On November 5, 2018 Kura Oncology, Inc., (Nasdaq: KURA) a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported third quarter 2018 financial results and provided a corporate update (Press release, Kura Oncology, NOV 5, 2018, View Source [SID1234530721]).

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"We are very encouraged by our growing body of data that support the potential of tipifarnib as a treatment for squamous cell carcinomas characterized by HRAS mutations," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "With our registration-directed trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC) now underway, we are focused on generating a data package to support an application for marketing approval in that indication, as we work to broaden the potential of tipifarnib in both HRAS mutant and non-HRAS mutant cancers. In that regard, we are encouraged by preliminary signals of clinical activity observed in patients with HRAS mutant SCCs as we believe this may represent a near-term opportunity to expand the use of tipifarnib into a broader set of HRAS mutant cancers."

"In addition," Dr. Wilson continued, "we believe the CXCL12 pathway also holds promise for identifying patients who will respond to tipifarnib, and we look forward to showing data next month at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from our ongoing Phase 2 clinical trial in patients with peripheral T-cell lymphoma (PTCL) in which we are evaluating, on a prospective basis, the role of the CXCL12 pathway and markers of bone marrow homing as potential biomarkers of clinical activity of tipifarnib."

Corporate Update

Update on positive Phase 2 trial of tipifarnib in HRAS mutant HNSCC – In October 2018, Kura reported an update on its ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress. As of the September 7, 2018 clinical data cutoff date, tumor size reductions were observed in nine of 11 evaluable patients, with five confirmed partial responses (PRs), including three patients with durable responses lasting more than 17 months. A sixth patient achieved a confirmed PR after the data cutoff. Four patients had stable disease, including two patients who experienced prolonged disease stabilization lasting more than six months. Only one patient experienced progressive disease as best response.

Preliminary results from cohort of other HRAS mutant SCCs – Preliminary results from an additional cohort of patients with other HRAS mutant squamous cell carcinomas (SCCs) were also reported at ESMO (Free ESMO Whitepaper). One of the two evaluable patients in this cohort achieved a confirmed PR and the other patient achieved prolonged disease stabilization lasting more than eight months. Four patients were not evaluable as of the data cutoff date, including two patients who were pending initial efficacy assessments.

Significant association observed between allele frequency and clinical benefit – An analysis of available tumor biopsy samples from patients in Kura’s ongoing Phase 2 trial in HNSCC/SCC cancers revealed a significant association between the allele frequency of HRAS mutations and clinical benefit. Of the 13 HNSCC and SCC patients with a tumor HRAS mutant allele frequency greater than 20%, six achieved PRs, one achieved an unconfirmed PR and two experienced disease stabilization greater than six months. No meaningful clinical benefit was observed in the seven patients with an allele frequency less than 20%. Based on these observations, Kura has introduced a minimum HRAS mutant allele frequency of 20% as an entry criterion in its registration-directed trial of tipifarnib in HRAS mutant HNSCC and is working to implement the same entry criterion in its ongoing Phase 2 study of tipifarnib in HRAS mutant SCCs.

Initiation of registration-directed trial of tipifarnib in HRAS mutant HNSCC – Earlier today, Kura announced that its registration-directed trial of tipifarnib in HRAS mutant HNSCC has been initiated and is open for enrollment. The global, multi-center trial has two cohorts: SEQ-HN, a non-interventional screening and outcomes cohort, and AIM-HN, a treatment cohort. AIM-HN is designed to enroll at least 59 patients with HRAS mutant HNSCC who have received prior platinum-based therapy. AIM-HN is expected to take approximately two years to fully enroll, with objective response rate as the primary endpoint. Based on feedback from the U.S. Food and Drug Administration, Kura believes that the trial, if positive, could support an application for accelerated approval.

Preliminary data from expansion cohorts in Phase 2 trial of tipifarnib in PTCL at ASH (Free ASH Whitepaper) – Kura is evaluating, on a prospective basis, the role of the CXCL12 pathway and markers of bone marrow homing as potential biomarkers of clinical activity for tipifarnib in various hematologic malignancies. The Company’s ongoing Phase 2 PTCL trial was the first of the three to begin and is actively enrolling patients into two cohorts: 1) patients with angioimmunoblastic T-cell lymphoma (AITL) and 2) patients with PTCL who have the absence of a single nucleotide variation in the 3’ untranslated region of the CXCL12 gene. Kura expects to provide preliminary data from these cohorts at ASH (Free ASH Whitepaper) in December 2018.
Financial Results

Research and development expenses for the third quarter of 2018 were $11.7 million, compared to $7.1 million for the third quarter of 2017.

General and administrative expenses for the third quarter of 2018 were $4.3 million, compared to $2.4 million for the third quarter of 2017.

Net loss for the third quarter of 2018 was $15.0 million, or $0.40 per share, compared to $9.3 million, or $0.38 per share, for the third quarter of 2017.

Cash, cash equivalents and short-term investments totaled $187.4 million as of September 30, 2018, compared with $93.1 million as of December 31, 2017.
Upcoming Milestones

Preliminary data from AITL and CXCL12+ cohorts in Phase 2 trial of tipifarnib in PTCL at ASH (Free ASH Whitepaper)

Additional biomarker-enriched data from other hematologic indications in 2019

Additional data from Phase 2 trial of tipifarnib in HRAS mutant SCC in 2019

Data from Phase 1 dose-escalation trial of ERK inhibitor KO-947 in 2019

Submission of an investigational new drug application for menin-MLL inhibitor KO-539 in first quarter of 2019
Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, November 5, 2018, to discuss the financial results for the third quarter of 2018 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 6593979. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.

On November 5, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology targeting tumor DNA Damage Response (DDR) to fight resistant cancers, reported positive interim results from the first three dose levels already evaluated out of six planned in its Phase 1 DRIIV-1 study of AsiDNA, the Company’s first-in-class DNA Damage Response inhibitor (Press release, Onxeo, NOV 5, 2018, View Source [SID1234530739]).

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A total of 10 patients with advanced solid tumors received 112 infusions of AsiDNA ranging from 200mg (DL1) to 600mg (DL3). The administration of DL4 (900mg) is ongoing and the full data set from DRIIV-1 is expected to be available in the first half of 2019.

Judith Greciet, Chief Executive Officer of Onxeo, said: "We are very pleased to report highly compelling interim results from our DRIIV-1 study. Beyond the safety endpoints of all phase 1 studies, DRIIV-1 was foremost designed to demonstrate that AsiDNA administered intravenously activates in patients’ tumors cells the intended DNA Damage Response biological targets. Midway through the study, data show that robust target engagement was demonstrated as early as the second dose level, which represents a meaningful proof-of-mechanism of AsiDNA in man. In addition, the results indicate a favorable safety profile for AsiDNA in a difficult-to-treat patient population. These proof-of-mechanism and activity results further support the clinical potential of AsiDNA in solid tumors and represent a major value catalyst in the development of our first-in-class drug candidate."

Pharmacokinetic parameters

Both Cmax (maximal concentration) & AUC (area under the curve) data show dose proportionality from dose level 1 to dose level 3, with systemic exposure rising proportionally to the dose.

Pharmacodynamic parameters (activity data)

In accordance with the study protocol, biopsies were performed during cycle 2 of treatment with AsiDNA and analyzed by comparison with baseline biopsies. Target engagement by AsiDNA was measured by quantifying through immuno-histochemistry two established biomarkers of the activation of DNA-PK, a major target for AsiDNA, gH2AX and pHSP90.

Post-treatment biopsies were available and analyzed for four patients (two post-DL2 and two post-DL3), showing a robust activation of DNA-PKA as evidenced by a significant post-treatment increase in the quantification of these activity biomarkers in patients’ tumor tissue. These data confirmed strong target engagement and activity in tumors at these two AsiDNA dosages.

Furthermore, the quantification of a well-known tumor proliferation biomarker, Ki67, showed a clear decrease of the proliferation rate in tumors of three patients and stabilization in one patient.

Safety data

Intravenous administration of AsiDNA was generally well-tolerated at DL1, DL2 and DL3, with no drug- related serious adverse event and no dose-limiting toxicity.

Olivier de Beaumont, Chief Medical Officer of Onxeo, concluded: "We are very encouraged by these first safety and proof-of-mechanism data, which confirm the activity and tolerability of AsiDNA via systemic administration. AsiDNA is now ready to enter the next stage of its clinical development. Our translational work on the combination of AsiDNA with PARP inhibitors is indicative of the unique properties of this combination, such as the prevention, and even reversal, of the resistance to PARP inhibitors. Promising data have also been obtained in combination with DNA-damaging agents such as platins or taxanes. Combining AsiDNA with these agents will therefore be our first priority as we expand its clinical development to Phase1b/2 efficacy studies in combination in 2019. In parallel, the DRIIV-1 study is progressing to plan and we are on track to deliver full results in the first half of 2019."

Onxeo will host a conference call in English with a Q&A session for analysts and investors at 5:30 pm CET / 11:30 pm ET today to discuss this announcement

Location

Phone number

France +33 1 72 72 74 03
United States +1 646 722 4916
United Kingdom +44 20 7194 3759
Denmark +45 8233 3187

Participation code: 33251686#

Access to the management presentation prior to the call

An audio replay file will be made available after the session on Onxeo’s website.
About the DRIIV-1 study

DRIIV-1 (DNA Repair Inhibitor administered IntraVenously) is an open-label, dose escalation, Phase 1 study evaluating the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AsiDNA via systemic (IV) administration in patients with advanced solid tumors. The study is being conducted at leading oncology centers in France and Belgium.

Six dose levels (DLs) are planned (DL1 to DL6): 200mg, 400mg, 600mg, 900mg, 1,300mg and 1,800mg. All patients receive a loading dose of AsiDNA for 3 consecutive days (1-hour IV infusion at day 1, day 2 and day 3), followed by a one-hour IV infusion once a week (at day 8 and day 15) of a 21 days treatment period (1 cycle = 21 days). In each subsequent cycle, AsiDNA is administered on a weekly basis (day 1, day 8 and day 15) of a 21 days treatment period. Patients are continuing study treatment until disease progression, unacceptable toxicity or patient’s refusal to continue.

Each dose level is stepped up following validation by a Data Safety Monitoring Board.

The primary objective is to determine dose-limiting toxicities and maximum tolerated dose of IV infusion of AsiDNA. Secondary objectives are to assess the safety profile, PK parameters and target engagement of AsiDNA based on the quantification of activity biomarkers in tumor tissue (YH2AX, pHSP90). In addition, proliferation tumor status as measured by KI67 immunostaining, and preliminary efficacy of AsiDNA, are also being evaluated.

On November 5, 2018 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and reported financial results for the third quarter ending September 30, 2018 (Press release, PTC Therapeutics, NOV 5, 2018, View Source [SID1234530863]).

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"We have been aggressively pursuing our vision to build a leading, fully integrated, multiplatform biotech company," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "The addition of gene therapy aligns with our goal of developing treatments for more patients with rare disorders and the in-licensing of Tegsedi and Waylivra leverages our commercial expertise. Over the last 20 years, our desire to bring new therapeutics to patients has been based on scientific innovation and we are continuing that mission."

Third Quarter Financial Highlights:
•
Total revenues for the third quarter of 2018 were $53.6 million, compared to $41.9 million in the same period in 2017. The change in total revenue was primarily a result of revenue from Emflaza, which launched in May 2017.
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Translarna net product revenues were $30.4 million for the third quarter of 2018, compared to $32.0 million reported in the third quarter of 2017.
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Emflaza net product revenues were $22.6 million for the third quarter of 2018, compared to $9.8 million reported in the third quarter of 2017.
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GAAP R&D expenses were $54.4 million for the third quarter of 2018, compared to $30.0 million for the same period in 2017. Non-GAAP R&D expenses were $49.9 million for the third quarter of 2018, excluding $4.4 million in non-cash, stock-based compensation expense, compared to $26.4 million for the same period in 2017, excluding $3.6 million in non-cash, stock-based compensation expense. The increase in GAAP and non-GAAP R&D expense was primarily due to increased investment in research programs and advancement of the clinical pipeline, as well as the Akcea Therapeutics, Inc. ("Akcea") upfront licensing fee of $12 million paid during the third quarter of 2018.
•
GAAP SG&A expenses were $38.4 million for the third quarter of 2018, compared to $31.4 million for the same period in 2017. Non-GAAP SG&A expenses were $33.9 million for the third quarter of 2018, excluding $4.5 million in non-cash, stock-based

compensation expense, compared to $27.9 million for the same period in 2017, excluding $3.5 million in non-cash, stock-based compensation expense. The increase in GAAP and non-GAAP SG&A expense was primarily due to continued investment in commercial activities for Emflaza and Translarna, as well as $1.5 million in expenses related to PTC’s acquisition of Agilis Biotherapeutics, Inc.
•
Net loss for the third quarter of 2018 was $51.0 million, compared to a net loss of $33.7 million for the same period in 2017.
•
Cash, cash equivalents, and marketable securities totaled approximately $249.4 million at September 30, 2018, compared to approximately $191.2 million at December 31, 2017.
•
Shares issued and outstanding as of September 30, 2018 were 50.4 million.

2018 Guidance:
•
PTC now anticipates full year 2018 net product revenues to be between $260 and $280 million, a decrease in the high-end range of its prior guidance of between $260 and $295 million. PTC reiterates Translarna net product revenue for the full year 2018 to be between $170 and $185 million. PTC projects a 5-year (December 31, 2022) compound annual growth rate of 15% for net product revenues, representing continued strong growth year-over-year by increasing penetration in current countries and pursuing opportunities for label expansion. PTC now anticipates full year 2018 Emflaza net product revenue to be between $90 and $95 million, a decrease in the high-end range of its prior guidance of between $90 and $110 million.
•
GAAP R&D and SG&A expense for the full year 2018 are now anticipated to be between $315 and $325 million, an increase from PTC’s prior guidance of between $280 and $290 million. The increase in anticipated full year 2018 GAAP R&D and SG&A expense is primarily due to increased spend related to the Agilis acquisition and the Akcea upfront licensing fee of $12 million paid during the third quarter.
•
Non-GAAP R&D and SG&A expense for the full year 2018 is now anticipated to be between $280 and $290 million, excluding estimated non-cash, stock-based compensation expense of approximately $35 million, an increase from PTC’s prior guidance of between $250 and $260 million, excluding estimated non-cash, stock-based compensation expense of approximately $30 million.

Key Third Quarter and Other Corporate Highlights:
•
Completed acquisition of Agilis Biotherapeutics adding a Central Nervous System (CNS) gene therapy platform. Acquisition included three programs in rare CNS disorders including Aromatic L-Amino Acid Decarboxylase (AADC), Friedreich Ataxia and Angelman Syndrome. PTC plans to file a biologics license application (BLA) in AADC in 2019. Pre-commercial efforts, such as patient identification efforts are ongoing. PTC estimates that there are 5,000 AADC deficiency patients worldwide with 1,200 patients in the United States. In addition, PTC plans to file an investigational new drug application (IND) in Friedreich Ataxia in 2019.

•
PTC in-licensed Latin America commercial rights to Tegsedi and Waylivra leverages strong commercial expertise. Tegsedi has been approved in the United States, European Union, and Canada for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). The polyneuropathic form of hATTR, occurs more frequently in individuals of Portuguese ancestry, where PTC estimates approximately 6,000 patients in Latin America are affected. PTC has started patient identification efforts and plan to submit an application for Tegsedi with ANVISA, the Brazilian regulatory authority in the first half of 2019.
•
Initial STRIDE registry data demonstrates that Translarna delays loss of ambulation. Preliminary data from the first international drug registry for Duchenne patients receiving Translarna demonstrated participants continuing to walk years longer and are remaining more physically able than untreated children. The data confirms Translarna’s long-term clinical benefit in delaying irreversible muscle loss in patients and was presented to experts at the 23rd International Annual Congress of the World Muscle Society.
•
Pursing label expansion with European Medicines Agency (EMA) for Translarna for non-ambulatory patients. In the third quarter, PTC filed for an extension of its existing label for Translarna to include non-ambulatory patients. The EMA has validated the application and the regulatory process is ongoing.
•
Continued advancement of the spinal muscular atrophy (SMA) program. Data demonstrating the clinical benefits of risdiplam in all types of SMA were presented at the 23rd International Annual Congress of the World Muscle Society. Babies from FIREFISH Part 1 study showed increased functional developmental milestones including sitting. The pivotal portion of FIREFISH is enrolling. Clinical data was presented for the first time for the Type 2 & 3 patients from the open label portion of SUNFISH demonstrating a median 3-point increase in motor function score which was supported by the increase of SMN protein measured in the blood. The pivotal portion of SUNFISH Part 2 study in Type 2 & 3 patients has completed enrollment.
•
Development in oncology program with two clinical advancements. PTC initiated a Phase 1 study evaluating the safety of PTC596 in patients with diffuse intrinsic pontine glioma (DIPG). Additionally, the PTC299 study is now actively enrolling patients in acute myeloid leukemia (AML).

Non-GAAP Financial Measures:
In this press release, the financial results and financial guidance of PTC are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, the non-GAAP financial measures exclude stock-based compensation expense. This non-GAAP financial measure is provided as a complement to financial measures reported in GAAP because management uses this non-GAAP financial measure when assessing and identifying operational trends. In management’s opinion, this non-GAAP financial measure is useful to investors and other users of PTC’s financial statements by providing greater transparency into the historical and projected operating performance of PTC and the company’s future outlook. Quantitative reconciliations of non-GAAP

financial measures to their closest equivalent GAAP financial measures are included in the tables below.

Today’s Conference Call and Webcast Reminder:
Today’s conference call will take place at 4:30 pm ET and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 2477754. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. The accompanying slide presentation will be posted on the investor relations section of the PTC website. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for two weeks.

On November 5, 2018 UCLB spinout Orchard Therapeutics, a biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through autologous ex vivo gene therapies, reported the closing of its initial public offering of 16,103,572 American Depositary Shares ("ADSs"), each representing an ordinary share at an initial public offering price of $14.00 per share (Press release, UCLB, NOV 5, 2018, View Source [SID1234530722]). The gross proceeds from the offering were $225.5 million before deducting underwriting commissions and estimated offering expenses.

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Orchard Therapeutics was founded in 2015, based on research arising from the groups of Prof. Bobby Gaspar and Prof. Adrian Thrasher, at the UCL Institute of Child Health.

On November 5, 2018 Aurigene reported (Press release, Aurigene Discovery, NOV 5, 2018, View Source [SID1234530740]):

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SITC – Nov 7-11, Washington D.C.:

(a) CA-170 – Small molecule oral antagonist of PD-L1/VISTA in Ph-2 (India)
(b) Small molecule oral antagonist of CD47
(c) Small molecule oral antagonist of TIGIT/PD-L1

EORTC-NCI-AACR – Nov 13-16, Dublin:

a. Covalent, highly selective CDK12 inhibitors
b. Degrader of SMARCA2/4
c. Dual antagonists of TIGIT and PD-1 pathways
d. Dual inhibitors of CD73 and A2AR

Details: SITC (Free SITC Whitepaper), Nov 7-11 Washington D.C.

CA-170 Small Molecule Oral Antagonist Targeting PD-L1/VISTA
Title: Phase 2 trial of CA-170, a novel oral small molecule dual inhibitor of immune checkpoints VISTA and PD-1, in patients with advanced solid tumor and Hodgkin lymphoma
Abstract Number: P714
Session Details: Late Breaking
Date & Location: Friday, Nov. 9 from 8 a.m. to 8 p.m. and Saturday, Nov. 10 from 8 a.m. to 8:30 p.m. Hall. E

Small Molecule Oral Antagonist Targeting CD47
Title: Efficacy and safety profile of AU7R-104, a small molecule targeting CD47/SIRPα pathway
Abstract Number: P529
Session Details: Innate Anti-Tumor Immunity (NK cells, monocytes, macrophages, etc.)
Date & Location: Friday, Nov. 9, from 12:45 – 2:15 p.m. and 6:30 – 8 p.m. Hall E

Small Molecule Oral Antagonist Targeting TIGIT/PD-L1 Pathways
Title: An orally bioavailable small molecule dual antagonist of TIGIT and PD-L1 pathways shows immune-mediated anti-tumor activity
Abstract Number: P694
Session Details: T-cell Checkpoints and Checkpoint Inhibitors
Date & location: Saturday, Nov. 10 from 12:20 – 1:50 p.m. and 7:00 – 8:30 p.m. Hall E

More details: View Source

Details of Poster Presentations at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper), Nov 13-16, Dublin

Covalent Selective CDK12 Inhibitors
Title: Potent anti-tumor activity correlated with inhibition of DNA damage response genes with highly selective and orally bioavailable CDK12 covalent inhibitors
Poster Session: "Drug Design" on 15 November 2018
Poster Time: Thursday 15 November: 10.00-17.30
Poster Abstract Number: 280
Poster Board Number: PB041

SMARCA2/4 Degraders
Title: In vivo anti-tumor efficacy with a dual degrader of SMARCA2 and SMARCA4
Poster Session: "Molecular Targeted Agents – PART II" on 16 November 2018
Poster Time: Friday 16 November: 10.00-14.00
Poster Abstract Number: 411
Poster Board Number: PB074

Small Molecule Oral Antagonists Targeting TIGIT/PD-L1 Pathways
Title: Oral immune checkpoint antagonists dually targeting TIGIT and PD-1 pathways for cancer therapy
Poster Session: "Immune Checkpoints" on 14 November 2018
Poster Time: Wednesday 14 November: 10:00-17:30
Poster Abstract Number: 230
Poster Board Number: PB081

Dual Inhibitors of CD73 and A2AR
Title: First-in-class dual inhibitors of CD73 and A2AR for effective suppression of the adenosine signaling pathway to improve anti-tumor immunity
Poster Session: "Late Breaking Poster Presentation" on 13-16 November 2018
Poster Time: Tuesday 13 November: 12.00-18.30; Wednesday 14 November: 10.00-17.30;
Thursday 15 November: 10.00-17.30; Friday 16 November: 10.00-14.00
Poster Abstract Number: LBA17
Poster Board Number: PB220

More details: View Source