On September 16, 2021 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, reported that encouraging initial clinical data on samuraciclib (CT-7001), an oral and first-in-class inhibitor of CDK7, at the 2021 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Press release, Carrick Therapeutics, SEP 16, 2021, View Source [SID1234587940]).

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Data presented from a Phase 2a study of samuraciclib in combination with fulvestrant in women with hormone receptor positive (HR+), HER2- advanced breast cancer (BC) previously treated with a CDK4/6 inhibitor (abstract: 1346 (265P)) demonstrated clinical activity and tolerability that supports further clinical development of the combination.

"Today, for the first time, we presented data from a clinical trial of our oral CDK7 inhibitor, samuraciclib. Results of the Phase 2a study in combination with fulvestrant demonstrated clinical activity and tolerability in patients with HR+, HER2- advanced breast cancer, reinforcing our conviction that samuraciclib has potential to be a first and best-in-class treatment," said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. "As a reminder, the FDA recently granted Fast Track designation to samuraciclib in combination with fulvestrant for CDK4/6 inhibitor resistant patients. This patient population is particularly difficult to treat, with a recent trial showing only 8 weeks mPFS benefit when women are treated with fulvestrant alone. Based on this initial data, we believe samuraciclib has the potential to provide a clinically meaningful benefit for all patients, most notably in those women that are TP53 wildtype. In addition to fulvestrant, we are exploring additional samuraciclib combinations, including with giredestrant, a next-generation oral SERD, through our recently announced clinical collaboration with Roche in metastatic breast cancer. We thank the women that participated in this Phase 2a trial and look forward to continuing the fight against this and other types of cancer."

As part of the Phase 2a study of samuraciclib in combination with fulvestrant in patients with advanced HR+, HER2- BC, 31 patients were enrolled with difficult-to-treat disease. 81% of these patients had visceral disease, including 45% with liver metastasis. All patients enrolled previously progressed following treatment with a CDK4/6 inhibitor. Of the 31 patients enrolled in the study, 24 patients were evaluable for response at the time of data cut-off:

17 (71%) had tumour shrinkage, with a best RECIST response of partial response (PR) in two (8%) patients and stable disease (SD) in 13 (54%) patients.
Median progression-free survival (mPFS) of the intent-to-treat (ITT) population was 16.1 weeks (n=31).
Notably, patients with no mutation in the TP53 gene had a mPFS of 32.0 weeks (n=18).
Prolonged disease control was also apparent in patients with no liver metastases at baseline (n=17), with mPFS having not yet been reached. At the point of this data cut-off, mPFS would be at least 28 weeks.
Adverse events were predominantly low-grade gastrointestinal (GI) events that were reversible and manageable using standard prophylactic treatment. No significant neutropenia or myelosuppression associated with other CDK inhibitors were observed.
This data supports the further development of samuraciclib in HR+ advanced BC.
"The data from this study show excellent preliminary evidence of activity of samuraciclib in combination with fulvestrant," said Dr. Sacha Howell, The Christie NHS Foundation Trust, Manchester, UK and a primary investigator in the Phase 2a study. "This population of patients, previously treated with CDK4/6 inhibitors, are known to have previously demonstrated short PFS benefit from fulvestrant alone. The efficacy data, particularly in participants with wildtype TP53, exceeded my expectations and offers the potential for durable endocrine disease control, further delaying the need for chemotherapy. Those participants remained on therapy for prolonged durations demonstrates tolerability and the main GI toxicity was manageable with supportive medication."

"Following the positive initial Phase 2a data, we are preparing to advance the randomized Phase 2b study of HR+, HER2-, post-CDK4/6 inhibitor breast cancer patients," said Dr. Stuart McIntosh, Chief Medical Officer of Carrick Therapeutics. "A key distinction from the Phase 2a will be the inclusion of patients with RECIST non-measurable disease in addition to those with visceral disease in the Phase 2b, in-line with the real-world population. Given the success noticed in the sub-group of patients with no mutation in the TP53 gene population, we will prospectively evaluate and stratify by mutation status as well. This success aligns with the known biological function of TP53 since its activation has been shown to sensitize cancer cells to CDK7 inhibition. Approximately 75% of breast cancer patients are TP53 wild-type, and we believe this may be an important potential biomarker for future studies."

In addition to the Phase 2a data presented today, data from the first-in-human study of samuraciclib in patients with advanced solid malignancies (abstract: 943 (230MO)) will be shared during an oral presentation at ESMO (Free ESMO Whitepaper) from 17:10 BST (12:10pm ET) on September 18, 2021. As part of the study, 44 patients were treated with escalating doses of samuraciclib monotherapy, which demonstrated evidence of antitumor activity with a manageable safety profile.

About Samuraciclib (CT7001)
Samuraciclib is the most advanced oral CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. In addition to the above study, it is currently being evaluated in triple negative breast cancer (TNBC) and prostate cancer with further potential in pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designations from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer and in combination with chemotherapy for the treatment of locally advanced or metastatic TNBC.

On September 16, 2021 FairJourney Biologics S.A. , leader in the discovery and optimization of antibodies, reported , after the overwhelming success of the 2021 ANTIBODY SERIES conference, planning for a larger scale 2022 ANTIBODY SERIES are underway (Press release, FairJourney Biologics, SEP 16, 2021, View Source [SID1234587884]).

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This year’s conference attracted over 800 online participants and a select group of 150 in-person attendees. Nobel Prize Laureate Sir Gregory Winter opened the inaugural event with a keynote presentation and Q&A, followed by a diverse panel of pioneers and leaders in industry and academia. THE ANTIBODY SERIES provided a platform for the exchanging of innovative ideas, approaches and solutions in the field of antibody discovery and development, and additional opportunities for panel Q&A, discussion, and networking.

Ton Logtenberg, who presented at this year’s conference has been announced as Chairman of THE ANTIBODY SERIES 2022.

Ton Logtenberg, Founder of MERUS N.V. commented: "A wonderful event combining superb presentations, excellent networking opportunities and festivities. The success of the meeting inspired the decision to organize THE ANTIBODY SERIES again in 2022. As the Chairman of that event, I invite you to join us for updates on progress in the exciting antibody field while greeting old friends and making new ones."

On September 16, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that final results from the Bal/Zal combination study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Conference 2021 in an abstract titled Balstilimab (anti-PD-1) in combination with zalifrelimab (anti-CTLA-4): final results from a Phase 2 study in patients (pts) with recurrent/metastatic (R/M) cervical cancer (CC) (Press release, Agenus, SEP 16, 2021, View Source [SID1234587897]).

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The data are being presented by lead investigator Dr. David O’Malley, Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine and the Director of the Division of Gynecologic Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).

"With a median follow-up of almost 2 years, the Bal/Zal combination showed high response rates, durable clinical activity, and promising overall survival results", said Steven O’Day, MD, Chief Medical Officer of Agenus. "Furthermore, later this year we expect to present new data on our next-generation CTLA-4 inhibitor AGEN1181, which we expect to further define the positive role this combination strategy could have in addressing unmet needs for cancer patients."

The Phase 2 trial was conducted in 155 patients with recurrent/metastatic cervical cancer (R/M CC) which has limited effective treatment options and disproportionately affects younger women. In the 125 evaluable patients, the objective response rate (ORR) in all patients was 26%, with 9% of patients achieving a complete response, and 17% of patients achieving a partial response. The median duration of response (DoR) was not reached after a 19.4-month median follow-up. Notably, responses were also observed in the PD-L1 negative and adenocarcinoma populations, with 9% of both patient groups achieving an ORR. Based on these observations, we predict more than half of the patients to be alive beyond 12 months*.

The Bal/Zal combination continued to show no unexpected toxicities and no new safety signals were identified.

Detailed results from this trial will be presented in a Mini Oral Session on September 19th from 11:35 – 11:40am ET by David O’Malley, MD. In addition, in a Trials in Progress abstract, Agenus presented the RaPiDS trial design for balstilimab alone or in combination with zalifrelimab as second-line treatment for patients with previously treated R/M CC.

"This trial represents the largest study evaluating PD-1 + CTLA-4 inhibition in relapsed cervical cancer to date and shows that the combination could represent a meaningful new option for patients in this setting," said Dr. O’Malley. "Efficacy outcomes continued to improve over time, and the combination likewise continued to show a positive safety profile."

* Updated data to be presented during September 19th Mini Oral session.

On September 16, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present a corporate overview at the virtual Oppenheimer Fall Healthcare Life Sciences and MedTech Summit, which is being held from September 20 – 23, 2021 (Press release, aTyr Pharma, SEP 16, 2021, View Source [SID1234587896]).

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The presentation will take place on Wednesday, September 22, 2021, at 3:45 p.m. ET.

In addition to the presentation, management will be available to participate in virtual one-on-one meetings with investors who are registered attendees of the conference.

Following the event, a replay of the live presentations will be available on the Investor’s section of the company’s website at www.atyrpharma.com.

On September 16, 2021, Gritstone bio, Inc. (the "Company") reported that it entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain purchasers identified on the signature pages thereto (the "Purchasers"), pursuant to which the Company issued and sold to the Purchasers, in an unregistered offering, an aggregate of 5,000,000 shares of common stock, par value $0.0001 per share (the "Common Stock") at a per share purchase price of $11.00 per share, for aggregate gross proceeds to the Company of $55.0 million (the "Private Placement"). The closing of the Private Placement occurred on September 17, 2021 (the "Closing") (Filing, 8-K, Gritstone Oncology, SEP 16, 2021, View Source [SID1234587887]).

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Pursuant to the Purchase Agreement, the Company has agreed to file a resale registration statement with the Securities and Exchange Commission as soon as practicable, and in all events within 30 days after the Closing, to register the resale of the Securities issued at the time of the Closing.

Cowen & Company LLC acted as sole placement agent for the Private Placement.

The foregoing summaries of the Private Placement, the Shares to be issued in connection therewith, and the Purchase Agreement are qualified in their entirety by reference to the definitive transaction documents. A copy of the Purchase Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference.