming milestones (Press release, Syros Pharmaceuticals, JAN 11, 2021, View Source [SID1234573830]).

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"Syros is rapidly accelerating toward becoming a commercial-stage company through three strategic priorities: advancing franchises in targeted hematology and selective CDK inhibition, as well as leveraging a robust gene control discovery engine to fuel our long-term growth," said Nancy Simonian, M.D., Syros’ Chief Executive Officer. "As we enter the new year, we are well-positioned to execute against each of these strategic priorities. We plan to launch three clinical trials across our portfolio of targeted hematology therapies in patients with higher-risk MDS, AML and APL, indications where we have the opportunity to set new standards of care."

"In parallel, we continue to build on our leadership in selective CDK inhibition, where we believe we can deliver highly selective product candidates with transformative potential for difficult-to-treat cancers. We are on track to report additional dose-escalation data, including clinical activity, from our Phase 1 trial of SY-5609 in the third quarter and move into the expansion phase of the trial in the second half of the year. These milestones bring us closer to our ultimate goal of bringing targeted therapies to market that provide profound benefits for patients with diseases that have eluded other approaches."

Expected Milestones

SY-1425: Oral RARα agonist

Initiate Phase 3 trial of SY-1425 in combination with azacitidine in the first quarter of 2021 in RARA-positive patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).
Initiate randomized Phase 2 trial of SY-1425 in combination with venetoclax and azacitidine in the second half of 2021 in RARA-positive newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard intensive chemotherapy.
SY-2101: Oral arsenic trioxide (ATO)

Initiate dose confirmation study of SY-2101 in the second half of 2021.
Initiate Phase 3 trial in patients with newly diagnosed acute promyelocytic leukemia (APL) in 2022.
SY-5609: Oral CDK7 inhibitor

Report additional dose-escalation data, including clinical activity data, in the third quarter of 2021 from the ongoing Phase 1 trial of SY-5609 in patients with breast, colorectal, lung, ovarian and pancreatic cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations.
Initiate expansion portion of Phase 1 trial in the second half of 2021.
Gene control discovery engine

Expect to nominate next development candidate in 2022.
Financial Guidance
Syros ended the year with approximately $174 million in cash, cash equivalents and marketable securities1, which the company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2022.