On August 19, 2021 NuCana plc (NASDAQ: NCNA) reported its financial results for the second quarter ended June 30, 2021 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, AUG 19, 2021, View Source [SID1234586776]).

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As of June 30, 2021, NuCana had cash and cash equivalents of £73.4 million compared to £78.6 million at March 31, 2021 and £87.4 million as of December 31, 2020. NuCana continues to advance its various clinical programs and reported a net loss of £9.1 million for the quarter ended June 30, 2021, as compared to a net loss of £6.1 million for the quarter ended June 30, 2020. Basic and diluted loss per share was £0.17 for the quarter ended June 30, 2021, as compared to £0.19 per share for quarter ended June 30, 2020.

"It has been a productive first half of 2021 with our release of important non-clinical and clinical data announcements. These include data from the NuTide:302 Phase Ib study of NUC-3373 in patients with advanced colorectal cancer as well as from the NuTide:701 Phase I study of NUC-7738 in patients with advanced solid tumors," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "These data presentations, made at several medical conferences, continue to support the favorable clinical profile we have observed to date and the broad potential of our ProTide technology."

Mr. Griffith continued: "As we look ahead to the second half of the year, we anticipate presenting additional clinical data from NUC-3373 and NUC-7738. Despite the COVID-19 pandemic, we remain on track to recruit sufficient patients in 2021 in the ongoing NuTide:121 Phase III clinical study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer to enable the first interim analysis in 2022. We are hopeful that this could enable us to submit an NDA in the United States under the FDA’s accelerated approval program. We are also on track with other key milestones, including the initiation this year of a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer."

Mr. Griffith also noted that NuCana has established preliminary objectives for the first half of 2022: "We are looking forward to 2022, which will be an important and active year for NuCana. With Acelarin, we anticipate announcing whether the NuTide:121 study has achieved the overall response rate objective at the first interim analysis in the first half of 2022. Additionally, based on the encouraging data seen to date with NUC-3373 and 5-FU’s broad usage in oncology, we anticipate initiating in 2022 a Phase Ib basket study of NUC-3373 in combination with other agents in a variety of solid tumors to identify further indications to target. We also expect to announce in 2022 data from the Phase II study of NUC-7738, which is anticipated to start later in 2021."

Mr. Griffith concluded: "Lastly, it is my pleasure to welcome Dr. Jeffrey Bloss to NuCana as our new Chief Medical Officer. Jeff brings more than two decades of relevant oncology experience leading clinical development and medical affairs at a number of companies. Over his career, he has been a key member of the teams responsible for the development, approval and commercialization of over ten successful oncology drugs including Gemzar, Tarceva, Sorafenib, Tykerb and Xtandi. His experience and contributions will be invaluable to NuCana as we continue to advance our pipeline of novel ProTides through the clinic and towards commercialization."

Anticipated Milestones: H2 2021 & H1 2022

•Acelarin (a ProTide transformation of gemcitabine)

ºIn 2021, NuCana expects to reach enrollment of at least 418 evaluable patients to enable the first interim analysis in 2022 of the Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer; and
ºIn the first half of 2022, NuCana expects to announce whether the overall response rate objective for the first interim data from this Phase III study has been met, which may enable an NDA submission in the United States under the FDA’s accelerated approval program.

•NUC-3373 (a ProTide transformation of 5-FU)

In 2021, NuCana expects to:

ºReport data from the Phase Ib study (NuTide:302) of NUC-3373 in combination with other agents with which 5-FU is typically combined, such as leucovorin, oxaliplatin and irinotecan in patients with advanced colorectal cancer;
ºInitate and report data from the Phase Ib expansion / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer;
ºInitiate a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer; and
ºReport data from the Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors.
In the first half of 2022, NuCana expects to:
ºInitiate a Phase Ib basket study of NUC-3373 in combination with other agents in a variety of solid tumors; and
ºExpand the Phase Ib / Phase II study to include second-line colorectal cancer patients, as well as evaluate NUC-3373 in combination with monoclonal antibodies such as bevacizumab (Avastin).

•NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2021, NuCana expects to:

ºReport data from the Phase I study (NuTide:701) of NUC-7738 in patients with advanced solid tumors; and
ºInitiate a Phase II study of NUC-7738 in patients with solid tumors.

In the first half of 2022, NuCana expects to:

ºAnnounce data from the Phase II study of NUC-7738 in patients with solid tumors.

On August 19, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported the second quarter 2021 (Press release, Oncopeptides, AUG 19, 2021, View Source [SID1234586773]).

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Financial overview April-June

Net sales amounted to SEK 66.4 M (0.0)
Operating loss amounted to SEK 344.8 M (loss: 399.3)
Loss for the period was SEK 24.1 M (loss: 401.0)
Loss per share, before and after dilution, was SEK 0.32 (loss: 6.79)
Cash and cash equivalents amounted to SEK 999.4 M (937.8) on June 30
Financial overview January-June

Net sales amounted to SEK 85.7 M (0.0)
Operating loss amounted to SEK 692.2 M (loss: 696.2)
Loss for the period was SEK 258.8 M (loss: 698.4)
Loss per share, before and after dilution, was SEK 3.63 (loss: 12.20)
Cash and cash equivalents amounted to SEK 999.4 M (937.8) on June 30
Significant events April-June

An application for conditional marketing authorization of melflufen in the EU was submitted in April
Topline results from the phase 3 OCEAN study were announced in May
Patient enrollment in the phase 2 PORT study was completed in May
A German affiliate was established in May
Clinical abstracts on melflufen was presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June
New clinical and preclincal melflufen data was presented at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in June
Significant events after the reporting period

Updated results from the phase 3 OCEAN study were announced on July 8: melflufen met the primary endpoint of superior PFS
Overall survival data, also released on July 8, led to the FDA requesting a partial clinical hold of all clinical studies with melflufen, pending further investigation
FDA issued a safety alert to patients and health care professionals on July 28, regarding an increased risk of death associated with Pepaxto in the OCEAN study.

Conference call for investors, analysts and the media

Investors, financial analysts and media are invited to participate in a webcast with a Q&A session at 12:00 CEST. The event will be hosted by CEO, Marty J Duvall, CMO, Klaas Bakker and CFO, Anders Martin-Löf.

The webcast will be streamed via this link which can also be found on the website: www.oncopeptides.com.

This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on August 19, 2021.

On August 19, 2021 Medivir AB reported that Interim Report January – June 2021 (Press release, Medivir, AUG 19, 2021, View Source;interim-report-january–june-2021-301358672.html [SID1234586772])

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April – June
Financial summary for the quarter

Net turnover amounted to SEK 0.9 (4.0) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -17.1 (-12.4) million. Basic and diluted earnings per share amounted to SEK -0.35 (-0.52) and SEK -0.35 (-0.52) respectively.
Cash flow from operating activities amounted to SEK -21.9 (-23.3) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 247.8 (94.9) million.
Significant events during the quarter

On April 16, it was announced that Magnus Christensen had been appointed interim CEO of Medivir. He took up his new role in connection with Medivir’s AGM on May 5, 2021.
On April 19, it was announced that the overall results from the first part of the phase Ib study with MIV-818 were positive with a good safety and tolerability profile. Thus, the starting dose for the second part of the phase Ib study could be determined.
In May, positive results from an investigator-initiated phase II clinical study of remetinostat in patients with squamous cell carcinoma (SCC) were released on clinicaltrials.gov.
In May, the design for the upcoming phase 1b/2a combination study with the company’s leading candidate drug, MIV-818 against liver cancer, was presented. In the study, MIV-818 will be administered in two combinations, with either lenvatinib, a tyrosine kinase inhibitor, or pembrolizumab, an anti-PD-1 checkpoint inhibitor.
January – June
Financial summary for the period

Net turnover amounted to SEK 10.8 (11.4) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -24.3 (-33.1) million. Basic and diluted earnings per share amounted to SEK -0.57 (-1.49) and SEK -0.57 (-1.49) respectively.
Cash flow from operating activities amounted to SEK -23.3 (-40.0) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 247.8 (94.9) million.
Significant events after the end of the period

In July, Malene Jensen was appointed Vice President Clinical Development. She will assume her role on September 6, 2021.
In August, it was announced that data from the MIV-818 phase 1b study will be presented at the ESMO (Free ESMO Whitepaper) Congress in September.
In August, the positive results from the phase II study with remetinostat against basal cell carcinoma were published in the scientific journal Clinical Cancer Research.
In August, it was announced that Medivir, through a renegotiated multi-party agreement, strengthens the business development potential for remetinostat.
Conference call for investors, analysts and the media
The Interim Report January – June 2021 will be presented by Medivir’s interim CEO, Magnus Christensen.

The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir’s website after completion of the conference.

CEO’s message
The clinical development of MIV-818 remains in focus. Positive topline results in the phase 1b monotherapy study. The design determined for the phase 1b/2a combination study in the clinical MIV-818 program.

Medivir’s central task is to advance the clinical program for our leading candidate drug MIV-818, which has the potential to be a liver-directed, orally administered drug that can help patients with various cancers of the liver. This work has also characterized our operations also in the past quarter.

In April we were able to announce that the results from the first part of the phase 1b study with MIV-818 were positive with a good safety and tolerability profile. Thereby, we were also able to determine the starting dose for the second part of the study, where we combine MIV-818 with standard treatment. Data from the first part of the phase 1b study will be presented at the ESMO (Free ESMO Whitepaper) scientific conference in September.

Due to its unique mechanism of action, MIV-818 is attractive to combine with a multitude of other drugs for the treatment of hepatocellular carcinoma (HCC). We have been working on refining the design for the next step in the clinical program, the upcoming phase 1b/2a combination study with MIV-818, and at the end of May we presented how the study is structured. MIV-818 will be administered in two combinations, either with lenvatinib, a tyrosine kinase inhibitor, or with pembrolizumab, an anti-PD-1 checkpoint inhibitor.

The study is an open-label, multi-center phase 1b/2a study that begins with a dose escalation part to determine the recommended phase 2 dose (RP2D). This is followed by the expansion study (phase 2a) with an initial evaluation of the safety and efficacy of the combinations of MIV-818 with lenvatinib or pembrolizumab. The study will include patients with HCC who have progressed on, or are intolerant of, first line standard therapy.

We plan to recruit the first patient for the combination study in the second half of 2021. However, we cannot guarantee that the Covid-19 pandemic will not affect our schedule.

MIV-818 is proprietary and wholly owned by Medivir, i.e. we do not have to pay any future milestones or royalties to any third party.

We have two more drug development projects in the clinical development phase, remetinostat, and MIV-711. Medivir does not conduct clinical development of these projects on its own, but instead seeks partners for further development.

During the quarter, positive results were published from an investigator-initiated clinical phase II study of remetinostat in patients with squamous cell carcinoma (SCC). The study was conducted at the Stanford University School of Medicine in California, USA. The primary objective of the study was to assess the effects of topical remetinostat on biopsy-proven SCC and SCC in situ tumors. In August, the positive results from the phase II study with remetinostat in patients with BCC were also published in the scientific journal Clinical Cancer Research.

The results are very promising and provide further support for the potential of remetinostat as a treatment for a number of skin-associated cancers in addition to cutaneous T-cell lymphoma (CTCL). Medivir renegotiated in August a multi-party agreement with the originators of remetinostat and TetraLogic Pharmaceuticals Corporation and The Leukemia & Lymphoma Society regarding the financial obligations for remetinostat in order to create better conditions for business development.

Medivir’s birinapant project, for the treatment of solid tumors, was outlicensed to the American company IGM Biosciences at the beginning of the year. IGM has the global and exclusive rights to develop birinapant. According to IGM’s Q2 report, they plan to initiate clinical trials with birinapant in combination with their proprietary antibody IGM-8444 during 2021.

At Medivir’s AGM on May 5, former CEO Yilmaz Mahshid was elected new board member and Uli Hacksell was elected chairman of the board. This guarantee continued scientific vitality and business acumen in the Board’s work.

In July, Malene Jensen was recruited as Vice President Clinical Development and a member of the company’s management team. With extensive experience in clinical development, Malene will focus on the clinical studies with MIV-818.

I am really impressed by the determination and dedication shared by all Medivir employees. The goal is to develop an effective drug against liver cancer through MIV-818. Given that this work continues to show good results, it could make a big difference for patients and for healthcare and thus also for the company’s shareholders.

On August 19, 2021 NeoDynamics reported that Interim report Jan-June 2021 (Press release, NeoDynamics, AUG 19, 2021, View Source [SID1234586771])

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Second Quarter 2021

Revenue amounted to SEK 411 (6,263) thousand, of which SEK 383 (5,787) thousand were capitalized costs.
Loss after tax amounted to SEK-18,263 (-5,516) thousand.
Loss per share SEK -0.30 (-0.18).
Cash and cash equivalents amounted to SEK 48,339 (7,177) thousand.
First half of 2021

Revenues amounted to SEK 816 (12,531) thousand, of which SEK 762 (12,090) thousand capitalized costs.
Cash flow from operating activities amounted to SEK -23,999 (-13,107) thousand.
Profit after tax amounted to SEK -35,519 (-12,751) thousand.
Earnings per share amounted to SEK -0.59 (-0.53).
The equity ratio was 95 (94) percent.
Significant events during the quarter

NeoDynamics presented a scientific abstract at the annual surgery conference ABS, Association of Breast Surgeons, in Birmingham, which describes how the company’s FlexiPulse needle surpasses standard biopsy in preclinical models by almost 300 percent in terms of volume.
The Annual General Meeting re-elected the Board members Carina Bolin, Claes Pettersson, Ingrid Salén, Jie Bao and Xiao-Jun Xu, and appointed Matthey E. Colpoys Jr. as a new Board member.
At mid-year, about 30 clinics with radiology teams in Sweden, the United Kingdom, Germany and other German-speaking countries in Europe had had workshops with the biopsy system NeoNavia.
Significant events after period-end

Hermann-Josef-Hospital in Erkelenz, a university hospital within the University of Aachen, became the first German hospital to order NeoNavia.
CEO comment

Clinics build experience

We continue to introduce the biopsy system NeoNavia in clinics in our markets in Europe. The pandemic has made traditional and effective launch methods impossible, which means introducing the product to doctors at congresses and trade fairs, in parallel with building experience through workshops and thereby reaching out more quickly. Instead, NeoDynamics has been forced to rely on individual hospital meetings with workshops where doctors are given the opportunity to test the product and train in how it is used.

The challenge with this procedure during the spring has been to get permission to be at the clinic. On a few occasions, smaller workshops have been held outside the hospitals. Once these workshops are completed, a majority of clinics want to use the product in regular operation for 2-3 months to see how it fits in and let the whole team of the hospital’s radiologists, or as in Germany gynecologists, get used to handling NeoNavia in clinical everyday life. In dialogue with the clinic, the hospital’s purchasing department is involved in designing a quote and qualifying NeoDynamics as a supplier. Only then can NeoDynamics expect an order for the product. The process takes time and varies between clinics. By mid-year, the team had conducted about 30 workshops.

First in Germany to place an order was the reputable breast center at Hermann-Josef-Hospital in Erkelenz, Germany, which belongs to the University Hospital of Aachen, which participated in the PULSE study and which also serves as a reference center. We expect to recruit more reference centers in different countries to pave the way for the majority of the clinics that have tried the product to also adopt the technology and submit orders during the latter part of 2021.

The team continues to arrange workshops with specialists and in the autumn, several conferences once again welcome participants to participate physically. The first conference we plan to attend on site is the Schweizerische Gesellschaft fur Senology, which will be held in Basel on September 8-9 to be followed by two further congresses in September and October for the German-speaking part of the country. A very positive sign which means that we in Europe are gradually beginning to return to a more normal market situation.

Publications create interest

Another important way to present NeoNavia to physicians is to present peer reviewed abstracts from our clinical program through various types of scientific conferences. Getting an abstract selected for presentation is a measure of the scientific level we hold in our study program – and of course a way to make NeoNavia known.

During the second quarter, NeoNavia was exposed in this way at the prestigious annual British Breast Surgery Congress, ABS. NeoDynamics continues the work of documenting the product through its clinical program and more scientific abstracts are expected this year. The work of course facilitates the dialogue with doctors, at the same time as it is also a part of creating interest in NeoNavia among potential partners.

United States the next major milestone

In the United States, work continues on compiling the registration application to be able to submit it to the US Food and Drug Administration FDA in the fall. We have a dialogue with the authority, which also communicates that their response times are longer than normal as a result of a large part of the authority’s resources being redirected to matters related to Covid-19. With a well-prepared application, however, the need for interaction with the authority after the file has been submitted decreases. The team’s ambition is to achieve an application of high quality through underhand dialogue with the FDA. A registration of the product in the USA is an important milestone for both NeoDynamics and NeoNavia as it is an important stamp of quality that also opens up a significant new market. It is also expected to lead to a significantly more concrete interest from potential partners.

During the quarter, NeoDynamics strengthened its expertise in the important US market through the election of Matt Colpoys to the Board. Matt adds valuable knowledge about both the market and potential partners. The pieces are thus beginning to come into place for NeoDynamics to be able to add the USA as a market.

On August 19, 2021 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that a bispecific antibody of AstraZeneca derived from COM902, Compugen’s high affinity anti-TIGIT antibody, will advance into clinical development (Press release, Compugen, AUG 19, 2021, View Source [SID1234586770]). AstraZeneca (LSE/STO/Nasdaq: AZN) plans to initiate a Phase 1/2 study evaluating AZD2936, a TIGIT/PD-1 bispecific antibody, in patients with advanced or metastatic non-small cell lung cancer.

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COM902 was licensed to AstraZeneca in 2018 exclusively for the development of bispecific and multi-specific antibody products, with AstraZeneca responsible for all research, development, and commercial activities. Compugen retains all other rights to the program with exception to those licensed to AstraZeneca.

"The advancement into the clinic of this bispecific derived from COM902 provides additional support for COM902’s therapeutic potential by a global leader in the development of antibody-based oncology therapeutics," said Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen. "We believe COM902’s properties, including its high affinity and superior binding compared to other anti-TIGITs tested in a preclinical setting, were key attributes that contributed to the decision to obtain rights for the development of bispecific products and further advancement of AZD2936 to the clinic. The exclusive license agreement with AstraZeneca allows us to broaden our product opportunities and specifically capitalize on bispecific products while maintaining ownership of COM902 for the development of various combination therapies in general, and DNAM-axis related specifically, including in combination with COM701 our first in class anti-PVRIG antibody. We are excited to disclose the identity of our program licensed to AstraZeneca and we look forward to reporting future milestone payments as they occur"

About the Compugen-AstraZeneca License Agreement

In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca for the development of bispecific and multi-specific antibody products derived from Compugen’s monospecific antibodies that bind to TIGIT, including COM902, with AstraZeneca responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. Compugen has received a $10 million upfront payment and an additional $2 million milestone payment to date, out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional products are developed, additional milestones and royalties would be due to Compugen. Under the terms of the license agreement, Compugen retained all other rights to its entire pipeline of programs as monotherapies and in combination with other products.

About the Study

Details are available on ClinicalTrials.gov, identifier: NCT04995523

About COM902

COM902 is a high affinity, fully human antibody that blocks the interaction of TIGIT with PVR, its ligand, and consequently enhances T cell function. Data suggests that COM902 has in vitro activity comparable or superior to TIGIT antibodies in clinical development. It is currently being evaluated by the Company in a Phase 1 clinical studies in patients with advanced malignancies who have exhausted all available standard therapies. Compugen has demonstrated in preclinical studies that simultaneous inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM axis, can increase antitumor immune responses, which may be further enhanced with the addition of PD-1 blockade. These data suggest that treatment with COM701 and COM902, targeting PVRIG and TIGIT, respectively, alone or in combination with a PD-1 inhibitor, has the potential to expand immuno-oncology treatment to patient populations who are non-responsive or refractory to existing immunotherapies. The discovery of TIGIT, using the Company’s computational discovery platform, was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).